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https://www.nationthailand.com/life/40006634

The Thoracic Society of Thailand under Royal Patronage, together with the Interstitial Lung Disease and Lung Disease from Occupational and Environmental Diseases (ILD assembly), organized a ‘Fill Up The Air’ live seminar on the ILDs Facebook page to improve awareness and understanding of Fibrotic-ILD (Fibrotic-Interstitial Lung Disease), a rare disease that has become more difficult to detect as a result of COVID-19 during screening, diagnosis and treatment. COVID-19 patients with severely damaged lungs may find their symptoms develop into pulmonary fibrosis which has a high risk of death if not treated early.

Assoc. Prof. Nitipatana Chierakul, President of Thoracic Society of Thailand under Royal Patronage, said, “Fibrotic-ILD is a rare disease that causes tissue inflammation in the lungs. There have been challenges in screening and diagnosis because symptoms are similar to other lung and respiratory diseases. Medical professionals are more familiar with chronic obstructive pulmonary disease (COPD) in men, congestive heart failure in women, tuberculosis, lung cancer and heart disease. However, the coronavirus outbreak presents even more challenges for doctors and patients because of COVID-19-like symptoms, such as shortness of breath, a dry cough and lung inflammation. But for doctors to make a more accurate diagnosis there needs to be a better understanding of the disease and its symptoms by patients. Tell-tale signs of pulmonary fibrosis include consistent coughing or shortness of breath over an extended period, for example more than two months, especially in non-smokers. Doctors should be looking more carefully at any anomalies or abnormality in lung X-rays, and listen for abnormal breathing sounds at the base of both lungs. They should listen carefully for sounds similar to Velcro being pulled apart, and numb fingers when exercising.
 

During Covid-19 pulmonary fibrosis patients have been additional impacted as they have been unable to attend hospital or had appointments cancelled or postponed, affecting their treatment whether it is access to medication, physical therapy sessions, or receiving oxygen therapy. At times they’ve received pills only by mail, and there has been a shortage of oxygen. The pressure on the healthcare system has also resulted in some patients being diagnosed too late as lung X-rays and biopsy tests take longer to arrange and this has an impact on diagnosis.

Additionally, the lungs are the main organ that COVID-19 will attack, and around 30-50% of all patients develop pneumonia that requires medical attention. Of these, after recovery, one in ten thousand or less may develop pulmonary fibrosis similar to Fibrotic-ILD, which can cause chronic problems. It interferes with the patient’s daily life and is a burden on the family and society.
 

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Assoc. Prof. Kamon Kawkitinarong, President of the Subcommittee on Interstitial Lung Diseases and Lung Diseases from Work and Environment, said: “Pulmonary fibrosis is a rare disease but is more common in Western countries where the prevalence of the disease is 90-100 people per 100,000 people, but in Thailand no official data is available. However, data from the IPF Registry Project shows there are 131 patients. Inflammation of the lungs is caused by breathing in both organic and inorganic pollutants, as well as internal factors. For example, autoimmune dysfunction may cause inflammation in the lungs. Physical examination history, along with high-resolution computed tomography (HRCT), can be used by doctors to evaluate patient condition. Pulmonary fibrosis has the potential to increase in severity. Invasive type, or PF-ILD (Progressive Phenotype ILD), causes fibrosis or scars around the alveoli and bronchioles. This makes it harder for oxygen to pass through the lungs and bloodstream. The patient will be short of breath and lacking oxygen, the organs will not function fully. Lung scars will not heal back to normal lung tissue condition, meaning that after being diagnosed with pulmonary fibrosis, patients need to visit the doctor regularly to closely monitor the spread of the disease.

The COVID-19 outbreak has affected access to treatment so an official LINE account called ‘Clear Lung’ (O2LUNG) has been set up to help people self-monitor. Patients can record abnormal symptoms and send them to the doctor without having to come to the hospital, while doctors can also publish useful information.”

