The European Union could approve Johnson & Johnson’s COVID-19 vaccine in early March and start distribution later that month.



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Johnson & Johnson's vaccine was approved yesterday in the United States (REUTERS)
Johnson & Johnson’s vaccine was approved yesterday in the United States (REUTERS)

European Medicines Agency could approve Johnson & Johnson’s coronavirus vaccine in early March and the EU could start distributing it at the end of the same month, French Industry Minister Agnès Pannier-Runacher said on Sunday.

The European Union (EU) will approve the vaccine “in early March, as the European Medicines Agency reviews all information provided by Johnson & Johnson in order to obtain[la] to the market, ”Pannier-Ruancher said on the France 3 television channel.

The first doses should “arrive at the end of March or the beginning of April”, he added, although these deadlines are still under discussion with the laboratory. “This is good news because this vaccine only needs one dose, instead it may require booster shots, we don’t know that yet,” he said.

According to a chart released by the European Commission on Thursday, the EU should have received nearly 600 million doses by the end of June, if all deliveries go as planned. The EU has set a target of vaccinating 70% of the adult population, or around 225 million people, by the end of the boreal summer.

The United States yesterday approved the Johnson & Johnson vaccine for people over 18. Development can be stored at standard refrigerator temperature, which “offers logistical and practical advantages”.

The keys to the Johnson & Johnson vaccine

1-single dose and refrigeration

Called Ad26.COV2.S, it is given as a single muscle dose. In turn, it can be stored for up to two years with a freezer system at -20 ° C and up to three months in the refrigerator in freezers at 2-8 ° C..

This is a distinct advantage since Pfizer and Moderna require two doses. Also, due to the fact that it can be stored at normal refrigerator temperatures rather than freezers, facilitates distribution and storage logistics, unlike its two competitors which require ultra-cold freezers.

(REUTERS)
(REUTERS)

2-Efficiency

The inoculant is approximately 66% effective in preventing moderate to severe COVID-19. The regulatory agency has called for the injection of J&J – which could help speed up vaccinations by requiring only one dose instead of two – it is safe to use.

Earlier this month, Johnson & Johnson said that data from clinical trials, conducted globally nearly 44,000 people participated, indicate that your COVID-19 vaccine has a 66% overall effectiveness in immunization against the disease; 72% in tests performed in the United States; 61% in Latin America and 64% in South Africa, where a more resistant variant has spread.

Although these numbers are not as high as those of its competitors, all COVID-19 vaccines around the world have been tested differently, which makes comparisons almost impossible. While it’s no surprise that one dose turns out to be slightly less than two, policymakers will decide whether this is an acceptable compromise to get more people vaccinated faster.

3-Surveys around the world

Clinical trials of this new vaccine have shown that it prevents 86% of severe cases in the United States and 82% in Latin America, which would mean in practice that it is very effective in preventing hospitalizations and deaths from the SARS-CoV-2 virus. The fact that this vaccine is designed to be given as a single injection, unlike those from Pfizer and Moderna, which require two doses, makes it one of the most anticipated, as it would speed up the vaccination campaign.

Ten years ago, researchers at Beth Israel Deaconess Medical Center in Boston, United States, developed a method of making vaccines from a virus called Adenovirus 26, or Ad26 for short. The Johnson & Johnson company has developed vaccines against Ebola and other diseases with Ad26 and it now has the brand new approval – limited by the global health emergency context – for its coronavirus inoculant. Last March, they received $ 456 million from the United States government to support their move towards production. After the vaccine provided protection in the monkey experiments, Johnson & Johnson began Phase I / II trials in July. Unlike other prominent vaccines in clinical trials, the company used one dose, not two.

Johnson & Johnson launched a Phase III trial in September, which they stopped on October 12 to investigate an adverse reaction in a volunteer. The trial resumed eleven days later. Although Johnson & Johnson initially set out to recruit 60,000 volunteers, it limited the trial to 45,000 in December as cases mounted.

On January 29, Johnson & Johnson announced that the trial had shown the vaccine to be safe and effective. On February 24, the FDA released its own analysis of the trial, concluding that the vaccine was 72% effective in the United States, 64% in South Africa, and 61% in Latin America. The next day, Bahrain became the first country to authorize the vaccine for emergency use.

South Africa has abandoned plans to use the AstraZeneca vaccine for its health workers after a small test failed to show its effectiveness against the B.1.351 variant which had become dominant nationwide. They started using Johnson & Johnson instead.

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