The Mainz-based pharmaceutical company Biontech is expecting the results of its ongoing clinical studies on the efficacy and safety of various corona vaccine candidates adapted to the omicron variant “in the coming weeks”.
The results should then be discussed “promptly” with the approval authorities, said CEO Ugur Sahin on Wednesday at Biontech’s online general meeting. Based on this data, the authorities would determine the further procedure that would be necessary for a possible approval of an adapted active ingredient.
Sahin expects the adapted vaccine to be approved by the fall. “Depending on the authorities’ decision, an adapted vaccine could be approved in August, September or autumn,” he said. 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 started the clinical study for the vaccine adapted to the omicron variant 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 company’s and its US partner Pfizer’s order books for the corona vaccine are well filled: According to Sahin, orders for around 2.4 billion doses have been received for this year (as of the end of April). CFO Jens Holstein confirmed the sales forecast of a total of 13 to 17 billion euros this year in front of the shareholders who were connected via video.
The success of the corona vaccine has made Biontech an “immunotherapy powerhouse”, Sahin said. There is potential for multiple product launches in the fight against cancer and infectious diseases over the next three to five years.
Key strategic goals this year included the further development of the existing Covid-19 vaccine and the development of “next-generation” vaccines to extend Biontech’s leadership in this area and to guard against possible new virus variants.
In addition, the mRNA technology used successfully in the corona vaccine should also be tested more intensively in possible therapies against autoimmune diseases, cardiovascular diseases and in regenerative medicine, said Sahin. Biontech is in an “extraordinary situation” to help shape the future of medicine.
Sahin did not comment on when the vaccine could be expected to be approved in China. The decision is in the hands of the Chinese authorities, with whom Biontech is in talks, he affirmed.