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The scientific journal New England Journal of Medicine (NEJM), one of the most prestigious in the world, published the full results on Thursday Phase III trials of Pfizer and BioNTech’s covid-19 BNT162b2 vaccine project, in which it is confirmed that this drug has an efficacy of 95 percent and offers safety conditions to apply it massively.
(We recommend: 10 things to know about the Pfizer vaccine against covid-19)
The publication refers in an editorial to a “triumph”, at a time when a committee of experts convened by the US Agency for Medicines (FDA) began to examine the vaccine data in public this Thursday, with the aim of recommending or not its authorization of launch to the market.
The publication of these results in a peer-reviewed article was one of the fundamental steps that this vaccine project needed to generate full confidence, despite the fact that since last Tuesday it began to be applied en masse in the United Kingdom.
(In addition: the United Kingdom recommends not vaccinating against covid-19 to severe allergies)
According to NEJM, a total of 43,548 participants were randomized, of whom 43,448 received injections: 21,720 with BNT162b2 and 21,728 with placebo.
There were eight cases of Covid-19 with onset of symptoms at least seven days after the second dose among participants assigned to receive BNT162b2 and 162 cases among those assigned to placebo. In this sense, it is concluded that BNT162b2 was 95 percent effective in preventing Covid-19 (95 percent credible range, 90.3 to 97.6).
Similar vaccine efficacy (generally 90 to 100 percent) was seen in subgroups defined by age, sex, race, ethnicity, baseline body mass index, and the presence of coexisting conditions. Among the 10 cases of severe COVID-19 that started after the first dose, nine occurred in placebo recipients and one in a BNT162b2 recipient.
(Also read: Oxford vaccine for covid-19 is effective and safe, confirms The Lancet)
Regarding safety, some of the reactions reported by the participants were mild to moderate short-term pain at the injection site, fatigue and headache. However, the incidence of serious adverse events was low and similar in the vaccine and placebo groups.
In conclusion, a two-dose regimen of BNT162b2 conferred 95 percent protection against COVID-19 in people 16 years of age and older..
‘A triumph’
These results had already been anticipated a few weeks ago, when the manufacturers published some data through press releases, even the FDA itself had already published its own detailed report on the efficacy and safety of this vaccine on Tuesday.
Two responsible for New England Journal of Medicine They point out in their editorial “minor problems” in the data, especially about the lack of knowledge of the ability of the vaccine to prevent asymptomatic forms of the disease.
But they conclude: “However, the trial results are impressive enough to be valid in any analysis. It is a triumph.”
(See: Know the three most advanced vaccines against covid-19)
Some limitations of the vaccine
For the vaccine to reach the people, Pfizer and its partner have to overcome a series of challenges, which, according to their own announcements, begin by preventing it from falling apart along the way.
As this vaccine is based on a synthetic piece of genetic material of the virus (mRNA) that causes defense reactions in the human organism, This decomposes if it is not kept refrigerated at temperatures below minus 70 degrees Celsius, which, in the words of health care worker Elizabeth Beltrán, requires huge logistics never before deployed for its transport and storage.
Also, since there are two doses, ensure that people complete the scheme within three weeks, which can be complex. However, some months ago agreements began to be signed to reserve large quantities of the vaccine.
Donald Trump separated 100 million doses for delivery in December for 1.9 million dollars, and signed an option to purchase another 500 million doses for the first half of 2021. Japan contracted 120 million doses and the European Union, 200 million so far. Colombia, as revealed last week, is negotiating to get 10 million doses.
For this purpose, Pfizer and BioNTech expect to have 1,300 million doses ready by the end of 2021, and for this, in parallel with the development of the project, they have already started mass production at their plants in Andover (Massachusetts) and Kalamazoo (Michigan). in the United States and in Puurs (Belgium), with the support of BioNTech in Germany, which will form part of the commercial supply network.
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– How does the new vaccine law benefit Colombians?
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