Questions for FDA

Peter Doshi, senior editor, The BMJUploaded 25-08-21The FDA should demand adequate, controlled studies with long term follow up, and make data publicly available, before granting full approval to covid-19 vaccineshttps://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, 2021https://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.aspxBNT162b2 is highly effective with 91.3% vaccine efficacyData cut-off date was 13 Marchmeasured seven days through up to six months after the second doseSix Month Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine, (Published 28 July)https://www.medrxiv.org/content/10.1101/2021.07.28.21261159v1Ongoing phase 3 covid-19 vaccine trialVE 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 monthsFDA Approves First COVID-19 Vaccine, (23rd August)https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccineBased 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 infectionJuly 25, 79.8%Age adjusted effectiveness against hospitalizationsJuly 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 infectionshttps://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 6Israel says Pfizer Covid vaccine is just 39% effective as delta spreads, but still prevents severe illnesshttps://www.cnbc.com/2021/07/23/delta-variant-pfizer-covid-vaccine-39percent-effective-in-israel-prevents-severe-illness.htmlData from June 20 and July 17Pfizer saleshttps://www.bmj.com/content/374/bmj.n2096https://www.fiercepharma.com/pharma/pfizer-now-expects-covid-19-vaccine-sales-33-5b-a-7-5b-increase-from-3-months-agoThe company now predicts 2021 sales of $33.5 billionPfizer 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 Learn more about your ad choices. Visit megaphone.fm/adchoices