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.
Pfizer and its partner BioNTech SE last week reported that a provisional analysis confirmed 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.”
On Tuesday, Pfizer’s CEO said that an essential safety milestone had been reached in the study of its Covid-19 vaccine. Bourla said the company was preparing to submit its data to the U.S. Food and Drug Administration a virtual conference hosted by the New York Times on Tuesday.
At 2:05 PM ET @AlbertBourla will join @matthewherper at the #STATSummit for a live discussion about Pfizer’s #COVID19 vaccine development program & more. Details here: https://t.co/hyvLgviarw pic.twitter.com/ldWnWlwBjn
— Pfizer Inc. (@pfizer) November 17, 2020
Pfizer had earlier said that it expects to contact the US Food and Drug Administration to apply for an Emergency Use Authorization by the third week of November, it means that the announcement could be soon.
“We are preparing now for submissions,” Bourla said at the conference without specifying when it anticipated to file for an emergency use authorization.
Bourla said that Pfizer would release more detailed efficacy results soon. The FDA had imposed a condition 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.
This trains the immune system to be ready to attack if it encounters SARS-CoV-2.
Both use mRNA (messenger ribonucleic acid) technology to deliver genetic material to the body that makes human cells create a protein from the virus.
While other vaccines are in late-stage trials, like one being developed by Johnson & Johnson and another by Oxford University and AstraZeneca, use modified viruses to deliver genetic material for the same purpose.
Anthony Fauci, the United States’ top infectious disease scientist said on Tuesday the technology had now “established itself” though no mRNA vaccines have ever been approved.
Bourla told Stat he was relieved that another vaccine was successful and hoped many more would enter the fray because the global need was so dismal.
After the companies apply, the EUAs could follow in a matter of weeks.
Earlier Moderna had said it expects to apply for an emergency use authorization by November 25.
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.
