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John Campbell

Questions for FDA

Bywebmaster

May 27, 2024



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

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

Source

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111 thoughts on “Questions for FDA”

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