US approves use of single-shot Johnson & Johnson COVID vaccineComments
The US is getting a third vaccine to prevent COVID-19, as the Food and Drug Administration (FDA) on Saturday cleared a Johnson & Johnson injection that works with just one dose instead of two.
Health experts are anxiously awaiting a one-and-done option to help speed up vaccinations, as they race against a virus that already has killed more than 510,000 people in the US and is mutating in increasingly worrisome ways.
The J&J vaccine known as Janssen Covid-19, which can be stored at refrigerator temperatures, joins those of Pfizer/BioNTech and Moderna in the huge vaccination campaign in the United States
The FDA said J&J’s vaccine offers strong protection against what matters most: serious illness, hospitalisations and death.
"After a rigorous analysis of the data, FDA scientists and physicians have determined that the vaccine meets the FDA's criteria for safety and efficacy for emergency licensure," said Peter Marks, director of the agency's Center for Biologics Evaluation and Research, in a statement.
One dose was 85.9 per cent protective against the most severe COVID-19 symptoms in a massive study that included 43,000 people and spanned three continents — protection that remained strong even in countries such as South Africa, where the variants of most concern are spreading.
"The more vaccines that have high efficacy that we can get into play, the better," Dr Anthony Fauci, the top US infectious disease expert, said ahead of the FDA’s ruling.
Shipments of a few million doses to be divided among states could begin as early as Monday. By the end of March, J&J has said it expects to deliver 20 million doses to the US, increasing to 100 million by the end of June.
J&J is also seeking authorisation for emergency use of its vaccine in Europe and from the World Health Organization (WHO). Worldwide, the company aims to produce about 1 billion doses globally by the end of the year. On Thursday, the island nation of Bahrain became the first to clear its use.