COVID19 Vaccines: Part 1
There is finally light at the end of the tunnel! Or, at least the promise of an end to the pandemic. The Covid19 vaccines are coming and there is a lot to talk about. In the coming weeks, I plan to write a series of articles about COVID19 vaccinations. Today’s introductory message is rather long. I apologize for that, but there is a lot to discuss. You may wish to scan down to headings that pique your interest.
Let’s start with the most important question: Should I receive the vaccine?
The answer is a definitive YES, and that means just about all of us, regardless of our state of health, whether we suffer from autoimmune disease, other chronic diseases, take immunomodulatory medicines, or already had COVID19 and recovered.
I will do my best to address the questions and concerns that many of you have raised and explain why I feel it is so important that we each make an effort to get vaccinated.
I plan to take the vaccine myself, as soon as I get the opportunity and will urge my staff to receive it, as well as my family, friends, and loved ones. And that includes just about all of my patients!
Detailed information about general vaccination biology and the specific COVID19 vaccine products will be discussed in future blogs. As we move into 2021, I will continue to write about the vaccine progress as we learn more and more over time.
Let’s start with a look at the best-case scenario: The COVID19 vaccines continue to prove effective and safe, with minimal adverse effects. They are distributed throughout the country (and the world) in the coming months, starting with those most in need and eventually being available to everyone by the spring, 2021. Most of the American population accepts the vaccine and elects to get vaccinated. Cases of infection consequently drop dramatically, herd immunity is achieved with >60% of people immune to the coronavirus and by the end of summer, COVID19 is virtually gone, just as poliovirus disappeared in the late 1950s, following the development of the Salk and Sabin vaccines. By mid-summer, COVID19 cases are rare and by September we begin to normalize activity, as schools and colleges resume usual, in-person instruction and business begins to recover, along with travel and live entertainment.
In reality, however, there are likely to be a number of bumps in the road which might send that idealized version of the future off course.
One concern is that many Americans appear to be wary of the vaccine for a variety of reasons and plan to refuse the opportunity. Of course, there has been an “anti-vaccine movement” for years before the pandemic. Some communities have rejected vaccination for children, resulting in the emergence of infections such as measles and whooping cough in recent years. And despite the fact that claims that vaccination in children can cause autism have been thoroughly debunked and proven absolutely untrue, some people still cling to unscientific beliefs.
Ironically, it is the great success of past vaccination programs that have led to a casual attitude regarding vaccination in general; few parents today have an awareness of the polio crisis in the 1950s or of the smallpox virus, which killed ⅓ of those infected until worldwide vaccination programs led to the eradication of the disease in 1980. Many forget that vaccination programs have been one of the great health care achievements of the 20th century. Childhood vaccines are estimated to prevent nearly 42,000 deaths, 20 million cases of the disease, and save billions of dollars over the lifetimes of our children.
But even amongst those who typically have complied with public health vaccination recommendations, concerns about the COVID19 vaccines have been raised and are prevalent on the internet and in social media. Over 50% of NYC Firefighters in a recent poll indicated their intention to avoid COVID19 vaccination!
There are 4 major reasons why people are apprehensive about the COVD19 vaccines: concerns about safety, suspicions regarding the rapid development of the vaccines politicization of the discussion, and the influence of unscientific claims in the media.
The most important question to ask is: Is the vaccine safe and effective?
Well-controlled studies thus far, at least with respect to the Pfizer and Moderna products, both mRNA (vaccines) suggest that the answer is yes, and yes. The FDA has issued conditional approval– an emergency use authorization (EUA) for both the Pfizer and Moderna vaccines. Pfizer’s vaccine has already been deployed in the US and several weeks ago in the UK. As other vaccine products are approved in the coming months, we will consider each of these. For now, the discussion is limited to the Pfizer and Moderna vaccines.
The clinical studies demonstrated that both vaccines are 90-95% efficacious, which means that those receiving the product were over 90% less likely to contract COVID19 than those who received the sham vaccine (placebo). That is very encouraging and much greater than anticipated. As a means of comparison, the flu vaccine in 2019-20 was estimated to be about 45-50% effective! One hopes that the real-world effectiveness of the COVID19 vaccines will continue to measure in that range.
