US and European regulators could approve Pfizer and BioNTech's experimental Covid-19 vaccine as early as mid-December, the German group's chief executive said on Wednesday, following the release of positive trial results.
Chief executive Ugur Sahin said, if all goes well, the Food and Drug Administration could grant emergency-use approval towards the end of the first half of December or early in the second half. Conditional approval in the European Union could be achieved in the second half of December, he added.
Pfizer said on Wednesday that final results from the late-stage trial of its Covid-19 vaccine showed it was 95 per cent effective and had no serious side effects – the first set of complete results from a late-stage vaccine trial as Covid-19 cases skyrocket around the globe.
The company said it now had the required two-months of safety data and would apply for emergency US authorisation within days.
The final analysis comes just one week after initial results from the trial showed the vaccine was more than 90 per cent effective. Moderna on Monday released preliminary data for its vaccine, showing similar effectiveness.
Pfizer said there were 170 cases of Covid-19 in its trial of more than 43,000 volunteers and only eight people with the disease had been given the shot rather than a placebo, meaning the vaccine had a 95 per cent efficacy rate.
Of the 10 people who developed severe Covid-19, one had received the vaccine.
Pfizer and BioNTech said that the vaccine’s efficacy was consistent across age, race and ethnicity.
The most common serious adverse event was fatigue, with 3.7 per cent of volunteers reporting tiredness after they took the second dose. Two percent of volunteers reported a headache after the second dose.
Older adults reported fewer and milder side effects, the companies said.
The Pfizer vaccine has been shown to produce both an antibody and T-cell response in the body to fight coronavirus.
Pfizer and BioNTech expect to be able to produce up to 50 million vaccine doses globally in 2020 and up to 1.3 billion in 2021.
The results of a vaccine study from Oxford University and AstraZeneca are expected soon. – Reuters / New York Times
