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FDA advisers debate standards for a coronavirus vaccine for young children

WASHINGTON – With coronavirus vaccines available to adolescents and adults, regulators are now turning their attention to younger children and the level of proof needed before authorizing shots for children as young as six months.

On Thursday, many members of a panel that advises the Food and Drug Administration on vaccines argued that faster authorization should be an option because of uncertainties about virus variants and a potential fall surge in cases.

The discussion was not centered on a particular vaccine, and it unfolded as Pfizer-BioNTech and Moderna conduct trials of their vaccines in children.

The Pfizer-BioNTech vaccine is already authorized for adolescents as young as 12, and Moderna announced Thursday it had submitted an application to the FDA for authorization for adolescents. Executives from Pfizer and Moderna have said that data showing whether their vaccines are effective in younger children are expected by fall.

The timeline is welcome news to many families eager to go back to normal and gain confidence about in-person school. But the expert discussion included many points of disagreement and often strayed into currently unanswerable questions about the future, reflecting how the question about vaccines for children may become emotional and tricky in the fall. Because covid-19, the disease caused by the virus, rarely results in serious illness in young children, several of the advisers argued that a longer and more conventional review of the vaccine should take place.

But A. Oveta Fuller, associate professor of microbiology and immunology at the University of Michigan Medical School, said that as the country opens up, she fears that unvaccinated children who have been largely insulated from the virus would begin to bear the burden of disease.

“We haven’t seen it for the children because they have been isolated, or there are other mitigations,” Fuller said at the meeting of vaccine advisers. As mitigation measures are relaxed, she said, the virus could take root in unvaccinated populations. “I think we are in an emergency situation, and we will be going into winter.”

Children can suffer a rare inflammatory condition after infection, and about 300 children and adolescents are among the nearly 600,000 people in the United States who have died of covid-19.

The risk to children varies with age: Data presented at the meeting showed that children under age 5 were less likely to be infected or to have illness with symptoms compared with older children. But hospitalization rates – although low compared to adults – were similar.

The role that children play in transmission is still poorly understood, but Hannah Kirking, a medical epidemiologist at the respiratory viruses branch of the Centers for Disease Control and Prevention, presented unpublished data that suggests children of all ages play a role similar to adults in transmission and infection.

“I very strongly believe that we need a vaccine for adolescents and children, but I want to be sure that the risk of the vaccine is lower than the risk of hospitalization” from covid-19, said Cody Meissner, an infectious-diseases physician at Tufts Medical Center, noting that vaccines can carry risks and young children have a very low risk of being hospitalized. “As we generate herd immunity, this disease is disappearing, between the vaccine and natural immunity.”

The meeting included a review of evolving data on rare cases of inflammation of the heart muscle – known as myocarditis – that most often occur days after the second dose of the Moderna or Pfizer-BioNTech vaccine, predominantly in younger men. Public health officials have not drawn a link to the shot, but are investigating. Israeli health officials have said there is a probable link.

Tom Shimabukuro, a CDC official, presented slides showing that half of the 528 cases reported in a safety database occurred in people 12 to 24 years old, even though they represent only 9% of vaccine recipients. He also showed that the cases in younger age groups are occurring more frequently than would normally be expected.

Some experts said that untangling whether there is a link between the vaccines and the myocarditis cases is necessary before making a vaccine more widely available to children.

Coronavirus cases have been plummeting in the United States, and the summer is expected to bring further relief, with much of the eligible population vaccinated. But the fall and winter present an unknown, and many on the panel did not share Meissner’s confidence that the virus would not be a threat in autumn.

With the virus continuing to circulate globally and children returning to in-person school, many of the FDA advisers expressed concern that the virus would take hold among people who are not vaccinated – sickening some children and resulting in transmission to other vulnerable people. Others pointed out that children are routinely vaccinated for diseases far more rare than covid-19.

“We still vaccinate children in this country for polio, even though we have not had a case since the 1970s,” said Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia. “The notion that we are not going to have to vaccinate children going forward, I think, is wrong.”

For full approval, the FDA would typically require six months of follow-up of 3,000 children ages 6 months to 12 years. But because of the health emergency, the agency has authorized coronavirus vaccines in other age groups based on two months of median follow-up of study participants. Granting emergency authorization would make it theoretically possible for children to have access to the vaccine as soon as this fall.

