Johnson & Johnson's Covid-19 vaccine will be scrutinized by a committee of experts this Friday.
Even if it is only advisory, its opinion will be taken into account for the conditional authorization of this third vaccine in the United States, which could intervene very quickly in the wake.
The discussions of this committee will be webcast live throughout the day, as was the case before the emergency authorizations of the vaccines from Pfizer / BioNTech and Moderna in the country.
Its members, around twenty people, mostly independent scientists, as well as an industry representative and a consumer spokesperson, were able to analyze in detail the data from clinical trials conducted on 40,000 people.
They will be able to ask their questions and make any criticisms in order to fuel the discussion.
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This unusual exercise in transparency is also intended to reassure the general public, by demonstrating the seriousness of the procedure.
Experts are tasked with answering the following question: Do the benefits of the vaccine outweigh the risks of its use?
They will vote, at the end of the day, in favor or not of what is called in the United States an authorization for emergency use.
The final green light will then have to be given by the US Medicines Agency, the FDA, which will make its decision "as quickly as possible", she promised.
For Pfizer and Moderna, authorization was granted the day after the committee's favorable opinion was rendered.
Single dose and store at refrigerator temperature
The vaccine from the pharmaceutical company Johnson & Johnson, whose injections have already started in South Africa, is particularly expected because, unlike other available sera, it can only be administered in a single dose.
It also has another advantage in logistics: it can be stored at refrigerator temperatures, which will greatly facilitate its distribution.
The authorization is actually little doubt, the FDA itself having released a series of documents this week in which it confirmed the effectiveness of the vaccine.
"The scans support a favorable safety profile without specific identified safety concerns that could prevent the issuance of an emergency use authorization," she wrote on Wednesday.
The vaccine's efficacy is 85.9% against severe forms of Covid-19 in the United States, the country most bereaved by the pandemic.
All regions of the clinical trial combined, it is 66.1% against moderate forms of the disease, and overall "similar" for all categories of the population (ages, ethnicities).
The most common side effects seen are pain at the injection site, headache, fatigue, and muscle pain.
The vaccination campaign could accelerate in the United States
At least three million doses are ready for distribution as early as "next week," according to the US government.
The American company has pledged to ship 100 million doses to the United States before the end of June.
With 600 million doses ordered in total from Pfizer and Moderna, the United States will already have, by the end of July, enough vaccines to immunize almost the entire population.
But the addition of those from Johnson & Johnson could further accelerate the vaccination campaign.
In total, more than 68 million injections have already been performed in the country.
But so far, only 6.5% of Americans have received the two doses needed for maximum immunity conferred by the two already licensed vaccines, which use the innovative messenger RNA technique.
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Johnson & Johnson's vaccine is a "viral vector" vaccine.
It uses as support another low virulent virus, transformed to add genetic instructions from part of the virus responsible for Covid-19.
Once in the cells, a typical SARS-CoV-2 protein is produced, educating the immune system to recognize it.
