FDA Approves Single Dose Johnson & Johnson Coronavirus Vaccine | Coronavirus



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The Food and Drug Administration has cleared Johnson & Johnson’s vaccine for emergency use, making it the third vaccine available to the American public and securing another vital step in the American fight to control Covid-19.

The decision was a formality after an independent expert advisory group recommended drug regulators on Friday afternoon to approve the vaccine in a single injection.

The move bolsters the Biden administration’s vaccination plans as it seeks to tackle a pandemic that has spiraled out of control under Donald Trump amid a largely botched response marked by anti-scientific sentiment, skepticism about the port of masks and promotion. of baseless conspiracy theories.

“The authorization of this vaccine expands the availability of vaccines, the best method of medical prevention for Covid-19, to help us in the fight against this pandemic, which has claimed more than half a million lives in the United States Said the acting commissioner of the FDA. Janet Woodcock in a statement.

Janssen – the vaccination affiliate of Johnson & Johnson – said this week at a congressional hearing that it plans to deliver 20 million doses by March and a total of 100 million doses by the end of June. This means that the new vaccine, along with those already circulating at Pfizer and Moderna, is expected to provide the United States with more than enough supply to immunize every eligible person.

Joe Biden has pledged that there will be enough vaccine for every American by the end of July and said that once the latest version is available, “we plan to roll it out as quickly as Johnson & Johnson can.” Anthony Fauci, Biden’s chief medical adviser, said he was “a little disappointed” with the initial number of doses provided by Johnson & Johnson, but that production will increase dramatically during the spring.

So far, more than 510,000 people in America have died from the coronavirus and more than 28 million have tested positive – both by far the worst numbers in the world. Currently, approximately 267 million Americans are eligible for a Covid vaccine.

The Johnson & Johnson vaccine would also be the easiest to distribute vaccine in the system. Unlike those from Pfizer and Moderna, the Johnson & Johnson vaccine can be stored at usual refrigerator temperature for up to three months.

But with that convenience comes caveats. The company’s clinical trials were the first to show the potential impacts of Covid-19 variants, or evolutionary changes in the virus, on vaccine effectiveness.

The vaccine has been shown to be 85% effective in preventing serious illness and providing comprehensive protection against Covid-19-related hospitalizations and death after 28 days. Johnson & Johnson’s vaccine has been shown to be 72% effective in clinical trials in the United States, but only 57% in South Africa, where a variant called B1351 comes from.

“With today’s clearance, we are adding another vaccine to our medical toolkit to fight this virus,” said Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA.

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