Present Users With Something Compelling
Since the Delta variant of concern (VOC) has become dominant, the case rate of COVID-19 (covid) in San Diego has been going up sharply. That is because the Delta VOC (Delta) is more transmissible (it spreads more easily) and also because it is much better able to infect people with prior immunity from past infections or vaccination.
In addition, many cases cause by Delta have a symptom presentation that looks less like classic covid (dry cough, profound fatigue, loss of smell, body aches) and more like a common cold (runny stuffy nose, sore throat, fever, and headache). Because covid caused by Delta can look just like a cold, many people are not getting tested and the true case numbers are probably much higher than what is being officially reported.
With current case rates that would call for closures of many businesses under last year's tiered system, and a new VOC that spreads so quickly and bypasses prior immunity at such a high rate, we are now facing what is arguably the most dangerous time thus far in the pandemic. An average more than 1,300 cases per day were reported in San Diego County as of August 23, an increase of 400% from this time last month. Here are the top dozen things you need to know to help navigate safely through this time:
COVID-19 Vaccines
Vaccines, along with antibiotics and sanitary procedures (especially with regard to food handling), are arguably the most important public health advances to emerge from medical science. A mere 100 years ago, infectious diseases like measles, polio, and smallpox were a deadly fact of everyday life with waves of infections sweeping through communities every year or every few years leaving death and sometimes permanent disability in their wake. Today, despite a dramatic increase in the density of urban populations, thanks to vaccination, many once-common diseases are now rare in advanced societies like ours.
Mass vaccination in the US began in 1922 when the government first mandated that children be inoculated against smallpox in order to attend public school. The smallpox vaccine would go on to essentially eradicate this deadly, highly-contagious disease. But not everyone welcomed vaccination with open arms. The case of Rosalyn Zucht, a student from San Antonio, Texas, who was excluded from public school when her parents refused to comply with the vaccination order, is an example of the fear and resistance that some Americans had at that time to what was then a strange and novel public health measure.
Suspicious of the government's intentions and ignorant of the science behind vaccination, the Zucht's filed a suit against the local authorities claiming that forced vaccination violated their and their child's individual liberties. The case was ultimately heard by the U.S. Supreme Court which ruled that it was "within the police power of the state to provide for compulsory vaccination." Since that time, vaccines for many diseases have been developed and deployed under the stringent regulatory oversight of government health agencies like the FDA with miraculous success, all but vanquishing not only smallpox but measles, mumps, rubella, polio, tetanus, and a host of other potentially life-threatening illnesses. But despite saving millions of human lives, fear of and resistance to vaccinations has not been vanquished. In fact today, nearly half of Americans express some measure of hesitation about getting vaccinated against COVID-19 and the United States is now becoming the least vaccinated advanced society on earth. We are also the country with the highest case rate of COVID-19 in the world and that is not a coincidence. It is estimated that unless and until a little over 90% of the population has immunity, we will not be able to return safely to a normal lifestyle of work, socializing, and travel. Eventually we will get there through a combination of vaccination and infections. But with an estimated 15-30% of covid infections going on to cause chronic illness and disability including fatigue, headaches, body aches, and 'brain fog,' the cost on our society will likely be enormous if nearly half the population gets COVID-19.
Some of the fears expressed about the new vaccines are the result of misunderstandings about how they work (misinformation). Some of it has been caused by falsehoods intentionally engineered for the purpose of dividing people politically or eroding their trust in scientific and/or governmental authorities (disinformation). Some people have chosen not to be vaccinated based on intuitive calculations of personal risk in the context of a philosophy that places oneself and or one's family as the chief and exclusive cause worthy of sacrifice. And some people have been frightened by reports of adverse events or have questions about risks vs. rewards that have not been answered properly. The purpose of this information piece is to help our patients make better informed decisions about vaccination against COVID-19 by identifying and discussing current concerns surrounding novel vaccines for a novel disease.
Overview
With very few exceptions, vaccines are effective and safe. In the broadest sense, they provide the immune system with needed exercise while offering protection from a wide array of specific serious illnesses that extend beyond infectious diseases to now include certain types of cancer and possibly allergies, too. Vaccination has saved the lives of millions of adults and children over the years and it would be hard to find any intervention that has had as much positive impact on public health. Amidst the current pandemic, with few effective therapies widely available, vaccines are once again playing a leading role in the war against a deadly infectious disease. But in order for vaccination to be successful against SARS-CoV-2, the virus that causes the disease COVID-19, nearly everyone must either be vaccinated or have gotten infected.
What is a Vaccine?
A vaccine is something that prepares a person's immune system to fight a particular disease. It is rare that vaccination is sufficient to prevent a person from catching a disease but in the vast majority of cases, it helps people to fight it off more quickly and feel less sick if they do become infected. Vaccinated people who catch the infection can still pass the disease to others even if they don't feel sick. Therefore, vaccination is only successful in eradicating a disease from a population when the vast majority of people have been vaccinated and behavioral public health measures (like masking, distancing, and avoiding group gatherings) remain in place for long enough to bring the infection rate way down.
How Are Vaccines Made?
1. Conventional Approach:
Until now, most vaccines were made by taking viruses or bacteria (pathogens) grown in chicken eggs or tissue cells in a lab and either killing them (inactivated pathogens) or weakening them (attenuated pathogens). Conventional vaccination involves injecting a small number of these inactivated or attenuated pathogens into the body (usually the muscle of the upper arm) to provoke an immune response. The body's immune response includes making special immune cells called B-cells and T-cells that fight off the pathogen and then hang around afterward, sometimes for years, always on the lookout for reinfection with that same pathogen. B-cells also make proteins called antibodies that block the pathogen from gaining access to cells and some antibodies also stick around long after infection/vaccination.
Time has proved conventional vaccines to be safe and effective. But conventional approaches are a little less effective against rapidly evolving pathogens like influenza (the virus that causes flu) than they are against more slowly evolving pathogens like variola (the virus that causes smallpox). Conventional vaccines take a long time to build and by the time they are produced to scale and distributed to the public, a rapidly evolving pathogen may sometimes have already changed (mutated) enough to make vaccination less effective. In the case of flu, for example, we need a new vaccine every year to keep up with rapid mutations in the virus and even then, flu vaccines are often about 50% effective by the time they reach the market. That means that about half of people who get the flu shot will have robust protection against getting sick from the flu if they are exposed to the influenza virus. Those are pretty good odds and the yearly flu shot is an extremely safe and effective public health tool that saves tens of thousands of lives each year. However, by comparison, the vaccine against smallpox which is caused by a slowly evolving virus is 95% effective. That means that 95% of people who get the smallpox vaccine will have robust protection against getting sick if they are exposed to the variola virus.
Conventional vaccine approaches are also less efficient when medical experts are mounting a defense against a newly emerging pandemic threat like COVID-19. It can take several years to develop an effective vaccine against a novel pathogen using conventional approaches, during which time therapies may be only slightly effective and many people may die or become disabled. As of the writing of this paper (12/31/20) there have been more than 330,000 deaths attributed to this novel disease in the US and about 10-15% of the nearly 20 million confirmed cases have resulted in some degree of chronic disability. Over the past year, in the absence of a widely available and effective therapy or vaccine, governments around the world have been forced to impose psychologically and economically costly measures such as quarantining, masking, distancing, travel restrictions, closures of some businesses, and shelter at home orders to safeguard the lives of their citizens. If the conventional approach to building a vaccine against COVID-19 was all that medical science had available, we would likely be stuck in this situation for another year or more.
2. New Approaches:
Rather than identifying, isolating, growing, and then killing or weakening pathogens, RNA-based vaccines are made of genetic code manufactured in a lab that instructs cells to make proteins called antigens that are found usually on the surface of the pathogen in question. The code, called mRNA, is typically wrapped in a fat droplet called a liposome and then injected into the arm, just like a conventional vaccine. The liposome helps mRNA penetrate into muscle cells where the fat dissolves, releasing the code which in turn instructs the protein-making part of the cell to manufacture antigens that look identical to those found on the pathogen. After some antigens are made, mRNA self-deactivates and is cleared. The body then mounts an immune response against the newly minted antigen proteins just as if it had come in contact with the virus itself–including B-cells, T-cells, and antibodies.
