Risk-Benefit Analysis of COVID-19 Vaccines
Data Problems
Any application of statistics is no better than the quality of the data. In the case of the COVID-19 vaccines, there are tremendous conflicts of interest.
Defintions Gamed
Risk Benefit New York Times OpEd
Are We Testing Coronavirus Vaccines the Right Way?
We may not find out whether the vaccines prevent moderate or severe cases of Covid-19.
By Peter Doshi and Eric Topol Sept. 22, 2020
Dr. Doshi is an associate professor at the University of Maryland School of Pharmacy. Dr. Topol is a professor of molecular medicine at Scripps Research.
Third, even if the studies are allowed to run past their interim analyses, stopping a trial of 30,000 or 44,000 people after just 150 or so Covid-19 cases may make statistical sense, but it defies common sense. Giving a vaccine to hundreds of millions of healthy people based on such limited data requires a real leap of faith.
Declaring a winner without adequate evidence would also undermine the studies of other vaccines, as participants in those studies drop out to receive the newly approved vaccine. There may well be insufficient data to address the aged and underrepresented minorities. There will be no data for children, adolescents and pregnant women since they have been excluded. Vaccines must be thoroughly tested in all populations in which they will be used.
None of this is to say that these vaccines can’t reduce the risk of serious complications of Covid-19. But unless the trials are allowed to run long enough to address that question, we won’t know the answer.
The trials need to focus on the right clinical outcome — whether the vaccines protect against moderate and severe forms of Covid-19 — and be fully completed. It is not too late for the companies to do this, and the Food and Drug Administration, which reviewed the protocols, could still suggest modifications.
These are some of the most important clinical trials in history, affecting a vast majority of the planet’s population. It’s hard to imagine how much higher the stakes can be to get this right. Cutting corners should not be an option. 1)
Link Drop
Steve Kirsch - Vaccine Risk Benefit by Age
https://docs.google.com/document/d/1IxbeUIczuy6MntYkSWu3N7qKI28KzwW8GvZpu6G0JKk/
https://gummibear737.substack.com/p/covid-19-and-vaccination-risks-in
Toby Rodgers Substack article titled What is the number needed to vaccinate
ACIP Presentation Slides: June 23-25, 2021 Meeting
COVID-19 mRNA vaccines in adolescents and young adults: benefit-risk discussion
ACIP meeting presentation on November 2-3, 2021 titled mRNA COVID-19 Vaccine-Associated Myocarditis
Evidence to Recommendation Pfizer-BioNTech COVID-19 vaccine in children aged 5–11 years
Sara Oliver MD, MSPH
ACIP Meeting
November 2, 2021
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-11-2-3/08-COVID-Oliver-508.pdf
Use of mRNA COVID-19 Vaccine After Reports of Myocarditis Among Vaccine Recipients: Update from the Advisory
Committee on Immunization Practices — United States, June 2021
Weekly / July 9, 2021 / 70(27);977–982
https://www.cdc.gov/mmwr/volumes/70/wr/pdfs/mm7027e2-H.pdf
Use of COVID-19 Vaccines After Reports of Adverse Events Among Adult Recipients of Janssen (Johnson & Johnson) and mRNA COVID-19 Vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee on Immunization Practices — United States, July 2021
Weekly / August 13, 2021 / 70(32);1094-1099
https://www.cdc.gov/mmwr/volumes/70/wr/pdfs/mm7032e4-H.pdf
Science Direct https://www.sciencedirect.com/science/article/pii/S221475002100161X