“I’d hate to not have the tool,” said Eric Rubin, an infectious-disease expert at the Harvard T.H. Chan School of Public Health. He said he feared what might happen when children return to school and people head back indoors, especially in swaths of the country with low rates of vaccination.

Doran Fink, an FDA vaccine expert, said increasing the size of pediatric vaccine trials would not necessarily flag rare events. Such reactions often are not detected until vaccines are used in millions of people.

Several experts recommended that infants and toddlers should be studied in slightly larger numbers given their especially low risk of covid-19 and because vaccine side effects that are manageable in adults, such as fever, could cause seizures.

Trials in children aim to figure out the protective dose – which may be lower – in progressively younger age groups. In the adult trials, researchers had to wait to see whether people who received the vaccine were less likely to fall ill than those who received a placebo. But the pediatric trials are immune bridging trials, designed to check whether children’s immune systems muster an equivalent immune response to people who were protected against illness in older age groups.

Pfizer announced this week that children between 5 and 11 years old will receive one-third the dose given to adults, with testing in that group starting this week. Children 6 months to 5 years old will receive a dose that is one-tenth of the adult dose, with studies likely to begin later in June. The Pfizer trial will include 4,500 children total in the United States, Finland, Poland and Spain. Two-thirds will receive the vaccine, and the rest will receive a placebo.

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Moderna’s 6,750-person trial began in March and follows a similar format, finding the right dose in three age clusters. The researchers start with a low dose and gradually increase it to a safe and tolerable level. Then, the researchers will test the safety and effectiveness of the vaccine in each age group.

Published : June 11, 2021

By : The Washington Post · Carolyn Y. Johnson

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Cancer patients should get inactivated Covid vaccine, says hospital director

A hospital director has advised cancer patients to choose inactivated Covid-19 vaccine to protect their weakened immune systems.

The only inactivated Covid-19 vaccine currently available in Thailand is the Sinovac brand.

Live attenuated vaccines elicit strong immune responses but are not suitable for people with a weakened immune system, said Dr Thanut Kuai-Charoenpanich, director of Chewamitra Hospital in Ubon Ratchathani.

Due to their lowered immunity, cancer patients, the elderly and those with congenital diseases are considered to be at high risk of developing severe symptoms when infected with Covid-19. They also take longer to rehabilitate than other Covid patients, Dr Thanut said.

These people need to get the Covid-19 vaccine to build immunity and reduce the risk of infection and severe symptoms, he added.

The American Cancer Society recommends that most patients with cancer or a history of cancer should get a Covid-19 vaccination but says factors to be considered include the type of vaccine, type of cancer, and treatment process.

Cancer patients who have completed treatment can be vaccinated immediately, Thanut said. However, cancer patients who are still being treated for the disease must consult their doctor to help determine the appropriate time for vaccination and also reduce the risk of side effects.

Published : June 11, 2021

By : The Nation

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Thailand’s Covid quarantine policy should keep families together, says Unicef

The United Nations Children’s Fund (Unicef) is advising Thai authorities on how to prevent unnecessary separation of families under third-wave quarantine and isolation measures.

“Separation of child and parent or primary caregiver when either one has tested positive for Covid-19 may worsen the psychological toll on children as well as expose them to greater risks of neglect or violence,” said Kyungsun Kim, Unicef representative for Thailand.

“No child should be left on their own and families must remain together wherever possible.”

If a child must be quarantined, isolated or treated at a hospital or hospitel, a parent or caregiver must be allowed to accompany them, the Unicef guideline advises. If not possible, the child must be placed in a facility close to their family and allowing for regular communication. The child and family’s contact details and information must be recorded before any separation takes place.

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“Children’s overall physical and mental wellbeing, in addition to protection, must be a primary consideration in all policies and decisions on Covid-19 measures for health and safety,” Kim said.

Unicef also advises that if a parent or caregiver must be quarantined, isolated or treated at a hospital or hospitel, children should stay with a relative or responsible guardian in agreement with the parent or caregiver. If a child has been left on their own, neighbours or witnesses must immediately contact the government hotline 1300 to help ensure the child’s safety and the provision of appropriate services and living arrangements.

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Published : June 09, 2021

By : The Nation

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FDA approves first drug to slow decline of Alzheimers disease

WASHINGTON – The Food and Drug Administration on Monday approved the first Alzheimers treatment intended to slow cognitive decline, a move hailed by patients and advocates but sharply criticized by others who argued there was not sufficient evidence the drug works.