In terms of adverse effects, the vaccines, so far, appear to be similar to that of commonly used vaccines, such as the flu, pneumonia, or tetanus shots: possible soreness at the injection site, and less commonly, fatigue and malaise or a low-grade fever for a day or two. Such reactions are usually quite mild, but no major problems have been reported. Only 2-4% of those studied had reactions more than mild injection site tenderness in the Pfizer studies, but the Moderna vaccine appears to result in more somewhat frequent transient post-vaccination reactions.
The most serious concern has been some instances of allergic reactions. These may occur with any vaccine and does not so far appear to be any more common than one experiences with other vaccine products. People with severe past reactions to vaccines or injectable medications will require close observation following vaccination, but this is not a contraindication to receiving the vaccine.
Bell’s palsy has also been reported, a transient facial paralysis. But the frequency of this event –following vaccination thus far is no greater than that occurring in the general population(estimated at 25-35 per 100,000 in the US).
There still are reasons to proceed with curation, however. Clinical studies leading to vaccine approval have been done in only about 30,000-60,000 people, which may seem like a lot, but pales in comparison to the 350 million people in the US. Often, following drug approval of any kind, post-marketing surveillance, that is, continued observation after the drug has been in use for a while reveals all kinds of additional information about side effects and actual drug effectiveness when used in real-world circumstances, not merely controlled populations.
The CDC is carefully watching for adverse effects following vaccinations and has developed a website and smartphone app: v-safe to encourage vaccine recipients to report any reactions.
Once the vaccines have been administered to millions of people, we will learn a lot more about their safety and effectiveness over time. Expect to hear about individual problems some people will experience after receiving the vaccine–indeed, giving any medication or vaccine to millions of people will surely result in some troubling results. Some reactions will bear no relationship to the actual vaccine. If, for example, someone has a heart attack in the days following vaccination or even gets into a car accident, such an event will be reported. Keep this in mind when the media starts reporting about the COVID 19 vaccine complications.
There is little reason to suspect that late adverse effects will develop in COVID19 vaccinated patients. Late adverse effects are rare in vaccines that have been employed for years. Still, mRNA vaccines are new and differ from the types of vaccines that have been previously used.
Another concern is while the research population studied was a diverse mix of sexes, ethnicity, and race, they did involve mostly healthy individuals aged 16 and older. Even though efficacy remained 94% in those over age 65, we really do not know much about certain groups of patients, especially those in high-risk categories: advanced age, those with chronic diseases, or those immune suppressed. These are the people who are most in need of protection from the coronavirus and who are first in line to receive vaccines, along with health care workers and first responders.
In summary, all indicators thus far suggest that these first two mRNA vaccine products are safe and very effective. New York State has established a Covid-19 Clinical Advisory Task Force composed of independent experts to evaluate the coming vaccines and render scientific recommendations for citizens of New York, and they are supporting these first two vaccine products.
I am not saying that there are no risks in receiving the vaccine. I am saying that they look to be minor. We will learn more in time. Ordinarily, one might wait longer before considering a new medication or vaccine, but we are facing a unique and serious pandemic. Surely the risk of contracting COVID19 infection is much greater than the risks posed by vaccination, with over 300,000 and counting Americans dead from the virus. And even though most people who become infected with the SARS-CoV2 virus experience mild symptoms and recover fully, 20% or more people will suffer, some with long-term symptoms and a small number will die. Plus, if you contract Covid19, even if you are asymptomatic, you may spread it to others and potentially hurt someone. The vaccine seems like a much better option!
Without a worldwide vaccination program, COVID 19 will never go away. It will continue to affect all of us, our communities, the economy, and our livelihoods.
What about Autoimmune Disorders?
This is an important question for many of our patients who suffer from rheumatic and other autoimmune disorders. The vaccine trials for both the Pfizer and Moderna vaccine specifically excluded such patients, so we do not have any data about safety or efficacy in this patient population. Vaccines for flu, pneumonia, shingles, tetanus, and others are not problematic in these patients and in fact, are encouraged. There are rare cases in which various types of vaccination have been associated with causing autoimmune diseases, but this tells us nothing about any specific risks for patients with existing autoimmune disorders.
In terms of COVID19 vaccine effectiveness, we simply do not know if, when compared to the general population, patients with autoimmune disorders have as good of a protective immune response. Again, in such patients, a satisfactory response to other vaccinations, even if not as robust, is the usual case.