RNA-based vaccines have shorter manufacturing times and seem to be more effective than conventional vaccines (or natural infection) at producing a strong immune response. They are also cheaper to make and less dangerous in some ways since they are safe for people with egg allergies and are not produced using infectious elements like inactivated or attenuated viruses. They can be standardized and scaled quickly and easily, allowing for much faster medical responses to epidemics and pandemics. mRNA vaccines were already being studied for use against other infectious diseases, certain types of cancer, and allergies before the COVID-19 pandemic. But they had not yet been brought to market. The two currently approved vaccines from Pfizer and Moderna are both mRNA vaccines. Early data from their clinical trials have shown both vaccines to provoke spectacularly robust immune responses (about 95% effectiveness rate) and, at least so far, they appear to be well-tolerated.
Are The COVID-19 Vaccines Safe?
All health interventions carry some risk and the new vaccines against COVID-19 are known to cause side effects in most people. For the vast majority, those side effects, in addition to pain in the injected shoulder/arm, are very similar to what we refer to as a viral syndrome, including headache, body aches, fatigue, and sometimes fever and chills, typically lasting 12 - 24 hours. Some people experience these side-effects for up to a few days. The vaccines do not contain live virus so these symptoms do not mean that you are infected or dangerous to others. This is also seen sometimes after other vaccinations but it is more common after the COVID-19 vaccines which are very effective at provoking a strong immune response.
A very small number of people have had more serious side effects following the covid vaccines, including allergic reactions which, to date have effected about 3 per one million people vaccinated in the US, all of whom have recovered quickly with epipen or administration of other routine medicines. In the US, as of September 9, 2021, more than 14.5 million people have been vaccinated with the Johnson & Johnson vaccine, mostly women under the age of 40, among whom 48 people subsequently developed rare blood clots and three died. There have been 3 similar cases of blood clots following 362 million doses of the Moderna vaccine, with no deaths. As of September 8, 2021, there have been 854 confirmed reports of myocarditis or pericarditis (swelling in or around the heart) among people ages 30 and younger who received either the Pfizer or Moderna vaccines, mostly in male adolescents and young adults out of more than 350 million doses given, with no reported deaths. There have been More than 380 million doses of all the COVID-19 vaccines administered in the US as of September 13, 2021. During this time, only the three deaths due to rare blood clots following the Johnson and Johnson vaccine have been linked to COVID-19 vaccines.
The Pfizer and Moderna vaccines have been built on a new platform (RNA-based), as described above, so there are no prior analogous vaccines to compare them to. The short-term and medium term (more than one year now) safety and efficacy of these vaccines have exceeded all reasonable expectations and there are good reasons, as stated above, to expect mRNA vaccines to be safer and better than conventional vaccines made from inactivated or attenuated pathogens. That said, there must remain uncertainty about the long-term effects of any new medicine, procedure, or vaccine until enough time has passed. Both Pfizer and Moderna have adhered to the extremely strict testing and safety and efficacy monitoring protocols required by the FDA for any new vaccine but neither has been around long enough to undergo the process of long-term monitoring of those who have been vaccinated. Despite this, the data collected thus far are so good that the FDA has now licensed the Pfizer vaccine and is expected to do the same with Moderna in the coming 1-2 months.
The Pfizer and Moderna vaccines have been brought to market to deal with a health emergency. Both Pfizer and Moderna began their phase 3 clinical trials in July so we now have more than a year of observational data on their efficacy and safety. So far, no serious late or delayed-onset adverse events have been recorded. This was expected since the vast majority of adverse events (AEs) following vaccination typically take place within 4-6 weeks–and often within 48 hours. But we do not yet have absolute proof that these vaccines will be equally as safe in the long-term as they seem to be in the short and medium-terms. Only time and careful monitoring will bear that out. The Advisory Committee on Immunization Practices (ACIP), a group of independent medical and public health experts, carefully evaluated all the available data and determined that the benefits of the new vaccines outweigh the potential risks caused by COVID-19. Compare, for example the three known deaths linked to the (Johnson and Johnson) COVID-19 vaccines to the 674,000 deaths linked to covid since the pandemic began.
Monitoring continues even after a vaccine is given EUA or is licensed by the FDA. It helps to ensure that the benefits continue to outweigh the risks among people receiving the vaccine. This is critical since even large clinical trials may not be big enough to detect rare AEs. For example, if an AE only happens in 1 out of 500,000 people, a phase 3 clinical trial with about 80,000 participants (the number of people in the Pfizer and Moderna vaccine trials combined) might not catch it. If the AE is very serious (severe illness or death) it is important to know about it even if it is very rare. Also, sometimes vaccine trials may exclude groups who might be expected to be particularly vulnerable to AEs such as people with chronic medical conditions, pregnant women, infants, and older adults. In the US, we monitor vaccination with the Vaccine Adverse Event Reporting System (VAERS), a national network used by scientists at the FDA and the Centers for Disease Control and Prevention (CDC) that collects reports of possible AEs that happen after vaccination. Scientists monitor VAERS to identify possible AEs that need to be studied further. All serious reports are reviewed by medical professionals on a daily basis. VAERS data provide medical professionals at CDC and FDA with an excellent tool for detecting what might be potential AEs. So far, neither the Pfizer nor the Moderna vaccine has been linked to any serious AEs.
What About Booster Shots?
Booster shots refer to giving an additional third dose of vaccine to those who received either the Pfizer or Moderna vaccines or a second dose to those who received the Johnson and Johnson vaccine. Vaccines provoke and immune response made up of antibodies and immune cells. Antibodies are proteins that gum up viruses and keep them from attaching to our cells to cause infections while immune cells are how the body fights the virus once it has already infected us. At about 10 weeks following primary vaccination (after the second shot of mRNA vaccine or the first shot of the Johnson and Johnson vaccine), antibody titers (the amount of antibodies circulating in the blood) start to decline, making people more susceptible to infection. Booster shots raise antibody titers to levels much higher than those seen after primary vaccination and it is believed that these higher titers will remain higher longer after the third shot compared to the second shot. Boosted people will higher antibody titers for longer periods of time offering them much more protection against infection than people who have only had the primary (two or one shot) vaccination.
COVID-19 is a novel disease caused by a novel pathogen called SARS-CoV-2. This new virus, in addition to causing COVID-19, also results in long-term health problems for a significant number of people. Sometimes referred to as long-covid somewhere between 15-30% of people who contract the virus, even if they develop mild or no disease, can will go on to experience debilitating persistent or activity-induced fatigue, headaches, muscle and joint pains, difficulty thinking, reasoning, remembering, reading, and understanding, as well as loss of smell and/or taste. What's more, even among people who do not develop long-covid, there is growing evidence that just having been infected can lead to damage to organ tissues including the heart, lungs, brain, kidneys, and blood vessels. For these reasons, we believe that booster shots make sense. We want all of our patients protected not just against hospitalizations and death, but against infections that might cause chronic illness or other health concerns later in life as a result of organ tissue damage. For more information about boosters, please speak with your provider or call to schedule a telemedicine visit with our COVID-19 specialist, Dr. Ehrlich: 858.450.5900
Some of the Questions We Have Been Getting From Our Patients
Are the new vaccines cause Bell's Palsy?
Neurological problems are among the most common adverse events associated with vaccines. Bell's palsy is a condition in which a nerve in the face suddenly stops working causing the muscles of facial expression to become paralyzed. No one knows for sure why some people get Bell's Palsy but about 85% of people who get it recover fully within about 3 weeks while another 10% take up to a few months to fully heal. In only about 5% of cases do people experience some long-term facial muscle weakness. For these reasons, Bell's Palsy is not considered a serious medical problem but it is an adverse event that has been associated with some vaccines in the past.
