FDA Approves Updated COVID Vaccines But With Restrictions

The FDA has approved updated COVID vaccines for the fall season but only for a smaller, high-risk group of people.

From the New York Times:

The agency authorized the vaccines for people who are 65 and older, who are known to be more vulnerable to severe illness from Covid.

Younger people would only be eligible if they have at least one underlying medical condition that put them at risk for severe disease. Healthy children under 18 could still receive the shots if a medical provider is consulted.

The F.D.A. also revoked Emergency Use Authorizations for the vaccines in children, which would make the Pfizer shot unavailable for children younger than 5.

Click here for a full list of those “underlying medical conditions” (HIV is on the list) that would allow a younger person to get the shot.

But — the vaccines still have to be recommended by a Centers for Disease Control and Prevention advisory committee.

And Health Secretary Robert F. Kennedy Jr. (lead photo) has shifted the makeup of that panel in recent months, reducing the panel’s size AND installing several COVID vaccine opponents.

Many insurance companies base whether or not they cover the shot on the recommendation of the CDC panel.

It’s worth noting that cases of COVID have ticked up in recent weeks. Dr. Janak Patel, an infectious disease and epidemiology specialist in Galveston, Texas, told the Times positive Covid tests reached levels of about 25 to 30 percent about six weeks ago and have remained high.

In his announcement on social media, Kennedy (a huge anti-vaxxer) listed one of his goals regarding COVID vaccines was “to demand placebo-controlled trials from companies.”

Many folks find that a bit misleading because the major COVID-19 vaccines, like Pfizer-BioNTech and Moderna, did undergo large-scale, randomized, placebo-controlled Phase 3 trials before initial approvals. Pfizer’s trial (NEJM, 2020) involved over 43,000 participants, with half receiving placebo.

His statement would seem to indicate otherwise.


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