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FDA Grapples With Timing for J&J Vaccine Booster

Angelo Moretti

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FDA Grapples With Timing for J&J Vaccine Booster



The Food and Drug Administration is wrestling with whether and when to offer a booster of the single-shot Johnson & Johnson COVID-19 vaccine — at six months or as early as two months. And a new study raises the prospect that using a different vaccine might give a better boost.

In an online review posted Wednesday, FDA scientists didn’t reach a firm conclusion about whether there’s enough evidence for J&J boosters, citing shortcomings with the company’s data and little information on protection against the extra-contagious delta variant of the coronavirus.

The review comes ahead of meetings Thursday and Friday when an FDA advisory panel will recommend whether to back booster doses of both the J&J and Moderna vaccines. That’s one step in the government’s vaccine review process: Next week, the FDA will make a final decision on authorizing those boosters and then the Centers for Disease Control and Prevention will debate who actually should get them.

Adding to the complexity is whether it’s OK to use a booster that’s a different brand than someone’s initial shots. Preliminary results of a U.S. government study suggest that mixing and matching boosters will work at least as well — and maybe far better for J&J recipients. Those people had a stronger immune response if they got either a Moderna or Pfizer shot as their booster than if they received another dose of the J&J vaccine, according to results posted online Wednesday. Mix-and-match is also up for discussion by the FDA panel this week.

Health authorities say all the vaccines used in the U.S. continue to provide strong protection against severe disease or death from COVID-19. But amid signs that protection against milder infections may be waning, the government already has cleared booster doses of the Pfizer vaccine for certain people starting at six months after their last shot.

Aiming for uniform recommendations, Moderna likewise asked the FDA to clear its booster dose at six months. But J&J complicated the decision by proposing a second shot over a range of two to six months.

FDA reviewers wrote that a study of the two-month booster plan suggests “there may be a benefit,” while pointing to only small numbers of people who got another shot at six months instead.

Overall, the J&J vaccine “still affords protection against severe COVID-19 disease and death,” the FDA’s reviewers concluded. But data about its effectiveness “are consistently less” than the protection seen with Pfizer and Moderna shots.

For its part, J&J filed data with the FDA from a real-world study showing its vaccine remains about 80% effective against hospitalizations in the U.S.

J&J’s single-dose vaccine was highly anticipated for its one-and-done formulation. But its rollout was hurt by a series of troubles including manufacturing problems and some rare but serious side effects including a blood clot disorder and a neurological reaction called Guillain-Barre syndrome. In both cases, regulators decided the shot’s benefits outweighed those risks.

Rival drugmakers Pfizer and Moderna have provided the vast majority of U.S. COVID-19 vaccines. More than 170 million Americans have been fully vaccinated with those companies’ two-dose shots while less than 15 million Americans got the J&J shot.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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Vaccine Mandates Create Conflict With Defiant Workers

Angelo Moretti

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Vaccine Mandates Create Conflict With Defiant Workers



Josh “Chevy” Chevalier is a third-generation shipbuilder who hasn’t missed a day of work during the pandemic in his job as a welder constructing Navy warships on the Maine coast.

But he’s ready to walk away from his job because of an impending mandate from President Joe Biden that federal contractors and all U.S. businesses with 100 or more workers be fully vaccinated against COVID-19.

“People are fighting for their constitutional rights — the way they think their life should be,” said Chevalier, one of hundreds of employees at Bath Iron Works threatening to leave.

Chevalier is among a small but significant number of American workers deciding whether to quit their jobs and careers in defiance of what they consider intrusive edicts that affect their freedoms.

The Biden administration, public health officials and many business leaders agree that vaccine requirements are legal, prudent actions necessary to help the world emerge from a pandemic that has killed more than 700,000 Americans and nearly 5 million people worldwide.

The defiant workers make up a small fraction of the overall workforce, with many cities, states and businesses reporting that more than 9 out of 10 of their workers are complying with mandates.

But they have the potential to create disruptions in a tight labor market and have become the latest roadblock in overcoming the vaccine hesitancy that allowed the COVID-19 crisis to take a devastating turn over the summer. In many cases, the reasons for the objections are rooted in misinformation.

The refusers come from all types of occupations — defense industry workers, police officers, firefighters, educators and health care workers. In Seattle, a group of city firefighters turned in their boots at City Hall on Tuesday to protest a vaccination requirement.

