The US Food and Drug Administration (FDA) on Monday gave the green light to updated COVID-19 vaccines from Moderna and Pfizer/BioNTech amid rising cases and hospitalizations, CNN reported.
Both vaccine manufacturers have said testing shows that their vaccines are effective against EG.5, the currently dominant strain in the United States.
The Advisory Committee on Immunization Practices, a group of independent experts that advises the US Centers for Disease Control and Prevention on its vaccination decisions, will now weigh the safety and effectiveness of the updated vaccines and make recommendations for their use. After the CDC director signs off on those recommendations, the vaccines can be administered.
The advisory group is scheduled to meet to discuss COVID-19 vaccines Tuesday, meaning the vaccines could become available within just a few days at certain pharmacies and doctor’s offices, according to CNN.
“Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a news release Monday. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness, and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.”
Overall, the new FDA decision “comes at a time when COVID-19 cases are once again climbing. Now, most people 6 months or older in the U.S. are eligible to receive this season’s COVID-19 vaccine, even if they have never been vaccinated against COVID-19 before,” Albert Bourla, chairman and chief executive officer at Pfizer, said in a news release.
The updated vaccines are approved for people 12 and older and are authorized under emergency use for individuals 6 months through 11 years old. As part of the FDA’s update, the bivalent Moderna and Pfizer/BioNTech Covid-19 vaccines are no longer authorized for use in the United States.
According to the FDA, babies and young children ages 6 months through 4 years who have not been vaccinated against the coronavirus are eligible to receive three doses of the updated Pfizer/BioNTech shot or two doses of the updated Moderna booster.
For those in that age group who have been vaccinated, the number and timing of doses depends on the doses they’ve previously received.
According to the FDA, people 5 and older are eligible to receive a single dose of the updated vaccines at least two months since their last dose of any COVID-19 shot, regardless of previous vaccination.
Human trial data showed the shot produced an 8.7-fold increase in neutralizing antibodies against the variant, also known as Pirola, which has been designated a variant under monitoring, the US biotech company said.
The Centers for Disease Control and Prevention (CDC) has said the new variant may be more capable of causing infection in people who have previously been vaccinated or had the disease.
In August, the World Health Organization said it is closely monitoring the BA.2.86 variant which has been detected in Israel, Denmark and the United States.
Pirola has more than 30 mutations in its spike protein compared to the XBB.1.5 strain. This raised concerns among scientists because it is a similar number to the mutations between the Delta and Omicron variants during the height of the pandemic.