Drug manufacturer Pfizer on Friday applied to United States’ health regulators for authorisation for emergency use of its potential coronavirus vaccine – one that it is developing with BioNTech. The company’s Chief Executive Officer Albert Bourla confirmed the application in a video posted on Pfizer’s official Twitter handle.
“...Our request for emergency use authorisation for our Covid-19 vaccine is now in the FDA’s [Food and Drug Administration] hands,” Bourla said.
He said that it took Pfizer and BioNtech 248 days from announcing their collaboration to submitting their application and called the occasion “a historic day”.
Bourla expressed confidence that the company would produce 50 million doses of the vaccine by the end of this year, and 1.3 billion of them by the end of 2021.
The US’ Food and Drug Administration said on Friday that it would hold a meeting of the advisory committee on December 10 at which members would discuss the vaccine, Reuters reported. The agency declined to predict how long its review would take, although both Pfizer and US Health Secretary Alex Azar have said the FDA could authorise the vaccine in mid-December, according to the news agency.
“The FDA recognises that transparency and dialogue are critical for the public to have confidence in Covid-19 vaccines,” the health agency’s head Stephen Hahn said in a statement, reported AFP.
On Wednesday, Pfizer had announced that the vaccine candidate had demonstrated 95% efficiency in late-phase, or phase 3 trials.
Meanwhile, Moderna is expected to be the next company to file a similar application, according to Reuters. Moderna’s potential vaccine has shown 94.5% efficiency in the third phase trials. Another vaccine candidate developed by the Oxford University and AstraZeneca has produced strong immune responses in older adults in second stage trials.
In India, biotechnology company Bharat Biotech had on Monday said that it has begun the phase 3 clinical trials of Covaxin in India, with 26,000 participants from across 22 sites in the country. The vaccine has so far been evaluated in 1,000 subjects in Phase I and Phase II clinical trials, the company added. Earlier this month, senior Indian Council of Medical Research scientist Rajni Kant had expressed hope that the Bharat Biotech vaccine could be available as early as February, months earlier than expected.
However, India has not yet signed a deal for a coronavirus vaccine so it is unclear when it will be available for use in the country, despite some leaders promising it will be available from as early as January. Availability of the vaccine in India would be subject to approval by domestic regulators, and the Indian government agreeing to purchase them.