Pfizer’s chief executive officer Albert Bourla (pictured above) has revealed that the company will not submit its BioNTech-partnered COVID-19 vaccine for approval in the US until November.
In an open letter published on Friday, Bourla said that Pfizer will not submit the vaccine candidate for emergency use authorisation in the US until the third week of November.
The renewed timeline comes after the Food and Drug Administration (FDA) announced a new requirement for companies to provide two months’ worth of safety data on half of the trial participants following the final dose of any investigational COVID-19 vaccine.
Pfizer and its partner BioNTech had previously planned to seek regulatory approval for their vaccine, BNT162b2, in October. In August, the companies said that if all goes to plan in the phase 2/3 efficacy trial involving 30,000 participants, they could file for regulatory review as early as October.
However, with pushback from the global research community as well as new, stricter FDA guidelines, Pfizer has delayed that initial projection.
In his open letter, Bourla added that “there are three key areas where, as with all vaccines, we (Pfizer) must demonstrate success in order to seek approval for public use”. This includes efficacy, safety and manufacturing quality.
Pfizer is awaiting a key data readout later this month, with Bourla adding that the company may know whether or not BNT162b2 is effective by the end of October.
However, this depends on the number of COVID-19 cases in the phase 2/3 trial, which must reach a certain number in order to compare the effectiveness of the vaccine compared to placebo.
On the safety front, as well as meeting the FDA two-month safety data guidelines, Pfizer will also continue monitoring and reporting safety data for all trial participants for two years, Bourla said.
Finally, Bourla added that Pfizer is continuing to invest in its manufacturing processes and rapidly ramp-up capacity, with manufacturing data set to be ready for submission before the safety milestone is reached.
On Sunday, Pfizer UK’s manager Ben Osborn told The Daily Mail that ‘several hundred thousand doses’ of the potential vaccine have already been manufactured at the company’s plant in Puurs, Belgium.
Bourla has previously aimed criticism at the politicisation of COVID-19 vaccine development, in particular the discussion of a potential shot during the first presidential debate in the US.
In a memo to staff – seen by the Financial Times – that refers to the debate, Bourla wrote: “I was disappointed that prevention of a deadly disease was discussed in political terms rather than scientific facts. People… are understandably confused [and] don’t know whom or what to believe.”