I am a former emergency nurse who was diagnosed with a primary immune deficiency ten years ago. I certainly have a vested interest in a successful vaccine for this horrible pandemic that has killed so many, left millions with chronic illness, and taken the lives of my colleagues who gave their lives caring for others.
However, the over-the-top celebrations of the initial vaccinations of health care workers leave me cold. Virtually every health care provider who received an injection on camera did so in front of a sign or media wall promoting their employer. The theory is that seeing people receive the vaccine will ease the concerns of the general public. Trust is the cornerstone of public health practice. If community members do not trust the authority figures, they are less likely to follow recommendations, like vaccination. Principles of Community Engagement notes:
Go to the community, establish relationships, build trust, work with the formal and informal leadership.
How can we establish trust in communities at particular risk for COVID-19 infection who will need to be vaccinated? By enlisting the formal and informal leaders within those communities. That is not an anonymous doctor on television. It’s a respected community member — a faith leader, a community worker, a mobile health outreach van, or perhaps a local elected official. The ideal health influencer is the provider who knows his or her patients, develops personal relationships with them, and treats them with respect. Then the patient is more likely to have confidence in his or her recommendations.
Sadly, we live in a world where prominent officials talk about “alternative facts,” and trust in the government is at an all-time low. Thus, the key to vaccination will be hyper-local thought leaders that community members believe, have confidence in, and listen to. If those thought leaders are misinformed, and people refuse the vaccine, this pandemic will not end. It’s that simple. At least 70% of the population has to be vaccinated before we can begin to think about shedding our masks and gathering together for the holidays next year. Melissa Ryan, a former colleague of mine, was quoted in the New York Times, discussing the misinformation crisis about vaccines. She started her Boston consulting firm to help people, policymakers, and organizations fight disinformation, extremism, and online toxicity. We may need to classify her as an essential worker who needs priority status to be vaccinated. Her work will be critical if we ever hope to get 70% of Americans fully protected.
In this article, I’ll address the questions I’ve been asked most often about the vaccines. In part two, I’ll give you the background on how we got where we are today. In short: SCIENCE!
As additional vaccines complete clinical trials and are given emergency authorizations for use, the answers to these questions will likely change. The first two vaccines, from BioNTech-Pfizer and Moderna, use the same biochemical technique, messenger RNA (or “mRNA”). Other vaccines will be handled, stored, and administered differently. For example, it’s 21 days between the Pfizer vaccine doses 28 days between Moderna’s.
How can I trust a vaccine that researchers developed in less than a year?
The first work on coronavirus vaccines began in 2003, following the SARS outbreak that reached Toronto. So, these vaccines have been in development for the better part of 17 years. The researchers had a running start. I didn’t see any corners cut in the science when I looked at the data from Pfizer researchers’ initial presentation to the FDA. Never before has there been so much money and cooperation among industry, governments worldwide, and academia with experts working 24/7 to find a solution.
The full clinical study for the (Pfizer) BNT162b2 vaccine was peer-reviewed and published in the New England Journal of Medicine (no subscription required). To summarize, 21,720 people received the vaccine, and 21,728 received a placebo. Eight people who received the vaccine got COVID-19 infections. There were 162 infections in those who did not receive the vaccine, 9 of which were severe. One severe case occurred in a vaccinated patient.
I expect clinical trial results will be published after full peer review once companies submit subsequent vaccine data to the FDA. After providing the research data to the members, the pharmaceutical company must make a day-long presentation to the Vaccines and Related Biological Products Advisory Committee. This advisory committee comprises independent experts that provide recommendations to the FDA — they are not members of the FDA and disclose conflicts of interest for any particular review. I trust their analysis and am firmly in favor of vaccination, based on what we know now.
95% efficacy sounds impossible. How did they come up with that?
I had the same thought when the first press release came out. (Expert tip: never consider medical decisions based on press release information.) The 95% efficacy is for people who went about their everyday lives, using precautions anyone would use (or not use) these days. The researchers did not intentionally place SARS-CoV-2 in the volunteers’ noses to see what happened. That would be unethical at this stage since there is no cure for the infection, and volunteers could die from their participation. Still, researchers are looking at the possibility of a human challenge trial in London early next year.
