COVID-19 Vaccines: Take One for the Team

“After a thorough, rigorous, transparent review process, today’s decision by the FDA to grant emergency use authorization (EUA) for the first COVID-19 vaccine by Pfizer and BioNTech is a monumental milestone with the potential to set us on a road to recovery.” - Susan Bailey, M.D., President, American Medical Association

“Vaccines are amazing, but they can’t work miracles.” - Jason Schwartz, Ph.D., vaccination policy researcher, Yale School of Public Health

One cannot ignore the horrendous death toll and destruction that the COVID-19 pandemic wrought this past week. The recent release of two vaccines highly effective against SARS-Co-V-2 counterbalances those grim facts by giving us hope for putting an end to this pandemic. While we are still learning about the long-term effectiveness of these vaccines, they are, nonetheless, game changers. They provide us with the means by which we can ultimately reach our goal of attaining herd immunity. These vaccines only work, however, if we are willing to take them. Therefore, the goal of this Germ Gem post is to focus on this positive news and to address some of the most common questions that people may have about COVID-19 vaccines.

Are the approved vaccines effective and safe? On December 11th, the U.S. Federal Drug Administration (FDA) granted emergency use authorization (EUA) to Pfizer-BioNTech’s COVID-19 mRNA vaccine for people 16 or older. (Within three days the government had delivered this vaccine to 145 sites in the U.S.) Arriving closely on the heels of this landmark accomplishment, on December 18th, a second mRNA vaccine, developed through a partnership of the biotechnology company Moderna and the U.S. National Institutes of Health (NIH), received FDA EUA for people 18 years or older. The clinical trials of both of these vaccines demonstrated not only their extraordinary efficacy (95% for Pfizer’s vaccine and 94.1% for the Moderna vaccine) but also their safety.

The safety of the COVID-19 vaccines is a top priority for the FDA, for the Center for Disease Control and Prevention (CDC), and for many other U.S. regulatory agencies. As noted in a viewpoint article in Science on December 11 (“Ensuring vaccine safety”), “vaccines are among the most successful medical and public health measures ever implemented, and safety should be considered at every phase of vaccine discovery, development, and testing. To enhance public confidence in vaccines by providing transparency, the FDA Center for Biologics Evaluation and Research has published protocols for SARS-CoV-2 vaccine safety and effectiveness evaluation.”

The FDA has taken and will continue to take the necessary steps to ensure that any COVID-19 vaccine released for use is safe. But that does not mean that the vaccine will be without side effects. People receiving the vaccine can expect pain at the injection site and other minor side effects similar to those one might experience after receiving a flu shot. Most people are more likely, however, to experience side effects after receiving the second dose of either the Pfizer or Moderna vaccine. These can resemble the symptoms of COVID-19 (low-grade fever, chills, fatigue, headache, and fatigue). Such symptoms are not unusual with vaccines, and in fact, they show that your body is developing a robust immune response, which is, of course, what you want. The CDC has created a smartphone-based tool (v-safe) that uses text messaging to help capture information on side effects and to provide valuable information after vaccination.

In the clinical trials leading up to the approval of the Pfizer and Moderna vaccines, tens of thousands of people were vaccinated and none of these participants reported any serious health problems. Nonetheless, these companies as well as the FDA and CDC are continually on the lookout for serious reactions now that the vaccines are being distributed to the general public. Following what appeared to be severe allergic reactions linked to the Pfizer vaccine in four individuals in Britain and the U.S., the FDA assessed the situation and stated that while the vaccine is safe for people with a history of allergies, those with a history of severe allergic reactions like anaphylaxis should consult their health care provider before getting vaccinated. (Anaphylaxis to vaccines occurs about once per 100,000 to 1,000,000 doses—about the same risk as after receiving a shot of penicillin.) Also, there have been some isolated cases of Bell’s Palsy, a temporary weakness or paralysis of facial muscles, in recipients of both vaccines.

How long will immunity last after vaccination? It is too soon to know how long immunity to SARS-CoV-2 lasts even after a natural infection, so it will take some time before we know whether the COVID-19 vaccines confer long lasting immunity. Some immunologists suggest that this is the million or, given the size of the investments, the trillion-dollar question. Studies of the levels of neutralizing antibodies against the virus after vaccination suggest that these antibodies persist for at least 90 days after vaccination. But right now, no one really knows: only time will tell.

Just like we don’t know whether a vaccine will confer long lasting immunity, we don’t know whether those who already have had COVID-19 need to be vaccinated. Some experts suggest that because the vaccine is safe and it may be beneficial, even those who have had COVID-19 should get the vaccine. And we still don’t know if these vaccines work in those under 16 years-of-age or in pregnant women. We are waiting for the results of clinical trials to tell us whether these populations are protected by any of the vaccines.

