Pfizer, BioNTech aiming to file coronavirus vaccine for approval by year-end

BioNTech, which is partnered with Pfizer on the BNT162 mRNA-based COVID-19 vaccine programme, is confident it will be ready to seek regulatory approval by December, the German biotech's CEO Ugur Sahin is reported as saying in The Wall Street Journal on Friday. According to the report, the executive indicated that "several hundred million doses" of the vaccine could be produced even before approval, and reiterated that this could rise to over 1 billion by the end of 2021.

Sahin's timeline is later than the expected October filing for the vaccine that Pfizer CEO Albert Bourla had hinted at in recent weeks.

Earlier this month, the companies reported positive early results from an ongoing Phase I/II trial, showing that their BNT162b1 candidate, the most advanced of four experimental coronavirus vaccines from their BNT162 programme, led to higher levels of antibodies than convalescing COVID-19 patients at day 28, which was seven days after study participants had received a second dose (for related analysis, see ViewPoints: BioNTech and Pfizer boost COVID-19 vaccine hopes).

The companies have also said that late-stage testing of the vaccine could begin as early as this month, with as many as 30,000 healthy participants, and potentially wrap up by the end of the year, when BioNTech would seek market approval from regulators around the globe. Pfizer and BioNTech would then jointly distribute the vaccine worldwide, excluding China, where the German company is already partnered with Fosun Pharma on BNT162.

If and when the vaccine is approved, Sahin suggested that mass vaccinations could start immediately in the US, Europe and elsewhere, although the effort would depend on countries' individual logistical capacities, among other factors. A first batch of BioNTech's vaccine would take between nine and 11 days to produce, the company said.

Meanwhile, even should several companies successfully launch vaccines, it could take a decade for the bulk of the world's population to achieve immunity, Sahin added. "I assume that we will only be done with this virus when more than 90% of the global population will get immunity, either through infection or through a vaccine," he added.    

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