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