So, does that mean I can ditch my mask after my second shot?
NO! We have to depend on one another to encourage enough people to get vaccinated to extinguish this virus. The vaccine is not 100% effective.
Will I be able to spread the virus after I’m vaccinated?
Most vaccines against viral illness also limit disease transmission by limiting virus shedding (like influenza). We don’t know if that will be the case for this messenger RNA vaccine against COVID-19. Researchers will need to track this aspect of real-world vaccine use as millions of people receive doses. It is one more reason for you to continue to wear a mask.
How long will I be protected?
Nobody knows. That is the one compromise with the speed the vaccines are getting to market — researchers will have to conduct that follow up on the millions of people who get vaccinated. Fortunately, health care workers are in the first group to be vaccinated, and they are easy to monitor over time for this follow-up. At worst, recipients will need boosters. The goal is to incorporate it into annual influenza vaccines if boosters become necessary.
Which is better? Natural immunity after having COVID-19, or immunity from the vaccine?
Traditionally, immunity is protective, regardless of how the body develops antibodies and memory cells for the virus. But, again, with a new virus never encountered before, there are many unanswered questions. We don’t know how long immunity lasts in people who’ve had the disease. Does a severe case confer immunity that lasts longer? What about people with no symptoms? The Red Cross has continued to examine how long antibodies are detectable in blood because they screen plasma donations from those who had the disease to be used therapeutically as convalescent plasma. After other coronavirus infections, such as SARS, the organization noted antibodies started to decline once the infection cleared. They believe this loss of protection may be accelerated in those with mild symptoms or none at all.
Was this vaccine tested in at-risk groups?
Yes and no. 41.9% of Pfizer’s study participants identified as persons of color. The median age was 52 with a range of 15 to 91, 35% had a BMI ≥ 30.0 (obese), and 21% had at least one pre-existing health condition. Researchers did not design the study to test efficacy specifically in these populations, so they could not conclude any one group. The goal was to represent a cross-section of a general population. Of note, for ethical reasons, pregnant women and children were excluded from this first trial.
What are the side effects?
Pain at the injection site, redness, swelling, and low-grade fever were the most common effects felt after the first injection. After the second injection, symptoms were more pronounced and included fatigue, headache, and muscle pain. Some people from the trial suggested getting the second injection on a Friday or scheduling the next day off from work to rest. Those symptoms are evidence of the immune system responding to the foreign material injected. The first injection primes the immune system, and then the second injection locks in the antibody and memory cell response.
What about these allergic reactions?
In the real world, just about anybody can be allergic to almost anything. Some people need significant exposure, while others need very little (that’s why there are no more peanuts offered on airplanes). That said, there have already been reports of two nurses who needed treatment in the hospital after vaccination. People who receive the vaccine must be observed before they leave. Once public vaccination begins, the plan in suburban areas is to vaccinate people while they sit in their cars. Workers will then direct the cars to a special parking area monitored by paramedics. If a recipient feels symptoms, they will honk their horn for immediate attention. Organizers will make other arrangements for urban areas and for people who use public transportation to get to the vaccination site.
The BioNTech-Pfizer vaccine consists of a tiny piece of messenger RNA that contains the genetic code of the protein on the spike of the virus. Since it is fragile, it is encased in a bubble, primarily made of lipids (fats) to be carried into the body. Once thawed, it is mixed with normal saline (saltwater) to make a fluid that is injected. Any micro-component could trigger an allergic reaction or the allergy related to the needle or the skin prep before it is inserted. Clinicians are required to report data on any severe allergic reactions (as with any drug). The manufacturer will analyze the data. The Moderna vaccine is produced in liquid form, but it also has inert ingredients that allow the fragile messenger RNA to be carried into the body through the injections.
In any case, we are very good at treating allergic reactions that occur while we’re observing a patient after an injection or treatment. Even an overnight hospitalization for monitoring after an allergic reaction is far less resource-intensive and life-threatening than a COVID-19 illness. When considering a risk-benefit decision, I’d take the vaccine without hesitation. (And I have been hospitalized for a full-blown anaphylactic reaction to an injected medication.)
