# Questions for FDA

Page: https://stenobird.com/podcast/dr-john-campbell-7851784/questions-for-fda
Text version: https://stenobird.com/podcast/dr-john-campbell-7851784/questions-for-fda.md
Podcast: [Dr. John Campbell](https://stenobird.com/podcast/dr-john-campbell-7851784)
Published: 2026-09-06T19:30:00+00:00
Episode link: https://traffic.megaphone.fm/VG4604255591.mp3
Audio file: https://traffic.megaphone.fm/VG4604255591.mp3
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JSON: https://stenobird.com/v1/public/podcasts/dr-john-campbell-7851784/episodes/questions-for-fda
Duration seconds: 1203

## Resource

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…

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