Part 2: The Realities of The COVID Vaccine

Last month was Part I of this topic. As an overview, I started with the ending: If the full regulatory licensing process is carried out (even with Operation Warp Speed in place), a COVID-19 vaccine will likely be available for distribution well into 2021. But the vaccine will not be a magic bullet that will put an end to wearing masks and practicing physical distancing. These practices will have to continue, and it will take until 2022 before we see some “normalcy” again. Recovery from a world-wide pandemic takes time; here’s why.

In the previous column, I addressed general information about how vaccines work to build antibodies against a disease – thus it is not a cure, but a form of prevention. I also reviewed the phases of vaccine development and the challenges with the COVID-19 vaccine being that this corona virus was found in bats and crossed over to humans, making it an atypical infection for humans. I also explained why vaccine development cannot be done hastily – much of which scientists have no control over because it simply takes time for the virus to activate in the body and for the immune system to respond. Finally, the research is in progress and changing almost daily, so things have already changed since this article was written
     
One of my sources was an excellent interviewee, who addressed the COVID vaccine. His credentials are impressive: Paul A. Offit, MD, is the director of the Vaccine Education Center at Children's Hospital of Philadelphia (CHOP), and he serves as the *Maurice R. Hilleman Professor of Vaccinology at the Perelman School of Medicine at the University of Pennsylvania. An internationally recognized expert in virology and immunology, he has published more than 150 papers in medical and scientific journals. *Maurice R. Hillman is considered the “father of modern vaccines” and is credited with saving more lives than any other medical scientist of the 20th century (https://www.medscape.com/viewarticle/936937?src=mkm_covid_update_200910_mscpedit_&uac=64796DZ&impID=2558382&faf=1#vp_8).

Part II: Could we see a vaccine come out at an earlier date?
Yes, if the office of the presidency and its administration approve an Emergency Use Authorization (EUA) for a vaccine. The federal government could choose to push to truncate the studies prior to the completion of a phase 3 trial and pull out a vaccine for use. But even if this occurred, submitting data does not signify that the vaccine will be ready for distribution, nor does it mean Americans will be immediately inoculated (https://www.sciencemag.org/news/2020/08/here-s-how-us-could-release-covid-19-vaccine-election-and-why-scares-some). EUA would be risky and highly unlikely. Why?

1. The American public is already skittish about the way the federal government has mismanaged COVID-19. Many would likely decline the vaccine and this would end in the failure of curtailing this corona virus infection. The domino effect would be a further delay in getting our nation, especially our economy, into recovery mode.
2. The use of EUA already has two strikes against it with the approval of hydroxychloroquine and convalescent plasma. Both failed, and the current administration would have a big 3rd strike if a vaccine for the whole nation failed because it was pushed out a few months to a half year too early.
3. The company, who develops the vaccine, is ultimately liable for this EUA decision.  We already have Operation Warp Speed in place; adding another layer of speed would pile on the risks. It will mean the company’s reputation is on the line. The company would be taking a big risk to push out a vaccine – to an entire nation – that is unsafe or ineffective. “Many of these companies have other vaccines, international portfolios of vaccines, and that would tarnish all of them”(https://www.medscape.com/viewarticle/936937?src=mkm_covid_update_200910_mscpedit_&uac=64796DZ&impID=2558382&faf=1#vp_8).  

Who Develops Vaccines?
Vaccines have traditionally been researched and developed by pharmaceutical companies (Pfizer, Merck & Co, Johnson & Johnson, Clover). However, many pharmaceuticals started getting out of the vaccine research business because it was so expensive and not profitable. Now with COVID-19, pharmaceutical companies have jumped back into the research arena. The financial gain will be enormous. In addition to universities, biotech companies (BioNTech, CureVac and Moderna) and research labs doing vaccine research, these companies are also working in conjunction with each other. For example BioNTech and Pfizer are working together; AstroZeneca is working with Oxford; and Alexion and Lilly are working with the NIHR Cambridge Biomedical Research Centre and the Cambridge Clinical Trials (https://www.cnbc.com/2020/03/17/hopes-of-a-coronavirus-vaccine-mount-as-three-key-biotech-players-make-progress.html).

