Johnson & Johnson vaccine’s emergency approval to accelerate public health campaign

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The Food and Drug Administration’s decision to approve the one-dose Johnson & Johnson vaccine for emergency use provides the U.S. a third tool to use in the COVID-19 crisis while sparking a debate about who will get the new version instead of the two existing vaccines.

Federal officials expect to ship up to 4 million doses of J&J’s adenovirus-based vaccine in the coming days, bringing the nationwide supply of coronavirus vaccines to roughly 20 million per week.

The J&J shot, approved late Saturday for people 18 and older, will accelerate the campaign by protecting against severe disease with a single dose.

Messenger-RNA vaccines from Pfizer/BioNTech and Moderna, in use since December, require two doses to achieve the protection demonstrated in their clinical trials.

J&J’s vaccine is also easier to store than the mRNA versions. It lasts in a normal refrigerator for up to three months, compared to five and 30 days for Pfizer and Moderna.

But its efficacy rate of 66% against all forms of disease wasn’t as robust as the 95% demonstrated by the mRNA vaccines. That’s sparked concern that people will try to shop around instead of grabbing up whatever vaccine they can get, as the U.S. races to outpace dangerous variants of the virus and achieve herd immunity.

Dr. Anthony Fauci, the government’s top infectious diseases expert, said Americans should take what they can get.

He emphasized that people who took the J&J vaccine in trials avoided hospitalization and death — the outcomes people fear the most. The J&J version was also tested in more difficult circumstances than the mRNA ones, competing with aggressive coronavirus variants circulating in Brazil and South Africa.

“All three of [the vaccines] are really quite good, and people should take the one that’s most available to them. If you go to a place and you have J&J, and that’s the one that’s available now, I would take it,” Dr. Fauci, director of the National Institute of Allergy and Infectious Diseases, told NBC’s “Meet the Press.”

“I think people need to get vaccinated as quickly and as expeditiously as possible,” he said. “And if I would go to a place where they had J&J, I would have no hesitancy whatsoever to take it.”

Advocates say federal and state officials will have to repeat that message as they work the J&J vaccine into the rotation.

“There is a significant concern that headline numbers are already leading to a sense among the public there are first- and second-class vaccines, with the latter relegated to low-income, rural or otherwise marginalized communities. That has the potential to exacerbate public mistrust. Public health authorities must address these perceptions head-on,” Sarah Christopherson, a policy advocacy director at the National Women’s Health Network, told the FDA’s Vaccines and Related Biological Products Advisory Committee, or VRBPAC.

The panel of advisers on Friday unanimously decided the benefits of the J&J vaccine outweigh any potential risks, clearing the path to regulatory approval over the weekend.

President Biden hailed J&J’s approval but tempered his enthusiasm with a warning — the virus is circulating at a very high level, so don’t get cocky.

“Though we celebrate today’s news, I urge all Americans — keep washing your hands, stay socially distanced, and keep wearing masks. As I have said many times, things are still likely to get worse again as new variants spread, and the current improvement could reverse,” he said. “There is light at the end of the tunnel, but we cannot let our guard down now or assume that victory is inevitable.”

Dr. Fauci, a top health adviser to President Biden, said the current case count is certainly down from last year but that the baseline is still too high. The rolling average of coronavirus cases has plummeted since a peak of over 250,000 per day in early January to around 68,000 now, though the decreases stalled out a bit this week, resulting in a worrisome plateau.

“We understand the need and the desire, understandably, to want to just pull back because things are going in the right direction,” he said. “But you’ve got to get that baseline down lower than it is now, particularly in light of the fact that we have some worrisome variants that are in places like California and New York and others that we’re keeping our eye on.”

David Sherfinski contributed to this report.

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