What happens when SARS-CoV-2 mutates? Perhaps the most important question of all is whether the current vaccines will work if when SARS-CoV-2 mutates. SARS-CoV-2 variants that replicate more efficiently have been isolated in several areas of the world. On December 19th, the U.K. imposed a harsher lockdown on London, citing a new variant of SARS-CoV-2 that appears to be more transmissible than previous versions. At a press conference that afternoon, Boris Johnson stated, “When the virus changes its methods of attack, we must change our method of defense.” In a December 16th article in Popular Science Magazine (“There’s a new coronavirus strain in the UK, but don’t panic”), the journalist Kat Eschner, however, pointed out this new mutation is one of 4,000 strains found in SARS-CoV-2 samples around the globe. Equally important, there is no evidence that this strain causes more severe disease. This advice—namely, don’t panic—is shared by scientists at Walter Reed Army Institute of Research who are studying the mutated strain.

What resources can I trust to answer my questions about COVID-19 vaccines? Like the development of the COVID-19 vaccines, basic and public health research on COVID-19 is proceeding at warp speed, including information about the new vaccines. In addition to turning to your doctor or your state Department of Health for reliable information about the status of the vaccines, the NIH has developed a new online resource that shows how we can help to fight COVID-19 (COMBAT COVID https://combatcovid.hhs.gov). This is also a rich resource of information about COVID-19, in general, as well as on vaccines. (If you are super-interested in the topic of what’s new with vaccines, I advise that you take a look at the New York Times “Coronavirus Vaccine Tracker.”) And last but not least, the CDC’s website (www.cdc.gov) on “COVID-19 Vaccination” is an exceptional source of reliable information.

Who NOT to trust? In addition to knowing where you can find trustworthy information about vaccines, it is equally important to know where not to turn for information about COVID-19 vaccines. In 2019, the World Health Organization (WHO) identified “vaccine hesitancy” as one of the top 10 public health threats in the world. The WHO mentioned that this public health threat, which at the time was linked to an upsurge of measles throughout the world, was transmitted by campaigns of misinformation promoted by social media. It comes as no surprise that the anti-vaxxers are now working overtime to spread misinformation about COVID-19 vaccines. Thus, I recommend that you avoid social media platforms “like the plague” when seeking information about COVID-19 vaccines.

When can I get vaccinated? Providing COVID-19 vaccines for even part of the U.S. population is an enormous logistical challenge involving a complicated supply chain filled with potential bottlenecks, not to mention hundreds of millions of vaccine doses that must each be kept at the right temperature every step of the way, then administered in two doses, after varied intervals of time, in order to be effective. It is going to take time to work out all the bugs for smooth delivery of vaccines. But be patient; it will happen.

Because it will take time before adequate supplies of vaccines are available throughout the U.S. (some authorities suggest this can be achieved by late spring of next year), administration of vaccines needs to be prioritized for essential populations. States are charged with prioritization of the vaccines they receive, and although there’s some disagreement regarding who’s essential, in most states, healthcare workers and residents and staff of long-term care facilities will be the first to receive the vaccine. Workers in high priority jobs and businesses and people who are at greatest risk of severe COVID-19, including people 75 years-of-age or greater, will be offered the vaccine next. To see when you might be able to receive the vaccine, stay in touch with your health care provider and with your state’s Department of Health. They will have the information that you need.

When can I return to my pre-COVID-19 lifestyle? The vaccines are only the beginning of the end of SARS-CoV-2’s grip on humanity. Herd immunity must be achieved before any of us can return to our lives as they were before COVID-19. That means enough people (at least 70% of the population) must be vaccinated making it difficult for the virus to find people to infect. Life will start approaching something like normal once we as a society reach this goal.

In the interim, we must look at what the vaccines will do for each of us now. Getting vaccinated should put to rest one’s fear of getting seriously ill with COVID-19. The evidence from the Pfizer and Moderna clinical trials demonstrated remarkable efficacy in preventing serious illness. And because fewer people will need to be admitted to the hospital, the strain that this pandemic has put on our healthcare system should be alleviated.

The possibility is still open, however, that some vaccinated people may develop asymptomatic infection and could silently transmit the virus—especially if they come in close contact with others or stop wearing masks. Data from additional studies will be required before this is ruled out. Until that time, it is advised that people who are vaccinated should not change their behavior, that is, they need to continue to avoid close contact with friends and loved ones, wear a mask, and avoid “swapping air” with others.

The vaccines provide us with a way out of this pandemic. It is now up to each of us to take advantage of science’s incredible gift and get vaccinated. The sooner we reach herd immunity, the sooner we can doff our masks, be with loved ones and embrace friends and family. How quickly this can be achieved depends in a large part on us. Are you willing to take one for the team? I am.