The vaccine developed by the Pfizer / BioNTech alliance is 95% effective in preventing COVID-19, based on the complete results of its large-scale clinical trial, matching the levels announced by Moderna this week.
In the statement published this Wednesday, the pharmaceutical companies present the conclusions of the result of phase 3, ensuring that their vaccine has an efficacy of 95%.
This is better than the partial results published last week that cited an efficacy of “more than 90 percent”, and supports the predictions of the US authorities that at least one vaccine could begin to be injected into the arms. of Americans before the end of the year.
This means that 162 members of the placebo group in the trial contracted COVID-19, compared with just eight in the vaccine group, within seven days of the second dose of the vaccine, which is taken in two doses with three. weeks apart.
The trial protocol called for efficacy to be assessed once a total of 170 cases was reached in both groups.
In total, more than 43,000 people volunteered for the trial, which began in late July and is expected to continue.
Nine severe cases of COVID-19 were seen in the placebo group and one in the vaccine group.
Marketing in December?
Pfizer will seek marketing approval “in a few days” from the US Food and Drug Administration (FDA).
The FDA could then give its green light to commercialization as early as December, a senior official in the government’s operation for vaccines, Moncef Slaoui, said on Monday.
The effectiveness of the Pfizer / BioNTech vaccine for people 65 and older was “more than 94%,” according to the statement.
This level of efficacy, if confirmed in the population, would place the vaccine among the most effective in the world, comparable to the measles vaccine, and much better than the influenza vaccine, which recently had an efficacy of only 19 to 60%.
The only significant side effects seen in more than 2% of the participants were fatigue (3.8%) and headaches (2%), leading the manufacturers to call the vaccine “well tolerated.”
Pfizer was waiting two months of follow-up for at least half of the participants before applying for FDA approval, a milestone the group knew would be reached 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.
For Ugur Sahin, co-founder of BioNTech, the small German biotechnology company that developed the novel technology behind the vaccine, messenger RNA, “this success illustrates the potential of messenger RNA as a new class of drugs.”
Moderna, a US company, announced on Monday similar results (94.5% effective) with a vaccine also based on messenger RNA. In both cases, the vaccines appeared to be particularly effective in preventing severe forms of Covid-19, the disease caused by the new coronavirus.
But the FDA will have to evaluate the efficacy and safety data for both vaccines in detail, details that have not been released by the manufacturers. The regulator has committed to doing so in the most public way possible.
The United States, Europe, and other countries have already reserved hundreds of millions of doses of the Pfizer vaccine. Pfizer expects to be able to produce 50 million doses this year, enough to vaccinate 25 million people, and 1.3 billion by 2021.