Pfizer and BioNTech announced their COVID-19 vaccine candidate is now 95% effective and will soon be submitted to the Food and Drug Administration for emergency use authorization.
On Wednesday, the drugmakers revealed they had completed the third phase of their vaccine and found it to be 95% effective against the coronavirus. The companies said no “serious safety concerns” were observed among the 43,000 people enrolled in the trial, with only 3.8% reporting fatigue and another 2% reporting a headache.
“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 Pfizer CEO Dr. Albert Bourla in a statement. “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.”
In a press release, the companies said they “plan to submit a request within days to the FDA for an EUA based on the totality of safety and efficacy data collected to date, as well as manufacturing data relating to the quality and consistency of the vaccine.”
Last week, Pfizer and BioNTech released a joint statement on preliminary findings that showed the vaccine to be 90% effective against the coronavirus. Following the news, President-elect Joe Biden warned that “Americans will have to rely on masking, distancing, contact tracing, hand washing, and other measures to keep themselves safe well into next year.”
Pfizer says it will produce 50 million doses of the vaccine in 2020 and up to 1.3 billion doses in 2021.
Earlier this week, pharmaceutical company Moderna announced its COVID-19 vaccine is almost 95% effective. Moderna is involved in the Trump administration’s Operation Warp Speed program and received approximately $1.5 billion to create and distribute its vaccine.
“This is a pivotal moment in the development of our COVID-19 vaccine candidate,” said Moderna CEO Stephane Bancel. “This milestone is only possible because of the hard work and sacrifices of so many.”
On Tuesday, the FDA approved emergency use for a new, at-home coronavirus testing kit. The all-in-one COVID-19 diagnostic test from Lucira Health gives users results within 30 minutes.
The test kit was authorized for at-home use for people who are at least 14 years old as well as at points of care, such as hospitals and emergency rooms. The test is only authorized for prescription use, according to the FDA. For children younger than 14, a sample must be taken by a healthcare provider.
