Drug major Pfizer Inc. (PFE) and German partner BioNTech SE (BNTX) announced Friday updated data from a Phase 2/3 clinical trial for Omicron BA.4/BA.5-adapted bivalent booster.
The data demonstrated a robust neutralizing immune response one-month after a 30-g booster dose of the companies' Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine.
The companies noted that immune responses against BA.4/BA.5 sublineages were substantially higher for those who received the bivalent vaccine compared to the companies' original COVID-19 vaccine, with a similar safety and tolerability profile between both vaccines.
These results reinforce the previously reported early clinical data measured 7 days after a booster dose of the bivalent vaccine, as well as the pre-clinical data. It suggests that a 30-g booster dose of the Omicron BA.4/BA.5-adapted bivalent vaccine may induce a higher level of protection against the Omicron BA.4 and BA.5 sublineages than the original vaccine.
Albert Bourla, Chairman and Chief Executive Officer, Pfizer, said, "As we head into the holiday season, we hope these updated data will encourage people to seek out a COVID-19 bivalent booster as soon as they are eligible in order to maintain high levels of protection against the widely circulating Omicron BA.4 and BA.5 sublineages."
In the next step, the companies plan to continue to evaluate the cross-neutralization of the adapted vaccine against new variants and sublineages, aiming to provide broader immunity against COVID-19 caused by SARS-CoV-2, including Omicron and other circulating strains.
Pfizer and BioNTech have shared these data with the U.S. Food and Drug Administration and plan to share with the European Medicines Agency and other global health authorities as soon as possible.
A booster dose of the BA.4/BA.5-adapted bivalent vaccine has been authorized for emergency use by the FDA for ages 5 years and older and has also been granted marketing authorization in the EU.
Separately, Pfizer and BioNTech are continuing to monitor immunogenicity of the BA.4/BA.5 bivalent booster against emerging Omicron subvariants.
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