Thousands of people have sought religious or medical exemptions that were rejected; others won’t stand to be told what to do and have quit or been fired.

Nick Rolovich, the football coach at Washington State University, was let go from his $3.2 million-a-year job on Monday, along with four assistants. Rolovich, the first major college coach to lose his job over vaccination status, claimed a religious exemption but has declined to elaborate. He is suing.

The conflict over mandates is likely to grow in the coming weeks. The Biden administration is expected to move forward any day with the mandate that employers with 100 or more workers require all employees be vaccinated or undergo weekly testing, though enforcement likely won’t start for several weeks. The rule for federal contractors goes into effect in December, with no testing option, but many businesses, governments and schools are already implementing mandates.

The U.S. Chamber of Commerce and other groups that represent large employers have warned workers might simply migrate to jobs at smaller businesses where they don’t face vaccination requirements. That could create challenges for large retailers going into the holiday season, among other disruptions, the chamber warned.

Some people would rather quit their jobs than get a COVID-19 vaccine, and make arguments about freedom or choice when declining a shot. But we have had mandatory vaccinations in schools and different industries for decades that did not generate significant protest, says Dr. Alok Patel. “Where were all of these people over the last 20 years?” he asks.

Individuals who’ve left their jobs and are seeking work that doesn’t require vaccinations are sharing information on social media. Small employers looking for workers are turning to online job boards such as RedBalloon, where employers sign a pledge that they won’t make vaccines a condition for hiring.

Andrew Crapuchettes, RedBalloon’s founder and chief executive, said he started the online job board more than two months ago for people “who just want to work and don’t want to get into politics in the office.” More than 800 companies have posted, and more than 250,000 people have visited the site, he said.

Some states, including Texas, Montana and Florida, are gearing up to fight or undercut the Biden mandates. Texas Gov. Greg Abbott issued an executive order Monday barring any entity from requiring vaccines.

Florida Gov. Ron DeSantis said Thursday he will call a special session to pass legislation to combat vaccine mandates, saying that, “in Florida, your right to earn a living is not contingent upon whatever choices you’re making in terms of these injections.”

Melissa Alfieri-Collins, a 44-year-old mother of two, said she resigned from her job as a nurse at Jersey Shore Medical Center in Neptune, New Jersey, rather than undergo regular COVID-19 testing.

She said the hospital recognized her request for a medical exemption, but she objected to the requirement that only unvaccinated people get tested, arguing that even vaccinated people can spread disease.

“My family and I, we had a long talk, and I basically don’t want to compromise my values any more,” said Alfieri-Collins, who hopes to become a nurse practitioner and pursue her own holistic practice.

“I am very sad because I am the type of nurse that loves my patients and my patients love me,” she said.

Anthony Polenski, director of strategic partnerships for tech recruiting company Jobfuture.ai, said he’s seeing candidates who want to know, “Will this company force me to take a jab?” Polenski said they are often leaving previous employers because of a vaccine mandate.

“They don’t want their vaccination status attached to their employment,” he said.

At the shipyard in Maine, frustration is rising among union members.

On Friday, some 100 shipbuilders gathered outside the shipyard during their lunch break to protest being forced to get vaccinated. They marched down the street, holding signs decrying the mandate and using choice four-letter words that made clear what they think of the president and his vaccine mandates.

The union fears it could lose more than 1,000 workers, or 30% of its membership, over the federal contractor mandate.

Dean Grazioso, a 33-year Bath Iron Works employee, said he’s not anti-vaccine but that he knows vaccinated coworkers, friends and family members who’ve contracted breakthrough COVID-19 infections. Such infections are rare and vaccinated people who get COVID-19 usually have mild symptoms and are far less likely to be hospitalized or die.

The 53-year-old is still deciding whether to get the shot.

“I’m still up in the air,” he said. “But I’ve got a huge decision to make.”

Catalini reported from Trenton, New Jersey, and Dazio reported from Los Angeles. Associated Press writer Anthony Izaguirre in Tallahassee, Florida, contributed to this report.

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Disruptions to Schooling Fall Hardest on Vulnerable Students

Angelo Moretti

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Disruptions to Schooling Fall Hardest on Vulnerable Students



Even as schools have returned in full swing across the country, complications wrought by the pandemic persist, often falling hardest on those least able to weather them: families without transportation, people with limited income or other financial hardship, people who don’t speak English, children with special needs.