To know whether a vaccine caused an AE or if a problem that came on after vaccination was merely a coincidence, scientists must determine if the problem is happening more often after vaccinations than would be expected to occur naturally (without vaccination). Clinical trials split participants into two groups: one that gets the drug/vaccine and one that gets a placebo (usually saltwater) which has no pharmacological effect and then compares the health outcomes of the two groups to determine whether the drug/vaccine is effective. One way to determine whether a problem that occurs after vaccination is an AE or a coincidence is to compare the incidence of the problem in the vaccine group against the incidence in the placebo group. If more people who received the vaccine get a particular problem than those who got the placebo, that could mean that the vaccine caused the problem. In both the Pfizer and Moderna vaccine groups, Bell's Palsy was more common compared to placebo. The other (better) way to determine whether a particular problem constitutes an AE or was just a coincidence is to compare the number of cases among those who get vaccinated against the number of people expected to develop that particular problem in the general (unvaccinated) population using yearly averages. After about a half-year of data, there have been so far seven reported cases of Bell's Palsy among those who have received either the Pfizer or Moderna vaccines. In addition, our office has seen one patient who developed Bell's Palsy after receiving the Pfizer vaccine, making our known total now 8. Although this may turn out to be an AE, the natural incidence of Bell's Palsy is about 23 per 100,000 population. Based on that, 8 cases among about 80,000 participants (in both trials) plus about another 2.5 million people who have been vaccinated since the clinical trials is, so far, actually lower than the natural incidence of Bell's Palsy in the general population. How many other medical offices will see patients with Bell's Palsy following vaccinations? Only time will tell whether this or some other health consequence might ultimately be linked to these new vaccines built using a novel (RNA-based) platform. However, at this time, the data do not support that anyone has had a serious AE and the jury is not yet in concerning whether or not Bell's Palsy might be a rare, non-serious AE of the new mRNA vaccines.
Can mRNA vaccines merge with or alter my DNA?
A video misrepresenting remarks made by Bill Gates was circulated widely on social media to suggest that mRNA vaccines could somehow alter a person's DNA (their own genetic code located inside the nuclei of their cells). However, that is not possible since mRNA does not enter the nuclei of cells. After it instructs the protein-making part of the cell which exists outside the nucleus to manufacture some spike antigen proteins, mRNA self-deactivates and is cleared from the body. mRNA never comes into contact with our own DNA so it never has a chance to interact with it.
Do spike protein antigens stay in the body permanently and if so, could that pose a health risk?
No. mRNA instructs the protein-making part of the cell outside of the nucleus to make spike protein found on the surface of the coronavirus and then it self-deactivates. Once the body sees a spike protein antigen, it mounts an immune response against it and clears it from the body, leaving behind antibodies and memory B and T cells that remain on the lookout for SARS-CoV-2, the virus that causes COVID-19. Just in the way that viruses are cleared from the body after infection, the spike protein antigens are cleared from the body after vaccination.
Can mRNA vaccines cause COVID-19?
No. The new mRNA vaccines order cells to make the spike protein found on the surface of the coronavirus but they do not make the whole virus and therefore, cannot cause COVID-19. The spike protein is the part of the virus that enables it to attach and gain entry into our cells. Once the body sees the newly minted, mRNA-induced spike proteins floating around, it mounts an immune response against it including B-cells, T-cells, and antibodies that stick around. If a person who has been vaccinated then gets infected with the coronavirus, the body immediately identifies its spike protein antigen and swiftly fights off the virus using the immune cells and antibodies created as a result of prior vaccination.
Do the new vaccines contain microchips that can be used by the government or big corporations like Microsoft to track my movements or monitor my health status?
No. The conspiracy theory that the government and/or Microsoft have been secretly introducing microchips into people's bodies during vaccinations to track their whereabouts and health status using 5G technology seems to have been first linked to the new COVID-19 vaccines by Alex Jones of InfoWars. He has offered no evidence in support of this outrageous and disturbing allegation. No microchip exists that can live inside a person's body and assess their health status. Should such technology becomes available one day, it will represent a giant leap forward in terms of disease detection and prevention but for now, it is safe to call Mr. Jones' conspiracy theory a form of disinformation. On the other hand, microchips can be tracked using GPS and smartphones do contain microchips specifically for that purpose. So smartphones (but not vaccines) may be worthy of concern for those interested in safeguarding the privacy of their whereabouts.
These vaccines came out faster than expected; were they rushed?
Well.. yes. It would likely have taken several years to develop an effective vaccine against a novel pathogen like SARS-CoV-2 (the virus that causes COVID-19) using conventional approaches. The Pfizer and Moderna vaccines, the first ones to make it to market, were developed and implemented in less than one year–an unprecedented feat. But the building of these vaccines was not done hastily or by cutting corners. The remarkable speed of development can be attributed rather to two things:
Should I get vaccinated now or wait until there are more data?
There are now enough data to say with confidence that any of the three new COVID-19 vaccines are safe and effective. Any drug, procedure, or intervention that can help treat a disease also carries some risk of causing harm. But the risk of harm from COVID-19 is so much higher than the risk of harm from vaccination that we recommend all people 12 and over get vaccinated unless they have a known allergy to any of the ingredients included in the vaccine.
We also recognize and affirm that, along with the privileges of being citizens of a great country, we have some responsibilities. And one of them is to do what is reasonably asked of us to contribute to the health and safety of our friends, neighbors, and fellow Americans. If I am young and healthy, my risk for severe disease and hospitalization from COVID-19 is low. But my risk of getting infected and having either long-covid or some other delayed onset health issue is not low. Nor is my risk of spreading the disease to others low. As a medical team, we are united in ensuring that none of our patients or team members contracts COVID-19 from us. That's why every member of our team has been vaccinated and why most of use have received boosters as well.
That said, we support our patients' right to make their own decision about whether or not to get vaccinated. Our role as medical providers is to clarify, support, and help guide those under our care–not to dictate. We believe that the risk of long-term disability and possible death from COVID-19 is higher than the risk of a serious AE caused by a vaccine. We want the assurance, as we continue to take care of our patients, that comes from having vaccination-induced immunity. After nearly two years of risking our health and that of our families and loved ones each day we come to work, we are longing to feel safer. We want to be part of the solution and to do what we can to help restore some semblance of normal, interconnected life. Remember, vaccination can vanquish an infectious disease–but only if almost everyone does it.
If getting infected gives me just as good immunity as getting vaccinated and the case fatality rate of COVID-19 (the likelihood of dying if you catch the disease) is just 1.6%, is it better to just get infected if I'm young and healthy and can reasonably expect a relatively mild course of the disease?
Some politicians have advocated against vaccines, noting that the vast majority of people who contract covid recover quickly without being hospitalized, the way people do after a cold or flu. We also now know that getting COVID-19 offers strong immune protection against reinfection–as good or better than primary vaccination. But the viruses that cause colds and flu do not attack the heart, brain, kidneys, testes, ovaries, and other organ tissues. They are not associated with high rates of chronic fatigue, brain fog, headaches, and increase rates of depression and suicide. If you've had COVID-19, you should consider yourself protected at about the level of someone who has had a primary two-shot vaccination and we recommend that you get a single dose of either of the mRNA vaccines as your booster 5 months after having been diagnosed.
Remember, the new vaccines would be able to bring about herd immunity in a matter of a few months if nearly everyone rolls up their sleeves and adhere to the public health measures of masking and avoiding congregate settings. If we could do this as a country, we could likely essentially eradicate COVID-19 in a very short time. So long as nearly half of Americans continue to refuse vaccination, the virus will continue to have a large reservoir of immune-naive people through which to spread, mutate, and become stronger.
Which is the best vaccine to take?
The efficacy rate of all three vaccines (Pfizer, Moderna, and Johnson and Johnson) are extremely high and comparable to one another. However, two shots of vaccine (such as is used for Pfizer and Moderna) seem to create longer-lasting immunity than just one shot (Johnson and Johnson). Spacing out the shots also increases the durability of immune protection. That's partly why the Moderna vaccine, which uses a four week inter-dose interval between their two shots, seems to offer longer-lasting protection against infection compared to the Pfizer vaccine which uses just a three week inter-dose interval. We now have data showing that a twelve-week inter-dose interval provokes the strongest immune response. Also, while Moderna and Pfizer use essentially the same vaccine (the same mRNA code), Moderna uses a dose that is more than three times higher than the dose used by Pfizer. We also now have data showing that the bigger Moderna dose also contributes to its longer-lasting protection. It is probably true that the larger dose also explains why Moderna seems to cause more/stronger side-effects after vaccination. Giving larger doses of the Pfizer vaccine and/or spacing the doses out more are ways your doctor may be able to improve its efficacy.
The bottom line: All the vaccines are great and we carry all three. Every member of our team is fully vaccinated with one team member getting the Johnson and Johnson vaccine and the rest about evenly split between Pfizer and Moderna.
What about children?
