Single-dose Johnson & Johnson COVID-19 vaccine could soon head to FDA

STANFORD, Calif. (KGO) -- As concerns grow over the slow pace of COVID-19 vaccinations in the U.S., there's hope that a new option could soon help turn the tide.

The vaccine from Johnson & Johnson would be first to be given in a single shot, without requiring a booster. It's been in clinical trial at sites across the country, including Stanford. And on Wednesday night, researchers say they've been given the word to lock the data they've gathered so the company can quickly begin the review process.

"They will review the data in an un-blinded fashion to see if the medication looks effective," says Dr. Philip Grant, M.D., who is leading a trial of the vaccine at Stanford.

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Dr. Grant believes an announcement from Johnson & Johnson could come early next month. If the data is positive, the next step would be the FDA and a possible emergency use authorization known as an EUA.

"At that point they'll be turning in their application for an EUA. With similar timing, we may see, if it works, approval by I'd say mid to late February," said Dr. Grant.


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While Dr. Grant cautions that the final data isn't in yet, earlier phase two results have been described as promising. And earlier this week Dr. Anthony Fauci said he believes that vaccines from Johnson & Johnson and AstraZeneca will reach the FDA for review in a matter of weeks, not months.
The impact could be significant on supply chain issues. Unlike the Moderna and Pfizer formulas, the Johnson & Johnson vaccine does not require any special deep-cold refrigeration, and experts say the single dose could make it much easier to distribute.

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"It's much easier if you say we have the supply here, we can give it to you, versus, we have the supply here, (but) what's going to be here in three weeks, it makes that management much more straightforward," he added.

Johnson & Johnson also used a similar platform to deliver a groundbreaking vaccine to fight a recent Ebola outbreak in Africa, earning it the reputation of being sturdy and transportable, something like a four-wheel-drive of vaccines.

Now, the hope is it will help drive down surging infections from COVID-19.

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