The US Food and Drug Administration is planning to hold an advisory panel meeting on October 22 to discuss Covid-19 vaccines, a top official of the agency said. This assumes significance as large-scale clinical trials of the leading vaccine candidates from Moderna Inc, Pfizer Inc and AstraZeneca Plc were launched in recent weeks.
A top US health regulator who will help decide the fate of a coronavirus vaccine said the trials were enrolling volunteers “reasonably well” and that it was “possible” data could be available to interpret as early as October. If not, the committee could still discuss broader regulatory issues regarding a vaccine, said Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research.
Meanwhile, Pfizer Inc. and BioNTech SE said the Covid-19 vaccine they are jointly developing is on track to be submitted for regulatory review as early as October, as they released additional data from an early-stage study.
The companies said the vaccine was well tolerated with mild to moderate fever in fewer than 20% of the participants. The companies are continuing to analyze data from the Phase 1 trials in the U.S. and Germany, they said in a statement.
Pfizer and BioNTech last month clinched a $2 billion deal to supply an initial 100 million doses of the vaccine to the US.
In the US, the race to produce a vaccine has become the centerpiece of his Trump administration’s response. The US government has invested nearly $11 billion to help develop and manufacture more than half a dozen coronavirus vaccine candidates.
Russia earlier this month approved a vaccine dubbed Sputnik V, although the shot is still in the midst of human testing. It has been developed by Moscow’s Gamaleya Institute and the sovereign Russian Direct Investment Fund, and plans to administer it widely in October
China meanwhile has shipped covid vaccine candidates to virus hotspots around the world like Brazil, Indonesia and Saudi Arabia to conduct final-stage trials.