The firm said it cannot apply for emergency use authorisation by the Food and Drug Administration just based on the efficacy results .
Washington : American pharmaceutical firm Pfizer and German biotechnology company BioNTech on Monday announced that their coronavirus vaccine was more than 90% effective in phase three clinical trials.
“The results demonstrate that our mRNA-based vaccine can help prevent COVID-19 in the majority of people who receive it,” Pfizer Chief Executive Officer of Albert Bourla said in a statement. “This means we are one step closer to potentially providing people around the world with a much-needed breakthrough to help bring an end to this global pandemic.”
Bourla said that the vaccine had proven to be effective in “participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis”.
The top executive called the result “a first but critical” in the efforts to develop a vaccine against the coronavirus. He, however, said that the companies cannot apply for emergency use authorisation by the Food and Drug Administration just based on the efficacy results.
“More data on safety is also needed, and we are continuing to accumulate that safety data as part of our ongoing clinical study,” Bourla said. “We estimate that a median of two months of safety data following the second and final dose of the vaccine candidate – required by FDA’s guidance for potential Emergency Use Authorization – will be available by the third week of November.”
Bourla said that the results brought a “great day for science and humanity”, according to Reuters. “We are reaching this critical milestone in our vaccine development programme at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen,” he was quoted as saying by the news agency.
Dr Anthony Fauci, the Director of United States’ National Institute of Allergy and Infectious Diseases, had said last month, that the first vaccine dose is likely to become available to some high-risk Americans in late December or early January. He had added that the availability of the vaccine will however be subject to safety and efficacy.
Pfizer, AstraZeneca and Moderna are among the front-runners in the global race to produce a vaccine to fight the infection. Eleven vaccines, including four in the US, are in late-stage trials, according to The New York Times.
India has not yet signed a deal for a coronavirus vaccine 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 US, UK, the European Union, Australia and Israel have made deals to buy millions of doses of the vaccines.
Globally, the coronavirus has infected more than 5.03 crore people and killed 12,55,250 people, according to the John Hopkins University data. The recoveries stand at 3,29,71,528.