Assoc. Prof. Chanchai Sittipunt, Vice President of Thoracic Society of Thailand under Royal Patronage, said, “Invasive pulmonary fibrosis is more severe than many cancers. Patients will continue to suffer loss of lung function, increased breathing difficulty and ultimately death when their lungs fail to function or they have a respiratory failure. When comparing the 5-year survival rate of various cancers, around 20% of lung cancer patients survive, 35% of idiopathic pulmonary fibrosis patients survive, 60% of colon cancer patients, 85% of breast cancer 85%, and 87£+% of prostate cancer patients are able to survive. Delayed treatment can significantly increase the mortality rate. For example, if treatment is delayed by one year there is a mortality rate of 8%. However, when delayed for up to two years this rises to 18%, and up to four years sees it rise to 27%. Delaying treatment longer than four years has a mortality rate of 32%.


Currently, there is targeted therapy anti-fibrotic drug approved to cover all three conditions: idiopathic pulmonary fibrosis; pulmonary fibrosis from scleroderma; and invasive pulmonary fibrosis. These can slow the progression of the disease, reduce acute exacerbations, and reduce the number of deaths. Other types of treatment, such as oxygen therapy pulmonary rehabilitation, are used to help patients improve their quality of life. The best way to prevent pulmonary fibrosis is to wear a mask or protective gear if you are at risk and avoid infecting the lungs.”

Mr Anuwat Noreewong, a 78-year-old pulmonary fibrosis patient said, “Pulmonary fibrosis is characterized by extreme fatigue, frequent choking, and persistent coughing that can be so severe it leaves me unable to speak. The disease too a long time to diagnose and the symptoms got worse as the cause could not be found due to symptoms being similar to other diseases. It took me many years to get proper treatment. I am fortunate that my daughter did some research on the Internet and found an expert like doctor Amornpun Wongkarnjana and that’s why I’ve survived. I want to encourage people to be more aware of the disease and recognise the symptoms by themselves, especially during this time of COVID-19. If they believe they suffer from any of these common symptoms they should consult a doctor.”
 

Published : September 25, 2021

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https://www.nationthailand.com/life/40006572

BANGKOK, 23 September 2021 – UNICEF continues its emergency support to Thailand’s COVID-19 response by providing 550 life-saving oxygen concentrators to help treat patients with respiratory diseases.

As COVID-19 cases continue to surge across the country, oxygen concentrators will help COVID-19 patients breathe when they cannot do so on their own. To increase patients’ access to the life-saving gas during this critical time and in the long term, oxygen concentrators worth 17 million baht (US$520,000) are being delivered to hospitals and field hospitals in severely affected areas.

“Responding to this COVID-19 surge requires providing life-saving supplies and equipment, including oxygen support. We all must continue ramping up our collective and immediate efforts to help treat patients and support the most vulnerable,” said Kyungsun Kim, UNICEF Representative for Thailand. “Together with our donors and partners, UNICEF is doing everything we can to deliver support to frontline workers to help save lives and minimize the COVID-19 impact on children and families.”

UNICEF’s emergency support to the COVID-19 response in Thailand so far also includes:

Reaching more than 275,000 disadvantaged children and adults with 607,000 hygiene supplies, including soap, hand sanitizer, alcohol spray, disinfectant and child and adult-size face masks.

Reaching 8,360 vulnerable children including children without parental care, urban poor children and migrant children, with Magic Box and Bag sets of books, toys, learning materials and parental guides to help keep young children learning while at home.

Supporting the establishment of a response system in communities, including community isolation and community childcare centres, as well as mobilizing and training volunteers to track new cases and provide COVID-19 testing, care and mental health support as well as facilitate referrals to health and child protection services in Klongtoey, urban poor communities, migrant communities and at construction sites.

Developing guidelines to support the authorities in minimizing family separation when implementing COVID-19 quarantine and isolation measures to ensure that children are not separated from parents or caregivers.

