BioNTech and Pfizer will start a clinical trial for a new vaccine for BA.4 and BA.5 variants of the Omicron strain this month as the German biotech forecasts an increase in demand at the end of the year. BioNTech expects to be able to start delivering those shots as early as October if it receives regulatory sign-off.
BioNTech’s chief executive Uğur Şahin said the company was expanding its Covid product pipeline, aiming for “prolonged and broad protection”.
Özlem Türeci, chief medical officer, said data from studies in mice — which has previously been predictive — showed that the shot targeted at BA.4 and BA.5 elicited a stronger immune response against those variants other sub-variants of Omicron. She said this data, combined with their extensive experience and data from prior Covid vaccines, may be sufficient for emergency approval and enable a “timely response”.
Regulators try to use the most up-to-date vaccines possible to keep up with the new variants, aiming to ensure both the safety and the efficacy of the shots.
The European Medicines Agency will need clinical data to approve its administration, whereas the US Food and Drug Administration is already prepared to approve the shots during trials.
Emer Cooke, head of the EMA, told the Financial Times that the agency would stick to the need for trial data before approval, saying “promises are not enough for me”.