FDA approves Pfizer and Moderna boosters for all US adults
pharmafile | November 22, 2021 | News story | Sales and Marketing |
The FDA and CDC have cleared the Pfizer and Moderna booster jabs for adults, after reviewing new data supporting the extra doses. This decision follows an initial rejection of the request for booster vaccines in September, citing a lack of data supporting the need for a third dose. The move allows the remaining 30-40% of adults previously ineligible to receive boosters to do so.
“As a clinician deep in the clinical trenches, I am really glad that we have clarity and streamlining of the recommendation so that all Americans can understand the vaccines that are recommended for them at this time,” CDC committee member Dr Camille Kotton shared.
“This Emergency Use Authorisation comes at a critical time as we enter the winter months and face increasing COVID-19 case counts and hospitalisations across the country,” said Stéphane Bancel, CEO of Moderna.
Any US adult may now receive a Moderna or Pfizer booster jab, regardless of which FDA-authorised vaccination they received, dependent on a six-month interval between their second and third dose.
“Throughout the course of the COVID-19 pandemic, the FDA has worked to make timely public health decisions as the pandemic evolves,” shared acting FDA commissioner, Janet Woodcock. “Authorising the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalisation and death.”
Previously, boosters had been cleared for those aged 65 and older, who received Pfizer or Moderna vaccinations at least six months ago, and for adults at high risk of developing severe COVID-19 symptoms.
Ugur Sahin, MD, CEO and Co-founder of BioNTech commented: “A booster dose of our vaccine has the potential to maintain a high-level of protection against tested variants, including Delta.”