At this time, all three vaccines are approved for children 12 and older. It is expected from the preliminary data that this will soon be extended to all children ages 5 and over. Along with the American Association of Pediatric Physicians, we strongly advocate for a return of children to school and getting them vaccinated is a critical element of protecting them from covid. Remember that even though children tend to get less severe disease when they get infected, they are not immune to long-covid or injuries to brain, heart, lungs, kidneys and other organs which could jeopardize their long-term health. The best outcome for children is to avoid having been infected during this pandemic and the vaccines must play a critical role in making that happen.
How should I expect to feel after getting vaccinated?
The most common side effects are injection site pain (sore/achy arm), fatigue, headache, muscle pain, and joint pain which typically come on the day after vaccination and last between 12 - 36 hours. Some people get a fever and chills and some people have symptoms that last longer (up to a few days) before fully going away. Side effects are more common after the second and/or third dose and are a sign that your immune system has been activated;. Younger adults, who have more robust immune systems, tend to report side effects more often than older adults. But minimal side-effects does not mean that your immune system is not working properly and many healthy, young people breeze through vaccination with minimal or no symptoms at all. Allergic reactions is always the chief concern after any vaccination. About 3 out of every million people experience a very strong allergic reaction called anaphylaxis after they get a shot. This usually comes on within a few minutes after administration of the shot and can be treated easily with epipen. We require that people spend at least 15 minutes at the office after their shot (or 30 minutes if they have a history of allergic reactions to any past vaccines) to make sure they are not experience an allergic reaction before leaving. The medical providers at LJVFMG are always on hand and are prepared to deal with any adverse events that might arise following vaccination at our office.
After I get vaccinated will I still need to wear a mask, avoid crowds, and keep social distancing?
Yes. Vaccines prepare the body's defenses to fight pathogens but are rarely able to prevent most people from getting infected if they place themselves at high risk. That means that once you are vaccinated, you are much less likely to get infected and if you do get infected, you are much less likely to feel sick. However, since the Delta variant took over, we now know that vaccinated people who get infected develop high viral titers and can pass the disease on to others just like unvaccinated people–even if they don't feel sick. Masking and avoiding closed spaces where you might share your air with others outside of your household bubble are the two most important measures for preventing infection. Cloth masks and surgical masks that do not fit the face snugly do not offer sufficient protection from COVID-19. We have stocked our office with very high quality KF94 masks which we are now making available to our patients.
I understand the vaccine has two doses spaced a few weeks apart; is it essential that I get the second shot or is one dose enough to protect me?
One shot offers some protection. Two shots offers significantly stronger and more long-lasting protection. A third shot is better still.
When can I get vaccinated?
You can be vaccinated at our office M - F between the hours of 8:30 AM and 4:40 PM. Call to schedule your vaccination appointment now at 858.450.5900.
Can I get the COVID-19 vaccine if I recently got another vaccine?
Yes. You can receive a COVID-19 vaccine even if you recently got another vaccine. Moderna is currently working on a combined vaccine for both COVID-19 and flu. If you have more questions, please call the office and schedule a telemedicine visit with our covid-specialist, Dr. Ehrlich: 858.450.5900.
After I get vaccinated can I go back to normal?
Not quite. Prior to the Delta variant, primary vaccination provided enough protection to enable us to go unmasked indoors with other fully vaccinated people. Waning antibodies and the more infectious nature of Delta quickly made that unsafe. Preliminary data are hopeful in showing that we have strong protection–including against Delta–following booster shots. But we need more data to confirm that. In the meantime, primary vaccination offers a lot of protection for up to about 5 months following the Pfizer vaccine and for up to 6 months following the Moderna vaccine but we still strongly recommend masking indoors among people who are not members of your own household and outdoors in groups. Outdoor dining and drinking remain extremely high-risk environments as so far, there are not vaccination requirements to have access to these places. Being unmasked around groups of other unmasked strangers who are talking, often in loud voices, even outdoors, is one of the riskiest behaviors there are for COVID-19. We strongly recommend that people who have been vaccinated, including (until we have more data) people who have received their booster shots, continue to wear high-quality face masks, avoid groups, keep physical distance, and practice good hand hygiene until most people have been fully vaccinated. As of 9/18/21, only 54% of Americans have been vaccinated. We will likely need to get more than 90% of people vaccinated before life can return to normal. Prior to that time, we hope and expect that booster shots, along with vaccination mandates and vaccination requirements to access public spaces like bars and restaurants will enable us to enjoy something closer to normal.
Still have questions?
LJVFMG is staying on top of he most current data. If you have a question that was not answered on our website, please send us an email at [email protected]. Please do not include any sensitive identifying info in your email such as date of birth or social security number. We can access your information in your medical records with just your first and last name and your written permission.
This information piece will be updated as new information becomes available. Our office has been on the cutting edge of COVID-19 research and safety protocols since the pandemic began and is committed to remaining so. If you have any questions about COVID-19 testing, vaccinations, masks, or emerging therapies, please do not hesitate to schedule a telemedicine appointment with one of our knowledgeable medical providers at 858.450.5900.
In addition, many cases cause by Delta have a symptom presentation that looks less like classic covid (dry cough, profound fatigue, loss of smell, body aches) and more like a common cold (runny stuffy nose, sore throat, fever, and headache). Because covid caused by Delta can look just like a cold, many people are not getting tested and the true case numbers are probably much higher than what is being officially reported.
With current case rates that would call for closures of many businesses under last year's tiered system, and a new VOC that spreads so quickly and bypasses prior immunity at such a high rate, we are now facing what is arguably the most dangerous time thus far in the pandemic. An average more than 1,300 cases per day were reported in San Diego County as of August 23, an increase of 400% from this time last month. Here are the top dozen things you need to know to help navigate safely through this time:
- A virus is an invisibly small parasite that cannot reproduce by itself. Once it infects us, however, a virus can direct the machinery of our cells to produce more viruses. This is called viral replication. Viral replication can produce many thousands of individual viruses (called virions) within a cell. These virions build up and then break out of the infected cell to travel to other cells, spreading the infection. When virions break through cells lining our airways, digestive tract, or urogenital tract, this is called viral shedding. Viral shedding is responsible for transmission.
- When viruses replicate, they sometimes make copy errors called mutations. Some mutations afford the virus an advantage such as making it more transmissible or making it better able to bypass prior immunity from previous infections or vaccination. We say these mutated viruses are more evolutionarily fit. Fitter viruses tend to outcompete other less fit viruses as it spreads through a community. The more a virus is able to spread widely, the more mutations occur and the higher the chances of fitter variants emerging. Delta replicates much faster and makes many more copies of itself compared to prior VOCs. This is why it spreads so quickly, outcompeted other variants, and breaks through prior immunity.
- The worst thing a society can be is partially vaccinated. In the US, where just a little oer half the population is currently vaccinated, there is still a large reservoir of people without immunity among which the virus can spread widely to create mutant variants, while at the same time there is a large number of immunized (vaccinated) people that the virus can bump up against–and learn from. When viruses are exposed to antibodies and immune cells, they can 'learn' how to mutate intelligently to evade them. The bottom line is that either almost all of us get vaccinated quickly or the virus will continue to spread, mutate, become fitter, and eventually be able to start the pandemic anew.
- SARS-CoV-2–the virus that causes COVID-19–infects almost all human organ tissues including the airways, gastrointestinal tract, blood vessels, heart, kidneys, brain, and sex organs (testes and ovaries). It is unusual that a virus attacks so many different tissues and it is as yet unknown what the long term effects of this will be for those who get infected.
- SARS-CoV-2 is spread when virions shed in the airways are projected from the mouth in the form of tiny particles called 'aerosols' that float through the air. Transmission takes place when someone inhales viral aerosols that were exhaled by someone who is already infected. At our office, we like to say, "Don't share your air." This is another thing about covid that's unusual. Colds and flu are mostly spread through touch (fomite transmission) or through droplets projected from coughs and sneezes (direct transmission) while covid is spread via airborne transmission (floating aerosols that can travel far and remain in the air for a long time). This is the reason masking is so very important. A high-efficiency mask that is properly fit to the face can protect both the wearer and those around them.
