US pharmaceutical company, Pfizer Inc and its German partner BioNTech have announced 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 added that they 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.
The CEO of Pfizer, Albert Bourla said in a statement that 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.”
Pfizer added that 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 take place in December.
The UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), is also poised to fast-track authorisation of the vaccine after the government ordered enough for 20 million people.
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.
The Pfizer-BioNTech late-stage trial involved nearly 44,000 volunteers. The results showed the vaccine to be consistently effective across people of different ages, races and ethnicities.
The pharmaceutical company added that for people above 65, the vaccine was shown to be 94 percent effective. There were no serious side effects, with only 2% of the 43,000 participants reporting a headache and 3.7% reporting fatigue. The trial will continue to collect data on efficacy and safety for two more years.
The 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.
Concerns have been raised about distribution of the Pfizer-BioNTech vaccine because it needs to be stored in ultracold temperatures of -70 degrees Celcius.
The companies addressed 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.”
Pfizer and Moderna’s vaccine trials are two of around 12 worldwide, including one being developed by AstraZeneca and Oxford University that are in the final stages of testing.
The 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.
