Pfizer Says It Could Seek Emergency Use Authorization for COVID Vaccine Next Month

The pharmaceutical giant Pfizer announced Friday it could seek an emergency authorization for a COVID-19 vaccine as soon as the end of November.

While the development of a vaccine for the novel coronavirus has moved at a historically fast pace, it is all but guaranteed the treatment won’t come before the Nov. 3 election, an ambitious goal set by President Donald Trump. Nevertheless, the vaccine has come together at breakneck speed.

In a statement released Friday, Pfizer CEO Albert Bourla said the leading drug manufacturer could know if its vaccine is effective by the end of October.

Transparency is important so I’d like to provide greater clarity around the timelines for @pfizer’s #COVID19 vaccine and the 3 key areas where we must demonstrate success in order to submit for Emergency Use Authorization (EUA) or Approval: https://t.co/EVSnMNoeRQ

— Albert Bourla (@AlbertBourla) October 16, 2020

Bourla said Pfizer is “operating at the speed of science.” He then outlined the process the company is going through to develop the vaccine.

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“First, the vaccine must be proven effective, meaning it can help prevent COVID-19 disease in at least a majority of vaccinated patients,” he explained, adding the treatment must also be “proven safe with robust safety data generated from thousands of patients” and be capable of being “consistently manufactured at the highest quality standards.”

Pfizer is currently conducting a 40,000-person trial on a vaccine.

“So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the U.S. soon after the safety milestone is achieved in the third week of November,” Bourla wrote. “All the data contained in our U.S. application would be reviewed not only by the FDA’s own scientists but also by an external panel of independent experts at a publicly held meeting convened by the agency.”

“The timelines above reflect our best estimates of when these important milestones could be achieved,” he added.

Pfizer is not the only pharmaceutical developing a COVID-19 vaccination. Several other companies are also in the third stage of development with their own vaccines, including AstraZeneca, Moderna, and Johnson & Johnson.

Earlier this week, Dr. Anthony Fauci, the country’s top infectious disease expert, said a “safe and effective” vaccine could be widely available to Americans by April of next year.