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Drug manufacturing giant Pfizer said earlier this week that it would be seeking emergency use of its COVID-19 vaccine in a matter of "days."
Well, that day has come.
The company announced that it is asking the Food and Drug Administration's regulators on Friday for approval of its vaccine, which, as the Associated Press reported, starts the clock on the process that could bring the drug to the public as early as December — and hopefully bring about an end to the pandemic.
Pfizer said Wednesday that clinical trials had shown its vaccine is 95% effective and appears to be safe.
The company said its most recent trial included 44,000 subjects, of which 170 developed COVID-19. But 162 of those were folks who had received the placebo, meaning only eight subjects who had received the actual vaccine contracted the virus.
The trial also found that there were no "serious safety issues" with the vaccine and that the "severe" side effects of the shot were fatigued (3.8% of subjects) and headaches (2% of subjects). The company also said the vaccine's efficacy was consistent "across age, gender, race and ethnicity demographics."
Considering the urgency of the situation, "the FDA is expected to move quickly," the Wall Street Journal reported:
Given the urgency, the FDA is expected to move quickly. The timing of the filing is in line with industry and government officials' projections for authorization and distribution to begin next month. Pfizer said the filing could allow for distribution to begin by the middle to end of December.
A green light would cap the fastest vaccine development program ever in the West, going from laboratory to authorization in less than a year. Pfizer, which partnered with Germany's BioNTech in March, has so far spent about $2 billion on the effort. Pfizer has said it is ready for a quick approval.
CEO Albert Bourla told the New York Times Tuesday that his company is ready to ship the vaccine "overnight."
According to the AP, about 25 million shots could be available in the U.S. in December.
The company also said it could have 50 million doses available globally by the end of the year, the AP said.
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