The medication, called aducanumab, is the first drug cleared for Alzheimer’s that is designed to alter the course of the disease by slowing the deterioration of brain function – not just to ease symptoms. No Alzheimer’s treatment has been approved since 2003, reflecting the extraordinarily high failure rate of drugs developed for the illness.

But, in an explicit acknowledgment of the uncertainties about the effectiveness of the drug, the FDA did not grant the medication full approval. Instead, the agency cleared the drug – its brand name will be Aduhelm – based on its ability to reduce clumps of amyloid beta in the brain, a hallmark of the disease. It ordered the drug’s maker, the biotech giant Biogen, to conduct a post-approval study confirming that the medicine actually slows cognitive deterioration. If the medication does not provide such a clinical benefit, the FDA’s approval could be withdrawn.

Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said officials believe it is “reasonably likely” that the reduction in amyloid clumps will confer “important benefits to patients.”

Monday’s FDA decision was the most contentious in years, and followed prolonged debate among researchers, doctors, patients and advocates about whether the medication works – a consequence of the drug’s complicated history. One of the biggest points of disagreement is whether a reduction in amyloid beta, a sticky compound that many scientists believe damages communication between brain cells and eventually kills them, results in a slowdown in cognitive decline.

Advocacy groups and patients praised the FDA decision, citing the paucity of drugs to help patients and saying the approval would stimulate newfound interest and investment in researching therapies for the progressive, terminal illness and give patients valuable time to be with their families and to perform everyday tasks.

The decision “is a victory for people living with Alzheimer’s and their families,” said Harry Johns, president and chief executive of the Alzheimer’s Association.

Jeff Borghoff, 57, who was diagnosed with early-stage Alzheimer’s five years ago and has received aducanumab in clinical trials, expressed elation about the FDA decision.

“This is epic news,” said Borghoff, a resident of Forked River, N.J., who credits the drug with keeping his condition stable. “Now, I may have time to watch my kids get married. My wife said, ‘I have more time with you now.'”

But critics assailed the decision, arguing that data on the drug’s effectiveness is weak and that the FDA approval represents a dangerous lowering of standards in response to pressure from patients and advocacy groups.

“I’m surprised and disappointed,” said Caleb Alexander, an internist and epidemiologist at the Johns Hopkins Bloomberg School of Public Health and a member of the FDA advisory committee that last fall resoundingly rejected the drug.

“I think this product was driven across the line by the magnitude of unmet need, which is enormous,” he said. “But unmet needs can’t trump regulatory standards, and my concern is that in this instance they may have.”

Alexander also noted that other amyloid-reducing drugs have not been shown to improve cognition – a point disputed by FDA officials, who said an internal agency study indicated that eliminating amyloid clumps could be helpful to patients.

Public Citizen, a watchdog group and frequent critic of the FDA, said in a statement Monday that the agency’s close collaboration with Biogen before and after the company’s application seeking approval “dangerously compromised the integrity of the agency’s review.”

The FDA’s Cavazzoni said she was satisfied the interaction between the staff and the company “was appropriate and necessary” given the FDA’s questions and the complexity of Biogen’s application.

The intravenous treatment does not cure Alzheimer’s disease or reverse it. On Monday, Biogen said it would charge $56,000 a year per patient, making it a blockbuster product for the company and adding billions of dollars to the nation’s health tab. Its stock rose 38 percent.

A Boston group that assesses the value of treatments – the Institute for Clinical and Economic Review – said earlier this year that aducanumab, to be cost effective, should be priced at $2,500 to $8,000 a year per patient.

Medicare is likely to shoulder much of the cost of the drug, given the age of people with Alzheimer’s, but it has not indicated its plans for coverage. Private payers will be under intense pressure to pay for the treatment but may push back on the price. It’s not clear yet how much patients on government or private insurance will have to pay in cost-sharing.

The medication is a monoclonal antibody, a protein made in the laboratory that can bind to substances – in this case, clumps of amyloid beta. It is designed to trigger an immune response that reduces the plaques.

About 6.2 million Americans have Alzheimer’s, a number projected to more than double by 2050, barring breakthroughs in treatment, according to the Alzheimer’s Association.

The drug was tested in people with the earliest stages of disease – those with mild cognitive impairment or early-stage dementia who had undergone testing to confirm the presence of amyloid clumps in their brains. Several doctors said Monday they were preparing to offer the drug to their patients and would focus on that population in using the drug. Biogen said Monday up to 2 million people in the United States might be eligible for the treatment.

