sfizer-BioNTech has announced that it now has the first human data to hint at the effectiveness of its new Omicron booster. The updated bivalent vaccine targets both the original SARS-CoV-2 strain and the currently circulating Omicron BA.4/5 variants and is authorized to use In Americans 12 years of age or older (and soon for ages 5 and older at a dose of 10 mcg for children, pending approval from the US Centers for Disease Control and Prevention). This license was granted based on animal safety and efficacy studies and data from a different vaccine targeting BA.1.
In the first results of human studies announced press release On October 13 and not yet fully published – Pfizer-BioNTech reported that 40 subjects aged 18 to 55 who were boosted with a bivalent injection produced higher levels of anti-viral antibody against Omicron BA.4/5 after seven days compared to their starting levels. Among subjects 55 and older, those who received the omicron booster produced higher levels of omicron antibodies than those boosters with the original vaccine. That subjects produced more Omicron-specific antibodies after taking the booster drug is encouraging, especially since the subjects in the study were not boosted for 11 months, on average, before receiving the bivalent vaccine. The companies did not provide a more detailed breakdown of the difference in levels in their press release, but more data is expected in a few weeks.
The results are the first from an ongoing study of more than 900 people 12 years of age and older receiving an Omicron booster in two doses: 30 mcg or 60 mcg. All study participants were boosted at least once with the original vaccine (meaning they received at least three doses of the original shot). Their immune responses will be compared to those obtained by those who received two doses of the original vaccine, or four doses. The U.S. Food and Drug Administration approved the booster at a dose of 30 mcg, but the trial will investigate whether a higher dose would provide additional protection. The companies plan to continue studying the bivalent Omicron BA.4/5 in young children as well.
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