One of them is a monovalent vaccine and the other is a bivalent vaccine. A total of 1,234 people over the age of 56 were enrolled in the Phase II/III studies of these two Omicron vaccines. It was found that as a booster vaccination, compared with the new coronavirus vaccine devel

2024/04/1713:24:33 science 1200

One of them is a monovalent vaccine and the other is a bivalent vaccine. A total of 1,234 people over the age of 56 were enrolled in the Phase II/III studies of these two Omicron vaccines. It was found that as a booster vaccination, compared with the new coronavirus vaccine devel - DayDayNews

On June 25, Pfizer/BioNTech announced that the two new crown vaccines developed in cooperation against the Omicron variant showed positive safety, tolerability and immunogenicity results in clinical trials. One of them is a monovalent vaccine and the other is a bivalent vaccine.

The two Omicron vaccines (30 μg and 60 μg) enrolled a total of 1,234 people over the age of 56 in the Phase II/III study. It was found that as a booster vaccination, compared with the new coronavirus vaccine developed by the company in 2019, it was more effective against Omicron BA. 1 variant strains can produce strong neutralizing antibody levels. The preset efficacy standard of the study was based on the neutralizing antibody geometric mean titer ratio (GMR). The results showed that the GMRs of the monovalent vaccine 30μg and 60μg were 2.23 (95% CI: 1.65, 3.00) and 3.15 (95%) respectively. CI: 2.38, 4.16). The GMRs of 30 μg and 60 μg bivalent vaccines were 1.56 (95% CI: 1.17, 2.08) and 1.97 (95% CI: 1.45, 2.68) respectively. The above-mentioned efficacy and safety results of the variant-adapted vaccine against Omic are in compliance with the regulatory requirements for emergency use authorization by regulatory agencies. One month after

vaccination, one dose of monovalent Omicron vaccine (30 μg and 60 μg) as a booster immunization can increase the neutralizing antibody geometric mean titer (GMT) by 13.5 and 19.6 times respectively compared with before the boost. Injection of one dose of bivalent Omicron vaccine (30 μg and 60 μg) increased GMT by 9.1 and 10.9 times, respectively. Both vaccines were well tolerated by people who had received other Omicron vaccines.

When conducting a SARS-CoV-2 live virus neutralization test on the subject's serum, it was found that the titer of the neutralized serum BA.4/5 was approximately 3 times lower than that of BA.1. Pfizer/BioNTech will continue to collect additional trial data against the Omicron BA.4/5 variant in the coming weeks.

Pfizer/BioNTech plans to discuss the above data with the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) and the EMA International Alliance of Medicines Regulators (ICMRA) on June 28 and June 30 respectively. The companies have submitted additional data to regulators on their existing COVID-19 vaccine, Comirnaty, as a booster shot.

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