Supporting the establishment of Centre for Children #COVID-19, which provides appropriate and timely services for children affected by COVID-19, including promoting kinship and foster care for children without parental care.

Organizing training for frontline workers on providing psychosocial support to children to help them cope with grief and loss.

Supporting training of 8,000 community members, leaders and migrant workers in affected communities and at construction sites on COVID-19 prevention and self-care tips.

Distributing COVID-19 information booklets in Thai, Khmer and Myanmar languages to 180,000 children and adults in urban poor and migrant communities.

 

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Published : September 23, 2021

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https://www.nationthailand.com/life/40006526

Pregnant people who get mRNA vaccines pass high levels of antibodies to their babies, according to a study published in American Journal of Obstetrics & Gynecology – Maternal Fetal Medicine on Wednesday.

The study — one of the first to measure antibody levels in umbilical cord blood to distinguish whether immunity is from infection or vaccines — found that 36 newborns tested at birth all had antibodies to protect against Covid-19 after their mothers were vaccinated with shots from Pfizer-BioNTech or Moderna.

“We didn’t anticipate that. We expected to see more variability,” said Ashley Roman, an obstetrician at NYU Langone Health System and co-author of the study.

The data could help encourage more people to get vaccinated during their pregnancies. Only 30% of pregnant people ages 18 to 49 are vaccinated, according to Centers for Disease Control and Prevention data from Sept. 11, despite growing evidence of prenatal vaccine safety. Given the study’s small sample size, the team is now looking at results from a larger group, as well as how long immunization lasts for infants after birth.

“We pushed this data out relatively early because it’s a unique finding and it has important implications for care,” Roman said. “Right now we’re recommending all pregnant women receive the vaccine for maternal benefit.”

Pfizer and BioNTech’s own study on how their shots affect pregnant people and their babies has been delayed due to slow enrollment, the Wall Street Journal reported Wednesday, citing researchers.

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Pfizer “stopped enrollment in the U.S. because of recommendations encouraging vaccination of pregnant women,” the drugmaker said in an emailed statement to Bloomberg. It’s looking at sites in countries that don’t advise pregnant people to get shots for possible study sites, according to the statement.

The researchers studied cord blood of 36 fully vaccinated people to look for antibodies to spike protein, which appears after vaccination or getting sick from Covid, and to nucleocapsid protein, which is only present after getting Covid. Prior studies focused on antibodies to the spike protein.

Among the 36 samples the researchers looked at, 31 tested negative for antibodies to the nucleocapsid protein. In other words, 31 pregnant people developed immunity from the vaccine. The other five weren’t tested for nucleocapsid protein, so the researchers can’t conclusively say the immunity was from the vaccine or from natural infection.

The findings show “very encouraging levels of antibody in cord blood,” said Linda Eckert, an obstetrics and gynecology professor at the University of Washington who wasn’t involved in the study. “This is another reason pregnant women should get vaccinated, as we are seeing more disease in younger infants and this is a proactive choice pregnant individuals can make to protect their infants.”

Published : September 23, 2021

#SootinClaimon.Com : ขอบคุณแหล่งข้อมูล : หนังสือพิมพ์ The Nation.

https://www.nationthailand.com/life/40006522

WASHINGTON – The Food and Drug Administration on Wednesday authorized a Pfizer-BioNTech coronavirus booster shot for people 65 and older and adults at risk of severe illness, an effort to bolster protection for the most vulnerable Americans against the highly transmissible delta variant of the virus.

The agency said boosters should be made available to people 18 through 64 years of age at high risk of severe illness from the coronavirus and those “whose frequent institutional or occupational exposure” to the virus put them at high risk of serious complications of the disease caused by the virus.

The agency said the extra dose of the Pfizer-BioNTech vaccine should be administered six months after its standard two-shot regimen.

