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FDA May Approve Johnson & Johnson Vaccine for US Use as Early as Saturday

FDA approval could come as early as Saturday and the company says it has 4 million doses ready to ship next week.

A health care worker receives a dose of the Johnson & Johnson vaccine against the COVID-19 coronavirus as South Africa proceeds with its inoculation campaign at the Steve Biko Academic Hospital in Pretoria, on February 17, 2021.

The Food and Drug Administration (FDA) has found the Johnson & Johnson COVID-19 vaccine to be safe and effective in a briefing document on Wednesday morning, lending support to its emergency use authorization.

The vaccine’s trial data results are “consistent with the recommendations set forth in FDA’s guidance Emergency Use Authorization for Vaccines to Prevent COVID-19,” wrote the FDA. They find that Johnson & Johnson “has provided adequate information to ensure the vaccine’s quality and consistency for authorization of the product” under emergency use authorization.

The vaccine was 66.9 percent effective at preventing moderate to severe infection in adults after 14 days and 66.1 percent effective in preventing the same after 28 days, the FDA says in a briefing document for the FDA’s Vaccines and Related Biological Products Advisory Committee. The FDA also finds that the vaccine has a “favorable safety profile” and relatively low mild or moderate side effects like headache and injection site pain.

The FDA also confirmed the company’s trial results that the vaccine was 100 percent effective at preventing hospitalization and death in their trials, a crucial benchmark for the vaccine. The FDA’s analysis was also slightly more optimistic than Johnson & Johnson’s original trial results. While the FDA found the same efficacy in the U.S. at preventing moderate to severe infection, 72 percent, they found a higher efficacy in South Africa than the trial results suggested, at 64 percent instead of 57 percent.

On Friday, the committee will meet to discuss the vaccine and vote on whether or not to recommend the vaccine for emergency use authorization. If they do vote to recommend the vaccine, then FDA approval could come as early as Saturday. This would make the Johnson & Johnson vaccine the third vaccine to be approved for use in the U.S., along with the two-shot Pfizer and Moderna vaccines.

Though the Johnson & Johnson vaccine’s trial results show that it is less effective than the two vaccines currently in use, health experts say that the results are still promising and that it could play a crucial role in helping to curb the virus. The first two vaccines approved for use had such a high efficacy rate that they set a higher bar than is necessary for an effective vaccine, said Anthony Fauci when the Johnson & Johnson results were originally released. Others have pointed out that the annual flu vaccine, for instance, is only 40 to 60 percent effective.

The Johnson & Johnson vaccine is also easier to store, ship and administer than the two vaccines currently in use, which will prove crucial as the U.S. rushes to vaccinate the population quickly. While it requires refrigeration for storage, it doesn’t require the ultra-low temperatures that the Pfizer and Moderna vaccines require. It’s also a single-shot regimen, as opposed to two, making it easier to manufacture and administer.

Since the Pfizer and Moderna vaccine rollouts began some months ago, there has been a growing body of evidence showing that the vaccines can prevent not only infection but also the spread of the virus — so, with at least two vaccines already cutting down on the spread of COVID-19 and a third likely to join them soon in helping to prevent hospitalization and death, there is hope yet in the face of a disease that has killed over half a million people in the U.S. so far.

However, there may still be supply issues with the Johnson & Johnson vaccine at first. The company had originally promised that it would have 12 million doses manufactured and ready to ship by the end of February, but on Tuesday, an executive for the company told lawmakers that it only had 4 million ready to ship by the time emergency authorization would come through. The White House confirmed on Wednesday that it was expecting 3 to 4 million doses by next week.

The company hopes to ramp up production by summer, however, and the executive said on Tuesday that Johnson & Johnson would have 20 million doses by the end of March and 100 million total doses available to deliver by the end of June.

The Biden administration also announced on Tuesday that it would be bumping up vaccine supplies to states with 14.5 million doses being shipped per week. White House Press Secretary Jen Psaki said that this was the fifth time the administration has increased distribution and is now at almost double the amount since Joe Biden took office.

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