FDA Johnson & Johnson Vaccine: As Advisers Recommend Approving 1-Shot Option, COVID Spike Remains Balanced

WASHINGTON – Even with a third vaccine nearing approval and a surge in vaccination coverage, officials say there could be another devastating Covid-19 spike on the horizon, depending on what the United States does next.

“The question at stake right now is, are we getting a fourth wave?” Dr. Tom Frieden, the former director of the U.S. Centers for Disease Control and Prevention, told CNN’s Wolf Blitzer on Thursday. “Any uncontrolled spread increases the risk that there will be dangerous varieties that can be more contagious, deadly or escape immune protection.”

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

That’s because the number of reported vaccinations reported by the U.S. Centers for Disease Control on Friday was nearly 2.2 million higher than the day before. The seven-day average of reported vaccinations was about 1.6 million Friday. According to the CDC, 14.2% of the total US population has now received at least one dose.

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 FDA’s vaccine division, said in a joint statement that emergency use authorization was coming soon.

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

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

If the FDA grants emergency use of the vaccine, as expected, CDC advisers will meet on Sunday to discuss CDC Director Dr. Rochelle Walensky to recommend whether people can actually get the vaccine. Walensky would then give the final green light. President Joe Biden has said that if the vaccine is approved, it will be rolled out immediately.

New cases and hospitalizations are starting to level off

However, the number of new cases begins to level off after six consecutive weeks of deterioration. While the drop was accompanied by an increase in vaccine delivery, experts say it’s not the only cause of the drop in vaccine numbers.

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

“In recent weeks, cases and hospital admissions have been declining in the United States since early January and the number of deaths has declined in the past week,” Walensky said at the White House. “But the latest data suggests that these declines may be stalling and possibly leveling off at a still very high number. We at CDC see this as a very worrying shift in the trajectory.”

US VACCINE TRACKER

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

Dr. Anthony Fauci, chief medical adviser to President Joe Biden, said the United States “needs to be careful” when it comes to the spread of disease.

“The point that Dr. Walensky made is crucial,” said Fauci. “If we reach a plateau at 70,000, we are in that very precarious position we had just before the fall rise, where anything could disrupt that could give us another wave.”

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

“I think it’s a relatively straightforward phone call. Obviously, it’s going way over the bar and it’s nice to have a single vaccine,” said committee member Dr. Eric Rubin after the vote. Rubin is editor-in-chief of the New England Journal of Medicine and a professor at Harvard University’s TH Chan School of Public Health.

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 and City Health Officials. Freeman said 14.5 million doses are currently allocated each week to states, tribes and territories, and 3.9 million represents about 26.9% of that.

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

States may start ordering the vaccine as soon as Sunday, once the vaccine gets the final nod 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 it is approved.

Ohio Gov. Mike DeWine said his state expects him to receive 90,000 doses in addition to the 310,000 doses already assigned to Ohio for next week.

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

The vaccine is also easier to transport and store, as it can be kept in refrigerators and is less fragile than the Pfizer / BioNTech and Moderna vaccines, which need to be stored at colder temperatures than a regular freezer.

Pfizer’s existing vaccine could also become easier to distribute quickly, thanks to the FDA agreeing on Thursday to ship and store it 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 are relaxing restrictions on salons, stadiums and socialization

Despite caution in paying too much attention to the downward trends of the past few weeks, many states are relaxing their restrictions.

RELATED: US Advisers Endorse Johnson & Johnson’s One-Time COVID-19 Vaccine

By Monday, barber shops and salons in Wyoming, including hair, nail and tattoo shops, will no longer have capacity constraints, Governor Mark Gordon said in a statement. Over the next month, the state will also ease other health restrictions, including allowing buffets to resume operation and limiting meetings to 50 people instead of 25.

In response to the “ongoing decline in cases,” the City of New Orleans is also making changes. Starting Friday, the city will increase group size limits to 75 people indoors and 150 outdoors, as well as table limits and indoor and outdoor stadium capacity limits to 15% and 25% respectively.

South Carolina Governor Henry McMaster said Friday that gatherings of more than 250 people no longer require approval, and that restaurants will be allowed to serve alcohol again from Monday.

One particular point of contention has been the reopening of schools: While some officials and parents think the need to have students back in class is urgent, there are teachers who worry that it is too early and not yet safe enough to open campuses .

Officials are expanding the suitability and availability of vaccines

As the vaccine qualifies, more than half of all doses have gone to people over 65, including residents of long-term care facilities, according to an analysis from the Kaiser Family Foundation released Friday.

In all, about 41% of people 65 and older in the US have received at least one dose of Covid-19 vaccine, about three times the 14% overall rate.

In some states, coverage among older adults is even higher, the analysis shows.

Twenty-one states and Washington, DC, report vaccination data for people 65 and older. Four of them report vaccinating a higher proportion of their older residents than the national average: North Carolina (49%), Florida (45%), Arizona (44%), and South Carolina (44%).

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

As well as educators and staff of K-12 students, Georgia Gov. Brian Kemp said Thursday that adults with developmental and intellectual disabilities and their caregivers and parents of children with complex medical conditions will be eligible for vaccines on March 8.

And starting Thursday, all people over the age of 16 who have certain co-morbidities will be eligible for the Utah vaccines, Governor Spencer Cox said.

Some states are abandoning the levels of eligibility and transitioning to an age-only system. In Maine, people 60 and older will be able to get vaccinated starting next week, Governor Janet Mills said Friday. A younger group is eligible each month.

In Connecticut, people over 55 can get the vaccine starting Monday, Gov. Ned Lamont said earlier this week.

The two-dose Pfizer and Moderna shots were found to be approximately 95% effective against symptomatic COVID-19. The numbers from J & J’s study are not that high, but it is not a comparison between apples and apples. One dose of the J&J vaccine was 85% protective against the most severe COVID-19. After addition in moderate cases, the overall effectiveness decreased to about 66%.

Importantly, the FDA reported this week that the J&J shot, like its predecessors, provides strong protection against the worst of consequences, hospitalization and death.

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

Source