Johnson & Johnson vaccine still halted by the FDA in the USA

Published by Laurent P., Alexandre G. · Published on 15 April 2021 at 16h31
This Thursday April 15, 2021, the Food & Drug Administration (FDA) has announced the Johnson & Johnson vaccine was still halted - as decided two days ago - for another week in the USA after suspicious cases of thrombosis in vaccinated people have been reported. Yet, the vaccine enjoyed emergency use approval by the regulator this past February 27.

After AstraZenecaJohnson & Johnson... The FDA, aka the Food & Drug Administration, announced this Tuesday April 13 they call for a pause in the use of the vaccine developed by the American laboratory in their own country after the outbreak of severe thromboses in several people given the shot. "We call for a pause", the American regulator states in a release. An investigation is going on.

Note the CDC - namely the United States federal public health agency - is to gather on Wednesday April 14 to give their conclusions on the investigation. In all, 6.8 million doses of Johnson & Johnson vaccine have been given already in the USA. The statement follows the European Medicines Agency's stating they will investigate after the outbreak of several cases of blood clots after inoculation.

As of Thursday April 15, the FDA goes stronger: the suspension is extended for at least one week, experts requiring more time to assess risks related to thromboses reported. The European Medicines Agency also decided to wait for another week, also waiting for the American regulator's results. In France, vaccinations could start as early as next week, as the Johnson & Johnson vaccine is only reserved for people aged 55+ for now, as Gabriel Attal reminded on Wednesday April 14. This target population will only be eligible from next week.

Yet, Johnson & Johnson vaccine had been approved several weeks ago by the American regulator. On February 27, 2021, the FDA announced they have approved Johnson & Johnson vaccine for people over the age of 18.

On Wednesday February 24, the FDA confirmed the effectiveness of Johnson & Johnson vaccine on severe forms of the virus in a document made public the same day, only two days before the regulator approves the produce issuance - or not. An effectiveness assessed to 85.9% agains severe diseases in the country - according to the document -, as well as 81.7% in South Africa, and 87.6% in Brazil. The vaccine is overall effective against severe coronavirus up to 85.4% 28 days following vaccination. Against mild diseases, yet, it is 66.1% effective, as announced a few days ago.

This Thursday February 4, Johnson & Johnson announced they sought marketing approval for their Covid vaccine to the FDA for a soon marketing in the USA. Issuance has been approved this Friday February 26: "After a thorough analysis of the data, the FDA’s scientists and physicians have determined that the vaccine meets the FDA’s expectations for safety and effectiveness appropriate for the authorization of a vaccine for emergency use" Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research stated. A determining step in the fight against coronavirus.

In Europe, Johnson & Johnson also announced this Tuesday April 13 they will delay the deployment of their vaccine because of the pause in injections in the United States.

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