Pfizer-BioNTech vaccine 95% effective, based on comprehensive clinical trial results

Illustrative image of a coronavirus vaccine. – JUSTIN TALLIS / AFP

The race for the coronavirus vaccine continues. Pfizer and BioNTech announced on Wednesday that their vaccine was actually 95% effective in preventing Covid-19, according to comprehensive results from their large-scale clinical trial.

This is better than partial results published last week which showed “more than 90%” of effectiveness, and it supports the predictions of the American authorities according to which at least one vaccine can begin to be injected in the arms of the Americans before. the end of the year.

43.0000 volunteers, a severe case among the vaccinated

This means that 162 members of the placebo group in the trial contracted Covid-19, compared to only 8 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 the trial, which began in late July, and 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 days” from the United States Drug Administration (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.

Fatigue and headaches

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 over 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, a step the group knew would be taken this week. “The trial marks an important milestone in the historic eight-month quest to develop a vaccine capable of ending this devastating pandemic,” said Pfizer CEO Albert Bourla.

FDA must look into as yet unknown details

For Ugur Sahin, the co-founder of BioNTech, a small German biotechnology company that developed the new technology on which the vaccine is based, messenger RNA, “this achievement illustrates the potential of messenger RNA as a new class of drugs. “.

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.

But the FDA will need to assess the data on the efficacy and safety of the two vaccines in detail, 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.

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