The US FDA has given the go ahead for the use of a third dose of the Pfizer–BioNTech COVID-19 vaccine in the over 65s and higher risk groups
The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for a third dose of the Pfizer–BioNTech COVID-19 vaccine for those aged 65 years and over, and for Americans who are at a higher risk of severe illness from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This includes essential workers whose jobs increase their risk for infection.
The Advisory Committee on Immunization Practices (ACIP), a panel of the Centers for Disease Control and Prevention (CDC), is expected to vote today to instruct doctors on how to administer the boosters, following a 2-day meeting.
Acting FDA Commissioner Dr Janet Woodcock said in a press release: ‘After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer–BioNTech COVID-19 vaccine to allow for a booster dose in certain populations such as healthcare workers, teachers and day care staff, grocery workers, and those in homeless shelters or prisons, among others.’
Last week, an FDA advisory panel determined that the benefits of a booster dose outweigh the risks for those now authorised to receive it.
The CDC’s ACIP panel also discussed situations the FDA will still need to consider, such as what should be done for Americans who were originally vaccinated with a Moderna or Johnson & Johnson vaccine. They are not covered under the revised EUA, which is only for those who received the Pfizer–BioNTech two-dose vaccine regimen.
‘That’s going to leave half of the people immunised in this age group having received the vaccine and being told that they’re at risk now for waning immunity and hospitalisation unable to get a booster dose,’ said committee member Dr Sarah S Long, Professor of Paediatrics at Drexel University College of Medicine in Philadelphia, Pennsylvania. ‘So that’s a big public health panic that we would like to avoid.’
Earlier this week, Johnson & Johnson reported that second doses of its vaccine boosted efficacy to almost 94% against COVID-19. A new study, published ahead of peer review, suggests that the efficacy of the single-dose Johnson & Johnson COVID-19 vaccine has fallen to about 78% against symptomatic infection during the surge of the Delta variant of the SARS-CoV-2 virus.
Moderna has also applied for permission to market third doses of its vaccine in the USA, but the FDA has yet to indicate when it might make a decision.
This article originally appeared on Medscape, part of the Medscape Professional Network.
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