Coronavirus outbreaks in school and individual quarantine orders when students get exposed to the virus make it a gamble on whether they can attend classes in person on any given day. Many families don’t know where to turn for information, or sometimes can’t be reached.

And sometimes, because of driver shortages, it’s as simple as the school bus not showing up.

Keiona Morris, who lives without a car in McKeesport, Pennsylvania, outside Pittsburgh, has had no choice but to keep her boys at home on days when the bus didn’t arrive. Her two sons have missed about two weeks’ worth of classes because of such disruptions, she said.

Taking her older son to school on the civic bus system those days would mean not making it home in time to get her youngest to elementary school, she said.

“I feel like they’re leaving my kid behind,” Morris said. “Sometimes, he feels like he’s not important enough to get picked up.”

For some families, it’s a matter of not having the private resources to deal with breakdowns in the public education system. For others, language barriers or other communication issues leave them uninformed about things like programs that let students return to school despite virus exposures, as long as they test negative for infection.

And while some students can keep up with school remotely during quarantines, others receive little to no instruction, or they lack internet or devices to connect.

As districts seek solutions, they have to consider that disproportionate burden, said Bree Dusseault, principal at the Center on Reinventing Public Education at the University of Washington.

“If you’re going to be using a test as a tool to shorten quarantine, then all students have equal and free and easy access to that test,” she said.

The first day the shortages affected her son’s route, Morris did not see an early morning email notification that her son’s bus would be canceled, and the two of them waited at the stop for a ride that never came.

Staying at home has taken a toll on her kids, who are both more engaged when learning in person. On the days their bus was canceled and they had no access to the day’s lesson, the makeup work built up, putting them behind in class, she said.

For her older son, she said, the transition to middle school and missing social aspects of being with peers have been especially hard.

The effects of unpredictable stretches at home can mirror those of chronic absenteeism and lead to long-term harm to learning, said Robert Balfanz, a research professor at the Johns Hopkins University School of Education.

“The irregularity of your attendance is as important as the total amount you miss,” Balfanz said. “It lingers with you because you miss key moments of learning that everything else builds upon, and that can even lead to later frustrations.”

Some families have had more guidance than others in navigating unexpected, unstructured periods of learning at home.

In Seattle, Sarah Niebuhr Rubin’s son was sent home for two weeks when he was identified as a possible virus exposure. Because the exposure counted as an excused absence, Rubin said her son received no live instruction and no consistent services for his reading disability, except for two sessions with specialists who went out of their way to meet with him.

Without those services, she said, he struggles to complete work without constant supervision, which she could not provide while working from home.

“There really was nothing,” Rubin said. When her son returned to the classroom, she said it felt like the school year was “starting all over again.”

To minimize days out of school, some districts have implemented a “test to stay” option, where children can remain in school despite exposure to infected people as long as they continue to test negative for COVID-19.

In Georgia’s Marietta City Schools, students who are being tested go to a central location, where they are given a rapid antigen test in the parking lot. A negative test means they can go to school that day, while those who test positive are directed to quarantine.

Roughly 30% to 40% of eligible students participate, Superintendent Grant Rivera said, and the district has begun to identify some barriers to access for families. Some cited transportation hurdles or time constraints, such as work schedules.

About a quarter of families said they weren’t aware of the program, Rivera said. Parents are notified of the testing program when they learn their child is a close contact, and the district follows up with an email.

“When we make this initial phone call, there’s kind of like input overload and shock of, ‘What am I going to do about my kid and childcare and work?’” Rivera said. “We’re following up with an email, but in a district with a high ESL immigrant population, the email may not be understood by everybody in the family, or they may not be getting it.”

Rivera said he hoped to expand messaging through community partners, as well as through other methods like texting.

The possibility of further disruptions keeps some parents on edge.

For a while, firefighters in McKeesport were volunteering to drive children to and from school. Recently, Morris’ children’s bus has been on time. But she worries she and her son will be left waiting again.

“I have that worry in the back of my mind that it’s going to happen again,” Morris said. “And if it does, I’m just going to be ready to pull my kids out of school and homeschool them, even though it’ll be more tough for me.”

