Johnson & Johnson this Thursday afternoon asked the Food and Drug Administration of the United States (FDA, for the acronym in English) for approval of the single-dose vaccine against covid-19 for emergency use. The pharmaceutical company has announced that it will also seek approval from the European health authorities in the coming weeks. FDA officials have announced that outside experts will discuss the vaccine at a public meeting on Feb. 26.
The request is a “critical step in reducing the burden of disease for people around the world and ending the pandemic,” said Dr. Paul Stoffels, Johnson & Johnson’s Chief Scientific Officer, in a statement. If the vaccine gets regulatory approval from the FDA, it would be the third vaccine to be licensed in the United States, a necessary step toward achieving long-awaited herd immunity. In addition to requiring only one dose, it has the advantage that it can be stored at refrigerator temperature and not freezing temperature.
The pharmaceutical giant’s claim comes after last week’s report in which it revealed that its vaccine is 66% effective in the three regions where the vaccine was researched: the United States, Latin America and South Africa. It is 85% effective in preventing severe forms of the disease; after 28 days, none of the vaccinated participants needed to be hospitalized.
The study found efficacy against moderate and severe diseases was 72% in the United States, but only 57% in South Africa, where a highly contagious variant of the coronavirus causes the most cases. The company said it plans to deliver the 100 million doses it promised to the United States by the end of June. About 30 million doses, made in the Netherlands and Baltimore, could be available in early April.
Unlike the two vaccines currently approved in the United States – Pfizer / BioNTech and Moderna – J & J’s does not require a second injection or a cold chain for transport and storage, making it a good candidate for use in locations where transportation and cold storage infrastructures are insufficient.
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