- But not all masks are up to the task. The fabric of cloth masks made from cotton or stretchy material have loose weaves that can allow the tiny viral aerosols to pass right through them. Masks made of high efficiency materials like N95 and KF94 respirators can also sometimes be ineffective if they do not form a tight seal around both the nose and mouth. Any gaps between the mask and skin will allow unfiltered air to enter the wearer's airway and project unfiltered air into the space around them, increasing the risk of transmission. Indoors, viral aerosols can accumulate and stay in the air for hours. At our practice we provide all our patients with high-efficiency masks and clips for a secure fit which must be worn at all times in the office. Behavioral safety is mainly about masking and masking is all about two things: quality and fit.
- Speaking increases the number of aerosols a person produces and the louder someone speaks, the more aerosols they generate. Singing is even worse. Some people, when they speak or sing, likely because of the particular anatomy of their voice box, make more aerosols than others. Such people are sometimes referred to as super-emitters. Most people who get covid don't wind up spreading it to others but a small number of people spread it widely. These high spreaders of disease are likely super-emitters. Unfortunately, we cannot know whether someone is a low, normal, or super-emitter of aerosols by looking at them and there is no commonly accessible way to test for it either.
- That is why environments such as bars and restaurants, where people are unmasked and talking (often in loud voices) are the most common settings of community outbreaks. In just the last 2 weeks, there were 478 community outbreaks in San Diego, just from bars and restaurants and many of these outbreaks took place among those who dined and drank outdoors. Anywhere people are packed together and unmasked/improperly masked is a high risk environment. This would not be true if everyone were vaccinated.
- We highly recommend vaccination and offer vaccines from Pfizer, Moderna, and Johnson & Johnson at our office. If you want a shot, you can get it along with your office visit–no need to schedule a separate appointment for vaccination. If everyone gets vaccinated soon, we can still shut down covid but the window to get this done is almost closed. Delta is close to the sort of VOC that could start the pandemic all over again. It is spreading five times faster among unvaccinated people but that does not make it safe for vaccinated people to go around unmasked any longer. The next VOC to emerge (likely from Delta as it rips through the US, infecting mostly unvaccinated people but bumping into a lot of vaccinated people too), may have even better transmissibility or evasion of prior immunity and that could be enough to start the pandemic all over again. The bottom line: if we all pull together and get vaccinated now we have a chance; if we don't, we are likely going to be trapped in this pandemic for a very long time.
- We highly recommend boosters for vaccinated persons at 3 months after vaccination with the Johnson & Johnson vaccine; 5 months after vaccination with the Pfizer vaccine; and 6 months after vaccination with the Moderna vaccine. Although the current administration is recommending people wait 8 months to get their boosters, this is not consistent with the available data and we expect those recommendation to change. La Jolla Village Family Medical Group, with whom we share clinic space, is providing vaccinations/boosters right now.
- COVID-19 is a very different disease from colds or flu. SARS-CoV-2 attacks many organs of the body and can cause significant disruption of the immune system. It is divided into viral and post-viral phases. During the acute viral phase that starts a few days after infection, some people have no or mild symptoms, some have very serious disease that requires admission to hospital or ICU care, and some develop illness somewhere between these extremes. Regardless of the severity of the acute viral phase, many people progress to have chronic problems for weeks, months, or possibly longer after the virus has been cleared from the body. This is referred to as the post-viral phase of illness because most people seem no longer to be carrying live virus even though they still feel sick. In many cases the post-viral phase causes more sickness than the viral phase with difficulty thinking, concentrating, and learning (referred to by some as 'brain fog'), profound bouts of fatigue, chest pain, cough, and headaches common for six months or more. Varying estimates of what is now being referred to as Post Covid Syndrome or long covid suggest that perhaps as many as one third of people who get infected, regardless of the severity of the acute viral phase, are likely to go on to have prolonged mental and physical disability. In one recent as yet unpublished but very well done study, brain injury was seen on MRI evaluation of virtually all patients who had gotten COVID-19, regardless of the severity of the acute viral phase. We should do all we can to not get infected–even if we are young, healthy, vaccinated, and likely not to suffer severe illness during the acute viral phase. The post-viral phase may turn out to be much worse.
- Staying safe is about layers. Proper masking with high-efficiency masks; avoiding huddles of people (such as in bars, restaurants, clubs, concerts, etc.); getting vaccinated; opening windows/doors; using air cleaners like HEPA units; and not socializing with anyone outside of your own household each provides a layer of protection against infection. When we put them all together, we have a high chance of making it through the pandemic without catching covid.
COVID-19 Vaccines
Vaccines, along with antibiotics and sanitary procedures (especially with regard to food handling), are arguably the most important public health advances to emerge from medical science. A mere 100 years ago, infectious diseases like measles, polio, and smallpox were a deadly fact of everyday life with waves of infections sweeping through communities every year or every few years leaving death and sometimes permanent disability in their wake. Today, despite a dramatic increase in the density of urban populations, thanks to vaccination, many once-common diseases are now rare in advanced societies like ours.
Mass vaccination in the US began in 1922 when the government first mandated that children be inoculated against smallpox in order to attend public school. The smallpox vaccine would go on to essentially eradicate this deadly, highly-contagious disease. But not everyone welcomed vaccination with open arms. The case of Rosalyn Zucht, a student from San Antonio, Texas, who was excluded from public school when her parents refused to comply with the vaccination order, is an example of the fear and resistance that some Americans had at that time to what was then a strange and novel public health measure.
Suspicious of the government's intentions and ignorant of the science behind vaccination, the Zucht's filed a suit against the local authorities claiming that forced vaccination violated their and their child's individual liberties. The case was ultimately heard by the U.S. Supreme Court which ruled that it was "within the police power of the state to provide for compulsory vaccination." Since that time, vaccines for many diseases have been developed and deployed under the stringent regulatory oversight of government health agencies like the FDA with miraculous success, all but vanquishing not only smallpox but measles, mumps, rubella, polio, tetanus, and a host of other potentially life-threatening illnesses. But despite saving millions of human lives, fear of and resistance to vaccinations has not been vanquished. In fact today, nearly half of Americans express some measure of hesitation about getting vaccinated against COVID-19 and the United States is now becoming the least vaccinated advanced society on earth. We are also the country with the highest case rate of COVID-19 in the world and that is not a coincidence. It is estimated that unless and until a little over 90% of the population has immunity, we will not be able to return safely to a normal lifestyle of work, socializing, and travel. Eventually we will get there through a combination of vaccination and infections. But with an estimated 15-30% of covid infections going on to cause chronic illness and disability including fatigue, headaches, body aches, and 'brain fog,' the cost on our society will likely be enormous if nearly half the population gets COVID-19.
Some of the fears expressed about the new vaccines are the result of misunderstandings about how they work (misinformation). Some of it has been caused by falsehoods intentionally engineered for the purpose of dividing people politically or eroding their trust in scientific and/or governmental authorities (disinformation). Some people have chosen not to be vaccinated based on intuitive calculations of personal risk in the context of a philosophy that places oneself and or one's family as the chief and exclusive cause worthy of sacrifice. And some people have been frightened by reports of adverse events or have questions about risks vs. rewards that have not been answered properly. The purpose of this information piece is to help our patients make better informed decisions about vaccination against COVID-19 by identifying and discussing current concerns surrounding novel vaccines for a novel disease.
Overview
With very few exceptions, vaccines are effective and safe. In the broadest sense, they provide the immune system with needed exercise while offering protection from a wide array of specific serious illnesses that extend beyond infectious diseases to now include certain types of cancer and possibly allergies, too. Vaccination has saved the lives of millions of adults and children over the years and it would be hard to find any intervention that has had as much positive impact on public health. Amidst the current pandemic, with few effective therapies widely available, vaccines are once again playing a leading role in the war against a deadly infectious disease. But in order for vaccination to be successful against SARS-CoV-2, the virus that causes the disease COVID-19, nearly everyone must either be vaccinated or have gotten infected.
What is a Vaccine?
A vaccine is something that prepares a person's immune system to fight a particular disease. It is rare that vaccination is sufficient to prevent a person from catching a disease but in the vast majority of cases, it helps people to fight it off more quickly and feel less sick if they do become infected. Vaccinated people who catch the infection can still pass the disease to others even if they don't feel sick. Therefore, vaccination is only successful in eradicating a disease from a population when the vast majority of people have been vaccinated and behavioral public health measures (like masking, distancing, and avoiding group gatherings) remain in place for long enough to bring the infection rate way down.
How Are Vaccines Made?
