Monday, the U.S. Food and Drug Administration authorized and approved updated COVID boosters in response to a nationwide increase in cases and hospitalizations.
The Pfizer-BioNTech and Moderna-manufactured boosters were designed to target variants that are presently circulating and are related to XBB, an offshoot of the omicron variant.
In a statement, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said, “Vaccination remains essential to public health and continued protection against serious consequences of COVID-19, including hospitalization and death.”
The public can rest assured that these updated vaccines have met the agency’s stringent safety, efficacy, and manufacturing quality standards. We earnestly encourage those who qualify to contemplate vaccination,” the statement continued.
Then, on September 12, an independent advisory commission from the Centers for Disease Control and Prevention will convene to make recommendations regarding who should be eligible for the new booster. The final stage will be a signature from the director of the CDC.
The injections are anticipated to become available later this week as they are delivered to pharmacies and healthcare providers, with a significant supply likely commencing the following week.
Currently, the FDA states that children aged 5 and older, regardless of prior vaccination, are eligible to receive one updated supplemental dose at least two months after their last COVID vaccination.
The updated boosters are authorized for use in minors between 6 months and 11 years of age in emergency situations.
Those aged 6 months to 4 years who have been previously immunized are eligible for one or two supplementary vaccinations, according to the agency. According to the FDA, unvaccinated individuals in this age group are eligible for three doses.
Boosters Offer Enhanced Protection Against Variants and Severe COVID for Vulnerable Groups
Recent evidence suggests that the booster could provide additional protection against presently circulating variants and protect against severe disease and mortality, especially for the elderly and those with compromised immune systems.
In a laboratory study, Moderna’s supplement increased the number of antibodies against the more recent subvariant BA.2.86 by nearly ninefold.
Previous results from the vaccine manufacturer indicated that the new adjuvant offered additional protection against the subtypes EG.5 and FL.1.5.1, which are currently predominant in the United States and account for an estimated 36 percent of all new cases, according to CDC data.
Stéphane Bancel, CEO of Moderna, said in a statement, “As the primary circulating strain continues to evolve, updated vaccines will be crucial for protecting the population this season.” “We appreciate the FDA’s prompt review and encourage people who are planning to get a flu shot to also get the updated COVID-19 vaccine.”
Similarly, Albert Bourla, chairman and CEO of Pfizer, praised the FDA’s decision and suggested that Americans could receive the vaccine alongside their annual flu injection.
“We expect this season’s vaccine to be available in the coming days, pending recommendation from public health authorities, so people can ask their doctor about receiving their COVID-19 vaccine during the same appointment as their annual flu shot, saving time now and helping to prevent severe disease later when respiratory viruses are at their peak,” he said in a statement.
Source: ABC News