The Food and Drug Administration (FDA) authorized updated COVID booster shots on Wednesday created to specifically target subvariants of Omicron.
The FDA shared the approval in a Wednesday announcement that amended the emergency use authorizations for both Pfizer/BioNTech and Moderna’s boosters.
“The COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalization and death) of COVID-19,” FDA Commissioner Robert Califf said in the statement. “As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants.”
Pfizer’s booster will be made available for those 12 years old and older. Moderna’s approval is for those 18 years old and above.
The boosters include the components of the original COVID vaccine along with an mRNA component to target the BA.4 and BA.5 subvariants of Omicron.
The most recent data provided by the CDC reveals that the BA.5 variant is responsible for 88.7% of all new cases between August 21 and August 27. The BA.4 variant included an additional 3.6% of new cases.
“The agility of the mRNA platform, together with extensive clinical experience with the Pfizer-BioNTech COVID-19 Vaccine, has allowed us to develop, test and manufacture updated, high-quality vaccines that align to circulating strains with unprecedented speed,” said Albert Bourla, chairman and CEO of Pfizer.
“Having rapidly scaled up production, we are positioned to immediately begin distribution of the bivalent Omicron BA.4/BA.5 boosters, if authorized, to help protect individuals and families as we prepare for potential fall and winter surges,” he added.
For both booster shots, individuals are eligible “if it has been at least two months since they have completed primary vaccination or have received the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine,” according to the FDA.
A committee from Centers for Disease Control and Prevention is expected to approve the final step in the process this week before the new vaccine boosters begin distribution later this month.
Some health professionals are concerned regarding the new FDA approval, however, as testing in humans has not yet been completed.
“I’m uncomfortable that we would move forward — that we would give millions or tens of millions of doses to people — based on mouse data,” Paul Offit, an FDA adviser and director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told the Wall Street Journal in a report published on Sunday.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the news release that much care has been given regarding the safety of those taking the new boosters.
“The public can be assured that a great deal of care has been taken by the FDA to ensure that these bivalent COVID-19 vaccines meet our rigorous safety, effectiveness and manufacturing quality standards for emergency use authorization,” he stated.