The COVID is a step closer to becoming available to the public. Pfizer and Biontech announced Wednesday they will be filing for Emergency Use Authorization, or EUA, with the Federal Drug Administration on Friday.
The companies say Phase 3 data in their vaccine trials show it’s 95 percent effective in protecting a person against infection, better than they previously thought.
“The risk of getting COVID-19 if you are vaccinated is twentyfold less as compared to having no vaccine,” said Dr. Uğur Şahin, Biontech’s CEO.
Among the requirements before the FDA approves it the company must show the vaccine’s benefit’s outweigh the risk and be more than 50 percent effective.
Dr. Richard Loftus, a doctor on the forefront of COVID treatment and research says the scientific community is thrilled with the data, “Wow this is so much better than what we were prepared to hear, you know we would have been happy with something that was 50 percent effective kind of what we have with an average influenza vaccine.”
The company also claims there have not been any serious safety concerns, and only fatigue and headaches happening in less than three percent of the 40,000 participants.
Another vaccine by Moderna also showed 95 percent effectiveness and does not require ultra cold storage.
Loftus says this breakthrough in mRNA technology, that essentially turn cells into mini vaccine factories may even bring protection that lasts years, “It looks like the kind of immunity that the vaccines are producing is almost like a supercharged immunity compared to what people get from natural infection with the SARS CoV-2.”
If the FDA grants EUA, the manufacturing, logistics and mass vaccination can begin. The company says they can produce 50 million doses by the end of this year and 1.3 billion by the end of 2021. The vaccine requires two doses.
The concern some have raised is the temperature the vaccine needs to be stored and shipped in to remain viable, minus 103 degrees Fahrenheit. The company says they have the cold infrastructure figured out and are not worried.
“If everything goes well and we have a very good organized vaccine supply, we could have a normal winter 2021 and normal summer,” says Şahin.
Loftus says this is hopeful news, “Which I think reinforces for everybody, hang in there, hope’s on the way, we just gotta get people safely through this winter surge.”
The FDA will also consult with an independent advisory committee before making a decision. The last drug it approved under EUA for COVID is hydroxychloroquine, but according to the FDA when it became clear the drug posed a risk and no benefit they pulled that approval.