Johnson & Johnson FDA vaccine: As advisers recommend allowing 1-shot option, COVID surge is in balance



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WASHINGTON – Even with a third vaccine on the way and an increase in vaccination rates, officials say another devastating peak in Covid-19 could be on the horizon depending on what the United States does then.

“The question that is open right now is: will we have a fourth outbreak?” Dr Tom Frieden, former director of the U.S. Centers for Disease Control and Prevention, told CNN’s Wolf Blitzer on Thursday. “Each uncontrolled spread increases the risk that there are dangerous variants which can be more infectious, more deadly or escape immune protection.”

A U.S. Food and Drug Administration committee on Friday recommended that Johnson & Johnson’s single-dose Covid-19 vaccine be cleared for emergency use, CNN reported. The FDA is expected to act quickly on the recommendation, which means the vaccine could be available early next week.

That’s because the number of vaccinations reported by the United States Centers for Disease Control on Friday was nearly 2.2 million more than reported a day earlier. The seven-day average of reported vaccinations was around 1.6 million on Friday. Today, 14.2% of the total U.S. population has received at least one dose, according to the CDC.

RELATED: Single Dose Johnson & Johnson Vaccine Effective Against COVID-19 Variants: Data

Acting FDA Commissioner Dr. Janet Woodcock and Dr. Peter Marks, who heads the vaccine arm of the FDA, said in a joint statement that emergency use approval will come soon.

“The agency has also notified our federal partners involved in the allocation and distribution of vaccines so that they can execute their vaccine distribution plans in a timely manner,” the statement said.

Andy Slavitt, senior advisor to the White House Covid-19 response coordinator, said in a Twitter message that he expects the FDA to make its decision on emergency use authorization on Saturday. “A safe and effective third vaccine is very good news,” Slavitt tweeted.

If the FDA grants clearance for emergency use of the vaccine as planned, CDC advisers are due to meet on Sunday to recommend to CDC director Dr. Rochelle Walensky whether people could actually get the vaccine. Walensky would then give the final green light. President Joe Biden said if the vaccine is approved it will be rolled out immediately.

New cases and hospitalizations have started to level off

However, the number of new cases has started to level off after six straight weeks of decline. While the drop has been accompanied by an increase in vaccine delivery, experts say they are not the only cause of the drop in numbers.

Walensky expressed concern on Friday that cases and hospitalizations do not continue to decline.

“Over the past few weeks, cases and hospital admissions in the United States have declined since early January, and deaths have declined over the past week,” Walensky told the White House. “But the latest data suggests that these declines could stagnate, potentially leveling off at a still very high number. We at the CDC see this as a very concerning course change.”

VACCINE TRACKER IN THE UNITED STATES

The most recent seven-day average – around 66,350 – is higher than the average reported on Wednesday, Walensky said, adding: “It’s important to remember where we are in the pandemic. Things are precarious.”

Dr Anthony Fauci, chief medical adviser to President Joe Biden, said the United States “must be careful” about the spread of the disease.

“The point made by Dr Walensky is essential,” Fauci said. “If we cap at 70,000, we’re in this very precarious position that we were right before the fall surge, where anything that could disrupt could give us another wave.

FDA committee voted unanimously to recommend J&J vaccine
The Johnson & Johnson vaccine is the only one of the three Covid-19 vaccines to gain unanimous support from the FDA advisory committee.

“I think it’s a relatively easy call. It clearly exceeds the bar and it’s good to have a single dose vaccine,” Committee member Dr Eric Rubin said after the vote. Rubin is editor of the New England Journal of Medicine and professor at the TH Chan School of Public Health at Harvard University.

Johnson & Johnson’s 3.9 million doses could add at least 25% more Covid-19 vaccination capacity for states, according to Lori Tremmel Freeman, CEO of the National Association of County Health Officials and cities. Freeman said that 14.5 million doses are currently allocated per week to states, tribes and territories, and 3.9 million is about 26.9% of that.

“About 2.8 million will go to state and local jurisdictions; 800,000 to the retail pharmacy program,” Freeman told CNN. She added that 70,000 will go to community vaccination centers and 90,000 to federally qualified health centers.

