U.S. health advisers on Friday approved the single-dose COVID-19 vaccine from Johnson & Johnson, putting the state on top to add a simpler option to fight the pandemic.
The Food and Drug Administration is expected to follow the recommendations quickly and make J & J’s shooting with the third vaccine approved for emergency use in U.S. vaccinations accelerate, but new supplies are urgently needed to prevent the mutating virus that killed more than 500,000 Americans.
After all-day discussions, FDA members unanimously voted that the benefits of the vaccine outweigh the risks to adults. If the FDA agrees, deliveries of several million doses could begin as early as Monday.
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More than 47 million people in the U.S., or 14 percent of the population, have received at least one injection of two-dose vaccines from Pfizer and Moderna, which were approved by the FDA in December. But the pace of vaccination has been disrupted by limited supplies and delays due to winter storms.
Although J&J’s early stocks will be small, the company said it could deliver 20 million doses by the end of March and a total of 100 million by the end of June. The J&J vaccine protects against the worst effects of COVID-19 after a single burst, and can be stored for up to three months at refrigerated temperature, making it easier to handle previous vaccines, which must be frozen.
One of the challenges in introducing the new vaccine will be to explain how protected J&J is after the astonishing success of the first American vaccines.
Pfizer and Moderna two-dose injections were found to be about 95 percent effective against symptomatic COVID-19. The numbers from J & J’s study aren’t that high, but it’s not a comparison between apples and apples. One dose of J&J vaccine was 85 percent protective against the most severe COVID-19. After adding in moderate cases, the overall efficiency dropped to about 66 percent.
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Some experts fear that fewer could feed the public’s perception that J&J’s injection is a “second-rate vaccine”. But the difference in protection is reflected in when and where J&J conducted its studies.
The J&J vaccine was tested in the United States, Latin America and South Africa at a time when more contagious mutated versions of the virus were spreading. That was not the case last fall, when Pfizer and Moderna were finishing testing, and it is not clear whether their number will offend the most worrying of those variants.
Most importantly, the FDA reported this week that, like its predecessors, the J&J shot offers strong protection against the worst outcomes, hospitalization and death.
Although J&J is seeking FDA approval for its single-dose version, the company is also studying whether the second dose boosts protection. Panel member dr. Paul Offit warned that launching a two-dose version of the vaccine on the road could create problems.
“You can see where that would confuse people who think,‘ ‘Maybe I didn’t get what I needed,’ ’said Offit, a vaccine expert at Children’s Hospital of Philadelphia. “It’s a challenge to exchange messages.”
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Representatives of J&J said that they decided to start with one shot because the World Health Organization and other experts agreed that it would be a faster and more efficient means in emergencies. Cases and hospitalizations have dropped dramatically since the peak in January following the winter holidays. But public health officials have warned that the profits may stop as more variants take root in the United States.
“We may end up with the virus, but obviously the virus is not over with us,” said the director of the Center for Disease Control and Prevention, Dr. Rochelle Walensky, speaking at the White House on Friday. She noted that new cases of COVID-19 have increased over the past few days.
Although it is too early to say whether the trend will continue, Walensky said adding a third vaccine would “help protect more people faster.” Another vaccine is being prepared. A CDC board meeting is expected on Sunday to recommend how best to prioritize the use of the J&J vaccine.
Other parts of the world are already facing the challenges that are best. Italy’s main teachers ’union recently protested when the government decided to book Pfizer and Moderna injections for the elderly and designate an AstraZeneca vaccine for younger at-risk workers. The AstraZeneca vaccine was thought to be about 70 percent effective in testing. Canada on Friday became the latest country to allow the use of the AstraZeneca vaccine.
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