Pfizer COVID-19 Vaccine Delayed Until At Least Late November

Andrew Cummings
October 17, 2020

"Based on our current trial enrollment and dosing pace, we estimate we will reach this milestone in the third week of November", he said, noting, "We are operating at the speed of science".

Moderna, another leading USA contender in the race to come up with an effective vaccine, previously announced that the earliest it could seek authorization of its own candidate would be November 25.

For an emergency use application, the FDA is requiring at least two months of safety data on half of the trial participants after their final vaccine doses, according to a guidance document released last week. The news lifted the company's shares two percent in the US.

The upshot is the US could roll out a vaccine before the end of the year, inoculating health care workers and first responders first.

A man works in the packaging facility of Chinese vaccine maker Sinovac Biotech, developing an experimental coronavirus disease (COVID-19) vaccine, during a government-organized media tour in Beijing, China, September 24, 2020.

That October timeline sounded even more aggressive when Moderna CEO Stephane Bancel, known for touting ambitious goals, said his company's shot, which was the first in the move into clinical testing, likely wouldn't have data until November. The US is the worst-hit country in the world with more than eight million cases and 218,000 deaths, according to a Johns Hopkins University tracker. Geographically, the major hotspots are in the Upper Midwest and parts of the Rocky Mountains in the west, while parts of the Northeast that were the first to be hit hard are seeing their outbreaks rekindling. It won't make COVID-19 magically disappear overnight. 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.

"First, the vaccine must be proven effective, meaning it can help prevent COVID-19 disease in at least a majority of vaccinated patients". "But I think we need to be cautious and understand that a vaccine isn't a magic bullet", she added.

Pfizer and Moderna, both with funding assistance from the United States government, launched Phase 3 of their clinical trials at the end of July, and both have started production of doses. Russian Federation approved a vaccine in August, without widespread testing.

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. It said it was working on a way to "distribute these limited vaccines in a fair, ethical, and transparent way".

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