The coronavirus vaccine developed by pharmaceutical company Pfizer and its German partner BioNTech offers strong protection against the infection about 10 days after the first dose, The New York Times reported on Tuesday, citing documents released by the United States Food and Drug Administration.
The documents were published ahead of Thursday’s meeting of outside experts to discuss whether the vaccine should be authorised for emergency approval in US. It also came on the same day when Britain’s National Health Service started vaccinating its oldest citizens with the Pfizer-BioNTech shots, making it the first clinically authorised, fully tested immunisation effort in the world.
The FDA staff did not raise any problems about the vaccine’s safety or efficacy. In November, Pfizer had announced that their two-dose vaccination had an 95% efficacy in phase three trials.
The analysis also found that the coronavirus vaccine worked well regardless of a volunteer’s race, weight or age. “This is what an A+ report card looks like for a vaccine,” Akiko Iwasaki, an immunologist at Yale University told The New York Times.
According to one graph in the briefing materials, new coronavirus cases quickly reduced in the vaccinated group of participants about 10 days after the first dose. On the contrary, cases kept steadily increasing in the group which was given placebos, which may be a similar-looking injection having no medical effect.
Data from 38,000 trial participants was used to review the vaccine, according to AFP. The drug regulator found “no specific safety concerns” and suggested that Pfizer has cleared the next hurdle in the race to get its vaccine approved for emergency use.
Other vaccines that are reviewed by regulators around the world include a collaboration between Oxford University and drugmaker AstraZeneca and one developed by US biotechnology company Moderna.
Meanwhile last month, India’s Union Health Minister Harsh Vardhan said that the country “may not need” the Pfizer vaccine, as the company does not have “linkages” to manufacture it. The vaccine also needs to be stored at temperatures of minus 70 degrees Celsius (-94 Fahrenheit) or below, making it a challenge for countries like India. Other problems include seamless cold chain distribution from manufacturers to airports to remote villages and areas.
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. 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, European Union countries, Canada, Australia and Israel have made deals to buy millions of doses of the vaccines.