The FDA, in issuing the emergency clearance, took an approach similar to what was recommended Friday by the agency’s outside panel of vaccine experts. But the agency interpreted the advisory panel’s guidance broadly to cover a larger swath of people.

The FDA action is not the final step before the booster is made available. The Centers for Disease Control and Prevention and its advisers still must recommend in detail who should receive the shots.

The CDC’s Advisory Committee on Immunization Practices met Wednesday to hear data about the safety and effectiveness of a Pfizer-BioNTech booster, and it is expected to make a recommendation for its use when the committee meets Thursday. The decision will hinge in large part on which groups the advisers believe are most at risk of becoming seriously ill from covid-19, the illness caused by the coronavirus.

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The recommendation from the CDC advisory committee will almost certainly receive a quick endorsement from agency Director Rochelle Walensky. The shots are expected to be available as soon as this week at pharmacies and some doctors’ offices.

The FDA decision Wednesday will help frame the recommendation by the CDC advisory panel on who should get the boosters. The challenge for the CDC advisers “is to make a recommendation that is appropriate from the public health perspective and easy to communicate,” said William Schaffner, an infectious-disease professor at Vanderbilt University School of Medicine and a liaison member of the vaccine advisory panel.

The CDC advisers, in previous meetings, have expressed a strong inclination to prioritize boosters for groups who were among the first to be vaccinated, including front-line health-care workers, people in nursing homes and then the elderly.

Several CDC advisers reiterated Wednesday that the key goal of booster shots should be the prevention of serious disease, not prevention of mild infection.

But Beth Bell, a global health expert at the University of Washington, said the panel should consider the importance of protecting health-care employees from even mild infections because those illnesses would require time off work.

Bell acknowledged that the panel will not be able to address many outstanding questions about boosters, such as the ability to use a Pfizer booster for people who have been vaccinated with the Moderna or Johnson & Johnson products.

“I think it’s extremely important for us to be keeping in mind that . . . these are interim recommendations, and there may be data forthcoming in the near future which might change those recommendations,” she said Wednesday.

The federal action on boosters this week pertains only to Pfizer-BioNTech. Federal officials have suggested that clearance of booster shots for the Moderna and Johnson & Johnson vaccines could happen in a few weeks. An FDA official participating in the CDC advisers meeting, Doran Fink, said the FDA has no data on the safety and efficacy of giving a Pfizer booster to someone who received a different vaccine.

But limiting action to the Pfizer product poses immediate practical challenges for front-line immunization and health workers, issues that surfaced repeatedly during the CDC vaccine advisory committee meeting Wednesday. Nursing home residents and employees, for example, have received Pfizer and Moderna shots.

“In North Dakota, the vast majority [of long-term-care facilities] had a mixture of people that needed both Moderna and Pfizer,” said Molly Howell, director of North Dakota’s immunization program and a liaison member to the CDC panel. “I don’t know that it’s realistic to keep going back with different brands.”

In some states, hospital systems already have been considering or moving forward with boosters before the FDA and CDC decisions.

“Our hospitals here in Alaska and many hospitals in the country are really facing unprecedented choices and decisions about care and trying to weigh the risk-benefit of things like a booster shot versus, you know, waiting,” Anne Zink, Alaska’s chief medical officer, said in a recent interview.

Federal health officials have already authorized a third shot of Pfizer and Moderna vaccines for people with weakened immune systems, such as cancer patients and organ-transplant recipients.

Some Americans, regardless of their health status, have received extra doses by showing up at pharmacies, sometimes on the advice of their clinicians. Consumers are not required to get a prescription or a letter from their doctors for the third shot. More than 2.3 million people have received an additional dose since an extra shot was authorized for people with frail immune systems, according to the CDC.

Limited data from Israel and from one of the U.S. coronavirus vaccine monitoring systems shows there were fewer side effects after a third dose of mRNA vaccines compared with the second dose, according to a presentation to the CDC advisers by Helen Keipp Talbot, an infectious-disease expert at Vanderbilt University who chairs the advisers’ safety work group.

