Pfizer and BioNTech’s Phase 3 trial showed their vaccine to be 95% effective against COVID-19, will now seek FDA Emergency Use Authorization.
The results are in for the forerunner in the race for a COVID-19 vaccine.
United States Pharma giant Pfizer Inc and its German partner BioNTech said on Wednesday that final results from the Phase 3 trial of their COVID-19 vaccine showed it to be 95 percent effective- the highest success rate for any pandemic candidate in late stage trials so far.
The drug companies will now submit an application with the US Food and Drug Administration for Emergency Use Authorization “within days” said Pfizer.
“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,” said Pfizer chief Albert Bourla in a statement. “We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world.”
Before the FDA authorizes any COVID-19 vaccine for emergency use, officials will review and discuss the trial data in a public meeting, “likely to be held in December” said Pfizer.
Pfizer and BioNTech expect to produce up to 50 million vaccine doses globally this year and up to 1.3 billion doses by the end of 2021.
The Pfizer-BioNTech late stage trial involved nearly 44,000 volunteers, of which 42 percent globally and 30 percent in the US had diverse backgrounds. The results showed the vaccine to be consistently effective across people of different ages, races and ethnicities.
The trial will continue to collect data on efficacy and safety for two more years.
The final analysis comes just a week after initial results from the trial showed the vaccine was more than 90 percent effective. Moderna Inc on Monday released preliminary data for its vaccine, showing 94.5 percent effectiveness.
The better-than-expected results from the two vaccines, both developed with new messenger RNA (mRNA) technology, have raised hopes for an end to a pandemic that has killed more than 1.3 million people and wreaked havoc upon economies and daily life.
However, while some groups such as healthcare workers will be prioritized in the United States for vaccinations this year, it will be months before large-scale rollouts begin.
Pfizer’s final results come as the virus is running rampant around the world, placing an enormous strain on healthcare systems with record numbers of new cases and hospitalizations.
Of the dozens of drugmakers and research groups racing to develop vaccines against COVID-19, the next data release will likely be from AstraZeneca Plc with the University of Oxford in November or December. Johnson & Johnson says it is on track to deliver data this year.