US As FDA advisers recommend authorizing a 3rd vaccine, a Covid-19 surge hangs in the balance

10:06  27 february  2021
10:06  27 february  2021 Source:   cnn.com

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FDA Commissioner, Dr. Stephen Hahn, told the Financial Times that the organization would consider emergency use authorization for a Covid - 19 vaccine before Phase 3 trials were completed.

Today, the FDA ’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), made up of independent scientific and public health experts from around the country, is meeting to discuss the first request for emergency use authorization (EUA) for a vaccine for COVID - 19 prevention, submitted by The FDA adds background material to web for upcoming VRBPAC meeting, approves new ANDA, issues safety message warning consumers not to wear face masks with metal parts during an MRI, authorizes first at-home diagnostic test to detect both COVID - 19 and influenza A and B (flu), and

Even with a third vaccine nearing authorization and a rise in vaccination rates, officials say another devastating Covid-19 spike could be on the horizon depending on what the United States does next.

In Denver, health care workers talk to patients at a tent outside Coors Field as the patients receive their second dose of a Covid-19 vaccine on Saturday. © Michael Ciaglo/Getty Images In Denver, health care workers talk to patients at a tent outside Coors Field as the patients receive their second dose of a Covid-19 vaccine on Saturday.

"The question that hangs in the balance right now is, will we have a fourth surge?" Dr. Tom Frieden, the former director of the US Centers for Disease Control and Prevention, told CNN's Wolf Blitzer on Thursday. "Every uncontrolled spread increases the risk that there will be dangerous variants that can be more infectious, more deadly, or can escape from immune protection."

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Johnson & Johnson's COVID - 19 Vaccine Candidate The Company's Janssen COVID - 19 Vaccine leverages the AdVac® vaccine platform, a unique and proprietary technology that was also used to develop and manufacture Janssen's European Commission-approved Ebola vaccine regimen and Forty-one percent of participants in the study had comorbidities associated with an increased risk for progression to severe COVID - 19 . Research and development activities for the Janssen COVID - 19 vaccine candidate, including the ENSEMBLE clinical trial and the delivery of doses for the U.S., have

A government advisory committee voted unanimously Friday to recommend authorizing a COVID - 19 vaccine from Johnson & Johnson for use in adults. "I think authorization of this vaccine will help meet the needs at the moment," committee member Dr. Archana Chatterjee, dean of the Two more candidate vaccines , one from AstraZeneca and Oxford University and another from biotech Novavax, are working their way through the clinical trial process and are expected to request FDA authorization in the next few months. The government pre-paid for all these vaccines , most for about per dose

A US Food and Drug Administration committee on Friday recommended that Johnson & Johnson's single-dose Covid-19 vaccine be authorized for emergency use. The FDA is expected to act on the recommendation quickly, meaning the vaccine may be available early next week.

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

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

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A health worker administers Covid - 19 vaccine during an event highlighting 50 million shots since President Joe Biden took office. Photographer: Doug Mills/The New York Times/Bloomberg. Listen to article. The all-day FDA meeting will include a presentation on how existing vaccines are holding up so far in practice, according to a pre-released agenda. In the morning, a Centers for Disease Control and Prevention official will highlight data on variants that are being closely watched for their threat to vaccine efficacy.

The US Food and Drug Administration has authorized the first Covid - 19 vaccine for emergency use in the United States. Millions of doses of the Pfizer and BioNTech coronavirus vaccine , which has been found to be 95% effective, will be soon shipped around the country so vaccinations can begin within days. Before vaccinations can begin, a US Centers for Disease Control and Prevention immunization advisory committee still must vote to recommend the vaccine , and the CDC must accept that recommendation. The Advisory Committee on Immunization Practices was scheduled to meet

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

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 its decision on emergency use authorization Saturday. "A third safe and effective vaccine is very welcome news," Slavitt tweeted.

If the FDA grants the vaccine emergency use authorization as expected, CDC advisers are due to meet Sunday to recommend to CDC Director Dr. Rochelle Walensky whether people could actually get the vaccine. Walensky would then give the final go-ahead. President Joe Biden has said if the vaccine is approved, it will be rolled out immediately.

New cases and hospitalizations have started to plateau

The number of new cases has started to plateau after six straight weeks of decline, though. Although the fall has come alongside an increase in the administration of vaccines, experts say that they are not the only cause for the lowered numbers.

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  Johnson & Johnson COVID vaccine cleared for expected FDA authorization within days If the FDA agrees with its review panel, as expected, the one-dose vaccine could begin rolling out to the American public next week."I think authorization of this vaccine will help meet the needs at the moment," committee member Dr. Archana Chatterjee, dean of the Chicago Medical School, said after casting her vote.

