On Our Way to a Vaccine - Part 4

Covid-19 Virus

Today's blog is a follow-up to three past blogs based upon an original article titled "On Our Way to a Vaccine," which is based upon an article in the New York Times Sunday Magazine. [ Entitled: "The Development of a Vaccine for COVID-19," June 14, 2020, Page 36-43, 56. ]

Once you know the vaccine that you want to test, what's the process?

Barouch says, "Vaccine development for a new pathogen traditionally takes many years or even decades. The process includes small-scale manufacuring; Phase 1, Phase 2 and Phase 3 clinical trials; and then regulatory approval and large scale manufacturing." 1

Phase 1 Objectives

In Phase 1 all you are doing, with a limited testing audience, is determining that there are no obvious side effects. These are called "safety trials" and they usually have to go through many iterations. If satisfied with Phase 1 trials, you then move on to Phase 2.

Phase 2 & 3 Objectives

In Phase 2 you test a larger audience and by doing this you are establishing the Phase 1 findings plus you are also testing to see if the vaccine actually has a beneficial effect as well. Yancopoulos says, " For example, Phase 2 might show that a drug lowers "bad cholesterol." But that doesn't mean it prevents a heart attack. Only when you do very large, well-controlled Phase 3 testing can you prove that lowering bad cholesterol prevents future heart attacks." 2

Barouch says, "For Covid-19, developers are talking about performing as many steps in parallel as possible, as opposed to sequentially." 3

Barouch says further that this is financially risky for the developer, but in this case worth the chance and the challenge. There are issues such as safety, efficacy and manufacturing and scalability that have to be accounted for by the FDA. The developer who can best demonstrate command over these critical issues  may be one in a half dozen major players and the winner of the vaccine prize.

Recently, the US government announced that it is going to buy the Pfizer and BioNTech coronovirus (COVID_19) vaccine. The US government will pay the companies $1.95 billion upon the receipt of the first 100 million doses of BNT162, following US Food and Drug Administration (FDA) authorization or approval. The US can also acquire up to an additional 500 million doses. 4

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(1) "The Development of a Vaccine fro COVID-19," June 14, 2020, Page 40. 

(2)  Ibid

(3)  Ibid

(4)  https://www.contagionlive.com/news/breaking-us-government-buying-100-million-doses-of-covid19-vaccine 

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Contributors for this Sunday Magazine NYTimes article were:

Dan Barouch, Director, Center for Virology and Vaccine, Beth Israel Hospital, Boston, MA.

Margaret (Peggy) Hamburg, Foreign Secretary, National Academy of Medicine; previous Commissioner of the F.D.A. from 2009 to 2015.

Siddhartha Mukerjee, Associate Professor of Medicine, Columbia University.

Susan R. Weiss, Professor and Vicechairwoman of the Department of Microbiology at the University of Pennsylvania, and the co-director of the Penn Center for Research on Coronavirus and Other Emerging Pathogens.

George Yancopulos, Co-founder, President and Chief Scientific Officer of Regeneron.