The Biden administration announced in mid-August that it hoped to make boosters for all three vaccines widely available beginning this week, pending sign-offs from the FDA and the CDC. But that announcement set off weeks of controversy as angry scientists complained the White House had gotten ahead of the agencies’ vaccine experts.

Ultimately, the heads of the CDC and the FDA told the White House that only the Pfizer-BioNTech booster could be cleared by this week. And last Friday, the FDA advisers declined to greenlight the Pfizer-BioNTech booster for all adults, saying there was a lack of robust safety data for younger adults. Several also argued that the two-shot regimen remains highly protective against serious illness, even though there are signs the efficacy of the vaccines may be waning somewhat against mild infections.

Booster shots have emerged as a hot topic as the delta variant has spread havoc in some areas, with intensive care units filling up with unvaccinated patients and a few hospitals rationing care. The pandemic’s death toll exceeds the 675,000 Americans killed by the 1918 influenza pandemic, according to data tracked by The Washington Post – although the population of the United States today is three times as large as in 1918.

At the same time, critics have pressed the Biden administration to wage a more vigorous campaign to get shots to countries that have not had access to vaccines, and for wealthier countries to forswear boosters until more people receive first shots. The administration, in an effort to show it can provide boosters to Americans and simultaneously offer shots to other nations, announced Wednesday that it has bought an additional 500 million doses to send overseas.

Published : September 23, 2021

#SootinClaimon.Com : ขอบคุณแหล่งข้อมูล : หนังสือพิมพ์ The Nation.

https://www.nationthailand.com/blogs/life/40006517

The Thai Food and Drug Administration (FDA) says it needs more data before approving Sinopharm vaccine for use in children.

FDA chief Paisan Dankhum said on Wednesday that information on the safety, quality and efficacy of the Chinese vaccine would be evaluated to decide whether it could be used to inoculate children aged 3 and up against Covid-19.

Sinopharm’s maker, Beijing Institute of Biological Products, insists the vaccine is safe for children aged 3 and over, citing data from a study published in the Lancet medical journal last week.

The Thai FDA has so far approved two vaccines – Pfizer and Moderna – as safe for use in children aged over 12. Thailand has already begun vaccinating children against Covid-19 in preparation for the reopening of schools next month.

The FDA said it will seek more data on Sinopharm from its importer, Biogenetech.

Published : September 22, 2021

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WASHINGTON – A second shot of the Johnson & Johnson vaccine boosts protection against symptomatic and severe covid-19, the disease caused by the coronavirus, the drug company announced early Tuesday.

Those booster shots also generated additional antibodies, molecules churned out by the immune system to help fight off infections.

“It’s very exciting news,” said Vanderbilt University Medical Center infectious-diseases and preventive medicine professor William Schaffner, though he cautioned not all the data have been seen and that information must be reviewed by the Food and Drug Administration before recommendations can be made.

“The people who received J & J have been a little concerned that they’ve been left in the shade, when it comes to repeat vaccination,” Schaffner said. These results, as presented, seem encouraging that those vaccine recipients might “expect a booster in their future.”

Under the FDA’s emergency use authorization, the Johnson & Johnson vaccine is given as a single dose, unlike the two shots required for full immunization with the Pfizer-BioNTech and Moderna mRNA vaccines.

Results published this summer indicate that the Johnson & Johnson vaccine generates lasting amounts of antibodies able to target the delta variant and other variants of concern. In June and July, when delta was ascendant, the effectiveness of the one-shot vaccine was 78% against observed covid-19, according to a report published Thursday that has not yet gone through peer review.

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A second dose, given 56 days after the first, further improves protection, the company said in a news release Tuesday. According to the company’s Ensemble 2 study, a Phase 3 randomized clinical trial, efficacy was 100% against severe or critical covid-19 when assessed at least two weeks after the booster. Efficacy against symptomatic disease in the United States was 94% and 75% globally.

