The US drug agency FDA has approved two vaccines targeting subtypes BA.4 and BA.5 of the Omicron coronavirus variant from the US company Moderna and the Mainz-based company Biontech and its US partner Pfizer.
The new vaccines aim to offer “better protection against Covid-19 caused by the omicron variant”, the FDA said on Wednesday. Pfizer and Moderna had already submitted an application to the European Medicines Agency (EMA).
The aim of the approval that has now been granted is to start a refresher campaign in the USA as quickly as possible. According to the US Department of Health and Human Services, it has already bought 105 million doses from Biontech/Pfizer and 66 million from Moderna.
The FDA approved the Biontech/Pfizer vaccine for booster vaccinations for children from the age of 12 and the Moderna vaccine from the age of 18. The green light from the US CDC is still pending before vaccinations can begin with the substances.
The deliberations of the responsible expert committee are to begin on Thursday, and CDC boss Rochelle Walensky will ultimately decide on the approval.
Vaccines based on mRNA technology could be available in the US from next week. The Biontech/Pfizer vaccine is “ready for immediate delivery,” Biontech said in a statement on Wednesday.
The vaccines now approved in the USA are so-called bivalent vaccines, which are directed both against the wild type of the coronavirus, which is prevalent at the beginning of 2020, and against the currently predominant omicron subtypes BA.4 and BA.5.
On Thursday, however, the EMA is to decide on the EU-wide approval for two other adapted corona vaccines. Biontech/Pfizer and Moderna also submitted applications for the vaccines directed against the omicron subtype BA.1.
In mid-August, Federal Minister of Health Karl Lauterbach (SPD) spoke out in favor of using vaccines based on the omicron subtype BA.4 and BA.5 – and not substances against BA.1. “In Germany we assume that BA.4/5 is the better vaccine composition for the current variant,” Lauterbach told the “Spiegel”.
