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United States: expert committee recommends authorization of Johnson & Johnson vaccine

This vaccine has two major advantages: it can only be administered in a single dose and can be stored at refrigerator temperatures.

UNITED STATES – A committee of experts recommended this Friday, February 26, the marketing of the single-dose vaccine from Johnson & Johnson in the United States, thus paving the way, when the emergency authorization will be confirmed by the health authorities, the imminent distribution of several million doses of a third vaccine against Covid-19 in the country.

The members of this panel – about twenty independent scientists – all voted, in a vote, that the benefits of the vaccine for people aged 18 and over outweighed the risks of its use.

The final green light will now have to be given by the US Medicines Agency, the FDA. For Pfizer and Moderna , the two remedies already approved in the United States, the authorization had been granted the day after the favorable opinion of the committee was rendered.

The experts gave their opinion after a day of discussions broadcast live on the internet, and after studying in detail the data from clinical trials conducted on some 40,000 people.

Several mentioned, to justify their decision, the “race” against time induced by the pandemic, the lack of doses of vaccines already authorized immediately available, and the appearance of new variants.

An unusual exercise in transparency, the retransmission of the meetings of this committee is partly intended to reassure the general public by demonstrating the seriousness of the procedure.

This vaccine has two significant logistical advantages: it can only be administered in a single dose and can be stored at refrigerator temperatures.

“We’ve all seen the news about Johnson & Johnson’s vaccine today – a safe and effective third vaccine,” Joe Biden said Friday from Houston, shortly after the committee vote.

“We are going to use every avenue imaginable to expand the manufacture of the vaccine, the third vaccine, and get even more rapid progress” in the vaccination campaign, added the US president.

“If the FDA approves the authorization of this vaccine, we have a device to distribute it as quickly as Johnson & Johnson can” follow, he said Thursday.

Efficient and safe

Johnson & Johnson’s vaccine conditional clearance is actually little doubt, as the FDA itself released a slew of documents earlier this week in which it confirmed the vaccine’s effectiveness.

“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 was 85.9% in trials against severe forms of Covid-19 in the United States.

All regions of the clinical trial combined, it was 66.1% against moderate forms of the disease, and overall “similar” for all categories of the population (ages, ethnicities).

The most frequently observed side effects were pain at the injection site, headache, fatigue, and muscle pain.

This vaccine is already in use in South Africa, where a case of anaphylaxis – a serious allergic reaction – has been observed, revealed Macaya Douoguih, of Johnson & Johnson, during the meeting on Friday.

Such reactions, although very rare, have also been noted after injections of Moderna and Pfizer vaccines.

Representatives of the FDA also mentioned a few cases of urticaria and rare cases of thromboembolic events (obstruction of the blood flow) and tinnitus, for which a link with the vaccination cannot be excluded but which require further analysis. pushes to determine it.

The pharmaceutical company also said it is studying the effect of two doses – instead of one – on immune protection, which has raised concerns among experts, who fear that this could mislead the public or that ‘He feels cheated if this option turns out to be more effective.

100 million doses

At least three million doses of the “J&J” product 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 by the end of June.

“If the FDA approves the authorization of this vaccine, we have a device to distribute it as quickly as Johnson & Johnson can” follow, declared Thursday the American president Joe Biden.

With 600 million doses ordered in total from Pfizer and Moderna, the United States will already have, by the end of July, enough vaccine to immunize almost the entire population.

But the addition of those from Johnson & Johnson could further accelerate the vaccination campaign.

In total, more than 70 million injections have already been carried out in the country, the country most bereaved by the pandemic. So far, however, only 6.8% 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.

The “J&J” 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 inside the cells, a protein typical of SARS-CoV-2 is produced, educating the immune system to recognize it.

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