- The Washington Times - Wednesday, February 24, 2021

The Food and Drug Administration on Wednesday said a single-shot vaccine from Johnson & Johnson is safe and effective and “consistent with” its standards, putting the U.S. on track to have a third weapon in its COVID-19 arsenal by next week.

Regulators reported the findings ahead of a Friday meeting with an advisory committee. A positive vote from the panel would clear the way for emergency approval as soon as the weekend.

“If authorized, we are ready to roll out this vaccine without delay,” White House coronavirus coordinator Jeff Zients said.

Emergency authorization would inject 2 million to 4 million doses of J&J vaccine into U.S. circulation in its first weekly shipment, federal officials said. That is not as many doses as the pharmaceutical giant initially projected, though it should bring the overall U.S. supply to roughly 20 million doses for the coming week.

The federal government currently is delivering at least 14.5 million doses of the Pfizer-BioNTech and Moderna vaccines weekly to states, tribes and territories. More than 2 million more doses are going to pharmacies through a federal retail program.



“Obviously, the prospect of a potential third approved vaccine is very encouraging and will help to improve the overall vaccine supply, which will allow more Americans to get access to getting vaccinated sooner,” Mr. Zients said.

Weekly allocations are based on state populations, and the J&J vaccine will be distributed the same way.

Delivered in a single shot, the vaccine is more efficient than Pfizer’s and Moderna’s versions, which require a return visit for the second dose 21 to 28 days later. The J&J vaccine can be refrigerated for up to three months, though states will have to sort out who will receive which vaccine.

“The governors are carefully planning their efforts and getting ready for the new vaccine,” Mr. Zients said.

The J&J vaccine uses an adenovirus vector. It was 72% effective against overall disease in the U.S., a lower efficacy reading than the 95% demonstrated by the Pfizer and Moderna vaccines, which use a messenger-RNA platform.

However, the J&J version was 86% effective against the most severe cases in the U.S. and 82% effective against severe disease in South Africa, which is battling an aggressive strain that accounts for most of its cases.

That means it is highly effective at keeping people out of the hospital — the main worry for those infected.

Florida Gov. Ron DeSantis, a Republican, said the J&J vaccine is a “huge, huge win.” He said people should look at the vaccine’s proven ability to ward off bad outcomes rather than the overall efficacy rate.

“It’s one dose. You take it once, and it’s done. And the clinical trials were very, very effective in terms of preventing hospitalization and mortality,” Mr. DeSantis said in Hernando County.

The company is conducting a trial of a two-dose regimen, “which might turn out to be as good or better than the mRNA vaccines,” said Peter Hotez, dean of the National School of Tropical Medicine and the Baylor College of Medicine.

Early supply of the J&J vaccine will be disappointing, however. The maximum estimate of 4 million doses to be shipped as soon as the vaccine is approved is short of the 12 million that the company initially projected by the end of February.

Dr. Richard Nettles of J&J told a House subcommittee Tuesday that the company would supply 20 million doses by the end of March.

The company is under contract for 100 million doses by the end of June, though U.S. officials are looking for ways to accelerate the rollout instead of waiting for the bulk to arrive later in the spring.

Mr. Zients said the Biden administration learned when it arrived in January that J&J had fallen behind in manufacturing but said efforts to ramp up production should pay off.

“I think the progress is real,” he said, “and we look forward to continuing to work with the company to accelerate their delivery and their capacity.”

The U.S. is averaging about 1.4 million shots per day, down from a peak of 1.7 million earlier this month. Wintry weather postponed appointments and delayed shipments last week. Officials said they have caught up on shipments and are pressing states to extend clinic hours to make up for lost time.

Also Wednesday, the Biden administration said it will spend $86 million to deliver 25 million masks to 1,300 health care centers and 60,000 food pantries and soup kitchens from March through May.

The program will focus on hard-hit communities where people might not have access to quality, well-fitting masks that can help control the spread of the virus.

The government said the coverings will be made in the U.S. and will be available in sizes for children and adults. The masks will comply with guidelines from the Centers for Disease Control and Prevention.

The departments of Defense, Health and Human Services and Agriculture will administer the program.

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