Who Approves Vaccines?
After clinical trials are completed and before vaccines are produced and distributed, the data goes through the following approval boards:

1. Usually the Data Safety Monitoring Board (DSMB) evaluates the research data. This is  multidisciplinary group, including people who are experienced with clinical trials, biostatisticians, bioethicists, immunologists, vaccinologists, and virologists. They review “blinded” data at all of the phase 3 clinical trials in order to move toward vaccine approval. This board can carry out a “stopping rule” of the research for either a problem with the study (deaths or severe adversities) or if the study is overwhelming pointing toward effectiveness. The DSMB is independent of the government and companies and members are not paid; they are academicians.
2. The manufacturer submits an application for licensing of the vaccine to the FDA (Food and Drug Administration). FDA files a biologics license application; the VRBPAC (Vaccine and Related Biological Products Advisory Committee) reviews the data at a public meeting, then votes on whether the vaccine should receive approval – a recommendation by the FDA normally follows (https://abcnews.go.com/Health/vaccine-developers-hustle-meet-fda-data-requirements-submit/story?id=72886902).
3. Then the data is reviewed by the FDA Advisory Committee, which makes recommendations to the FDA Commissioner. The FDA Commissioner can honor the recommendation or override it. The FDA is an agency of the United States Department of Health and Human Services. The commissioner is appointed by the president of the United States and must be confirmed by the Senate.
4. As part of the typical approval process, the inspection of the vaccine’s manufacturing plants can often take 1 year (https://www.sciencemag.org/news/2020/08/here-s-how-us-could-release-covid-19-vaccine-election-and-why-scares-some).

What are Some of the Concerns for a COVID-19 Vaccine?

• Dr. Offits states: “I wish there was a little more humility from some of these companies. They're always sort of pounding their chests as to how they're going to have this vaccine. I think, just in the past day, the CEO of Pfizer said, ‘I think we can have a vaccine by the end of October.’ I'm sorry; are you on the Data Safety Monitoring Board (DSMB)?” (https://www.medscape.com/viewarticle/936937?src=mkm_covid_update_200910_mscpedit_&uac=64796DZ&impID=2558382&faf=1#vp_8).  
  
• The U.S. will need at least 400 million initial doses, (or as many as 700 million depending on which vaccine candidate is approved). Worldwide, the demand is two billion. Kaiser Health News announced that the U.S. is experiencing a huge setback in the development of a vaccine because we are no longer a part of the World Health Organization (WHO). On a daily basis, participants in WHO share critical data including disease surveillance, research and emergency response and vaccine development ideas. Since our withdrawal in July 2020, we are missing out on all of this.
• Because we cannot wait years for the vaccine studies to be done, we will not be able to rule out rare side effects from the vaccine until after it is in use. As long as we stay on track with Operation Warp Speed and not be forced by the current administration to take on Emergency Use Authorization, we will at least know the common and uncommon side effects of the vaccine.
• The research studies are being carried out with mostly healthy, fairly young, Caucasian testing pools. This is because this virus adversely effects the greater-than-65-year-old population, certain minority groups, obese people and persons who are compromised with health issues. As a result, there will not be adequate data to substantiate these groups getting the vaccine. Yet, these are the people more likely to die from COVID-19.

There is hope:

• We have the technology and systems in place to move vaccine development and production much faster than in the past; we just need to be smart and patient in order to carry it out in the most effectual manner.
• Once we know the characteristics of these vaccines, it'll be much easier to try to explain what we know and what we don't know. It is best to be honest and transparent about this to earn the public’s trust.
• Depending on who is in office, we could see the government actually offer the vaccine for free. That would be the ethical thing to do in my opinion, especially since the American public has already paid billions in tax dollars for vaccine research.

We have to accept that this vaccine is not the magic bullet to make it all go away. There are two ways to stop this virus: One is hygienic measures — face masks, physical  distancing, and handwashing — and the other is the vaccine. Initially the COVID vaccine effect could actually increase the number of people who are asymptomatic carriers. There will be vulnerable populations who cannot be vaccinated right away. Thus, people have to have realistic expectations: We will still need to wear masks and practice physical distancing and handwashing. With hygienic measures and a vaccine, we will be able to bring this virus under control. That is – if Americans do care about each other and recognize that we are a community, dependent on each other for many things, including survival. And America cannot practice isolation when it comes to this virus; we are connected to the world.
     Note: Medscape requires a login registration; it is free.
Charlotte Michos is a clinical nurse specialist who values personal-centered care and serves as a Healthcare Consultant in helping others make informed decisions. For more information, email her or call (845) 548-5980.