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 a 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 (EUA) “within days” and to share trial data with other regulatory agencies around the globe, 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 authorises any COVID-19 vaccine for emergency use, officials will review and discuss the trial data in a public meeting likely to take place next month, said Pfizer.
Pfizer and BioNTech expect to produce up to 50 million vaccine doses globally this year and as many as 1.3 billion doses by the end of 2021.
If the FDA grants emergency use, it will still be months before the vaccine is widely available. Governments though are expected to give priority to groups such as front-line healthcare workers and immunocompromised individuals to receive the vaccine this year.
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. For people above 65, the vaccine was shown to be 94 percent effective, said Pfizer.
Some 170 infections were observed in the study, eight of which were observed in people who received the vaccine rather than a placebo. One of those eight who received the vaccine developed a severe case of COVID-19.
The trial will continue to collect data on efficacy and safety for two more years.
Wednesday’s announcement comes a week after initial results from the trial showed the vaccine was more than 90 percent effective and days after Moderna Inc released promising preliminary trial data for its COVID-19 vaccine that showed it be 94.5 percent effective.
Neither Pfizer-BioNTech nor Moderna’s vaccines are made with the coronavirus. Instead, they were developed with new messenger RNA (mRNA) technology that relays genetic instructions to teach the human immune system – how to make virus-slaying antibodies.
Logistical concerns have been raised about distribution of the Pfizer-BioNTech vaccine because it needs to be stored in ultracold temperatures of -70 degrees Celcius (-94 degrees Fahrenheit).
The companies sought to assuage those concerns, saying they have developed speciality temperature-controlled thermal shippers that can be used as temporary storage units for 15 days by refilling them with dry ice.
“We have confidence in our vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world,” said Pfizer.
The better than expected results from late-stage trials of Pfizer-BioNTech’s vaccine as well as Moderna’s have ignited hopes that a gamechanger is within grasp to conquer a pandemic that has claimed more than 1.3 million lives around the world, decimated the global economy, obliterated livelihoods, and exacerbated inequalities between and within nations.
Pfizer’s final results come as new infections are raging across the world, with surges of new cases straining healthcare systems that are dealing with record spikes in hospitalisations.PUBLICITÉ
Dozens of drug companies and research groups are working to develop a safe and effective vaccine against COVID-19.
SOURCE : AL JAZEERA