Pfizer prepares to file COVID-19 shot after reaching safety milestone
Pfizer is preparing to file its COVID-19 vaccine after a trial reached the safety milestone required by US regulators for emergency use, according to press reports.
The company’s CEO Albert Bourla said that the company is preparing to submit its data to the FDA following last week’s announcement that the vaccine is more than 90% effective, according to an interim analysis of a phase 3 trial.
Bourla was speaking at a virtual conference hosted by the New York Times, without saying when the company expected to file for the Emergency Use Authorization with the FDA.
“We are preparing now for submissions,” said Bourla.
However the company has already said it would have the two months of safety data required by the FDA by the third week of November.
But according to Bloomberg he conceded that there are important questions about the vaccine that remain to be answered, such as how long it remains effective.
“When it comes to how durable the protection could be, this is something we don’t know yet,” he said.
More efficacy results are due soon, he said.
Developed in partnership with Germany’s BioNTech, Pfizer’s vaccine is slightly ahead of a rival from Moderna in development.
Both vaccines are based on mRNA technology but Moderna’s rival seems to be slightly more effective with an efficacy of 94.5%.
Moderna’s shot is also easier to handle, requiring storage at -20C instead of the much more challenging -70C for the Pfizer vaccine.
There are also issues with access to an already available therapy for COVID-19, Eli Lilly’s antibody therapy bamlanivimab, according to reports.
Reuters reported that hospitals in the US are rationing use of the drug because demand is outstripping supply following an EUA from the FDA last week.
The federal government has paid $1,250 per dose for 300,000 doses of bamlanivimab, enough to last for a week at current infections levels, according to Reuters.
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