The Biden administration’s Food and Drug Administration has approved the bivalent COVID vaccine for babies as young as six months old.
The new vaccines from Pfizer and Moderna are supposed to be given to babies in three doses. Bivalent vaccines differ from the previous mRNA vaccines in that they combine the original vaccine with a reformulation allowing the vaccine to attack the BA.4 and BA.5 viruses that sprang from the Omicron variant.
“More children now have the opportunity to update their protection against COVID-19 with a bivalent COVID-19 vaccine, and we encourage parents and caregivers of those eligible to consider doing so,” FDA Commissioner Robert M. Califf stated in a press release.
The announcement from the FDA flies in the face of a new study showing that a rising COVID subvariant called BQ.1.1, is emerging as the dominant form in the United States and is proving much more resistant to the new bivalent vaccines than other variants present in the country.
“The BA-5-bivalent booster did not produce robust neutralization against the newly emerged BA.2.75.2, BQ.1.1, or XBB.1,” the study asserted.
“Vaccines remain the best defense against the most devastating consequences of disease caused by the currently circulating omicron variant, such as hospitalization and death,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, claimed, adding:
Based on available data, the updated, bivalent vaccines are expected to provide increased protection against COVID-19. Parents and caregivers can be assured that the FDA has taken a great deal of care in our review, and we encourage parents of children of any age who are eligible for primary vaccination or a bivalent COVID-19 vaccine booster dose to consider seeking vaccination now as it can potentially help protect them from COVID-19 during a time when cases are increasing.
In October, the FDA approved the bivalent vaccines for children five years and older. Marks stated at the time, “Since children have gone back to school in person and people are resuming pre-pandemic behaviors and activities, there is the potential for increased risk of exposure to the virus that causes COVID-19. Vaccination remains the most effective measure to prevent the severe consequences of COVID-19, including hospitalization and death.”
Last June, President Biden bragged, “We are the first country to protect our youngest children with COVID-19 vaccines, offering safe and highly effective mRNA doses to children as young as six months old.”
“The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices,” the FDA states.