The FDA did not restrict which patient groups could get the drug. Peter Stein, director of the Office of New Drugs in the drug center, said in an interview that there was “no particular reason” why the reduction of amyloid clumps would benefit patients at one stage of the disease and not others, and said physicians should discuss the medication with their patients and decide on the best course.

Ronald Petersen, director of the Mayo Clinic’s Alzheimer’s Disease Research Center, called the FDA’s conditional approval “a good outcome to a complicated situation.” He said the decision means patients will be able to receive the treatment outside of clinical trials, but that because of the “equivocal nature” of the efficacy data, the company will have to conduct another trial proving the therapy works.

If the FDA had required such a trial before granting approval, he said, the drug would not have been available to patients outside of studies for another three to five years, an outcome he viewed as undesirable. He also predicted Aduhelm will be just one element in an anti-Alzheimer’s arsenal in coming years as researchers develop combinations that are more effective than single medications.

Jason Karlawish, a neurologist at the University of Pennsylvania’s Perelman School of Medicine, had a starkly different view. He wrote in a May 30 column for Stat News, a news site that covers medicine and health, that he would not prescribe aducanumab if approved, because the data were incomplete and the therapy had not been properly studied.

On Monday, after the FDA announcement, he expressed continued reservations about the drug but said he would discuss it with his patients and respect their choices. But he said some patients and colleagues had expressed discomfort about the FDA’s decision, saying evidence that lowering amyloid and improving cognition was thin. And he said he was concerned it would be difficult to conduct the follow-up study on the drug once it is widely available outside of clinical trials.

The FDA has used its accelerated approval program many times for cancer drugs, clearing therapies, for example, that shrink tumors and then requiring a follow-up study showing whether the drug improves survival. But getting pharmaceutical companies to comply with mandates to conduct the post-approval studies has at times been difficult, and the agency has sometimes been slow to yank approved drugs from the market, even when the follow-up studies fail or aren’t completed.

The drug has followed a rocky road. In 2019, Biogen halted two late-stage trials halfway through after an assessment concluded the studies would not reach their goals of slowing cognitive and functional impairment in Alzheimer’s patients. But, in a sharp reversal, a company analysis with additional data released several months later came to a different conclusion.

In one of the clinical trials, that analysis found, people given the drug declined 22 percent more slowly than those who received a placebo. The other trial failed to reach its goal, though the company was encouraged by data from a subset of study participants who got more of the drug. Biogen concluded a key to effectiveness was giving patients a high enough dose for a long enough time.

Critics, however, said the data had been selected to make the drug look better than it was. In an acrimonious meeting last fall, an FDA advisory committee recommended against the drug’s approval, and harshly rebuked the agency’s review staff for supporting the medication so strongly and working closely with the company.

But supporters of the drug Monday were ecstatic about what they called a watershed moment following years of crushing disappointments in trying to find a way to treat the devastating disease.

Michel Vounatsos, chief executive at Biogen, called the decision a “historic moment” that would “transform the treatment of people living with Alzheimer’s disease and spark continuous innovation in the years to come.”

The approval bolsters the long-debated theory proposed in the early 1990s that targeting amyloid plaques can be an effective way to treat Alzheimer’s. Detractors have complained that the focus on amyloid has squeezed out work on other important approaches such as targeting a protein called tau or examining the role of inflammation.

Supporters counter that while multiple approaches should be pursued, the aducanumab approval shows that anti-amyloid treatments can be beneficial.

Aduhelm can sometimes cause side effects, the FDA said, including temporary swelling of the brain that usually does not cause symptoms, though some people may have headache, confusion and dizziness. Other potential complications are tiny bleeds in the brain and disorientation.

Published : June 08, 2021

By : The Washington Post · Laurie McGinley

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What we know about the highly infectious coronavirus delta variant

The coronavirus variant labeled “delta” was first recorded in India, where a slow vaccination drive and complacency about pandemic rules helped spark a record-breaking covid-19 surge this spring.

Since then the variant has spread, and as new cases rise in Britain, it has become dominant, despite one of the most successful vaccination programs anywhere. Its newfound prevalence could upend plans for a return to normalcy.

On Monday, British Health Secretary Matt Hancock said the country was still evaluating the data to see whether it can reopen fully by June 21 as planned, with a deadline to decide by next Monday.

