FDA eases on COVID-19 vaccination, but did they go far enough? Q&A 152. Dr. Peter McCullough says New England Journal of Medicine article by Drs. Prasad and Makary and new FDA framework on COVID-19 shots misses the mark (05/22/25, podcast 58 min)

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Cardiologist and internist Dr. Peter McCullough — who held high initial hopes for COVID shots but over time realized their severe harms and has publicly and repeatedly called for them to be pulled from the market — lays out the shortcomings of the FDA COVID-19 Recommendations (timestamp 00:28 - 28:06).

Background

The FDA introduced a major policy shift, limiting routine annual COVID-19 vaccine approvals for healthy younger adults and children. The new framework limits the type of testing needed for adults 65+ and those with health risks but requires large, lengthy studies for vaccines targeting healthier populations.

ED NOTE
“High risk groups” includes pregnant and recently pregnant women as well as inactive people and smokers (who, surprisingly, tolerated COVID-19 better than non-smokers). These people, especially pregnant women, should NOT receive COVID shots. See first image below.

This change, detailed in the New England Journal of Medicine, could affect 100-200 million people’s access to annual COVID shots, especially those wishing to take them “free” via government or insurance programs.

Pro-COVID shot critics of the FDA change, including Dr. Paul Offit (who is widely discredited among those who have studied these products seriously), warn the policy may make COVID shots less likely to be covered by insurance and less available to those who want them (an increasingly small number as the word gets out about their harms).

For detailed links and references see Substack Note:

FDA Says No Licenses for COVID-19 Vaccines for Many Americans Without Trial Data. The trials ‘can provide reassurance that the American repeat-boosters in-perpetuity strategy is evidence-based,’ officials said.

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