1. Conventional Approach:
Until now, most vaccines were made by taking viruses or bacteria (pathogens) grown in chicken eggs or tissue cells in a lab and either killing them (inactivated pathogens) or weakening them (attenuated pathogens). Conventional vaccination involves injecting a small number of these inactivated or attenuated pathogens into the body (usually the muscle of the upper arm) to provoke an immune response. The body's immune response includes making special immune cells called B-cells and T-cells that fight off the pathogen and then hang around afterward, sometimes for years, always on the lookout for reinfection with that same pathogen. B-cells also make proteins called antibodies that block the pathogen from gaining access to cells and some antibodies also stick around long after infection/vaccination.
Time has proved conventional vaccines to be safe and effective. But conventional approaches are a little less effective against rapidly evolving pathogens like influenza (the virus that causes flu) than they are against more slowly evolving pathogens like variola (the virus that causes smallpox). Conventional vaccines take a long time to build and by the time they are produced to scale and distributed to the public, a rapidly evolving pathogen may sometimes have already changed (mutated) enough to make vaccination less effective. In the case of flu, for example, we need a new vaccine every year to keep up with rapid mutations in the virus and even then, flu vaccines are often about 50% effective by the time they reach the market. That means that about half of people who get the flu shot will have robust protection against getting sick from the flu if they are exposed to the influenza virus. Those are pretty good odds and the yearly flu shot is an extremely safe and effective public health tool that saves tens of thousands of lives each year. However, by comparison, the vaccine against smallpox which is caused by a slowly evolving virus is 95% effective. That means that 95% of people who get the smallpox vaccine will have robust protection against getting sick if they are exposed to the variola virus.
Conventional vaccine approaches are also less efficient when medical experts are mounting a defense against a newly emerging pandemic threat like COVID-19. It can take several years to develop an effective vaccine against a novel pathogen using conventional approaches, during which time therapies may be only slightly effective and many people may die or become disabled. As of the writing of this paper (12/31/20) there have been more than 330,000 deaths attributed to this novel disease in the US and about 10-15% of the nearly 20 million confirmed cases have resulted in some degree of chronic disability. Over the past year, in the absence of a widely available and effective therapy or vaccine, governments around the world have been forced to impose psychologically and economically costly measures such as quarantining, masking, distancing, travel restrictions, closures of some businesses, and shelter at home orders to safeguard the lives of their citizens. If the conventional approach to building a vaccine against COVID-19 was all that medical science had available, we would likely be stuck in this situation for another year or more.
2. New Approaches:
Rather than identifying, isolating, growing, and then killing or weakening pathogens, RNA-based vaccines are made of genetic code manufactured in a lab that instructs cells to make proteins called antigens that are found usually on the surface of the pathogen in question. The code, called mRNA, is typically wrapped in a fat droplet called a liposome and then injected into the arm, just like a conventional vaccine. The liposome helps mRNA penetrate into muscle cells where the fat dissolves, releasing the code which in turn instructs the protein-making part of the cell to manufacture antigens that look identical to those found on the pathogen. After some antigens are made, mRNA self-deactivates and is cleared. The body then mounts an immune response against the newly minted antigen proteins just as if it had come in contact with the virus itself–including B-cells, T-cells, and antibodies.
RNA-based vaccines have shorter manufacturing times and seem to be more effective than conventional vaccines (or natural infection) at producing a strong immune response. They are also cheaper to make and less dangerous in some ways since they are safe for people with egg allergies and are not produced using infectious elements like inactivated or attenuated viruses. They can be standardized and scaled quickly and easily, allowing for much faster medical responses to epidemics and pandemics. mRNA vaccines were already being studied for use against other infectious diseases, certain types of cancer, and allergies before the COVID-19 pandemic. But they had not yet been brought to market. The two currently approved vaccines from Pfizer and Moderna are both mRNA vaccines. Early data from their clinical trials have shown both vaccines to provoke spectacularly robust immune responses (about 95% effectiveness rate) and, at least so far, they appear to be well-tolerated.
Are The COVID-19 Vaccines Safe?
All health interventions carry some risk and the new vaccines against COVID-19 are known to cause side effects in most people. For the vast majority, those side effects, in addition to pain in the injected shoulder/arm, are very similar to what we refer to as a viral syndrome, including headache, body aches, fatigue, and sometimes fever and chills, typically lasting 12 - 24 hours. Some people experience these side-effects for up to a few days. The vaccines do not contain live virus so these symptoms do not mean that you are infected or dangerous to others. This is also seen sometimes after other vaccinations but it is more common after the COVID-19 vaccines which are very effective at provoking a strong immune response.
A very small number of people have had more serious side effects following the covid vaccines, including allergic reactions which, to date have effected about 3 per one million people vaccinated in the US, all of whom have recovered quickly with epipen or administration of other routine medicines. In the US, as of September 9, 2021, more than 14.5 million people have been vaccinated with the Johnson & Johnson vaccine, mostly women under the age of 40, among whom 48 people subsequently developed rare blood clots and three died. There have been 3 similar cases of blood clots following 362 million doses of the Moderna vaccine, with no deaths. As of September 8, 2021, there have been 854 confirmed reports of myocarditis or pericarditis (swelling in or around the heart) among people ages 30 and younger who received either the Pfizer or Moderna vaccines, mostly in male adolescents and young adults out of more than 350 million doses given, with no reported deaths. There have been More than 380 million doses of all the COVID-19 vaccines administered in the US as of September 13, 2021. During this time, only the three deaths due to rare blood clots following the Johnson and Johnson vaccine have been linked to COVID-19 vaccines.
The Pfizer and Moderna vaccines have been built on a new platform (RNA-based), as described above, so there are no prior analogous vaccines to compare them to. The short-term and medium term (more than one year now) safety and efficacy of these vaccines have exceeded all reasonable expectations and there are good reasons, as stated above, to expect mRNA vaccines to be safer and better than conventional vaccines made from inactivated or attenuated pathogens. That said, there must remain uncertainty about the long-term effects of any new medicine, procedure, or vaccine until enough time has passed. Both Pfizer and Moderna have adhered to the extremely strict testing and safety and efficacy monitoring protocols required by the FDA for any new vaccine but neither has been around long enough to undergo the process of long-term monitoring of those who have been vaccinated. Despite this, the data collected thus far are so good that the FDA has now licensed the Pfizer vaccine and is expected to do the same with Moderna in the coming 1-2 months.
The Pfizer and Moderna vaccines have been brought to market to deal with a health emergency. Both Pfizer and Moderna began their phase 3 clinical trials in July so we now have more than a year of observational data on their efficacy and safety. So far, no serious late or delayed-onset adverse events have been recorded. This was expected since the vast majority of adverse events (AEs) following vaccination typically take place within 4-6 weeks–and often within 48 hours. But we do not yet have absolute proof that these vaccines will be equally as safe in the long-term as they seem to be in the short and medium-terms. Only time and careful monitoring will bear that out. The Advisory Committee on Immunization Practices (ACIP), a group of independent medical and public health experts, carefully evaluated all the available data and determined that the benefits of the new vaccines outweigh the potential risks caused by COVID-19. Compare, for example the three known deaths linked to the (Johnson and Johnson) COVID-19 vaccines to the 674,000 deaths linked to covid since the pandemic began.
Monitoring continues even after a vaccine is given EUA or is licensed by the FDA. It helps to ensure that the benefits continue to outweigh the risks among people receiving the vaccine. This is critical since even large clinical trials may not be big enough to detect rare AEs. For example, if an AE only happens in 1 out of 500,000 people, a phase 3 clinical trial with about 80,000 participants (the number of people in the Pfizer and Moderna vaccine trials combined) might not catch it. If the AE is very serious (severe illness or death) it is important to know about it even if it is very rare. Also, sometimes vaccine trials may exclude groups who might be expected to be particularly vulnerable to AEs such as people with chronic medical conditions, pregnant women, infants, and older adults. In the US, we monitor vaccination with the Vaccine Adverse Event Reporting System (VAERS), a national network used by scientists at the FDA and the Centers for Disease Control and Prevention (CDC) that collects reports of possible AEs that happen after vaccination. Scientists monitor VAERS to identify possible AEs that need to be studied further. All serious reports are reviewed by medical professionals on a daily basis. VAERS data provide medical professionals at CDC and FDA with an excellent tool for detecting what might be potential AEs. So far, neither the Pfizer nor the Moderna vaccine has been linked to any serious AEs.