The Associated Press’ reporting around issues of race and ethnicity is supported in part by the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

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US Officials Keep Close Watch on the ‘Delta Plus’ Covid Mutation as It Spreads in the UK

Angelo Moretti

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US Officials Keep Close Watch on the ‘Delta Plus' Covid Mutation as It Spreads in the UK



Formally known as AY.4.2, the “delta plus” subvariant includes two new mutations to the spike protein, A222V and Y145H, which allow the virus to enter the body.The AY.4.2 subvariant has been detected in at least five cases in the U.S.: in Washington, D.C., California, North Carolina, Washington state and Massachusetts.Francois Balloux, director of the Genetics Institute at University College London, said it could be 10%-15% more contagious than delta.

U.S. health officials are keeping a close eye on an emerging Covid-19 subvariant, dubbed “delta plus,” that some scientists say may be more contagious than the already highly transmissible delta variant.

Formally known as AY.4.2, delta plus includes two new mutations to the spike protein, A222V and Y145H, which allow the virus to enter the body. Those mutations have been found in other Covid variants, so it’s unclear how dramatically those changes affect the virus.

Francois Balloux, director of the Genetics Institute at University College London, said it could be 10%-15% more contagious than delta, which first appeared in India and spreads easier than Ebola, SARS, MERS and the 1918 Spanish flu, according to the Centers for Disease Control and Prevention.

Delta has an R-naught, or reproductive rate, of eight or nine, according to CDC Director Dr. Rochelle Walensky, meaning that every person who has Covid will spread it to up to nine other people. The “wild type” or original strain of Covid had an estimated R-naught of about three. Someone infected with the delta variant carries 1,000 times the viral load of the original Covid strain.

India’s Ministry of Health reported in June that delta plus was more transmissible than the delta variant, adding that the subtype binds more strongly to lung cell receptors and could even reduce the effectiveness of monoclonal antibody treatments.

The mutation has been detected in the U.S., but there hasn’t been a noticeable uptick in delta plus cases nationwide, Walensky said at a White House Covid briefing Wednesday.

“We particularly monitor for sublineages that could impact therapeutics, such as monoclonal antibodies and vaccines,” Walensky said. “At this time, there is no evidence that the sublineage AY.4.2 impacts the effectiveness of our current vaccines or therapeutics.”

The AY.4.2 subvariant has been detected in at least five cases in the U.S. since August: in Washington, D.C., California, North Carolina, Washington state and Massachusetts, according to Outbreak.info. The website collects data from GISAID, a global genomic database on Covid and influenza cases.

Top health authorities have cautioned for weeks that more powerful and potentially vaccine-resistant Covid variants could develop as long as widespread outbreaks continue to occur, fueled by billions of people worldwide who remain unvaccinated. White House chief medical advisor Dr. Anthony Fauci said in August that the U.S. could be “in trouble” if another mutation surpassed delta, asking the unvaccinated to get their shots in hopes of curbing a surge that crushed the nation’s health-care systems this summer.

Delta plus could also eventually affect the age groups eligible to receive Covid booster doses, Dr. Peter Marks, the Food and Drug Administration’s lead vaccine regulator, said Wednesday night. The FDA and CDC have authorized Covid boosters for a wide array of adults in the U.S. from all three manufacturers in the U.S.: Moderna, Johnson & Johnson and Pfizer.

“The exact age of that will be based on what we see of the emerging situation, which is quite dynamic right now because we continue to see reports of new variants coming up,” Marks said. “And we’re also seeing changes in the epidemiology of Covid-19 in our country right now with new hotspots coming up even as certain places die down.”

Concerns over delta plus are running high in the U.K., where officials are battling a surge in cases and facing a renewed health crisis. Delta plus cases represented roughly 6% of all sequenced Covid cases as of the week beginning Sept. 27, according to the latest data from the country’s Health Security Agency. The sublineage is “increasing in frequency” in the U.K., the agency noted, and doctors from the National Health Service Confederation in London are calling for a return to stricter Covid protocols heading into the winter.

But global health leaders are urging the public not to panic. Though the emergence of a Covid subtype isn’t the same as an entirely new variant evolving, keeping track of delta’s progression could allow the medical community to better understand the mutation, Dr. Sylvain Aldighieri, Covid-19 incident manager at the World Health Organization’s regional branch for the Americas, said at a briefing Oct. 6.

“Looking to these additional changes, it may help researchers to track the variants on a fine scale,” Aldighieri said. “But they do not imply any functional or biological difference.”

— CNBC’s Holly Ellyatt in London contributed to this report.

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