FDA Authorizes Fourth COVID Doses for Many Americans

March 29, 2022 — The FDA said Tuesday it has approved fourth doses of COVID-19 vaccines for many Americans to protect the most vulnerable from severe COVID-19 illness, hospitalization, and death.

According to an FDA press release, anyone over the age of 50 and people over the age of 18 who have had a solid organ transplant or have a similar level of immune risk are now eligible for a second Pfizer or Moderna booster vaccine.

“Based on an analysis of new data, a second booster dose of Pfizer-BioNTech or Moderna’s COVID-19 vaccine may help increase levels of protection for these at-risk individuals,” Peter Marks, MD, director of the FDA Center. “Furthermore, the data show that the initial booster dose is critical to protect all adults from the potentially severe effects of COVID-19.”

“Therefore, those who have not received their initial booster dose are strongly encouraged to do so,” he said.

Along with the data provided by each company, the FDA also reviewed data from an ongoing study in Israel evaluating the immune response to the fourth dose among healthcare workers at a medical center. All workers received the Pfizer vaccine as their first booster. A total of 154 people received a second Pfizer booster, and another 120 received a second Moderna booster.

The fourth dose increased the level of neutralizing antibodies against coronavirus compared to the levels that people had 5 months after the first revaccination.

None of the data reported new security issues.

The FDA says it will continue to review data on the safety and efficacy of the second booster in other age groups.

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