What About Booster Shots?
Booster shots refer to giving an additional third dose of vaccine to those who received either the Pfizer or Moderna vaccines or a second dose to those who received the Johnson and Johnson vaccine. Vaccines provoke and immune response made up of antibodies and immune cells. Antibodies are proteins that gum up viruses and keep them from attaching to our cells to cause infections while immune cells are how the body fights the virus once it has already infected us. At about 10 weeks following primary vaccination (after the second shot of mRNA vaccine or the first shot of the Johnson and Johnson vaccine), antibody titers (the amount of antibodies circulating in the blood) start to decline, making people more susceptible to infection. Booster shots raise antibody titers to levels much higher than those seen after primary vaccination and it is believed that these higher titers will remain higher longer after the third shot compared to the second shot. Boosted people will higher antibody titers for longer periods of time offering them much more protection against infection than people who have only had the primary (two or one shot) vaccination.
COVID-19 is a novel disease caused by a novel pathogen called SARS-CoV-2. This new virus, in addition to causing COVID-19, also results in long-term health problems for a significant number of people. Sometimes referred to as long-covid somewhere between 15-30% of people who contract the virus, even if they develop mild or no disease, can will go on to experience debilitating persistent or activity-induced fatigue, headaches, muscle and joint pains, difficulty thinking, reasoning, remembering, reading, and understanding, as well as loss of smell and/or taste. What's more, even among people who do not develop long-covid, there is growing evidence that just having been infected can lead to damage to organ tissues including the heart, lungs, brain, kidneys, and blood vessels. For these reasons, we believe that booster shots make sense. We want all of our patients protected not just against hospitalizations and death, but against infections that might cause chronic illness or other health concerns later in life as a result of organ tissue damage. For more information about boosters, please speak with your provider or call to schedule a telemedicine visit with our COVID-19 specialist, Dr. Ehrlich: 858.450.5900
Some of the Questions We Have Been Getting From Our Patients
Are the new vaccines cause Bell's Palsy?
Neurological problems are among the most common adverse events associated with vaccines. Bell's palsy is a condition in which a nerve in the face suddenly stops working causing the muscles of facial expression to become paralyzed. No one knows for sure why some people get Bell's Palsy but about 85% of people who get it recover fully within about 3 weeks while another 10% take up to a few months to fully heal. In only about 5% of cases do people experience some long-term facial muscle weakness. For these reasons, Bell's Palsy is not considered a serious medical problem but it is an adverse event that has been associated with some vaccines in the past.
To know whether a vaccine caused an AE or if a problem that came on after vaccination was merely a coincidence, scientists must determine if the problem is happening more often after vaccinations than would be expected to occur naturally (without vaccination). Clinical trials split participants into two groups: one that gets the drug/vaccine and one that gets a placebo (usually saltwater) which has no pharmacological effect and then compares the health outcomes of the two groups to determine whether the drug/vaccine is effective. One way to determine whether a problem that occurs after vaccination is an AE or a coincidence is to compare the incidence of the problem in the vaccine group against the incidence in the placebo group. If more people who received the vaccine get a particular problem than those who got the placebo, that could mean that the vaccine caused the problem. In both the Pfizer and Moderna vaccine groups, Bell's Palsy was more common compared to placebo. The other (better) way to determine whether a particular problem constitutes an AE or was just a coincidence is to compare the number of cases among those who get vaccinated against the number of people expected to develop that particular problem in the general (unvaccinated) population using yearly averages. After about a half-year of data, there have been so far seven reported cases of Bell's Palsy among those who have received either the Pfizer or Moderna vaccines. In addition, our office has seen one patient who developed Bell's Palsy after receiving the Pfizer vaccine, making our known total now 8. Although this may turn out to be an AE, the natural incidence of Bell's Palsy is about 23 per 100,000 population. Based on that, 8 cases among about 80,000 participants (in both trials) plus about another 2.5 million people who have been vaccinated since the clinical trials is, so far, actually lower than the natural incidence of Bell's Palsy in the general population. How many other medical offices will see patients with Bell's Palsy following vaccinations? Only time will tell whether this or some other health consequence might ultimately be linked to these new vaccines built using a novel (RNA-based) platform. However, at this time, the data do not support that anyone has had a serious AE and the jury is not yet in concerning whether or not Bell's Palsy might be a rare, non-serious AE of the new mRNA vaccines.
Can mRNA vaccines merge with or alter my DNA?
A video misrepresenting remarks made by Bill Gates was circulated widely on social media to suggest that mRNA vaccines could somehow alter a person's DNA (their own genetic code located inside the nuclei of their cells). However, that is not possible since mRNA does not enter the nuclei of cells. After it instructs the protein-making part of the cell which exists outside the nucleus to manufacture some spike antigen proteins, mRNA self-deactivates and is cleared from the body. mRNA never comes into contact with our own DNA so it never has a chance to interact with it.
Do spike protein antigens stay in the body permanently and if so, could that pose a health risk?
No. mRNA instructs the protein-making part of the cell outside of the nucleus to make spike protein found on the surface of the coronavirus and then it self-deactivates. Once the body sees a spike protein antigen, it mounts an immune response against it and clears it from the body, leaving behind antibodies and memory B and T cells that remain on the lookout for SARS-CoV-2, the virus that causes COVID-19. Just in the way that viruses are cleared from the body after infection, the spike protein antigens are cleared from the body after vaccination.
Can mRNA vaccines cause COVID-19?
No. The new mRNA vaccines order cells to make the spike protein found on the surface of the coronavirus but they do not make the whole virus and therefore, cannot cause COVID-19. The spike protein is the part of the virus that enables it to attach and gain entry into our cells. Once the body sees the newly minted, mRNA-induced spike proteins floating around, it mounts an immune response against it including B-cells, T-cells, and antibodies that stick around. If a person who has been vaccinated then gets infected with the coronavirus, the body immediately identifies its spike protein antigen and swiftly fights off the virus using the immune cells and antibodies created as a result of prior vaccination.
Do the new vaccines contain microchips that can be used by the government or big corporations like Microsoft to track my movements or monitor my health status?
No. The conspiracy theory that the government and/or Microsoft have been secretly introducing microchips into people's bodies during vaccinations to track their whereabouts and health status using 5G technology seems to have been first linked to the new COVID-19 vaccines by Alex Jones of InfoWars. He has offered no evidence in support of this outrageous and disturbing allegation. No microchip exists that can live inside a person's body and assess their health status. Should such technology becomes available one day, it will represent a giant leap forward in terms of disease detection and prevention but for now, it is safe to call Mr. Jones' conspiracy theory a form of disinformation. On the other hand, microchips can be tracked using GPS and smartphones do contain microchips specifically for that purpose. So smartphones (but not vaccines) may be worthy of concern for those interested in safeguarding the privacy of their whereabouts.
These vaccines came out faster than expected; were they rushed?
Well.. yes. It would likely have taken several years to develop an effective vaccine against a novel pathogen like SARS-CoV-2 (the virus that causes COVID-19) using conventional approaches. The Pfizer and Moderna vaccines, the first ones to make it to market, were developed and implemented in less than one year–an unprecedented feat. But the building of these vaccines was not done hastily or by cutting corners. The remarkable speed of development can be attributed rather to two things:
- An unprecedented degree of open-source information sharing among the world's scientific community to defeat COVID-19.
- The existence, prior to COVID-19, of new, faster platforms on which to build vaccines.
Should I get vaccinated now or wait until there are more data?
There are now enough data to say with confidence that any of the three new COVID-19 vaccines are safe and effective. Any drug, procedure, or intervention that can help treat a disease also carries some risk of causing harm. But the risk of harm from COVID-19 is so much higher than the risk of harm from vaccination that we recommend all people 12 and over get vaccinated unless they have a known allergy to any of the ingredients included in the vaccine.
We also recognize and affirm that, along with the privileges of being citizens of a great country, we have some responsibilities. And one of them is to do what is reasonably asked of us to contribute to the health and safety of our friends, neighbors, and fellow Americans. If I am young and healthy, my risk for severe disease and hospitalization from COVID-19 is low. But my risk of getting infected and having either long-covid or some other delayed onset health issue is not low. Nor is my risk of spreading the disease to others low. As a medical team, we are united in ensuring that none of our patients or team members contracts COVID-19 from us. That's why every member of our team has been vaccinated and why most of use have received boosters as well.
