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Expert Panel Set to Consider Approval of J&J COVID Vaccine

FRIDAY, Feb. 26, 2021 -- An advisory panel for the U.S. Food and Drug Administration will spend Friday weighing whether a coronavirus vaccine made by Johnson & Johnson should be approved for emergency use.

The expert panel is expected to endorse the vaccine, meaning that the United States could have a third vaccine at its disposal as early as Saturday, The New York Times reported.

Scientists from Janssen Pharmaceuticals, the drug development arm of Johnson & Johnson, will make presentations on the vaccine's efficacy and safety, with a panel vote expected in the late afternoon or early evening.

Briefing documents posted this week show the vaccine had an overall efficacy rate of 72 percent in the United States and 64 percent in South Africa, where a concerning variant emerged in the fall and has since spread to the United States, the Times reported.

The vaccine was particularly effective at preventing severe illness or death: It showed 86 percent efficacy against severe forms of COVID-19 in the United States, and 82 percent against severe disease in South Africa. None of the nearly 22,000 vaccinated people in the trial died of COVID-19.

When the FDA advisory panel met in December to consider the two-dose coronavirus vaccines made by Pfizer and Moderna, the sky-high efficacy rates of those shots -- roughly 95 percent -- prompted strong endorsements from the panel. But the discussion on Friday could be more cloudy, the Times said.

Johnson & Johnson's vaccine does have real advantages, however: It requires only a single dose, doesn't need to be stored in sub-zero temperatures, and uses a different kind of technology than the first two authorized vaccines. The Johnson & Johnson trial was also huge, spanning eight countries, three continents and 45,000 participants. Ironically, that resulted in a large data set that is likely to prompt a more complex discussion, the Times said.

The FDA's analysis estimated that the vaccine has an efficacy rate of 74 percent against asymptomatic infections, which suggests that it may also help reduce the spread of the virus by vaccinated people, the Times reported. That is likely to be discussed at the meeting, as health officials tackle whether vaccination should — or shouldn't — change behavior when cases remain high, the Times reported.

Nursing homes see steep drop in COVID cases, deaths

In a hopeful turnaround during a long pandemic, U.S. nursing homes that were once the epicenter of coronavirus infections are now seeing both cases and deaths fall steeply as the country's vaccination rollout starts to take hold.

From late December to early February, new cases among U.S. nursing home residents fell by more than 80 percent, nearly double the rate of improvement in the general population, the Times reported. The downward trend in deaths was even more heartening: Even as fatalities spiked overall this winter, deaths inside nursing homes have dropped by more than 65 percent.

"I'm almost at a loss for words at how amazing it is and how exciting," Dr. David Gifford, chief medical officer for the American Health Care Association, which represents thousands of long-term care facilities across the country, told the Times.

The good news comes not a moment too soon: Since the pandemic began, the coronavirus has raced through some 31,000 long-term care facilities in the United States, killing more than 163,000 residents and employees and accounting for more than a third of all virus deaths since the late spring, the Times said.

But with the arrival of vaccines, which were sent to long-term care facilities starting in late December, new cases and deaths in nursing homes have fallen steeply, outpacing national declines, the Times reported. It offers an early glimpse of what might be in store for the rest of the country, as more and more people get vaccinated.

"If we are seeing a robust response with this vaccine with the elderly with a highly contagious disease, I think that's a great sign for the rest of the population," Giffords told the Times.

About 4.5 million residents and employees in long-term care facilities have received at least one dose of the vaccine, according to the U.S. Centers for Disease Control and Prevention, including about 2.1 million who have been fully vaccinated.

Now, new cases in nursing homes are at their lowest point since May, when the federal government began tracking such data, the Times said.

"What is certainly surprising to me is how quickly we're seeing this," Dr. Sunil Parikh, an associate professor of epidemiology and medicine at Yale School of Public Health in Connecticut, told the Times.

Pfizer, Moderna say big jump in vaccine supply coming

Officials from both Pfizer and Moderna delivered reassuring news about their COVID-19 vaccines to Congress this week: There will be a sharp rise in the delivery of doses in the coming month, and they will be able to provide enough doses to vaccinate most Americans by summer.

By the end of March, Pfizer and Moderna expect to have delivered a total of 220 million vaccine doses to the U.S. government, a significant uptick from the roughly 82 million doses that the U.S. Centers for Disease Control and Prevention says have shipped so far.

"We do believe we're on track," Moderna President Stephen Hoge told a House subcommittee after describing how the company has ramped up production. "We think we're at a very good spot."

That encouraging news comes as federal regulators plan to weigh the emergency use of a third COVID-19 vaccine, from Johnson & Johnson, on Friday. The Biden administration said Tuesday that it expects about 2 million doses of that vaccine to be shipped in the first week after approval, and the company told lawmakers it should provide enough of the single-dose option for 20 million people by the end of March, the Associated Press reported.

By summer, Pfizer and Moderna said they expect to complete delivery of 300 million doses each, while J&J aims to provide an additional 100 million doses. That would be more than enough to vaccinate every American adult, the AP reported.

Two other manufacturers, Novavax and AstraZeneca, have vaccines in the pipeline and anticipate eventually adding to those totals, the AP said.

When asked whether they face shortages of raw materials, equipment or funding that would delay vaccine deliveries, all of the companies testified that they had enough supplies and had already addressed some early bottlenecks in production.

"At this point, I can confirm we are not seeing any shortages of raw materials," said Pfizer's John Young.

Even with no further interruptions, other issues could still delay or block the United States from vaccinating 70% to 80% of its population -- the critical threshold needed to neutralize the spread of coronavirus -- by summer.

As of Friday, nearly 68.3 million people had received at least one dose of a COVID-19 vaccine, including 21.5 million people who have received both doses, according to the CDC.

A global scourge

By Friday, the U.S. coronavirus case count passed 28.4 million while the death toll passed 508,000, according to a Times tally. On Friday, the top five states for coronavirus infections were: California with over 3.5 million cases; Texas with more than 2.6 million cases; Florida with nearly 1.9 million cases; New York with over 1.6 million cases; and Illinois with nearly 1.2 million cases.

Curbing the spread of the coronavirus in the rest of the world remains challenging.

In India, the coronavirus case count was more than 11 million by Friday, a Johns Hopkins University tally showed. Brazil had nearly 10.4 million cases and over 251,000 deaths as of Friday, the Hopkins tally showed.

Worldwide, the number of reported infections passed 113 million on Friday, with over 2.5 million deaths recorded, according to the Hopkins tally.

© 2021 HealthDay. All rights reserved.

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