FDA Clears 4th COVID-19 Shot for All Americans Aged 50 and Above

U.S. drug regulators on March 29 announced they’ve granted emergency authorization for a second booster of the Pfizer and Moderna COVID-19 vaccines

The Food and Drug Administration (FDA) is allowing a fourth dose of the jabs to all Americans aged 50 and above.

In addition, Americans aged 12 above with weakened immune systems may get Pfizer’s second booster, and Americans over the age of 18 who are immunocompromised may get a second booster of Moderna’s jab.

Both vaccines are built on messenger RNA technology and both are administered in two-dose primary regimens.

Initially promoted as highly effective against both infection and severe disease from the CCP (Chinese Communist Party) virus, which causes COVID-19, the vaccines have performed worse against later strains of the virus, prompting the FDA in 2021 to clear booster doses for many Americans.

But the protection from a single booster shot against infection rapidly wanes, and its shielding against hospitalization also drops over time, paving the way for the new clearance.

“Current evidence suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these higher-risk individuals.”

Most of the data the FDA cited comes from Israel.

That includes surveillance data of Israeli’s Ministry of Health from approximately 700,000 second boosters of Pfizer’s shot, which the regulator said revealed no new safety issues.

Another piece was an ongoing open-label, non-randomized clinical study in health care workers at a single site, which found minimal potential benefits for young, healthy people from an additional Pfizer shot.

The only data cited for Moderna’s authorization was described as “an independently conducted study” in which 120 people who received a two-dose primary series of one vaccine and a first booster of Pfizer’s shot received a Moderna shot for a second booster. But the study only informed the view on safety, revealing no new safety concerns during the three weeks of follow-up.

The FDA didn’t immediately respond to a request for comment for a citation for the Moderna study, nor did Moderna, which did not mention such a study in a press release.

Other data from Israel indicates protection against infection from a second booster quickly drops. Protection against hospitalization was largely maintained, but that is already high after the first booster.

The FDA did not convene its expert advisory panel before clearing the second boosters, though it has a scheduled meeting with the committee on April 6.

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