That said, we support our patients' right to make their own decision about whether or not to get vaccinated. Our role as medical providers is to clarify, support, and help guide those under our care–not to dictate. We believe that the risk of long-term disability and possible death from COVID-19 is higher than the risk of a serious AE caused by a vaccine. We want the assurance, as we continue to take care of our patients, that comes from having vaccination-induced immunity. After nearly two years of risking our health and that of our families and loved ones each day we come to work, we are longing to feel safer. We want to be part of the solution and to do what we can to help restore some semblance of normal, interconnected life. Remember, vaccination can vanquish an infectious disease–but only if almost everyone does it.
If getting infected gives me just as good immunity as getting vaccinated and the case fatality rate of COVID-19 (the likelihood of dying if you catch the disease) is just 1.6%, is it better to just get infected if I'm young and healthy and can reasonably expect a relatively mild course of the disease?
Some politicians have advocated against vaccines, noting that the vast majority of people who contract covid recover quickly without being hospitalized, the way people do after a cold or flu. We also now know that getting COVID-19 offers strong immune protection against reinfection–as good or better than primary vaccination. But the viruses that cause colds and flu do not attack the heart, brain, kidneys, testes, ovaries, and other organ tissues. They are not associated with high rates of chronic fatigue, brain fog, headaches, and increase rates of depression and suicide. If you've had COVID-19, you should consider yourself protected at about the level of someone who has had a primary two-shot vaccination and we recommend that you get a single dose of either of the mRNA vaccines as your booster 5 months after having been diagnosed.
Remember, the new vaccines would be able to bring about herd immunity in a matter of a few months if nearly everyone rolls up their sleeves and adhere to the public health measures of masking and avoiding congregate settings. If we could do this as a country, we could likely essentially eradicate COVID-19 in a very short time. So long as nearly half of Americans continue to refuse vaccination, the virus will continue to have a large reservoir of immune-naive people through which to spread, mutate, and become stronger.
Which is the best vaccine to take?
The efficacy rate of all three vaccines (Pfizer, Moderna, and Johnson and Johnson) are extremely high and comparable to one another. However, two shots of vaccine (such as is used for Pfizer and Moderna) seem to create longer-lasting immunity than just one shot (Johnson and Johnson). Spacing out the shots also increases the durability of immune protection. That's partly why the Moderna vaccine, which uses a four week inter-dose interval between their two shots, seems to offer longer-lasting protection against infection compared to the Pfizer vaccine which uses just a three week inter-dose interval. We now have data showing that a twelve-week inter-dose interval provokes the strongest immune response. Also, while Moderna and Pfizer use essentially the same vaccine (the same mRNA code), Moderna uses a dose that is more than three times higher than the dose used by Pfizer. We also now have data showing that the bigger Moderna dose also contributes to its longer-lasting protection. It is probably true that the larger dose also explains why Moderna seems to cause more/stronger side-effects after vaccination. Giving larger doses of the Pfizer vaccine and/or spacing the doses out more are ways your doctor may be able to improve its efficacy.
The bottom line: All the vaccines are great and we carry all three. Every member of our team is fully vaccinated with one team member getting the Johnson and Johnson vaccine and the rest about evenly split between Pfizer and Moderna.
What about children?
At this time, all three vaccines are approved for children 12 and older. It is expected from the preliminary data that this will soon be extended to all children ages 5 and over. Along with the American Association of Pediatric Physicians, we strongly advocate for a return of children to school and getting them vaccinated is a critical element of protecting them from covid. Remember that even though children tend to get less severe disease when they get infected, they are not immune to long-covid or injuries to brain, heart, lungs, kidneys and other organs which could jeopardize their long-term health. The best outcome for children is to avoid having been infected during this pandemic and the vaccines must play a critical role in making that happen.
How should I expect to feel after getting vaccinated?
The most common side effects are injection site pain (sore/achy arm), fatigue, headache, muscle pain, and joint pain which typically come on the day after vaccination and last between 12 - 36 hours. Some people get a fever and chills and some people have symptoms that last longer (up to a few days) before fully going away. Side effects are more common after the second and/or third dose and are a sign that your immune system has been activated;. Younger adults, who have more robust immune systems, tend to report side effects more often than older adults. But minimal side-effects does not mean that your immune system is not working properly and many healthy, young people breeze through vaccination with minimal or no symptoms at all. Allergic reactions is always the chief concern after any vaccination. About 3 out of every million people experience a very strong allergic reaction called anaphylaxis after they get a shot. This usually comes on within a few minutes after administration of the shot and can be treated easily with epipen. We require that people spend at least 15 minutes at the office after their shot (or 30 minutes if they have a history of allergic reactions to any past vaccines) to make sure they are not experience an allergic reaction before leaving. The medical providers at LJVFMG are always on hand and are prepared to deal with any adverse events that might arise following vaccination at our office.
After I get vaccinated will I still need to wear a mask, avoid crowds, and keep social distancing?
Yes. Vaccines prepare the body's defenses to fight pathogens but are rarely able to prevent most people from getting infected if they place themselves at high risk. That means that once you are vaccinated, you are much less likely to get infected and if you do get infected, you are much less likely to feel sick. However, since the Delta variant took over, we now know that vaccinated people who get infected develop high viral titers and can pass the disease on to others just like unvaccinated people–even if they don't feel sick. Masking and avoiding closed spaces where you might share your air with others outside of your household bubble are the two most important measures for preventing infection. Cloth masks and surgical masks that do not fit the face snugly do not offer sufficient protection from COVID-19. We have stocked our office with very high quality KF94 masks which we are now making available to our patients.
I understand the vaccine has two doses spaced a few weeks apart; is it essential that I get the second shot or is one dose enough to protect me?
One shot offers some protection. Two shots offers significantly stronger and more long-lasting protection. A third shot is better still.
When can I get vaccinated?
You can be vaccinated at our office M - F between the hours of 8:30 AM and 4:40 PM. Call to schedule your vaccination appointment now at 858.450.5900.
Can I get the COVID-19 vaccine if I recently got another vaccine?
Yes. You can receive a COVID-19 vaccine even if you recently got another vaccine. Moderna is currently working on a combined vaccine for both COVID-19 and flu. If you have more questions, please call the office and schedule a telemedicine visit with our covid-specialist, Dr. Ehrlich: 858.450.5900.
After I get vaccinated can I go back to normal?
Not quite. Prior to the Delta variant, primary vaccination provided enough protection to enable us to go unmasked indoors with other fully vaccinated people. Waning antibodies and the more infectious nature of Delta quickly made that unsafe. Preliminary data are hopeful in showing that we have strong protection–including against Delta–following booster shots. But we need more data to confirm that. In the meantime, primary vaccination offers a lot of protection for up to about 5 months following the Pfizer vaccine and for up to 6 months following the Moderna vaccine but we still strongly recommend masking indoors among people who are not members of your own household and outdoors in groups. Outdoor dining and drinking remain extremely high-risk environments as so far, there are not vaccination requirements to have access to these places. Being unmasked around groups of other unmasked strangers who are talking, often in loud voices, even outdoors, is one of the riskiest behaviors there are for COVID-19. We strongly recommend that people who have been vaccinated, including (until we have more data) people who have received their booster shots, continue to wear high-quality face masks, avoid groups, keep physical distance, and practice good hand hygiene until most people have been fully vaccinated. As of 9/18/21, only 54% of Americans have been vaccinated. We will likely need to get more than 90% of people vaccinated before life can return to normal. Prior to that time, we hope and expect that booster shots, along with vaccination mandates and vaccination requirements to access public spaces like bars and restaurants will enable us to enjoy something closer to normal.
Still have questions?
LJVFMG is staying on top of he most current data. If you have a question that was not answered on our website, please send us an email at [email protected]. Please do not include any sensitive identifying info in your email such as date of birth or social security number. We can access your information in your medical records with just your first and last name and your written permission.
This information piece will be updated as new information becomes available. Our office has been on the cutting edge of COVID-19 research and safety protocols since the pandemic began and is committed to remaining so. If you have any questions about COVID-19 testing, vaccinations, masks, or emerging therapies, please do not hesitate to schedule a telemedicine appointment with one of our knowledgeable medical providers at 858.450.5900.