Pfizer is “very close” to requesting an emergency use approval for its Covid-19 vaccine after collecting safety data to send to US regulators, the company’s chief executive said Tuesday, according to a report. Last week, Pfizer and its partner BioNTech SE reported that an interim analysis showed that their experimental vaccine was more than 90% effective in preventing symptomatic cases of Covid-19.
“We are very close to applying for an emergency use authorization,” Albert Bourla told medical news site Stat. “We will announce it as soon as we are doing it.”
Pfizer has previously said that it expects to contact the US Food and Drug Administration to request an Emergency Use Authorization before the third week of November, which means the announcement could take a few days.
On Tuesday, Pfizer’s chief executive said a key safety milestone had been reached in the study of its Covid-19 vaccine. In a virtual conference hosted by the New York Times on Tuesday, Bourla said the company was preparing to submit its data to the US Food and Drug Administration.
“We are now preparing for the presentations,” Bourla said at the conference without specifying when he anticipated requesting an emergency use authorization.
Bourla added that Pfizer would soon publish more detailed efficacy results.
The FDA had imposed a requirement on manufacturers of Covid-19 vaccines to have at least two months of follow-up with volunteers after their second dose, taken 28 days after their first, to ensure the drugs are safe.
On Monday, another Moderna pharmacist and the US National Institutes of Health announced similar preliminary results from their own trial, and found that their vaccine was nearly 95% effective.
They both use mRNA (messenger ribonucleic acid) technology to deliver genetic material to the body that causes human cells to create a protein from the virus.
This trains the immune system to be ready to attack if it encounters SARS-CoV-2.
Other vaccines in late-stage trials, such as one being developed by Johnson & Johnson and another by the University of Oxford and AstraZeneca, use modified viruses to deliver genetic material for the same purpose.
No mRNA vaccine has ever been approved, but Anthony Fauci, America’s leading infectious disease scientist, said Tuesday that the technology had been “established.”
Bourla told Stat that he was relieved that another vaccine was also successful and that he hoped many more would enter the fray because the global need was so dire.
Moderna has previously said that it hopes to apply for an emergency use authorization before November 25.
After companies submit their application, the US could follow in a matter of weeks.
In India, there are five COVID-19 vaccine candidates in various stages of clinical trials in India, of which two are in the third phase.
.