“We now have generated evidence that a booster shot further increases protection against covid-19 and is expected to extend the duration of protection significantly,” Johnson & Johnson chief scientific officer Paul Stoffels said in a statement.

Full data from that trial was not released, the company said. It said it will be submitted for publication in months.

“This is good news and moves us closer to having an answer about the utility of boosters for the millions of Americans who received the J & J covid-19 vaccine,” said Lisa L. Maragakis, an infectious-disease epidemiologist at Johns Hopkins University School of Medicine. “Of course, we will need to wait to see the actual data and hear from both the FDA and CDC as they review it.”

Antibody levels, too, spiked after booster shots. People who received a Johnson & Johnson booster shot two months after vaccination had antibody levels four to six times higher, while the levels in people who had boosters at six months rose 12-fold in the following four weeks, the company said.

“An increase in antibodies is associated with two good features,” Schaffner said. First, this increase can lead to longer-lasting protection. Second, he said, “not only do you get more antibodies, but a wider display of antibodies,” which means an immunized person is likely to be better defended against a variety of variants.

Regulators would have to authorize Johnson & Johnson booster shots before the public could receive them. Health communication expert Scott Ratzan, co-founder of vaccine literacy initiative CONVINCE USA, said the results looked “promising” but regretted they were delivered by a news release. “Generally speaking, this is not the way we should be having vaccines approved and discussed,” said Ratzan, who was a vice president at Johnson & Johnson until 2013.

On Sunday, National Institute of Allergy and Infectious Diseases Director Anthony Fauci told NBC News that the FDA review of second Johnson & Johnson shots, as well as Moderna boosters, is “a couple to a few weeks away. . . . We’re working on that right now to get the data to the FDA so they can examine it and make a determination about the boosters for those people.”

Because it does not require a second appointment, the Johnson & Johnson vaccine had been sent to harder-to-reach communities soon after the shot became available. Nearly 15 million Americans received Johnson & Johnson doses, while about 166 million people have been fully vaccinated with the vaccines made by Pfizer-BioNTech and Moderna.

Published : September 22, 2021

#SootinClaimon.Com : ขอบคุณแหล่งข้อมูล : หนังสือพิมพ์ The Nation.

https://www.nationthailand.com/life/40006412

A lower dose of the Pfizer-BioNTech coronavirus vaccine – one-third the amount given to adults and teens – is safe and triggered a robust immune response in children as young as 5 years old, the drug companies announced in a news release Monday.

The finding, eagerly anticipated by many parents and pediatricians, is a crucial step toward the two-shot coronavirus vaccine regimen becoming available for younger school-aged children, perhaps close to Halloween.

The highly transmissible delta variant has collided with school reopening to reveal why children could benefit from a vaccine. Nearly 30 percent of cases in the first week of September were among children, according to the American Academy of Pediatrics. Although children rarely suffer severe illness, when they do it can be devastating. A vaccine could protect against rare cases of severe illness, cut the risk of long-haul covid and tamp down outbreaks.

The companies still must prepare and submit the data to the Food and Drug Administration, a process they expect to complete by the end of September. Then, the full data – which is not yet published or peer reviewed – will be scrutinized by regulators to ascertain that the vaccine is safe and effective. That could take weeks, or up to a month.

Sharon Nachman, a pediatric infectious-disease specialist at Stony Brook Medicine in New York, said a vaccine for children would be a “huge, huge step forward” and that she is “cautiously optimistic” about Monday’s announcement.

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“As most physicians are, I’m very cautious when it comes to the health of children,” Nachman said. “I think it will be critical to have the data presented to a group of experts who are unbiased and have no conflicts of interest.”

Regulators have made clear they are working as fast as possible, but also need to ensure the vaccine meets the highest standards – especially because a rare but concerning vaccine side effect of heart muscle inflammation has been identified, most frequently in the younger males eligible for the vaccines. An FDA analysis estimated that among 16- to 17- year old males, the risk was close to 1 in 5,000.

