Johnson & Johnson FDA vaccine: As consultants recommend authorizing a dose option, the peak of COVID remains balanced

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

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

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

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

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

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

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

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

If the FDA grants authorization for emergency use of the vaccine as expected, CDC advisers are due to meet on Sunday to recommend to the CDC Director, Dr. Rochelle Walensky, whether people could actually receive the vaccine. Walensky would then give the final green light. President Joe Biden said that if the vaccine is approved, it will be launched immediately.

New cases and hospitalizations began to stagnate

The number of new cases started to stabilize after six consecutive weeks of decline. Although the drop occurred along with an increase in vaccine administration, experts say they are not the only cause for the reduced numbers.

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

“In recent weeks, cases and hospital admissions in the United States have declined since the beginning of January and deaths have declined in the past week,” said Walensky at the White House. “But the most recent data suggest that these declines may be stopping, potentially stabilizing at an even very high number. We at the CDC see this as a very worrying change in trajectory.”

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

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

“Dr. Walensky’s point is critical,” said Fauci. “If we reach the plateau at 70,000, we will be in that very precarious position that we were in before the fall wave, where anything that could disturb us 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 have unanimous support from the FDA advisory committee.

“I think it is a relatively easy decision. It clearly goes beyond the limit and it is good to have a single dose vaccine,” said committee member Dr. Eric Rubin after the vote. Rubin is editor-in-chief of the New England Journal of Medicine and professor at Harvard University’s TH Chan School of Public Health.

Johnson & Johnson’s 3.9 million doses could add at least 25% more to Covid-19’s vaccination capacity for states, according to Lori Tremmel Freeman, CEO of the National Association of County Health Officials and City. Freeman said that 14.5 million doses are currently allocated per week to states, tribes and territories, and 3.9 million represent 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 health centers qualified by the federal government.

States can start ordering the vaccine as early as Sunday, once the vaccine receives final approval from the CDC, said Freeman, who saw the plans.

Some state governors are already reporting the number of doses of the new vaccine they hope to receive next week, if authorized.

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

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

The vaccine is also easier to transport and store, as it can be stored in refrigerators and is less delicate than vaccines from Pfizer / BioNTech and Moderna, which must be stored at lower temperatures than those of a common freezer.

Pfizer’s existing vaccine may 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” normally 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 a third dose protects them.

States loosen restrictions on halls, stadiums and socialization

Despite caution about paying close attention to the downward trends of the past few weeks, many states are loosening their restrictions.

RELATED: U.S. Advisers Endorse Johnson & Johnson’s COVID-19 Single-dose Vaccine

On Monday, Wyoming’s barbershops and salons, including hairdressers, nails and tattoos, will no longer have capacity restrictions, Governor Mark Gordon said in a statement. Over the next month, the state will also ease other health restrictions, including allowing buffets to resume and limiting meetings to 50 instead of 25.

In response to the “sustained reduction in the case count,” the city of New Orleans is also making changes. As of Friday, the city is increasing the meeting size limits for 75 people indoors and 150 outdoors, as well as increasing table limits and increasing capacity limits for indoor and outdoor stadiums to 15% and 25%, respectively.

South Carolina Governor Henry McMaster said on Friday that meetings of more than 250 people no longer need approval and that restaurants will be allowed to serve alcohol from Monday.

A particular point of contention was the reopening of schools: although some staff and parents think that the need to have students back to school is urgent, there are teachers who worry that it is too early and not yet safe enough to open campuses .

Officials extend vaccine eligibility and availability

As vaccine eligibility expands, more than half of all doses went to people 65 and older, including residents of long-term care facilities, according to an analysis by the Kaiser Family Foundation released Friday.

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

In some states, coverage among the elderly is even greater, the analysis concluded.

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

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

In addition to educators and staff for elementary and high school students, Georgia Governor Brian Kemp announced on Thursday that adults with intellectual and developmental disabilities and their caregivers and parents of children with complex medical conditions will be eligible for vaccines in March 8th.

And as of Thursday, all people over the age of 16 and with certain comorbidities are eligible for vaccines in Utah, said Governor Spencer Cox.

Some states are abandoning eligibility levels and moving to an age-based system. In Maine, people aged 60 and over will be able to be vaccinated starting next week, Governor Janet Mills said on Friday. Each month, a younger group will be eligible.

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

The two-dose injections of Pfizer and Moderna were found to be about 95% effective against symptomatic COVID-19. The numbers in the J&J study are not that high, but it is not a comparative comparison. One dose of the J&J vaccine was 85% protective against the most severe COVID-19. After adding in moderate cases, the total effectiveness dropped to about 66%.

It is important to note that the FDA reported this week that, like its predecessors, the J&J injection offers strong protection against the worst results, hospitalization and death.

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