States can start ordering the vaccine as early as Sunday, after the vaccine receives the last sign from the CDC, said Freeman, who has seen the plans.

Some state governors are already reporting the number of doses of the new vaccine they expect to receive next week if allowed.

Ohio Governor Mike DeWine said his state plans to receive 90,000 doses in addition to the 310,000 doses already allocated to Ohio for next week.

California expects to receive 380,300 doses by next week, Gov. Gavin Newsom said, while New Jersey could receive about 70,000 doses, according to Governor Phil Murphy.

The vaccine is also easier to transport and store because it can be stored in the refrigerator and is less delicate than the vaccines from Pfizer / BioNTech and Moderna, which must be stored at temperatures cooler than those in a regular freezer.

Pfizer’s existing vaccine could also become easier to distribute quickly, thanks to the FDA’s agreement on Thursday to allow it to be transported and stored for up to two weeks at “conventional temperatures” typically found in pharmaceutical freezers.

The company and its partner BioNTech are also responding to the growing threat of variants with new tests to see how well a third dose protects against them.

States relax restrictions on lounges, stadiums and socializing

Despite being cautious not to overstate the downward trends of recent weeks, many states are relaxing their restrictions.

RELATED: U.S. Advisors Approve Johnson & Johnson’s Single Injection COVID-19 Vaccine

By Monday, hair salons and salons in Wyoming, including barbers, nail salons and tattoo parlors, will no longer have capacity restrictions, Governor Mark Gordon said in a statement. Over the next month, the state will ease other health restrictions as well, including allowing buffets to resume their operations and limiting gatherings to 50 people instead of 25.

In response to “a sustained decline in the number of cases,” the city of New Orleans is also implementing changes. Starting Friday, the city is increasing the size limits for gatherings to 75 indoors and 150 outdoors, while increasing table limits and increasing indoor and outdoor stadium capacity limits to 15. % and 25%, respectively.

South Carolina Gov. Henry McMaster said on Friday gatherings of more than 250 people no longer needed approval and restaurants would again be allowed to serve alcohol starting Monday.

A particular point of contention has been the reopening of schools: While some officials and parents believe that it is urgent to bring students back to the classroom, there are teachers who fear that it is too early and not still safe enough to open campuses.

Officials expand vaccine eligibility and availability

As vaccine eligibility increases, more than half of all doses have gone to people 65 and older, including residents of long-term care facilities, according to published Kaiser Family Foundation analysis Friday.

Overall, about 41% of people 65 and over in the United States have received at least one dose of the Covid-19 vaccine, about three times the overall rate of 14%.

In some states, coverage among seniors is even higher, according to the analysis.

Twenty-one states and Washington, DC, report immunization data for people 65 years of age and older. Four of them say they vaccinate more of their older residents than the national average: North Carolina (49%), Florida (45%), Arizona (44%) and South Carolina (44%).

Starting March 15, teachers and other essential workers in Missouri will be eligible for the vaccine, Governor Mike Parson said Thursday.

In addition to educators and staff of K-12 students, Georgia Governor Brian Kemp on Thursday announced that adults with intellectual and developmental disabilities, their caregivers and parents of children with developmental disabilities health complexes would be eligible for vaccines on March 8.

And as of Thursday, all people over the age of 16 with certain co-morbidities are eligible for vaccines in Utah, Gov. Spencer Cox said.

Some states are dropping eligibility levels and moving to a system based solely on age. In Maine, people 60 and over will be able to get the vaccine starting next week, Governor Janet Mills said on Friday. Each month, a younger group will be eligible.

In Connecticut, those 55 and over can receive the vaccine starting Monday, Gov. Ned Lamont said earlier this week.

The two-dose injections of Pfizer and Moderna have been shown to be about 95% effective against symptomatic COVID-19. The numbers in the J&J study aren’t that high, but it’s not an apple-to-apple comparison. One dose of the J&J vaccine was 85% protective against the most serious COVID-19. After adding moderate cases, the total efficiency dropped to around 66%.

Importantly, the FDA reported this week that, just like its predecessors, the J&J vaccine offers strong protection against worse outcomes, hospitalization, and death.

The-CNN-Wire & 2021 Cable News Network, Inc., a Time Warner Company. All rights reserved.



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