Sanofi Sees EU Regulatory Decision on Its COVID Booster in Weeks

BRUSSELS (Reuters) – The European Union’s drugs regulator may be a few weeks from deciding whether to approve the experimental COVID-19 vaccine developed by French drugmaker Sanofi and its British partner GSK, a Sanofi executive said on Monday.

The companies’ bivalent vaccine targets the Beta variant as well as the original Wuhan strain of the virus. Trial results also showed the shot confers protection against the Omicron variant currently widespread in Europe.

Thomas Triomphe, Sanofi’s executive vice-president for vaccines, told a hearing in the European Parliament that he believed the European Medicines Agency (EMA) would decide on the possible approval of the vaccine in a few weeks.

The EMA was not immediately available to comment.

Sanofi and GSK, two of the world’s biggest vaccine makers, are hoping to gain a foothold in the market for variant-focused COVID shots, after falling behind competitors including Moderna, AstraZeneca and Pfizer-BioNTech, in the original race to contain the pandemic.

Triomphe said manufacturing of the vaccine had already started, and deliveries to EU countries could begin immediately after approval by the EMA, which is currently reviewing the shot.

The vaccine could be used as a booster for people who had received any other COVID-19 vaccine, Triomphe said.

The EU secured up to 300 million doses of the Sanofi-GSK vaccine at the early stages of the pandemic in 2020, but the companies’ difficulties in developing the vaccine pushed them behind other manufacturers.

Triomphe said Sanofi was in talks with the EU to allow the shipment of its vaccine to poorer nations after purchase by EU governments.

(Reporting by Francesco Guarascio @fraguarascio; Editing by Jan Harvey and Mark Potter)

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