Pfizer won't seek Covid-19 vaccine approval before mid-November

Henrietta Strickland
October 17, 2020

President Trump has boosted the prospect of a pre-election vaccine as November 3 inches closer, saying that one would be ready by that "special day" and that a preventative COVID-19 shot would be available "within weeks".

The Covid-19 vaccine Pfizer is developing with Germany's BioNTech will probably not be available for emergency use until after the USA presidential election, the company said Friday.

Pfizer CEO Albert Bourla has long said it's possible that testing might reveal by the end of October whether his company's vaccine actually protects against the coronavirus.

On Monday, Johnson & Johnson announced it had paused a large, late-stage clinical trial of its coronavirus vaccine after one of its volunteers became ill with an unexplained sickness. This would allow the companies to file for an emergency use authorization.

Bourla said the Pfizer trial, involving 30,000 participants, might produce results on the vaccine's efficacy within the next two weeks.

The Food and Drug Administration (FDA), which authorizes pharmaceuticals for distribution in the USA - asked vaccine developers last week to spend two months monitoring for serious side effects after the second dose is given to trial participants.

The FDA said earlier this month that, before it reviews a coronavirus vaccine application, a company must have safety data that extends for a median of two months. "To do so, we must accumulate a certain number of COVID-19 cases in our trial to compare the effectiveness of the vaccine in vaccinated individuals to those who received a placebo".

The American “Pfizer” expects to launch its vaccine against Corona after
Pfizer to seek vaccine approval in November

Bourla estimated Pfizer's 44,000-person study will reach that milestone in the third week of November. It needs to be stored at sub-zero temperatures, creating logistical headaches in how to effectively ship and store doses so that millions of Americans can be inoculated.

What's more, the company will also gather manufacturing data to demonstrate "the quality and consistency of the vaccine that will be produced", Bourla said.

Last month, President Donald Trump said that a COVID-19 vaccine would be distributed within 24 hours of completion of phase 3 trials and FDA approval.

"There's this unstated hope that the day the vaccine is approved, we can stop all the social distancing and mask wearing. That's wrong", Schaffner said.

Widespread mask use might also mean that when people do get infected, they have less virus in their body which makes them less sick.

He told The Indian Express that India is heading fast towards vaccine development, as two manufacturers are already in phase-3 trial and one in the phase-2 trial, and more players are joining the race.

Other reports by Click Lancashire

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