FDA Johnson & Johnson vaccine: As advisers recommend approving 1-shot option, COVID boom hangs in the balance

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

“The question that currently hangs in the balance is: will we have a fourth boom?” 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 variants that could be more contagious, 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 authorized for emergency use, CNN reported. The FDA is expected to respond quickly to the recommendation, meaning the vaccine will be available early next week.

This is because the number of reported vaccinations reported by the U.S. Centers for Disease Control on Friday was nearly 2.2 million more than reported a day earlier. The seven-day average vaccinations reported on Friday were about 1.6 million. Now, 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 FDA’s vaccine arm, said in a joint statement that permission for emergency use 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 vaccine distribution plans in a timely manner,” the statement said.

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

If the FDA grants the emergency use authorization for vaccine as expected, CDC advisers should meet Sunday to discuss dr. Rochelle Walensky, director of CDC, to recommend whether people can get the vaccine. Walensky would then give the final chance. President Joe Biden said if the vaccine is approved, it will be rolled out immediately.

New cases and hospitalizations started flat

However, the number of new cases began to flatten after six consecutive weeks of decline. Although the decline is accompanied by an increase in the administration of vaccines, experts say that it is not the only cause for the reduced numbers.

Walensky on Friday expressed concern that cases and hospitalizations are not continuing to decline.

“Over the past few weeks, cases and hospital admissions in the United States have been declining since early January and deaths have been declining over the past week,” Walensky said in the White House. “But the latest data suggests that these declines may come to a halt and may still slow down a very high number. We at CDC see this as a very worrying shift in the orbit.”

US Vaccine Tracker

The latest average of seven days – about 66,350 – is higher than the average reported on Wednesday, Walensky said, adding: ‘It is important to remember where we are in the pandemic. Things are few. ‘

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

“The point made by Dr. Walensky is critical,” Fauci said. “If we have a peak of 70,000, we are in that very precarious position that we were right before the storm, where anything that could disturb us could give a new impetus.”

The FDA committee unanimously voted to recommend J&J vaccine
The Johnson & Johnson vaccine is the only one of the three Covid-19 vaccines that the FDA’s advisory committee unanimously supports.

“I think it’s a relatively easy call. It’s clearly crossing the line and it’s nice to have a single dose vaccine,” said Dr. Committee member Eric Rubin said 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.

The 3.9 million doses of Johnson & Johnson could add at least 25% more Covid-19 vaccination capacity to states, according to Lori Tremmel Freeman, chief executive of the National Association of County and City Health Officials. Freeman said 14.5 million doses are currently being administered to states, strains and territories per week, and 3.9 million represent about 26.9% of them.

“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 go to community center centers and 90,000 to federally qualified health centers.

States can begin ordering the vaccine as soon as Sunday, as soon as the vaccine gets the last nod from the CDC, said Freeman, who saw the plans.

Some state executives are already reporting the number of doses of the new vaccine they expect next week if approved.

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

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

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

Pfizer’s existing vaccine could also spread rapidly, thanks to the FDA’s agreement on Thursday to allow it to be transported and stored for up to two weeks at ‘conventional temperatures’ commonly 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 it.

States release restrictions on salons, stadiums and socialization

Despite the warning that they are paying too much attention to the downward trends of the past few weeks, many states are easing their restrictions.

RELATED: US Advisers Endorse Johnson & Johnson’s Single Shot COVID-19 Vaccine

By Monday, barbers and salons in Wyoming, including hair, nail and tattoo parlors, will no longer have capacity constraints, Gov. Mark Gordon said in a statement. During the next month, the state will also ease other health restrictions, including allowing buffets to resume work and limiting events to 50 people instead of 25.

In response to ‘sustained declines in the number of cases’, the city of New Orleans is also making changes. From Friday, the city will increase the limits of the gathering complex to 75 people inside and 150 outside, and increase the table limits and increase the capacity limits for indoor and outdoor stadiums to 15% and 25% respectively.

South Carolina Gov. Henry McMaster said Friday that meetings of more than 250 people no longer need approval, and that restaurants may serve alcohol again from Monday.

A particular point of contention was the reopening of schools: Although some officials and parents think it is urgently necessary to have students back in the classroom, there are teachers who are concerned that it is too early and not yet safe enough to campus does not open.

Officials extend the admission and availability of vaccines

As admission to the vaccine has expanded, more than half of all doses have gone 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 65 and older in the U.S. received at least one dose of Covid-19 vaccine, about three times the total rate of 14%.

In some states, the 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 that they vaccinate a larger 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, Gov. Mike Parson said Thursday.

In addition to educators and staff of K-12 students, Georgia Gov. Brian Kemp announced Thursday that adults with intellectual and developmental disabilities and their caregivers and parents of children with complex medical conditions will be eligible for vaccinations on March 8.

And as of Thursday, all people over the age of 16 who have certain medical conditions are eligible for the vaccines in Utah, Spencer Cox said.

Some states abandon the levels of fitness and go for a system based on age alone. In Maine, people 60 and older can be vaccinated from next week, governments Janet Mills said Friday. Each month a younger group is eligible.

In Connecticut, 55 people and older can get the vaccine from Monday, Governor Ned Lamont said earlier this week.

The two doses of Pfizer and Moderna shots are approximately 95% effective against symptomatic COVID-19. The numbers from J & J’s study are not that high, but this is not an apple-to-apple comparison. One dose of the J&J vaccine was 85% protective against the most severe COVID-19. After adding in moderate cases, the overall effectiveness dropped to about 66%.

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

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