Pfizer CEO, facing pushback, shifts COVID vaccine timeline to late November

Modesto Morganelli
Ottobre 17, 2020

In July, the U.S. Department of Health and Human Services and the Department of Defense (DoD) announced an agreement with Pfizer for an initial order of 100 million doses of a coronavirus vaccine for the price of $1.95 billion, following EUA or licensure.

Pfizer confirmed Friday it expects to seek emergency authorization of its experimental vaccine against Covid-19, if it is effective, in the third week of November.

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

In an open letter released Friday, Pfizer CEO and Chairman Albert Bourla said that "assuming positive data, Pfizer will apply for Emergency Authorization Use in the US soon after the safety milestone is achieved in the third week of November". But he added in the letter that the new FDA safety standards would push the company to ask for emergency approval in late November.

Trump's hopes had been bolstered by Pfizer executives, who have said that they could have clinical trial results sometime in October.

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

Pfizer is partnering with the German company BioNTech on the research.

Bourla estimated that Pfizer's 44,000-person study would reach that milestone in the third week of November.

That requires a massive amount of spending both by state and local governments and by federal agencies like the Centers for Disease Control.

Dr. William Schaffner, professor of preventative medicine at Vanderbilt University, told TPM in an interview last month that the vaccine would not singlehandedly end the pandemic.

While vaccines are a crucial tool against the virus, experts have warned they can't be a substitute for behavioral measures like masks and social distancing to curb transmission. "That's wrong", Schaffner said.

Then, in late September, more than 60 researchers and bioethicists urged Pfizer to wait until late November at earliest to file its vaccine for FDA review, arguing a submission before accruing at least two months of safety data would "severely erode public trust and set back efforts to achieve widespread vaccination".

"India is heading fast towards vaccine development, as two manufacturers are already in phase-3 trial and one in the phase-2 trial".

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