A committee of experts unanimously recommended on Friday February 26 the emergency authorization in the United States of Johnson & Johnson’s single-dose vaccine against Covid-19 for people aged 18 and over. The opinion of this committee, composed mainly of independent scientists, is advisory, but it still confirms the probable authorization of the vaccine by the American health authorities, expected in the wake. This will be issued by the US Medicines Agency (FDA, for Food and Drug Administration, in English).
For Pfizer and Moderna, authorization was granted the day after the committee’s favorable opinion was rendered. Millions of doses are ready for distribution as early as next week in the country. The twenty experts estimated, in a vote, that the benefits of the vaccine outweighed the risks of its use. They gave their opinion after a day of discussions broadcast live on the Internet, and after studying the clinical trial data in detail.
“We are in a race against the new variants”, commented one of them, Doctor Jay Portnoy, to justify his decision. The Johnson & Johnson vaccine is particularly eagerly awaited because it can only be administered in a single dose. It also has another logistical advantage: it can be stored at refrigerator temperatures, which will greatly facilitate its distribution.
A final authorization expected
Johnson & Johnson’s vaccine conditional clearance is actually little doubt, as the FDA itself released a host of documents earlier this week in which it confirmed the vaccine’s effectiveness. “The scans support a favorable safety profile with no specific safety concerns identified that could prevent the issuance of an emergency use authorization”, she wrote on Wednesday.
The efficacy of the vaccine was 85.9% during 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 population categories (ages, ethnicities). The most frequently observed side effects were pain at the injection site, headache, fatigue and muscle pain.
The vaccine is already in use in South Africa, where a case of anaphylaxis – a severe allergic reaction – has been observed, Macaya Douoguih of Johnson & Johnson revealed 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.
100 million doses expected
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. At least three million doses of J & J’s product are ready for distribution as soon 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. “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 President of the United States, 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 vaccines to immunize almost the entire population. But the addition of those from Johnson & Johnson could speed up the vaccination campaign.
