“Depending on the decision of the authorities, an adapted vaccine could be approved in August, September or autumn,” said Sahin on Wednesday at the general meeting of the Mainz-based biotech company.
According to Sahin, the US Food and Drug Administration (FDA) has planned a meeting at the end of June to specify what the agency expects from the vaccines adapted to the omicron variant. Sahin also expects the European Medicines Agency EMA to take such a step.
BioNTech and its US partner Pfizer are working on a vaccine adapted to the omicron variant and started a clinical study in January. This has since been expanded to include several new cohorts, including one also investigating a bivalent omicron vaccine that also covers the original Wuhan variant of the virus. The results of the clinical trials are expected in the coming weeks, Sahin confirmed. “On the basis of the clinical data, the regulatory authorities will determine the further regulatory procedure that will be necessary for a possible approval of an adapted vaccine.”
Sahin did not comment on when the vaccine could be expected to be approved in China. The decision is in the hands of the local authorities, with whom BioNTech is in talks, he affirmed. The Mainz-based vaccine is one of the most commonly used against Covid-19 in the world. However, it is still not on the market in China, although Biontech had already concluded a license agreement with the Chinese Fosun Pharma in spring 2020 to develop and market the vaccine in China, Hong Kong, Macau and Taiwan. So far, the People’s Republic has only used vaccines that were developed and produced in China – above all Sinovac and Sinopharm.
Source: Nachrichten
