The U.S. Food and Drug Administration (FDA) approved updated COVID-19 vaccines from Moderna and Pfizer/BioNTech in response to the surge in cases and hospitalizations. Both manufacturers have reported that their vaccines demonstrate effectiveness against the currently dominant EG.5 strain in the United States.
The Advisory Committee on Immunization Practices, an independent expert group advising the U.S. Centers for Disease Control and Prevention (CDC), will now assess the safety and efficacy of these updated vaccines and provide recommendations for their deployment. Following approval by the CDC director, the vaccines will be available for administration.
The advisory group plans to convene immediately, suggesting that the vaccines may soon be accessible at select pharmacies and healthcare facilities.
Health authorities have emphasized the urgency of vaccination once the shots become available. The new release coincides with a late summer surge in COVID-19 hospitalizations and growing concerns over the potential impact of respiratory viruses, including COVID-19, influenza, and respiratory syncytial virus, in the upcoming fall and winter seasons.
Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, underlined the importance of vaccination in protecting against severe COVID-19 consequences.
“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,” Marks wrote in a news release.
Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, noted that despite an increase in infection rates and hospitalizations, the rates of severe disease, hospitalizations, and death are still significantly lower than in previous years.
Albert Bourla, CEO of Pfizer, highlighted the significance of this decision, especially with COVID-19 cases on the rise again. He said that nearly all individuals aged six months or older in the U.S. are eligible for this season’s COVID-19 vaccine, even if they have not been previously vaccinated.
The updated vaccines are approved for individuals 12 and older, with emergency use authorization for those aged six months to 11 years. 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 from six months to four years who have not been vaccinated can receive three doses of the updated Pfizer/BioNTech shot or two doses of the updated Moderna booster. Those who have been previously vaccinated will follow specific dosage guidelines. For those five and older, a single dose of the updated vaccines is recommended at least two months after their last COVID-19 shot, irrespective of previous vaccination.
Stéphane Bancel, CEO of Moderna, emphasized the critical role of updated vaccines in protecting the population during the peak respiratory virus season. “COVID-19 remains a leading cause of death in the U.S. and poses a significant threat to vulnerable populations, particularly as we enter peak respiratory virus season,” Bancel said.
The mRNA vaccines have been adjusted to combat the XBB.1.5 Omicron sub-variant of the coronavirus and related strains.
The FDA anticipates that COVID-19 vaccine compositions may need annual updates, similar to seasonal influenza vaccines.
Dr. Ugur Sahin, CEO/co-founder of BioNTech, said: “Our goal is to provide people worldwide with COVID-19 vaccines that are adapted to circulating virus variants or sub-lineages.”
The updated vaccines, administered in a single dose, are expected to be available at no cost to those in need.
Novavax’s updated COVID-19 vaccine has not yet received FDA authorization but is currently under review for individuals aged 12 and older.
Under the Affordable Care Act, most insurance plans cover the total cost of vaccines, eliminating co-pays for insured individuals. The uninsured or underinsured can access the vaccine at no cost through the CDC’s Bridge Access Program, a temporary initiative set to conclude by December 2024.
Officials noted that this is the first instance of vaccines being provided through the commercial market. According to CNN, during a Pfizer investor call in October, officials estimated a potential list price of $110 to $130 per single dose for adults.