“I know that these restrictions have not been easy, and with our vaccination program moving at such pace, I am confident that one day soon freedom will return,” he told Parliament.

Britain has fully vaccinated more than 41 percent of its population, while more than 60 percent have received at least one shot. But over recent weeks, the number of new cases recorded daily has ticked slowly but surely up, while health authorities confirmed last week the delta variant had come to dominate new infections.

The situation could have significant impact for vaccination and reopening plans around the world – including in the United States, where rates of vaccination have slowed despite the Biden administration’s target of having 70 percent of the country vaccinated by July 4.

Q: What is the delta variant?

A: Also known by the scientific name B. 1.617, the variant was first identified in Maharashtra, India, in October 2020. It became the delta variant after the World Health Organization implemented a new naming system based on Greek letters earlier this month.

Though it is just one of many variants to have arisen during the pandemic, it is considered one of the most alarming. The World Health Organization has labeled it a “variant of concern.”

It has splintered into several sub-variants – including one, known as B. 1.617.2, that is widespread in Britain.

While scientists are still studying the variant to better understand it, its impact can be seen in India, where it contributed to a surge in cases in recent months that led to daily death tolls topping a record 4,500.

On Monday, Hancock said before Parliament that the British government believed that the delta variant was 40 percent more transmissible than the alpha variant, also known as B.1.1.7, which was first detected in Britain. Scientists are still studying the matter.

A model released by a team of researchers at the University of Warwick last month warned that if the delta variant were 50 percent more transmissible than the alpha variant, it could lead to Britain’s biggest wave of hospitalizations yet: around 10,000 a day.

Q: What about vaccinations?

A: British data shows that the majority of new cases in the country are among those not yet vaccinated. Nearly all serious cases were recorded among the unvaccinated or partially vaccinated.

As of June 3, according to data Hancock cited, only three fully vaccinated people infected with the new variant had been hospitalized.

“The jabs are working,” Hancock said. “We have to keep coming forward to get them and that includes vitally that second jab which we know gives better protection against the Delta variant.”

A preprint publication by Public Health England put released last month found that one dose of a Pfizer or AstraZeneca vaccine was only 33 percent effective against the delta variant, compared to 50 percent for the alpha variant. That gap closed with a second dose.

In Britain, where two-dose vaccines produced by Pfizer, Moderna and AstraZeneca are commonly used, the government has focused on getting first shots out to a wide number of people, with second doses sometimes becoming available months after the first.

The concern is bigger, however, in countries vaccinating less swiftly than Britain is, or using vaccines with lower rates of efficacy, such as the Chinese-produced Sinopharm vaccine.

Q: Where has the delta variant been found?

A: Britain is among the world leaders in sequencing viruses, which is one reason it is so focused on variants. Other nations, including the United States and India, have lagged behind in this aspect of virus-tracking.

As of last month, according to the WHO, cases of the Delta variant had been confirmed in 62 countries. That includes the United States, where it made up 3 percent of covid-19 cases as of May 8, according to the Centers for Disease Control and Prevention.

WHO officials have warned that variants, combined with reopening plans, could lead to outbreaks.

“Relaxation of public health and social measures, increased social mobility, virus variants and inequitable vaccination are a very dangerous combination,” Maria Van Kerkhove, the WHO’s covid-19 technical lead, said at a briefing last week.

Published : June 08, 2021

By : The Washington Post · Adam Taylor

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Getting a jab each of AstraZeneca and Sinovac offers greater immunity

People who received doses of both the Sinovac and AstraZeneca vaccines have better immunity against Covid-19 than those who received both shots of the same brand, according to the Centre of Excellence in Clinical Virology research.

Chulalongkorn University virology specialist and chief of the Centre of Excellence in Clinical Virology, Dr Yong Poovorawan, said in a Facebook post on Sunday that research had been done on five samples.

“However, in practice, receiving different brands of Covid-19 vaccine is not recommended because it is a new vaccine,” he said.

According to the research, four samples who received first the Sinovac vaccine and the second dose of AstraZeneca had higher immunity than people who received both shots of Sinovac.

Meanwhile, one sample who received AstraZeneca first and then Sinovac also had higher immunity than the average.

Dr Yong added that the centre would continue its research based on safety, as it would be another way to use Covid-19 vaccines amid the vaccine shortage, or stimulate immunity after receiving the second shot.

Published : June 06, 2021

By : The Nation