NEW YORK – Pfizer Inc said on Wednesday that the potential COVID-19 vaccine it is developing with BioNTech SE has proven to be 95 percent effective in clinical trials and has already met the safety requirement to be authorized for use in the United States.
A little more than a week after releasing preliminary results showing 90 percent efficacy, the US-based pharmaceutical giant said that the latest data demonstrate the formula is 95 percent effective at preventing infection with the coronavirus.
Among test subjects older than 65, the demographic at the highest risk of dying from COVID-19, the vaccine was 94 percent effective, Pfizer said in a press release.
The data monitoring committee appointed by the US National Institutes of Health for the study has not raised any serious safety concerns about the vaccine, which is administered in two doses.
Of the nearly 44,000 people worldwide taking part in the clinical trials, 170 have tested positive for COVID-19. All but eight of those cases involved test subjects who received the placebo.
More than 41,000 participants had received a second dose of the vaccine candidate as of Nov. 13.
“The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic,” Pfizer Chairman and CEO Albert Bourla said.
Pfizer and Germany’s BioNTech “plan to submit a request within days to the FDA (US Food and Drug Administration)” for Emergency Use Authorization and will likewise provide all relevant data to regulatory agencies in other nations.
Observers have pointed out that the handling requirements for the Pfizer/BioNTech drug, which must be maintained at the super-cold temperature of minus 70C (minus 94F), could represent a challenge for less-developed countries.
But Pfizer, the world’s second-biggest pharmaceutical firm, said it was “confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world.”
Founded in 1849 and with more than 88,000 employees, Pfizer is vying with tiny Moderna, a 10-year-old firm with a staff of fewer than 900, to be the first to bring a coronavirus vaccine to market in the US, which leads the world in COVID-19 cases, 11.4 million, and deaths, 248,000.
Moderna said on Monday that its vaccine candidate demonstrated 94 percent effectiveness in clinical trials.
The company noted that its formula can be transported and stored at temperature in the range of 2-8C (36-46F), “the temperature of a standard home or medical refrigerator.”
Moderna said it will approach the FDA “in the coming weeks” to request Emergency Use Authorization for its vaccine.
Other vaccine candidates currently undergoing Phase 3 clinical trials include one developed by British-based AstraZeneca in collaboration with the University of Oxford; CoronaVac, a creation of China-based Sinovac Biotech; and Russia’s Sputnik V.
Dr. Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases, said on Tuesday that seeing Phase 3 clinical trials of vaccines producing results just months after the discovery of a new pathogen was “beyond historic.”
Cautioning that measures such as mask-wearing and social distancing will need to continue, he said that a successful vaccine “should be an incentive for people who have COVID fatigue and are really tired of public health measures to say, you know there is light at the end of the tunnel, help is coming, let me hang in there a bit longer.”