Pfizer: no emergency approval for Covid-19 vaccine until after US election
US-based pharmaceutical giant Pfizer said today that the earliest it plans to file for authorisation for its Covid-19 vaccine would be the third week of November.
Pfizer CEO Albert Bourla said in an open letter that filing depended on when data on the effectiveness of the vaccine would be available.
Bourla said this data could be available by late October, allowing Pfizer to file for FDA approval in late November, making it unlikely that a vaccine will be available before the US presidential election on 3 November.
Vaccine
Pfizer is developing a vaccine with German company BioNTech. In July the US government placed an initial order of 100 million doses of the vaccine.
The US Food and Drug Administration requires companies to provide two months of safety data on trial participants following the final dose of the vaccine.
Earlier this month, Pfizer released a statement stressing it would not be influenced by political pressure to speed along the development of the vaccine.
The public stance came shortly after Trump claimed – during the first US presidential debate – that the company was weeks away from finalising a vaccine.