Has the J&J COVID Vaccine Been Accepted?

By Ernie Mundell and Robin Foster HealthDay Reporters

FRIDAY, Feb. 26, 2021

An advisory panel for the U.S. Meals and Drug Administration will spend Friday weighing whether or not a coronavirus vaccine made by Johnson & Johnson ought to be permitted for emergency use.

The skilled panel is predicted to endorse the vaccine, which means that america may have a 3rd vaccine at its disposal as early as Saturday, The New York Instances reported.

Scientists from Janssen Prescription drugs, the drug improvement arm of Johnson & Johnson, will make displays on the vaccine’s efficacy and security, with a panel vote anticipated within the late afternoon or early night.

Briefing paperwork posted this week present the vaccine had an total efficacy price of 72 % in america and 64 % in South Africa, the place a regarding variant emerged within the fall and has since unfold to america, the Instances reported.

The vaccine was notably efficient at stopping extreme sickness or demise: It confirmed 86 % efficacy in opposition to extreme types of COVID-19 in america, and 82 % in opposition to extreme illness in South Africa. Not one of the practically 22,000 vaccinated individuals within the trial died of COVID-19.

When the FDA advisory panel met in December to think about the two-dose coronavirus vaccines made by Pfizer and Moderna, the sky-high efficacy charges of these pictures — roughly 95 % — prompted robust endorsements from the panel. However the dialogue on Friday may very well be extra cloudy, the Instances stated.

Johnson & Johnson’s vaccine does have actual benefits, nevertheless: It requires solely a single dose, does not must be saved in sub-zero temperatures, and makes use of a special form of expertise than the primary two approved vaccines. The Johnson & Johnson trial was additionally large, spanning eight international locations, three continents and 45,000 contributors. Sarcastically, that resulted in a big information set that’s more likely to immediate a extra advanced dialogue, the Instances stated.

The FDA’s evaluation estimated that the vaccine has an efficacy price of 74 % in opposition to asymptomatic infections, which means that it could additionally assist scale back the unfold of the virus by vaccinated individuals, the Instances reported. That’s more likely to be mentioned on the assembly, as well being officers sort out whether or not vaccination ought to — or should not — change habits when circumstances stay excessive, the Instances reported.

Nursing properties see steep drop in COVID circumstances, deaths

In a hopeful turnaround throughout a protracted pandemic, U.S. nursing properties that have been as soon as the epicenter of coronavirus infections at the moment are seeing each circumstances and deaths fall steeply because the nation’s vaccination rollout begins to take maintain.

From late December to early February, new circumstances amongst U.S. nursing residence residents fell by greater than 80 %, practically double the speed of enchancment within the basic inhabitants, the Instances reported. The downward pattern in deaths was much more heartening: Whilst fatalities spiked total this winter, deaths inside nursing properties have dropped by greater than 65 %.

“I am virtually puzzled at how superb it’s and the way thrilling,” Dr. David Gifford, chief medical officer for the American Well being Care Affiliation, which represents 1000’s of long-term care amenities throughout the nation, instructed the Instances.

The excellent news comes not a second too quickly: Because the pandemic started, the coronavirus has raced by some 31,000 long-term care amenities in america, killing greater than 163,000 residents and staff and accounting for greater than a 3rd of all virus deaths for the reason that late spring, the Instances stated.

However with the arrival of vaccines, which have been despatched to long-term care amenities beginning in late December, new circumstances and deaths in nursing properties have fallen steeply, outpacing nationwide declines, the Instances reported. It gives an early glimpse of what may be in retailer for the remainder of the nation, as increasingly individuals get vaccinated.

“If we’re seeing a strong response with this vaccine with the aged with a extremely contagious illness, I believe that is an awesome signal for the remainder of the inhabitants,” Giffords instructed the Instances.

About 4.5 million residents and staff in long-term care amenities have obtained at the very least one dose of the vaccine, in keeping with the U.S. Facilities for Illness Management and Prevention, together with about 2.1 million who’ve been totally vaccinated.

Now, new circumstances in nursing properties are at their lowest level since Might, when the federal authorities started monitoring such information, the Instances stated.

“What’s actually shocking to me is how rapidly we’re seeing this,” Dr. Sunil Parikh, an affiliate professor of epidemiology and drugs at Yale College of Public Well being in Connecticut, instructed the Instances.

Pfizer, Moderna say huge leap in vaccine provide coming

Officers from each Pfizer and Moderna delivered reassuring information about their COVID-19 vaccines to Congress this week: There shall be a pointy rise within the supply of doses within the coming month, and they’re going to be capable of present sufficient doses to vaccinate most Individuals by summer season.

By the top of March, Pfizer and Moderna count on to have delivered a complete of 220 million vaccine doses to the U.S. authorities, a major uptick from the roughly 82 million doses that the U.S. Facilities for Illness Management and Prevention says have shipped to this point.

“We do consider we’re on observe,” Moderna President Stephen Hoge instructed a Home subcommittee after describing how the corporate has ramped up manufacturing. “We predict we’re at an excellent spot.”

That encouraging information comes as federal regulators plan to weigh the emergency use of a 3rd COVID-19 vaccine, from Johnson & Johnson, on Friday. The Biden administration stated Tuesday that it expects about 2 million doses of that vaccine to be shipped within the first week after approval, and the corporate instructed lawmakers it ought to present sufficient of the single-dose possibility for 20 million individuals by the top of March, the Related Press reported.

By summer season, Pfizer and Moderna stated they count on to finish supply of 300 million doses every, whereas J&J goals to supply an extra 100 million doses. That may be greater than sufficient to vaccinate each American grownup, the AP reported.

Two different producers, Novavax and AstraZeneca, have vaccines within the pipeline and anticipate ultimately including to these totals, the AP stated.

When requested whether or not they face shortages of uncooked supplies, tools or funding that may delay vaccine deliveries, the entire corporations testified that they’d sufficient provides and had already addressed some early bottlenecks in manufacturing.

“At this level, I can affirm we’re not seeing any shortages of uncooked supplies,” stated Pfizer’s John Younger.

Even with no additional interruptions, different points may nonetheless delay or block america from vaccinating 70% to 80% of its inhabitants — the important threshold wanted to neutralize the unfold of coronavirus — by summer season.

As of Friday, practically 68.3 million individuals had obtained at the very least one dose of a COVID-19 vaccine, together with 21.5 million individuals who have obtained each doses, in keeping with the CDC.

A worldwide scourge

By Friday, the U.S. coronavirus case rely handed 28.4 million whereas the demise toll handed 508,000, in keeping with a Instances tally. On Friday, the highest 5 states for coronavirus infections have been: California with over 3.5 million circumstances; Texas with greater than 2.6 million circumstances; Florida with practically 1.9 million circumstances; New York with over 1.6 million circumstances; and Illinois with practically 1.2 million circumstances.

Curbing the unfold of the coronavirus in the remainder of the world stays difficult.

In India, the coronavirus case rely was greater than 11 million by Friday, a Johns Hopkins College tally confirmed. Brazil had practically 10.4 million circumstances and over 251,000 deaths as of Friday, the Hopkins tally confirmed.

Worldwide, the variety of reported infections handed 113 million on Friday, with over 2.5 million deaths recorded, in keeping with the Hopkins tally.

Extra info

The U.S. Facilities for Illness Management and Prevention has extra on the brand new coronavirus.

SOURCES: The New York Instances; Related Press

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