FDA Review Finds J&J COVID Vaccine Safe, Effective

WEDNESDAY, Feb. 24, 2021 (HealthDay News) -- A single-shot coronavirus vaccine made by Johnson & Johnson completely prevented hospitalizations and deaths in a large clinical trial, a new review released Wednesday by the U.S. Food and Drug Administration found.

What would be the third vaccine to be authorized in the United States for emergency use could be approved as soon as this weekend, the Washington Post reported. The J&J vaccine was more than 85 percent effective at preventing severe illness, including in a region dominated by a concerning variant, but only 66 percent protective overall when moderate cases were included.

FDA scientists found the "known benefits" of the vaccine included reducing the risk of symptomatic and severe cases of COVID-19, at least two weeks after vaccination. The review found its efficacy against severe illness "was similarly high across the United States, South Africa, and Brazil."

"We know this vaccine prevents 85 percent of the severe disease. . . . It was 100 percent effective in preventing hospitalization and deaths, and that's really what's important," Nancy Bennett, a professor of medicine and public health sciences at the University of Rochester School of Medicine and Dentistry, told the Post. "Those facts are the most important thing to recognize."

The vaccine was less effective in a subgroup of adults older than 60 who also had risk factors for severe illness, but regulators noted there were no deaths or cases requiring medical intervention a month after those older adults received vaccines. Overall, there were seven deaths in the trial, all in the group that received a placebo shot, the Post reported.

An FDA advisory panel is set to meet Friday to recommend whether the FDA should authorize the shot for emergency use.

Public health officials have eagerly awaited the arrival of the J&J vaccine because it can be stored in a refrigerator for several months, which should ease the challenges of distributing vaccines in sub-zero temperatures, and it doesn't require a follow-up booster shot, the Post said.

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 on Tuesday: 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, later this week. 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.

The U.S. vaccination campaign continues to accelerate after a sluggish start and recent disruptions caused by a series of brutal winter storms. But state health officials say demand for shots still outstrips the weekly shipments they are given by the federal government.

"The most pressing challenge now is the lack of supply of vaccine doses," Rep. Diana DeGette, a Colorado Democrat, said as she opened the subcommittee hearing. "Some of the companies here today are still short of the number of doses they promised to initially deliver when they last testified before this subcommittee in July."

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 Wednesday, more than 65 million people had received at least one dose of a COVID-19 vaccine, including 19.8 million people who have received both doses, according to the CDC.

U.S. Sees 500,000 COVID deaths

President Joe Biden marked the once unthinkable milestone of half a million Americans lost to coronavirus with a somber, candlelit ceremony at the White House on Monday night.

"The people we lost were extraordinary," Biden said. "They span generations. Born in America, immigrated to America. But just like that, so many of them took their final breath alone in America."

The nation's coronavirus death toll is now higher than in any other country in the world. It has surpassed early predictions of loss by some federal experts, and more Americans have died from COVID-19 than did on the battlefields of World War I, World War II and the Vietnam War combined, The New York Times reported.

The United States now accounts for about 20 percent of the world's known coronavirus-related deaths, but makes up just 4.25 percent of the global population, the Times reported.

About 1 in 670 Americans has died of COVID-19, and it has become a leading cause of death in the country, along with heart disease and cancer, the Times said. The pandemic has also driven down life expectancy more drastically than seen in decades.

During the early days of the pandemic, Dr. Anthony Fauci, the nation's top infectious disease expert, and Dr. Deborah Birx, the official coordinating the coronavirus response at the time, projected that even with strict stay-at-home orders, the virus might eventually kill as many as 240,000 Americans — a number that seemed unimaginable at the time.

Less than a year later, the virus has killed more than twice that number. It has spread to every corner of America, decimating both densely populated cities and rural counties.

In New York City, more than 28,000 people have died of the virus — or roughly 1 in 295 people. In Los Angeles County, the toll is about 1 in 500 people, the Times reported. In Lamb County, Texas, where 13,000 people live scattered across 1,000 square miles, the loss is 1 in 163 people.

The virus has torn through nursing homes and other long-term care facilities, which account for over 163,000 deaths, roughly one-third of the country's death count.

Minorities have suffered far more than others during the pandemic: the coronavirus death rate for Black Americans has been almost two times higher than it is for white Americans, 2.3 times higher for Hispanics than for white Americans; and 2.4 times higher for Native Americans, the Times reported.

A global scourge

By Wednesday, the U.S. coronavirus case count passed 28.2 million while the death toll passed 502,000, according to a Times tally. On Wednesday, 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 Wednesday, a Johns Hopkins University tally showed. Brazil had just over 10.2 million cases and more than 248,000 deaths as of Wednesday, the Hopkins tally showed.

Worldwide, the number of reported infections passed 112.2 million on Tuesday, with nearly 2.5 million deaths recorded, according to the Hopkins tally.

More information

The U.S. Centers for Disease Control and Prevention has more on the new coronavirus.

SOURCES: Associated Press; Washington Post; The New York Times; CBS News; CNN