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
