U.S. drugmaker, Pfizer Inc., and German company BioNTech SE, on Friday, asked regulators in the United States to allow emergency use of their COVID-19 vaccine.
If the Federal Drug Administration (FDA) approves their request, both companies will start distributing their vaccine as early as next month.
Pfizer Inc. on Wednesday said final data on its coronavirus vaccine candidate, developed with German company BioNTech SE, showed it to be 95 percent effective, a week after it said interim data revealed the vaccine to be 90 percent effective.
Pfizer said on Wednesday it had the two months of safety data necessary to apply for an emergency use authorization from the FDA.
BioNtech, the German company, will also apply for approval from EUA and both companies will share data with other regulatory agencies around the globe.
Both companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021.
On Monday, Pfizer said it was starting a pilot program to deliver its experimental vaccine to four U.S. states – New Mexico, Texas, Rhode Island and Tennessee.
The announcement was made the same day Moderna, another American drug company said interim data revealed its own coronavirus candidate to be 94.5 percent effective, and that it will be applying for FDA approval in the coming weeks after obtaining final safety and efficacy data.
Pfizer did not receive development funds from the Donald Trump administration through its Operation Warp Speed, but Moderna was given $955 million for the development of its vaccine.
Vaccine efficacy
Pfizer said its vaccine candidate is 95 percent effective “against COVID-19 beginning 28 days after the first dose.”
It said the efficacy rate was consistent across age, gender, race and ethnicity groups.
The company added that for adults older than 65, who are at greater risk of dying from COVID-19, the efficacy rate was also more than 95 percent.
Pfizer said about 43,000 participants enrolled in its vaccine candidate trial, and 170 people came down with the coronavirus.
Among those who tested positive for coronavirus were 162 people who received the placebo or ‘fake vaccine’ and only 8 people who received the ‘real vaccine’, numbers that informed its 95 percent rate efficacy.
It said no serious safety concerns were observed, adding that the only Grade 3 adverse event greater than 2% in frequency was fatigue at 3.8% and headache at 2.0%.
“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. We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world,” said Dr. Albert Bourla, Pfizer Chairman and CEO. “With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world.”
If approved, health care workers and other higher risk populations will be prioritized in the distribution beginning in December.
Dr. Anthony Fauci and other health experts have said the vaccine will not likely reach the general public until about April next year.