Can I get the shot if I have respiratory symptoms, like a cough or runny nose that could be from allergies?
The official instructions for use list known allergies to any components as a reason to avoid this vaccine. You’d need to discuss your symptoms with your health care provider who knows you (ideally) or the person who is giving you the vaccine.
When can I get my vaccine?
It depends. But don’t hold your breath. From the beginning of this process, the Trump administration decided that the states should control resource allocation decisions, including PPE, ventilators, key drugs, testing, and now vaccines. The New York Times has published a Vaccine Distribution Tracker, but keep in mind those data are provided by the Department of Health and Human Services, which may or may not be giving the media accurate data. Many news organizations are working on a tracker that charts doses received by each state, not only those allocated. And, don’t forget, these first vaccines each require two doses. Also, the new Biden administration may centralize more decision-making — we don’t know yet.
What is not up for debate is the groups that get priority vaccination: health care workers, first responders, and residents and staff of long-term care facilities. Each state can tweak those categories based on how many doses they get. (Pfizer, for example, is holding back one dose for each shipped to ensure that every person will get the required two doses.) There are approximately 21 million health care workers and 3 million nursing home residents and staff within a U.S. population of 331 million. The first doses allocated? 2.9 million.
If you want to see where your state stands, check the Vaccine Distribution Tracker (above) and then go to the Vaccine Allocation Planner. This tool was designed to help states determine, by county, where they should send the product they receive.
For example, I live in Connecticut, where the number of high-risk health care workers is 214,802; first responders, 20,044; and older adults in residential homes, 25,849. That makes a total for the first wave 260,695 people. Assuming the initial pool is 10 million doses and that those doses are distributed proportional to population, Connecticut would get 104,210 doses for 52,105 people (2 doses per person). If the vaccines are distributed by population within the state, each county will get 20% of needed vaccinations. Suppose 10 million total doses distributed across the U.S. cover 20% of our highest risk residents. Then we will need 50 million total doses distributed across the nation to cover our highest risk residents. Go to the site and play with the numbers your state will need. That will give you an idea of where you might be in the cue.
The National Academies of Sciences, Engineering, and Medicine published a consensus report on equitable allocation of COVID-19 vaccine, as has the CDC’s Advisory Committee on Immunization Practices (ACIP). However, Health Affairs has published a detailed exposition on how the CDC and FDA have been politicized during this pandemic as a prologue to the authors’ recommendations on protecting these precious internationally renowned health resources from harmful political interference in the future. I cannot endorse recommendations from the CDC until a new administration takes over and has had time to review guidance documents published on the Center’s Web site.
Moderna has promised 200 million doses to the U.S. government by the end of JUNE 2021. The mRNA vaccine is the first product this company has brought to market. The government placed an order for 100 million doses with BioNTech/Pfizer in July of 2020, to be delivered after the vaccine obtains an emergency use authorization, which happened last week. Moderna has promised 20 million doses by the end of December.
If we get lucky, we might be able to get our health care workers and nursing home residents vaccinated by early 2021. Then, who’s next? ACIP says the next group should be “critical risk workers,” teachers, and school staff (and ACIP delays first responders to this second wave). NASEM says the second group should be people with significant pre-existing conditions and older adults who live in overcrowded or congregate settings. Who is a critical risk worker? The American Bankers Association has asked the CDC to designate bank tellers as priority workers who should get vaccines right after the first wave and before people with medical conditions.
So when can you expect to get vaccinated? It depends on whether you work in health care and take care or transport patients with COVID-19. There are also those who live and work in a nursing home. These groups will be the focus of the next month or two. Then, it sounds like y industry groups, unions, advocacy groups, and any other group that believes it has a particular need for getting ahead of others will be actively lobbying the states for their place in line.
For now, I am thrilled that our front-line workers who are exposed day-in and day-out are finally getting protection, as are the patients in long-term care at the highest risk for dying from this horrific pandemic. For the rest of the population, it’s going to be a while. Realistically, I hope I will be able to resume my local theater subscriptions for the fall 2021-2022 season and maybe hug my loved ones next Christmas.