For those patients taking biologic or other immunosuppressive medications for their condition, “live” vaccines, that is, vaccines containing live virus, such as with measles mumps and rubella, poliovirus, and some types of flu vaccines are contraindicated. But the Pfizer and Moderna vaccines ARE NOT live vaccines and thus are not contraindicated for these patients.
Some concern has been raised in this patient population because it has been observed that a significant number of patients hospitalized with COVID19 and who did not previously have autoimmune disease developed autoantibodies during the infection.
We do not know the fate of these autoantibodies that some sick COVID patients develop; having autoantibodies is not the same as having an autoimmune disease. In fact, autoantibodies are commonly found in patients with viral infections of many kinds. It seems that immune stimulation due to infection is a relatively common cause of autoantibody production. Some of these antibodies may cause injury in the affected patient But usually, after recovery, they disappear. I am unaware of any reports that a chronic autoimmune disorder has developed in a recovered COVID19 patient.
What might this have to do with vaccination? The Pfizer and Moderna vaccines induce a host immune response directed against the spike protein of the coronavirus. While some coronavirus molecules have been associated with autoantibody development, the spike protein is not one of them. This protein does not cause an infection and the only coronavirus elements involved are the mRNA coding for the spike protein, so this would not be expected to bear any relation to autoimmune disease. It remains possible that vaccination could induce an autoimmune condition in a susceptible person, but to date, this has not been reported with the COVID19 vaccines.
Because of these uncertainties and the lack of data, the American College of Rheumatology has yet to render recommendations with regard to the administration of COVID19 vaccines to patients with autoimmune disorders.
In my opinion, for patients with autoimmune disorders, COVID19 vaccination is still recommended. For those who may choose to wait a few months to see if any data emerge regarding these issues, one must balance the risk of a COVID19 infection with the theoretical risk of vaccination. It is not unreasonable to wait a few months if you are more comfortable waiting.
Operation Warp Speed and the Rapid Development of COVID19 Vaccines
Some people are wary of these vaccines due to the speed with which they have been developed. It is indeed true that in usual circumstances, it takes 10-20 years to develop a safe and effective vaccine and the COVID19 vaccines are emerging in less than a year from the first discovery of the SARS-CoV-2 virus. But not since the 1919 flu pandemic has the whole world been impacted by a new infection. The world has come together to solve this problem with billions of dollars of support from many governments and not-for-profit organizations. Never before have scores of scientists all over the world put aside their interests to focus on a solution to this pandemic. The greatest experts in infectious disease, viral biology, and vaccine development have come together in urgency to develop vaccines. In the past 9 months, there have been over 72,000 scientific articles about SARS-CoV-2 virus and COVID19 infections published in the medical literature. This circumstance is like no other in our lifetime. That is why solutions are emerging so quickly.
Some are suspicious of the pharmaceutical industry, and rightly so! The costs of new drugs in recent years are appalling; it often seems that the profits of the pharmaceutical companies are more important than their mission to cure disease. But this is a unique circumstance and in the end, all pharmaceutical companies want to develop effective and safe solutions for the population. This effort has been a cooperative one between scientists in academia, government, and the pharmaceutical industry.
Politics and the COVID19 Vaccines
Politics seem to have a way of interfering with our best intentions. Some people believe that political influences, particularly during the election season have resulted in a rush for vaccine development, possibly leading to shortcuts and oversights with regard to proper and safe vaccine production and analysis. I do not believe this to be the case. The scientists working on these vaccines, at least in the US and Europe are serious and independent experts and are doing everything to make certain that the population is as safe as possible.
There is such a wide variety of reactions to the pandemic amongst Americans. Some feel that the fear of COVID19 is exaggerated, or that mask mandates and the “shutdowns” are wrong and fear excessive government control over our lives. Others are very fearful of COVID19, wary of leaving their home, and would opt to keep all non-essential businesses closed. Whatever your position, the issue of vaccination is another matter. It is completely distinct from debates about mask use and the curtailing of economic activity. It is a matter of public health. Getting as many people as possible vaccinated not only protects the individuals receiving the vaccines, but it protects the public and provides our best opportunity to defeat coronavirus and end the pandemic.
