Pfizer Inc and BioNTech could secure emergency U.S. and European authorization for their COVID-19 vaccine next month after final trial results showed it had a 95% success rate and no serious side effects, the drugmakers said on Wednesday.
The vaccine's efficacy was found to be consistent across different ages and ethnicities - a promising sign given the disease has disproportionately hurt the elderly and certain groups including Black people.
The U.S. Food and Drug Administration could grant emergency-use by the middle of December, BioNTech Chief Executive Ugur Sahin told Reuters TV. Conditional approval in the European Union could be secured in the second half of December, he added.
"If all goes well I could imagine that we gain approval in the second half of December and start deliveries before Christmas, but really only if all goes positively," he said.
The success rate of the vaccine developed by the U.S. drugmaker and German partner BioNTech was far higher than what regulators had said would have been acceptable. Experts said it was a significant achievement in the race to end the pandemic.
Of the 170 volunteers who contracted COVID-19 in Pfizer's trial involving over 43,000 people, 162 had received a placebo and not the vaccine, meaning the vaccine was 95% effective. Of the 10 people who had severe COVID-19, one had received the vaccine.
UGUR SAHIN: We have, of course, to wait for authorization and approval. If everything goes well, we could start to supply the vaccines to Europe and the United States in the second half of December. And you can see that, of course, as a Christmas present. But it is, of course, of course, of course, most important to address all the questions and to get the approval first.
We are working on formulations which could allow us much better conditions for transportation and storage. And we will update on this in the coming months. I expect that in the second half of 2021 we will have a formulation suitable for transportation without any cold chain to any place on the planet.
So the clinical trial was successful with regard to of all objectives. And we have observed a 95% efficacy protection from disease. An important finding was that protection works well at the same level regardless of the age of the participants. So we have more than 94% efficacy, even in subjects older than 65 years of age. And this is, of course, an important finding because this population, this elderly population has a particularly higher risk for severe COVID-19 disease.