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?
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:
What are Some of the Concerns for a COVID-19 Vaccine?
There is hope:
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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.
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