The vaccine developed by the Pfizer / BioNTech alliance is 95% effective in preventing Covid-19. This rate, even better than that revealed by the first results (90%), is based on the full results of the clinical trial made public on Wednesday.
This means that 162 members of the placebo group in the trial contracted Covid-19, compared with only eight in the vaccinated group within seven days of the second dose of the vaccine, which is taken in two doses three weeks apart. The trial protocol was to assess efficacy once a total of 170 cases were reached in both groups.
In total, more than 43,000 people have volunteered for this trial, which began at the end of July, and which is expected to continue. Nine severe cases of Covid-19 were observed in the placebo group, and one in the vaccinated group.
Pfizer will apply for marketing authorization “within a few days” of the US Medicines Agency (FDA). The FDA could then give the green light for marketing as early as December, a senior official in the government operation for vaccines, Moncef Slaoui, said on Monday.
Side effects in 2% of patients
The effectiveness of the Pfizer / BioNTech vaccine for people over 65 was “over 94%,” the statement said. This level of efficacy, if confirmed in the population, would place the vaccine among the most effective in the world, comparable to that of measles, and much better than the influenza vaccine, which recently was only effective. at 19% to 60%.
The only significant side effects seen in more than 2% of participants were fatigue (3.8%) and headaches (2%), leading manufacturers to say that the vaccine is “well tolerated”. Pfizer was waiting to have two months of follow-up for at least half of the participants before seeking clearance from the FDA.
In competition with Moderna
Moderna, an American company, announced on Monday similar results (94.5% effectiveness), with a vaccine also based on messenger RNA. In both cases, the vaccines appeared particularly effective in preventing severe forms of Covid-19, the disease caused by the new coronavirus.
>> Watch the interview with the Managing Director of Moderna at 7:30 p.m .:
But the FDA will need to thoroughly assess the data on the efficacy and safety of the two vaccines, details that have not been made public by the manufacturers. The regulator is committed to doing so as publicly as possible.
The United States, Europe and other countries have already reserved hundreds of millions of doses of the Pfizer vaccine. The group plans to be able to produce 50 million this year, which is enough to vaccinate 25 million people, and 1.3 billion in 2021.
>> See also our monitoring of the pandemic in the world:
ats / vajo