If things go accordingly, the vaccine developed by Pfizer Inc in partnership with BioNTech could be released in the market even before Christmas, BioNTech was quoted telling Reuters.
The vaccine candidate, which is in the race towards formulating a preventive mechanism for covid-19, has shown promising responses with its final trial results giving a 95% success rate.
The drugmaker said on Wednesday that their development could receive the emergency-use authorization from the US and European nations next month after witnessing its rate of efficiency with no serious side effects with its administration.
Adding to the vaccine’s plus points was its efficacy that is found to be the same amongst all age groups and ethnicities as well, given the fact that the virus shows its severity and hits harder in the elderly people and Blacks.
As such, the BioNTech Chief Executive, Ugur Sahin, told the media that the US FDA (Food and Drug Administration) could release a permit for emergency-use to their vaccine till mid-December. A conditional approval is also on the cards from the European Union by the later half of December, the CE said.
“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,” Mr. Sahin said.
The proven success rate of this vaccine was found to be much higher than what it was previously expected to deliver. According to experts, this could be a major achievement in the global attempts to put an end to the deadly infection.
The US drug maker and its German ally’s formulated vaccine had 43,000 participants who received the shots. Out of these, 170 contracted covid-19. However, 162 of these 170 had received placebos and not the actual vaccine. This meant that the vaccine is 95% efficient. Moreover, from the 10 patients of this trial who were hit with the severe form of covid-19, only one had been given the vaccine.
A biologist belonging to Philadelphia’s Temple University, Enrico Bucci, while calling the day of the final trial results as “special”, said, “A first in the history of mankind: 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.”
According to Mr. Sahin, the EUA (emergency use authorization) permit will be put in force in the United States on Friday.
Though the FDA did not prefer to respond on the matter, sources in touch with it say that an FDA advisory board is planning to setup a meeting on 8-10 December to discuss the same. However, they termed the dates as tentative as it can change.
A week before the final trial reports came into picture, the company had said that their vaccine was over 90% effective. Later on Monday, Moderna announced 94.5% efficacy of their vaccine candidate gathered from preliminary data.
Alex Azar, the US Health and Human Services Secretary, seemed pleased with the vaccines as he spoke about the development and presence of “two safe and highly effective” vaccines which are on the verge of receiving the authorization from the FDA and being distributed within a few weeks.
According to the US officials, the vaccine developed by Moderna could receive its authorization permit after 7-10 days of Pfizer getting its own EUA with states geared up for distributing the vaccine in 24 hours.
The latter US drugmaker said it is getting ready to develop around 50 million vaccines this year, which will be sufficient for protecting 25 million people. The production scale could go upto 1.3 billion next year, Pfizer added.