Pfizer ask FDA to authorise COVID booster in adults
pharmafile | November 10, 2021 | News story | Research and Development |
Pfizer have requested that the FDA authorise booster shots of the COVID-19 vaccine in all Americans 18 and older, citing data from a 10,000-person trial which found third shots of the vaccine to be safe and effective for adults of all ages. The request follows the authorisation of Pfizer boosters for seniors and other higher-risk adults.
An FDA advisory panel voted against a request for all adults to have a booster in September. Experts at the FDA and CDC stated that they needed more data on how the booster jab might affect young people, and whether the shot was necessary considering the enduring protection from the vaccine against hospitalisation and death observed in that group.
Currently, those who received Pfizer or Moderna COVID vaccines six or more months ago may get a booster if they are 65 years or older, at risk of severe COVID because of a medical condition such as diabetes, kidney disease or pregnancy, or at higher risk because of work or living conditions.
Pfizer have stated that new data from a large clinical trial of over 10,000 fully vaccinated individuals found a booster dose over 95% effective against COVID-19, compared to those who were fully vaccinated but did not receive a booster dose. The efficacy of the booster dose was consistent across different ages, racial and ethnic groups.
The company stated in a press release: “there were 5 cases of COVID-19 in the booster group, and 109 cases in the non-boosted group.”
Nearly 25 million booster doses have been administered in the US, and nearly a third of those who are 65 and older and fully vaccinated have received a booster. Around 67.5% of the US population has had at least one vaccination dose.
Ana Ovey
