Pfizer confirmed Friday that it and partner BioNTech have applied for emergency use authorization for their coronavirus vaccine, becoming the first to do so in the USA or Europe as the pandemic rages around the world.
If there's an emergency green light, "that vaccine is still deemed investigational". Faced with the prospects of another recession and uncertainty over how long the crisis may last, European leaders are increasingly counting on vaccines to provide relief.
In the case of COVID-19, the USA government wanted to be ready to begin distributing the vaccine the moment the results of the phase 3 trials were known and the safety data had been analyzed.
Pfizer and BioNTech to Submit Emergency Use Authorization Request Today to the US FDA for COVID-19 Vaccine [news release].
Not far behind Pfizer is competitor Moderna's COVID-19 vaccine. Once the FDA grants Pfizer and BioNTech authorization, they plan to ship millions of doses of the vaccine within 24-hours.More news: U.S. election: Reporter asks Donald Trump if he's 'being a sore loser'
It is not clear how long the FDA will take to study the data.
"I am confident that if everything goes well, and we have a very organized vaccine supply, that we could have a normal summer and winter 2021", Şahin said.
Seen purely from a clock time perspective, Pfizer's dash to the finish line has broken all vaccine development speed records, and on a totally new technology platform called mRNA - which has no benchmarks yet. The reason that vaccines may be approved so quickly is that the large clinical trials to assess vaccine efficacy and safety are happening at the same time as the large-scale manufacturing preparation, funded by the federal government's Operation Warp Speed program. Between the two companies, enough vaccine could be made and available for more than 20 million Americans anticipated by the end of December.
"Filing for Emergency Use Authorization in the United States is a critical step in making our vaccine candidate available to the global population as quickly as possible", said Ugur Sahin, MD, CEO and co-founder of BioNTech, in a prepared statement.
A separate candidate vaccine being developed by the University of Oxford and AstraZeneca has been shown to be safe and effective in a smaller study of older adults, and is now in a phase 3 trial. While some have said they will price their vaccines so they don't profit from them, Bourla says Pfizer is making its vaccine available on a non-for-profit basis only for lower-income countries receiving vaccines through the World Health Organization vaccine distribution coalition run by GAVI.More news: Apple's AirPods Pro are just $190 at Woot
The committee's recommendations are not binding, however, and a final decision on whether or not to authorize the vaccine will be up to the scientists at the FDA.
There are a dozen coronavirus vaccine candidates in late-stage trials worldwide that use a variety of approaches, and no company could produce enough of one to protect the world's 7.8 billion people.
Moderna, which worked with scientists from the National Institutes of Health, said Monday its vaccine was 94.5% effective against SARS-CoV-2 and the disease it causes, COVID-19.
That messenger RNA, or mRNA, instructs the body to make some harmless spike protein, which then trains immune cells to recognize the real coronavirus if it comes along. Health and Human Services Secretary Alex Azar also said Wednesday there is an effort to move the CDC advisory meeting up to coincide with that of the FDA advisers.
The Moderna-NIH vaccine is given 28-days-apart at locations across the USA on some 30,000 volunteers, in a trial part funded by the taxpayer.More news: Listen to Shawn Mendes and Justin Bieber's New Song 'Monster'