Pfizer ‘ready to roll’ if BioNTech COVID-19 shot is approved

Pfizer now has hundreds of thousands of doses of BioNTech’s COVID-19 vaccine coming off the production line at a facility in Belgium, ready for delivery if it clears phase 3 testing.

The output of the plant in Puurs should allow the partners to have 100 million doses of BNT162b2 ready for delivery by the end of the year, according to a Mail on Sunday report, which claims 40 million of those doses are destined for the UK.

As two doses of the mRNA-based shot are required to stimulate an immune response against the coronavirus, that would be enough to vaccinate 20 million people.

The COVID-19 shot started a rolling review at the European Medicines Agency (EMA) earlier this month – which involves the agency evaluating data as they become available rather than in one block – and that means approval could come shortly after the 44,000-patient trial readout which is due by the end of this month.

Video footage of vaccine vials coming off the production line have generated excitement and puts Pfizer and BioNTech in pole position to get the first COVID-19 shot approved.

Pfizer is predicting a longer timeline in the US than Europe however, saying it won’t be able to file for emergency use authorisation in the US until the third week of November – assuming trials go as planned of course.

While top-line data on efficacy could be ready this month, at least half the recipients of the shot in the trial will have to be followed for safety for two months after the second dose, and that will set back the EUA filing.

That timescale dashes any chance of a feelgood coronavirus vaccine story for Donald Trump as he campaigns for a second term as US President. Pfizer and BioNTech were among a group of nine COVID-19 vaccine developers who pledged not to launch before thorough tests are completed.

The federal government agreed an initial order of 100 million doses of BNT162b2 in July, with an option on up to 500 million, and Pfizer and BioNTech reckon they have the capacity to make 1.3 billion doses next year.

The Pfizer update comes as the UK’s deputy chief medical officer Prof Jonathan Van-Tam suggested that Oxford University and AstraZeneca’s AZD1222 shot – based on a different technology – could be available in the UK “soon after Christmas”.

That timeframe would allow vaccination of elderly and vulnerable people as well as key workers to begin in the New Year, according to an article in the Sunday Times. The comments were made at a joint Commons and Lords national security strategy committee meeting.

Chief scientific officer Sir Patrick Vallance told the panel that a vaccine is unlikely to be widely available until next spring, and reiterated his view that the SARS-CoV-2 coronavirus will become endemic. However, he suggested it’s level of threat could be reduced to that of seasonal flu if effective vaccines are available.