FDA approves Johnson & Johnson's single-dose coronavirus vaccine
The Food and Drug Administration (FDA) has authorized Johnson & Johnson’s (J&J) vaccine for emergency use, making it the third vaccine available to the US public and securing another vital step in the US fight to control Covid-19.
The decision was a formality after an independent expert advisory panel late on Friday afternoon recommended drug regulators approve the one-shot vaccine.
The move is a boost to the Biden administration’s vaccination plans as it seeks to tackle a pandemic that spiralled out of control under Donald Trump amid a largely botched response that was marked by anti-scientific sentiment, skepticism over the wearing of masks, and the promotion of baseless conspiracy theories.
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“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for Covid-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” said the acting FDA commissioner, Janet Woodcock, in a statement.
Janssen – Johnson & Johnson’s vaccine subsidiary – told a congressional hearing this week that it expects to deliver 20m doses by March and a total of 100m doses before the end of June. That means the new vaccine, along with those already in circulation from Pfizer and Moderna, should provide the US with more than enough supply to vaccinate every eligible person.
Joe Biden has promised that there will be enough vaccine shots for every American by the end of July and said once the latest version is available “we have a plan to roll it out as quickly as Johnson & Johnson can make it”.
Dr Anthony Fauci, Biden’s chief medical adviser, has said he’s “a little disappointed” by the initial number of doses provided by Johnson & Johnson but that production will ramp up significantly 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 around 267m Americans are eligible for a Covid vaccine.
Johnson & Johnson’s vaccine would also be the easiest to distribute of the vaccines in the system. Unlike those from Pfizer and Moderna, the Johnson & Johnson vaccine can be stored at common refrigerator temperatures for up to three months.
But this convenience comes with 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 the efficacy of the vaccine.
The vaccine was found to 85% effective at preventing severe disease and to provide complete protection against Covid-related hospitalization and death after 28 days. Johnson & Johnson’s vaccine was found to be 72% effective in clinical trials in the US, but only 57% effective in South Africa, where a variant called B1351 originated.
“With today’s authorization, we are adding another vaccine in our medical toolbox to fight this virus,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
Ashish Jha, Dean of the Brown University School of Public Health, said that coronavirus and its variants had not rendered as ineffective any of the vaccines approved so far.
Of J&J, he told CNN on Sunday morning: “This is a terrific vaccine. I would take it, I would recommend it to my family.”
But Richina Bicette, an emergency medical physician and assistant medical director at Baylor College of Medicine in Houston, Texas, warned Americans to keep restrictions and measures such as mask-wearing that help prevent infection.
“Now is not the time to be rolling back mandates,” she said, noting that Texas confirmed 11,000 new cases of coronavirus on Saturday alone.
