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The FDA said Tuesday that it approved fourth doses of COVID-19 vaccines for many Americans to protect the most vulnerable people against severe COVID-19 illness, hospitalization, and death.
According to an FDA news release, anyone over 50, and people over 18 who have gotten a solid organ transplant or have a similar level of immune risk, are now eligible for a second booster of either the Pfizer or Moderna vaccine.
“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,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in the release. “Additionally, the data show that an initial booster dose is critical in helping to protect all adults from the potentially severe outcomes of COVID-19.”
“So, those who have not received their initial booster dose are strongly encouraged to do so,” he said.
Along with data submitted by each company, the FDA also reviewed data from an ongoing study in Israel assessing immune response to a fourth dose among health care workers at a health care center. All the workers received the Pfizer vaccine as their first booster shot. A total 154 people received a second booster with the Pfizer vaccine, while 120 others received a Moderna second booster.
The fourth dose increased neutralizing antibody levels against the coronavirus, compared to the levels people had 5 months after the first booster.
No new safety concerns were reported in any of the data.
The FDA says it will continue reviewing data on safety and efficacy of a second booster in other age groups.
Sources:
FDA: “Coronavirus (COVID-19) Update: FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines for Older and Immunocompromised Individuals.”
Damian McNamara is a staff journalist based in Miami. He covers a wide range of medical specialties, including infectious diseases, gastroenterology, and critical care. Follow Damian on Twitter: @MedReporter.
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