Watch: Pfizer vaccine is 95% effective and has passed safety checks, new data shows
It said its data indicated that their mRNA vaccine works equally well across all ethnicities and races of people.
Pfizer said there had been "no serious safety concerns" reported. Just 2% of the 43,000 people testing the vaccine said they had experienced a headache, and 3.7% had reported fatigue.
Pfizer is now planning to apply for emergency-use authorisation from the US Federal Drug Administration “within days.” Pfizer’s stock was up by 4% and BioNTech’s by around 7% before the market open on Wednesday.
Pfizer and BioNTech were the first to announce preliminary success with their vaccine, announcing just over a week ago that it had proved to be around 90% effective.
Today, they announced that in the final efficacy analysis, the vaccine protected 95% of trial participants within four weeks of receiving the first dose. The vaccine is administered in two doses.
The UK’s drug regulator, the Medicines and Healthcare products Regulatory Agency, is gearing up to fast-track approval of the vaccine as well. The companies are submitting their data on a “rolling” basis to the European regulator, the EMA.
The UK signed an agreement in July to buy 30 million doses of this vaccine. It also ordered five million doses of Moderna’s (MRNA) COVID-19 vaccine, hours after the US-based biotech company reported that its vaccine candidate had shown almost 95% efficacy in its large Phase 3 trial in the US.
“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.”
“We are grateful that the first global trial to reach the final efficacy analysis mark indicates that a high rate of protection against COVID-19 can be achieved very fast after the first 30 µg dose, underscoring the power of BNT162 in providing early protection,” said Ugur Sahin, MD, CEO and co-founder of BioNTech.
“These achievements highlight the potential of mRNA as a new drug class. Our objective from the very beginning was to design and develop a vaccine that would generate rapid and potent protection against COVID-19 with a benign tolerability profile across all ages.
“We believe we have achieved this with our vaccine candidate BNT162b2 in all age groups studied so far and look forward to sharing further details with the regulatory authorities. I want to thank all the devoted women and men who contributed to this historically unprecedented achievement.”
Watch: European stocks rise on vaccine hopes