Questions for FDA

Peter Doshi, senior editor, The BMJ The FDA should demand adequate, controlled studies with long term follow up, and make data publicly available, before granting full approval to covid-19 vaccines https://blogs.bmj.com/bmj/2021/08/23/does-the-fda-think-these-data-justify-the-first-full-approval-of-a-covid-19-vaccine/ Pfizer press release, 1 April, 2021 https://investors.pfizer.com/investor-news/press-release-details/2021/Pfizer-and-BioNTech-Confirm-High-Efficacy-and-No-Serious-Safety-Concerns-Through-Up-to-Six-Months-Following-Second-Dose-in-Updated-Topline-Analysis-of-Landmark-COVID-19-Vaccine-Study/default.aspx BNT162b2 is highly effective with 91.3% vaccine efficacy Data cut-off date was 13 March measured seven days through up to six months after the second dose Six Month Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine, (Published 28 July) https://www.medrxiv.org/content/10.1101/2021.07.28.21261159v1 Ongoing phase 3 covid-19 vaccine trial VE against COVID-19 was 91% (95% CI 89.0-93.2) through up to 6 months of follow-up, The current report provides updated efficacy analyses conducted on cases accrued up to March 13, 2021. Efficacy, an average decline of ~6% every 2 months FDA Approves First COVID-19 Vaccine, (23rd August) https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease. New COVID-19 Cases and Hospitalizations Among Adults, by Vaccination Status — New York, May 3–July 25, 202, (Published 18th August) https://www.cdc.gov/mmwr/volumes/70/wr/mm7034e1.htm?s_cid=mm7034e1_w (NY data) Protection against infection July 25, 79.8% Age adjusted effectiveness against hospitalizations July 25, 91.9% to 95.3% During May 3–July 25, 2021, the overall age-adjusted VE against new COVID-19 cases for all adults declined from 91.7% to 79.8%. During the same period, the overall age-adjusted VE against hospitalization was relatively stable, ranging from 91.9% to 95.3%. Israel sees drop in Pfizer vaccine protection against infections https://www.reuters.com/world/middle-east/israel-sees-drop-pfizer-vaccine-protection-against-infections-still-strong-2021-07-05/ Vaccine effectiveness in preventing both infection and symptomatic disease fell to 64% since June 6 Israel says Pfizer Covid vaccine is just 39% effective as delta spreads, but still prevents severe illness https://www.cnbc.com/2021/07/23/delta-variant-pfizer-covid-vaccine-39percent-effective-in-israel-prevents-severe-illness.html Data from June 20 and July 17 Pfizer sales https://www.bmj.com/content/374/bmj.n2096 https://www.fiercepharma.com/pharma/pfizer-now-expects-covid-19-vaccine-sales-33-5b-a-7-5b-increase-from-3-months-ago The company now predicts 2021 sales of $33.5 billion Pfizer and BioNTech now expect to deliver 2.1 billion doses of Comirnaty worldwide this year and manufacture 3 billion. (at average price of $15.95) 2022 production capacity at 4 billion doses Learn more about your ad choices. Visit megaphone.fm/adchoices