“You need to do these kind of studies, and it’s going to be important to vaccinate children,” said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. He called the results – that the vaccine triggered a robust immune response in children – somewhat predictable, but important.

With the school year in full swing and cases soaring among children, pediatricians have been inundated with requests to bend the rules and give children a shot now. The new data seems likely to intensify the pressure, even though the existing vaccine is triple the dose tested in the trial. Younger children’s immune systems are not the same as adults, and the companies tested and found a much smaller dose was safe and effective.

Evan Anderson, a professor of pediatrics at Emory University School of Medicine in Atlanta, said the pediatric trials at his institution had to turn away many families, with 10 times as many people who wanted to participate as they had slots available.

“Parents kind of recognize that their children going off to school is a significant issue for them: The lack of ability to control their exposure, whether in the lunch room or the classroom,” Anderson said.

But experts, including a Pfizer scientist, agreed that parents should be patient for regulators to pore over the details instead of seeking out doses on their own.

“No one should really be freelancing – they should wait for the appropriate approval and recommendations to decide how best to manage their own children’s circumstances,” said William C. Gruber, Pfizer’s senior vice president of vaccine clinical research and development, who explained that younger children tend to have more “exuberant” immune responses than older people, both to this vaccine and others.

“Nature has equipped us, particularly when we are young, to respond very well to an assortment of things we will encounter in nature – and we will use vaccines to accelerate that process and really improve on nature,” Gruber said.

Detailed data from the study in school-aged children was not immediately released Monday.

“Until we look at the data, I can’t comment on this, other than to say: We need a vaccine for children,” said Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia who serves on the expert committee that advises the FDA.

The step forward for a children’s vaccine may deepen the rift between families eager for the vaccine and parents who are hesitant. Hospitalizations among children have increased in the delta surge, but children have been far less likely to develop severe illness and death than older people throughout the pandemic, leading to a perception among some that the disease is not harmful to them.

Among 12- to 17-year-olds eligible for the Pfizer-BioNTech shot since May, only about half have received at least one dose, according to the American Academy of Pediatrics. More than 5 million cases of covid-19, the illness caused by the coronavirus, have been reported among children and teens, causing 460 deaths since the start of the pandemic. There have been 20,000 hospitalizations among 24 states and New York City. Many families and schools have been navigating disruptive quarantines and at times divisive policies on use of masks.

“We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory approval, especially as we track the spread of the Delta variant and the substantial threat it poses to children,” Pfizer chief executive Albert Bourla said in a statement. “Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. – underscoring the public health need for vaccination.”

In July, the FDA asked Pfizer and Moderna to increase the size of their children’s trials to ensure the safety database was robust. There were nearly 2,300 children between ages 5 and 11 in Pfizer’s trial, two-thirds of whom received the vaccine. The rest received saltwater shots.

The trial showed that children who received the vaccine had equivalent immune responses to teens and young adults who were protected, according to the companies. Two shots of a 10 microgram dose, spaced three weeks apart, were well-tolerated, with side effects similar to young adults.

Gruber said there appeared to be less fever and fewer chills among younger children than in a comparison group of 16- to 25-year-olds, increasing the companies’ confidence they had found the right dose. There were no cases of myocarditis – the heart inflammation condition – in the trial, but because it is a rare event, it may only show up in monitoring as the vaccine is used in larger numbers.

Pfizer and BioNTech are seeking emergency use authorization as they continue to accumulate data to support an application for full approval in children.

Data on children younger than 5 is expected by the end of the year. Moderna is also conducting a trial with children as young as six months.

The urgency for the littlest children is just as great, in part because they may not be old enough to wear masks, or may struggle to use them consistently.

“We have school-aged children, and they do have masks and they’re able to follow rules,” Nachman said. “Little kids in day care have more trouble following rules.”

Published : September 21, 2021