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University of Nebraska Medical Center

FDA clears second bivalent COVID boosters for some Americans

CBS News

Some Americans will soon be able to get another shot of the bivalent COVID-19 vaccines, the Food and Drug Administration authorized Tuesday, including seniors ages 65 and older and people with compromised immune systems.

Seniors can get the dose as early as four months after their first shot of bivalent vaccine. Immunocompromised Americans can get more doses as early as two months after.

These additional shots will come from the same Moderna or Pfizer-BioNTech vaccines that were updated last year for the BA.4 and BA.5 variants of Omicron. 

As with previous changes, vaccinators can administer doses only after the Centers for Disease Control and Prevention issues updated recommendations. CDC Director Dr. Rochelle Walensky is expected to sign off on these changes this week.

The FDA’s new authorizations come as part of a sweeping set of revisions to streamline the myriad of immunization schedules that had been laid out for Moderna and Pfizer-BioNTech, moving them close to the annual seasonal flu shot.

“At this stage of the pandemic, data support simplifying the use of the authorized mRNA bivalent COVID-19 vaccines and the agency believes that this approach will help encourage future vaccination,” the FDA’s top vaccines official Dr. Peter Marks said in a release announcing the decisions.

Around 20% of adults and 43% of seniors have gotten their first bivalent vaccine dose so far, according to the CDC’s figures

Additional shots have already been cleared in some countries abroad. The United Kingdom began offering second doses of bivalent vaccine this month to some vulnerable residents, like those 75 and older.

The CDC said last week in a filing that officials had decided “late Monday” to convene a meeting of its outside vaccine advisers, the Advisory Committee on Immunization Practices, to weigh all of the FDA’s changes. The panel is only scheduled to discuss, but not formally vote, on COVID-19 vaccines.

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