COVID-19 booster vaccines targeting the Omicron BA.4 and BA.5 sub-variants currently dominating in the United States could be available in the next few days, but their arrival comes with some controversy. .
with human data on the BA.1 vaccine. The companies also presented lab or animal data on the BA.4 and BA.5 vaccine candidates.
In mice studies presented to the FDA, Pfizer said its new booster increased the antibody responses to all the Omicron variants, including BA.4 and BA.5. that the new shots involve very small changes in the mRNA sequence and that should not impact safety.The lack of convincing neutralizing antibody data against BA.4 and BA.5 in people is a problem, says Paul Offit, MD, an infectious disease expert and director of the Vaccine Education Center at Children’s Hospital of Philadelphia.
“Those are the ones getting hospitalized,” he says. He sees the goal of the updated vaccine as preventing serious illness. He pointed out that mice data is used every year to update the flu vaccine quadrivalent program.
“If you need a vaccine to combat what some think will be an increase in [cases in] the winter, you won’t have an updated vaccine in time if you wait for a clinical trial,” he says.As for safety, “we know a vast amount about the [vaccine’s] safety and effectiveness,” Schaffner says. “I think the majority of the public health and vaccinology communities are quite content that we are doing these immune-bridging studies that show [updated vaccines] performed similarly to previous vaccines.
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