Pfizer Inc applied to US health regulators on Friday for emergency use authorization (EUA) of its Covid-19 vaccine, the first application of its kind in an important step to provide protection against the novel coronavirus.
The application to the US Food and Drug Administration (FDA) comes just days after Pfizer and its German partner BioNTech SE reported final trial results showing the vaccine was 95% effective in Covid-19 prevention without major security issues.
Pfizer CEO Albert Bourla confirmed that the request had been made in a video posted on the company’s website on Friday afternoon.
Pfizer shares rose 1.3% and BioNTech shares 9.3% in New York late Friday afternoon, as the prospect of a vaccine soon raised hopes for the end of a pandemic that has spread. claimed more than a quarter of a million lives in the United States. and more than 1.3 million worldwide.
The app also includes safety data on about 100 children between the ages of 12 and 15. The company said 45% of trial participants in the US are between 56 and 85 years old.
If the data is strong, “we could literally be weeks away from a 95% effective vaccine being licensed,” US Secretary of Health and Human Services Alex Azar said on CBS’s “This Morning.”
The companies expect the FDA to grant the EUA in mid-December and said they will begin shipping the doses almost immediately. Pfizer has said it expects to have 50 million doses of vaccines ready this year, enough to protect 25 million people.
An FDA advisory committee tentatively plans to meet Dec. 8-10 to discuss the vaccine, a source familiar with the situation told Reuters, though the dates could change.
Final data from the trial showed that the vaccine provided a similar level of protection across ages and ethnicities, an encouraging result as the disease disproportionately affects the elderly and minorities.
Of the 170 volunteers who contracted Covid-19 in the Pfizer trial that involved more than 43,000 people, 162 had received just a placebo, meaning the vaccine was 95% effective, much higher than originally expected. The US FDA had set a minimum efficacy limit of 50%. Pfizer said that nearly 42% of global participants and 30% of American participants in the phase 3 study have racial and ethnic backgrounds.
“Filing in the US represents a critical milestone in our journey to deliver a Covid-19 vaccine to the world and we now have a more complete picture of the efficacy and safety profile of our vaccine,” Bourla said in a statement.
Moderna Inc is expected to be the next company to apply for an emergency use clearance in the US for a Covid-19 vaccine. An initial analysis of their late-stage trial data showed the vaccine to be 94.5% effective. Final results and safety data are expected in the next few days or weeks.
Both the Pfizer / BioNTech and Moderna vaccines work using a new technology to trigger an immune response known as synthetic messenger RNA that can be produced at scale much faster than traditional vaccines.
Of the dozens of drug manufacturers and research institutions vying to develop Covid-19 vaccines, the next late-stage data is expected to come from AstraZeneca Plc, which is working with Oxford University, in November or December.
Johnson & Johnson said it hopes to have the data necessary to apply for US authorization for its experimental vaccine in February.
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