Drug manufacturer Pfizer on Wednesday announced that the phase three study of its Covid-19 vaccine candidate being developed in collaboration with German biotechnology company BioNTech has met all “primary efficacy endpoints”.
“The study reached 170 confirmed cases of Covid-19, with the vaccine candidate BNT162b2 demonstrating 95% efficacy beginning 28 days after the first dose,” Pfizer’s official account tweeted. “Additionally, the safety milestone required by the US FDA [United States Food and Drug Administration] for Emergency Use Authorization (EUA) has been achieved. To date, no serious safety concerns related to the vaccine candidate have been reported.”
The drug company said that it was planning to submit a request to the US FDA “within days” for an EUA on the basis of the “totality of safety and efficacy data collected”. The authorisation will also be based on manufacturing data related to the “quality and consistency” of the vaccine candidate.
“We also plan to submit the efficacy and safety data from the study for peer-review in a scientific journal once analysis of the data is completed,” the company added.
Pfizer, AstraZeneca and Moderna are among the front-runners in the global race to produce a vaccine to fight the infection.
On November 9, Pfizer and BioNTech had announced that their coronavirus vaccine was more than 90% effective in phase three clinical trials. On Monday, drug manufacturer Moderna said its vaccine candidate against the coronavirus had proven to be 94.5% effective against the virus during its phase three trials.
India has not signed a deal for a coronavirus vaccine yet so it is unclear when it will be available for use in the country, despite some leaders promising it will be available from as early as January. Availability of the vaccine in India will be subject to approval by domestic regulators, and the Indian government agreeing to purchase them. So far, many other nations including the United States, United Kingdom, the European Union, Australia and Israel have made deals to buy millions of doses of the vaccines.
The Union health ministry on Tuesday said the cold-chain requirements of the coronavirus vaccine developed by Pfizer posed a big challenge to India’s mass-vaccination campaign, but the government is examining all possibilities for its procurement. Pfizer’s vaccine must be shipped and stored at freezing temperatures of -70 degrees Celsius from the moment they are bottled to the time they are ready to be injected. This is significantly lower than the standard 2-8 degrees Celsius storage requirement.