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Pfizer said on Monday that its COVID-19 vaccine works for children aged 5 to 11, and that it will seek U.S. clearance for this age group soon – a key step towards the start of vaccinations for them. youth.
The vaccine manufactured by Pfizer and its German partner BioNTech is already available to anyone 12 years of age and older. But with children now back in school and the extra-contagious delta variant causing a huge increase in pediatric infections, many parents are anxiously awaiting vaccinations for their young children.
Dr Cameron Wolfe, an infectious disease expert at Duke University, said he was pleased with the antibody response reported by Pfizer, but said he wanted to see the pharmaceutical company’s data on the vaccine’s effectiveness for prevent infection with COVID-19.
“The amount of antibodies that children generate is exactly the same as their adolescent counterparts despite taking a lower dose,” he said. “It’s almost a perfect answer.”
Wolfe expects efficacy data to be revealed when Pfizer requests emergency use. Her sons, aged 6 and 8, were two of more than 2,000 participants enrolled in Pfizer’s clinical trial. He said their side effects were similar to those that many adults have experienced.
“Their shoulders hurt and probably a day or two after that they both felt tired and a little more restless at home than they usually are,” he said.
A small price to pay, he said, for personal protection and the protection of others.
A survey carried out in August by the Kaiser Family Foundation shows that 4 in 10 parents of children under 12 “will wait a while to see how it works” before having their child vaccinated.
Pediatrician Dr Hope Seidel of the Cary Pediatrics Center said parents were most concerned about long-term side effects.
“We don’t have long-term studies on this or COVID-19, but there is some very compelling emerging data that COVID-19 is causing long-term side effects as we continue to see the virus persist in our people, ”she said. noted.
Immunizing children, she said, is essential to keep them in school and protect the most vulnerable
“The longer we wait, the more we will be here,” she said.
North Carolina State Health Director Dr Elizabeth Tilson said Monday morning that in the past two weeks, children in the 0 to 17 age group had for the first time during pandemic the highest case rates of any age group.
High school and middle school students have the highest rates of spread, while young children and preschoolers have a lower rate, she said. Young children are also less likely to become seriously ill than adolescents.
“Fortunately, hospitalization rates are low among children in general,” Tilson said. “They have relatively mild to moderate illness.”
Children can transmit COVID-19 to older children and adults, Tilson says, which is another risk.
“There are a lot of studies out there that say kids are pretty effective spreaders for their households,” she said. “They are very good at passing it on to household members who may have a higher risk of serious illness and death from COVID. “
Tilson said that with recent news from Pfizer, a vaccine could be available for the 5-11 age group this fall, and children as young as 6 months could have access by the end of the year. .
For school-aged children, Pfizer tested a much lower dose – one-third of the amount in each injection currently. Yet after their second dose, children aged 5 to 11 developed levels of anti-coronavirus antibodies as strong as adolescents and young adults receiving the regular injections, Dr Bill Gruber told The Associated Press. , senior vice president of Pfizer.
The children’s dosage was also found to be safe, with similar or fewer temporary side effects – such as sore arms, fever, or body aches – experienced by teens, he said.
“I think we’ve really hit the sweet spot,” said Gruber, who is also a pediatrician.
Gruber said the companies plan to apply to the Food and Drug Administration by the end of the month for emergency use in this age group, followed shortly thereafter by requests to European regulators and British.
Earlier this month, FDA chief Dr Peter Marks told the AP that once Pfizer turns over the results of its study, his agency will assess the data “hopefully in a few weeks. “to decide if the injections are safe and effective enough for young children.
An outside expert said scientists wanted to see more details, but called the report encouraging.
“These early results are very good news,” said Dr Jesse Goodman of Georgetown University, former FDA vaccine officer. The level of immune response reported by Pfizer “probably appears to be protective”.
So far, many Western countries have not vaccinated before the age of 12, pending proof of the right dose and its effectiveness. Cuba last week started vaccinating children as young as 2 years old with its local vaccines, and Chinese regulators have licensed two of its brands up to the age of 3.
While children are at lower risk of serious illness or death than the elderly, more than 5 million children in the United States have tested positive for COVID-19 since the start of the pandemic and at least 460 have died , according to the American Academy of Pediatrics. Cases in children have increased as the delta variant swept across the country.
“I feel a great sense of urgency” to make the vaccine available to children under 12, Gruber said. “There is a pent-up demand for parents to be able to bring their children back to normal life.”
In New Jersey, 10-year-old Maya Huber asked why she couldn’t get the shot like her parents and two teenage brothers. Her mother, Dr Nisha Gandhi, an intensive care physician at Englewood Hospital, enrolled Maya in the Pfizer study at Rutgers University. But the family has not relaxed their masking and other virus precautions until they find out whether Maya received the real vaccine or a fictitious injection.
Once she knows she is protected, Maya’s first goal: “a huge slumber party with all my friends.”
Maya said it was exciting to be a part of the study, even though she was “super scared” of getting stung. But “after you get it, at least you feel happy you did and relieved it didn’t hurt,” she told the AP.
Pfizer said it has studied the lowest dose in 2,268 kindergarten and elementary school children. The FDA has demanded what is called an immune “bridging” study: evidence that young children have developed levels of antibodies already proven to be protective in adolescents and adults. This is what Pfizer reported on Monday. in a press release, not a scientific publication. The study is still ongoing, ongoing, and there have not yet been enough cases of COVID-19 to compare rates between those who have been vaccinated and those who have received a placebo – something that might offer additional evidence.
The study is not large enough to detect extremely rare side effects, such as inflammation of the heart which sometimes occurs after the second dose, mainly in young men. FDA Marks said the pediatric studies should be large enough to rule out any higher risk to young children. Gruber of Pfizer said that once the vaccine is cleared for young children, they will be carefully monitored for rare risks, like everyone else.
A second American vaccine maker, Moderna, is also studying its vaccines in school-aged children. Pfizer and Moderna are also studying even younger toddlers, up to 6 months old. The results are expected later this year.
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AP reporter Emma Tobin contributed to this report.
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The Associated Press’s Department of Health and Science 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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