An Emergency Task Force (ETF) of the European Medicines Agency (EMA) has announced that it supports the use of bivalent mRNA COVID-19 vaccines for primary inoculations. The vaccines, which contain mRNA from the original SARS-CoV-2 and the Omicron BA.4/BA.5 strains, were previously only used as boosters for those who have already been vaccinated with one of the original versions of the shots.
The UK’s NHS has begun the rollout of Pfizer/BioNTech’s bivalent COVID-19 boosters. The launch comes after the Medicines and Healthcare Products Regulatory Agency (MHRA) approved the shot for those 12 and older last week. The vaccine contains spike protein mRNA from both the original SARS-CoV-2 virus and the BA.1 Omicron strain.
The European Medicines Agency (EMA) has just issued conditional marketing authorization (CMA) for both Pfizer and BioNTech’s bivalent COVID-19 vaccines. The agency’s Committee for Medicinal Products for Human Use (CHMP) approved the vaccines as boosters for people 12 and up. These vaccines contain spike protein mRNA for the original SARS-CoV-2 virus and the BA.4/BA.5 Omicron strains currently dominant across the globe.
The US Food and Drug Administration (FDA) has approved both bivalent COVID-19 vaccine boosters from Moderna and Pfizer/BioNTech. The boosters contain spike pro mRNA from the original SARS-CoV-2 virus and the BA.4/BA.5 omicron strains currently dominant worldwide. The approval comes as the agency waits for more human data to come in.
Insider sources say that the US Food and Drug Administration could authorize the new bivalent COVID-19 vaccines from Moderna and Pfizer/BioNTech as early as Labor Day, September 5th. The vaccines contain mRNA for spike protein from the BA.4/BA.5 SARS-CoV-2 that currently dominating worldwide and the spike protein from the original strain from 2019 and early 2020.
The makers of the Comirnaty COVID-19 vaccine have applied to the US Food and Drug Administration (FDA) for an emergency use authorization for their new Omicron BA.4 and BA.5 booster shots. The new version of Pfizer and BioNTech’s vaccine is bivalent, containing spike protein mRNA from the original SARS-CoV-2 and Omicron BA.4/BA.5.