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WASHINGTON: The United States (US) on Friday authorized Pfizer and Moderna COVID-19 vaccine boosters to all people aged 18 and older, the Food and Drug Administration (FDA) said.
The regulator’s decision paves the way for millions of Americans to get additional protection and is aimed at addressing waning protection among fully vaccinated Americans in the face of Delta variant-driven breakthrough cases of the illness.
Boosters were previously available to the immune compromised, over 65s, people at high risk of severe disease and people in high-risk occupations. It authorised the Pfizer/BioNTech or Moderna booster for all adults who had their second dose of the vaccine six months prior.
“Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one,” Peter Marks, director of the FDA’s Center for Biologics Evaluation, said.
The final regulatory review moves to a meeting of an advisory committee to the Centers for Disease Control and Prevention (CDC) on boosters scheduled for noon on Friday, and then a recommendation from the agency’s director, who has publicly supported boosters for all.
Over 31 million Americans have already received a booster shot, but current CDC guidelines recommend extra doses only for some population groups.
The FDA said that the decision was supported by data showing that a booster of the vaccine increased the immune response in studies of both Moderna and the Pfizer/BioNTech vaccine.
Pfizer has also reported data from a large clinical study that showed a booster dose of its vaccine was 95.6% effective against the coronavirus when compared with a vaccinated group that did not get the third shot. Israeli data has also showed that administering Pfizer/BioNTech booster shots widely slowed virus transmission.
Nearly 60% of adult Americans — some 195.6 million people — are considered fully vaccinated, having received two doses of either the Pfizer/BioNTech or Moderna vaccines, or one shot of the Johnson & Johnson vaccine.