Status: 08/31/2022 5:40 p.m
The US Food and Drug Administration (FDA) has granted emergency use authorization to BioNTech and Moderna’s omicron variant-adapted corona vaccine. The European Medicines Agency (EMA) wants to hold a special meeting on Thursday.
The US Food and Drug Administration (FDA) has given two Covid-19 vaccines, which also take into account the omicron variant, emergency use authorization as booster vaccinations. These are so-called bivalent mRNA vaccines from the companies Biontech/Pfizer and Moderna, as the authority announced. The vaccines are tailored to the variants BA.4/BA.5 as well as to the original virus strain.
Omikron booster approved from 12 and 18 years
According to the approval, the adapted vaccines can be administered no earlier than two months after vaccination against the virus. The FDA approved Moderna’s bivalent vaccine as a single booster dose in people ages 18 and older. The one from Biontech/Pfizer can therefore be administered as a one-time booster dose to people aged 12 and over. “Now that we are moving towards autumn and spending more time indoors, we recommend that everyone who is eligible consider a booster dose of a bivalent Covid-19 vaccine to provide better protection against the current circulating variants,” said FDA chief Robert Califf.
Bivalent means that two components are taken into account: The preparations should offer protection against both the original Sars-CoV-2 and the omicron sublines BA.4 and BA.5.
In June, the FDA asked vaccine manufacturers to coordinate vaccinations with the two subvariants BA.4/BA.5, which are responsible for the recent increase in global corona infections. The BA.5 subvariant is currently responsible for more than 88 percent of infections in the United States. In the European Union, on the other hand, boosters against the omicron variant BA.1, which caused a massive increase in infections last winter, should probably be approved first.
EMA special session on omicron boosters on Thursday
The European Medicines Agency (EMA) has scheduled a special meeting for Thursday to discuss the Biontech/Pfizer and Moderna booster vaccine submissions. The UK became the first country in the world to approve Moderna’s BA.1 booster in mid-August.
Federal Health Minister Karl Lauterbach had announced that the first 14 million vaccine doses with the adapted booster vaccinations from BioNTech/Pfizer and Moderna should be delivered in Germany in the two weeks starting September 5th. He expects both boosters to be approved by the EU Commission on September 1st or 2nd. If the EU Commission then also approves the vaccine adapted to the BA.4/BA.5 virus variants at the end of September or the beginning of October, Germany will also be supplied “very quickly” by BioNTech/Pfizer with a first tranche of 9.5 million doses, it said in a letter from Lauterbach to those involved in the vaccination campaign.
There is still no recommendation from the Standing Vaccination Commission (STIKO) for the adapted Omikron booster vaccinations. The STIKO now recommends a fourth vaccination for everyone over the age of 60. According to Lauterbach, the STIKO is currently “very intensively” working on the study data for the adapted vaccines with the aim of coming up with an updated recommendation in a timely manner.