Some have argued that natural herd immunity will result if we simply leave the virus to run its course so that 60-70% of the population has been infected while securing those at risk from serious consequences of COVID19 infection, similar to the experiment in Sweden. I consider this approach dangerous and disastrous for public health, but it actually makes little sense. In such a case, the virus will never go away; since natural immunity from infection appears to be temporary, the virus will continue to infect millions of people and the pandemic will persist! Vaccination appears to confer a much stronger immune response and protection is greater and longer-lasting than most natural infection-it offers the possibility of true herd immunity.
Others worry that vaccination will be “imposed” upon us by the government and resist the vaccine for that reason alone. This is not the case. The Federal and State governments are strongly encouraging vaccination, but citizens still have the choice to make for themselves. However, it is quite possible that businesses will require it of their employees or airlines might demand it of their customers to ensure safety for all.
The Media and Science
People get their information from many different sources. The days of the 6 O’clock news are long gone. There are now countless means to gather information, whether accurate or not, with 24h news broadcasts from numerous outlets and social media platforms of many kinds. Many people have lost faith in government and institutions and are skeptical of what they are told. Self-proclaimed experts render opinions on these platforms, regardless of their validity. Some feel that scientists are unduly influenced by politics and suspicious of their motives. Indeed, statements by even well-regarded experts and scientists are often conflicting. It is all very confusing.
But people are intelligent and can use their judgment, albeit with a healthy dose of skepticism. Consider the source. Understand the biases inherent in any source of information. Distinguish opinion from fact. Healthy skepticism is just that: healthy. It is intelligent and thoughtful. Scientists are imperfect and scientific beliefs are not always correct, but the consensus amongst scientists is the best path we have to finding the truth, even if sometimes off the mark.
Recently, there was a program on a cable TV network that spent a whole segment on the adverse effects reported in a few patients who have received the Pfizer COVID19 vaccine. All that does is increase fear and apprehension about the vaccine program and exaggerates the reality. This is a nation of 350 million people! Rare events appear on television and are made to seem common. Be wary of these reports. Be careful about outrageous claims you may hear from media outlets, like reports that nanoparticles or microchip tracking devices have been put into the vaccines so that the government can control us. That type of nonsense is silly. Keep in mind that the news media have become entertainment and fear and sensationalism is the fuel that drives it.
I already had COVID19 and recovered. Do I still need to be vaccinated?
Yes. The immunity following natural infection is variable and may not last. Vaccination is safe in this group of individuals and confers a better immune response.
How long does the vaccine last?
Unknown, at present,.The vaccine probably provides protection for at least a year or two, but we will find out in time. It may turn out that vaccination boosters are required every few years. Time will tell.
If I receive the vaccine, can I still spread the virus to others?
Probably not, but this has not yet been proven. In the case of other vaccines, those immunized do not carry and spread infection, but we do not yet know for certain. For that reason, after receiving a COVID19 vaccine, we will still have to wear masks and social distance, at least for some period of time, until we learn more and more of the public has been vaccinated so that the prevalence of COVID19 is substantially reduced in the community.
When Will the Vaccine Be Available?
This is still a bit confusing, as NY State is issuing guidelines for administration and certain distribution centers will be providing vaccines to the public. Initially, there are limited doses available, so they must be prioritized. The first shipments–for Phase 1-went to hospitals to vaccinate the front line doctors and nurses and additional provision for nursing home residents are being deployed via “hubs” that are assigned by NY State ( because the Pfizer version requires special ultra-low temp freezers, only some facilities can handle that vaccine). Phases 2-6 will be rolled out over time, as more vaccines are made available. Assuming there are no holdups in vaccine production and distribution, it looks like the high-risk populations will receive the vaccine in January and February, lower-risk individuals in March, and the general public by April.
I have registered with the NY State Bureau of Vaccination, NYSIIS( New York State Immunization Information System) of the NY State Department of Health, and the CDC and have been approved to administer COVID19 vaccines. However, since the vaccines are just now being delivered in limited quantities and mostly to hospitals and special hubs, it may be several weeks before I can provide vaccines for our patients. I have the capability to handle the Moderna vaccine, but the office does not have a suitable freezer for the Pfizer product. We will make our patients aware when we have vaccines for administration, hopefully shortly into the New Year.
Have a safe and joyous holiday season!!