Bengaluru, NFAPost: Amid 95% success rate and no side effects during the final trials, leading drugmakers made it clear that Pfizer Inc and BioNTech are going ahead with its plan to secure emergency US and European authorisation for their COVID-19 vaccine next month.
According to sources familiar with the development, the newly developed vaccine’s consistent efficacy across different ages and ethnicities – a promising sign given the disease has disproportionately hurt globally the elderly and certain groups including Black people.
Expressing confidence, BioNTech chief executive officer (CEO) Ugur Sahin said the US Food and Drug Administration (FDA) could grant emergency-use by the middle of December.
At the same time, conditional approval in the European Union (EU) could be secured in the second half of December,” said BioTEch Chief Executive Officer Ugur Sahin adding that the drug will expand globally for the needy.
“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 added.
Medical experts claim that the success rate of the vaccine developed by the US drugmaker and German partner BioNTech is far higher than what regulators had said would have been acceptable. Experts also added that it is a significant achievement in the race to end the pandemic globally.
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.
Temple University in Philadelphia biologist Enrico Bucci claimed that the testing of the vaccine is first in the history of mankind.
“That too less than a year from the sequence of the virus to the large-scale clinical trial of a vaccine, moreover based on a whole new technique. Today is a special day,” said Enrico Bucci.
BioNTech’s Sahin said US emergency use authorisation (EUA) would be applied for on Friday. An FDA advisory committee tentatively plans to meet on December 8-10 to discuss the vaccine, a source familiar with the situation said, though the dates could change.