A: The FDA advises consumers to be beware of websites and stores selling products that claim to prevent, treat, or cure COVID - 19 . If you have a question about a product sold online that claims to treat, prevent, or cure COVID - 19 , talk to your health care provider or doctor. Watch this video and read this Consumer Update to learn how to protect yourself and your family from coronavirus fraud. The FDA ’s authority includes authorizing or approving COVID - 19 vaccines for use in the United States, but the FDA is not responsible for vaccine distribution.

The FDA wants two months of follow-up data after volunteers get their second dose of Covid - 19 vaccine as part of clinical trials testing potential coronavirus vaccines .

Walensky expressed concern Friday that cases and hospitalizations aren't continuing to decline.

"Over the last few weeks, cases and hospital admissions in the United States have been coming down since early January and deaths had been declining in the past week," Walensky said at the White House. "But the latest data suggest that these declines may be stalling, potentially leveling off at still a very high number. We at CDC consider this a very concerning shift in the trajectory."


The most recent seven-day average of cases -- 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 tenuous."

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

"The point that Dr. Walensky made is critical," Fauci said. "If we plateau at 70,000, we are at that very precarious position that we were right before the fall surge, where anything that could perturb that could give us another surge."

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FDA committee voted unanimously to recommend J&J vaccine

The Johnson & Johnson vaccine is the only one of the three Covid-19 vaccines to get unanimous support from the FDA advisory committee.

Video: The FDA says the Johnson & Johnson Covid-19 vaccine meets emergency use requirements (CNN)

"I think it's a relatively easy call. It clearly gets way over the bar and it's nice 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 a professor at Harvard University's T.H. Chan School of Public Health.

The 3.9 million doses from Johnson & Johnson 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 per week to states, tribes, and territories, and 3.9 million represents 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 vaccine centers and 90,000 to federally qualified health centers.

States can begin ordering the vaccine as soon as Sunday, once the vaccine gets the final nod from the CDC, said Freeman, who has seen the plans.

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Some state governors are already reporting the number of doses of the new vaccine they expect to get next week if it is authorized.

Ohio Gov. Mike DeWine said his state anticipates getting 90,000 doses in addition to the 310,000 doses already allotted to Ohio for next week.

California expects to get 380,300 doses by next week, Gov. Gavin Newsom said, while New Jersey may get roughly 70,000 doses, according to Gov. Phil Murphy.

The vaccine is also easier to transport and store, since it can be kept in refrigerators and is less delicate than the vaccines from Pfizer/BioNTech and Moderna, which have to be stored at temperatures colder than that of a regular freezer.

The existing vaccine from Pfizer could also become easier to distribute quickly, thanks to the FDA agreeing Thursday to allowing 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 testing to see how well a third dose protects against them.

States loosen restrictions on salons, stadiums and socialization

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

By Monday, Wyoming barbershops and salons, including hair, nail and tattoo parlors, will no longer have capacity restrictions, Gov. 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 gatherings to 50 people instead of 25.

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In response to "sustained decrease in case counts," the city of New Orleans is also implementing changes. Beginning on Friday the city is increasing gathering-size limits to 75 people indoors and 150 outdoors, as well as raising table limits and increasing indoor and outdoor stadium capacity limits to 15% and 25%, respectively.

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

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

Officials extend vaccine eligibility and availability

As vaccine eligibility expands, 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 US have received at least one dose of Covid-19 vaccine, about three times the overall rate of 14%.

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

Twenty-one states and Washington, DC, report vaccination data for people 65 and older. Four of them of them report vaccinating a larger share 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, Gov. Mike Parson said Thursday.

As well as 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 vaccines on March 8.

And as of Thursday, all people who are older than 16 and have certain comorbidities are eligible for the vaccines in Utah, Gov. Spencer Cox said.

Some states are abandoning the tiers of eligibility and moving to a system based on age alone. In Maine, people 60 and older will be able to get vaccinated starting next week, Gov. Janet Mills said Friday. Each month, a younger group will be eligible.

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

U.K. Steps Up Vaccinations; Japan Eyes Approvals: Virus Update .
The U.K. is expanding its vaccination program in a signal that it’s on track to meet its targets in fighting the pandemic. About 1.7 million people aged 56 to 59 are being invited to book an inoculation, the National Health Service said on Sunday. More than 80% of people between 65 and 69 took up the offer. Those aged 50 to 55 are set to be invited shortly. © Bloomberg Healthcare workers prepare doses of the Moderna Covid-19 vaccine at a McLeod Health mass vaccination site inside the Darlington Raceway in Darlington, South Carolina, U.S., on Wednesday, March 5, 2021.

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