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WASHINGTON — Over the past 10 months, tens of millions of children and teenagers have been vaccinated with Pfizer-BioNTech, while the companies’ main competitor, Moderna, has stayed on the sidelines, with shots limited to adults.
But Moderna may now be ready for a comeback at a critical juncture in the country’s vaccination campaign. The company is expected to send the first data to federal officials this week on how well the coronavirus vaccine is working for the nation’s youngest children.
About 18 million children under the age of 5 are the only Americans yet to be vaccinated. While uptake has been slow for older children, many parents still anxiously await the chance to protect their babies, toddlers, and preschoolers.
Moderna is going head-to-head with Pfizer-BioNTech for the opportunity to vaccinate this group, hoping some scientists have found the dose of “Goldilocks”: strong enough to provide lasting protection, but not strong enough to cause widespread alarming side effects such as high fever.
Moderna has chosen a two-dose regimen for children younger than 6 years, at one-quarter the adult dose. Those for people 12 years and older.
Moderna is also expected to release data soon from its clinical trial on the next age group, children aged 6 to 11 years.
D., professor of pediatric infectious diseases at Stanford and principal investigator at the Stanford field of Pfizer’s pediatric vaccine trials. Yvonne Maldonado said the new data from both Moderna and BioNTech in the coming weeks will provide critical insights into the efficacy of pediatric vaccines. He said researchers are watching carefully to see if stronger doses of Moderna result in stronger immune responses than Pfizer elicits in younger children.
A series new studies ask questions How long Pfizer’s low doses protect elementary school-aged children has sparked interest in Moderna’s choices among federal scientists and vaccine experts.
A pediatrician at Harvard Medical School and a member of the Food and Drug Administration’s independent vaccine advisory committee, Dr. Ofer Levy said he thinks Pfizer may have chosen a dose that is too low for 5- to 11-year-olds. priority to maximize safety. ”
To date, Pfizer has been the only player to vaccinate young Americans, gaining authorization to vaccinate 12- to 15-year-olds last May, followed by 5- to 11-year-olds in October. Its authorization for adults also covers 16 and 17 year olds.
Moderna sought permission to vaccinate young people last June, but the FDA delayed considering the request due to concerns over the risk of myocarditis, a condition involving heart inflammation linked to both the Moderna and Pfizer vaccines.
More than 22 million people under the age of 18 in the United States are currently fully vaccinated with the Pfizer vaccine, but vaccine uptake is stabilizing. For example, although this group has been offered vaccination for over four months, only roughly one in four children aged 5 to 11 years are fully vaccinated.
But there is still a demand to protect the youngest children as the country unmasks more people, more parents return to their workplaces and the summer travel season approaches.
An infectious disease specialist and fellow at the Harvard TH Chan School of Public Health, Dr. Compared to adults, “there is no doubt that the benefit of an effective vaccine in children is less because fewer patients actually get sick,” said Eric Rubin. Advisory panel to the Food and Drug Administration.
“But it will benefit some people,” he said. “It will save several lives.” According to the Centers for Disease Control and Prevention, 336 children in the United States Since the beginning of the pandemic, under 5 years old have died from Covid.
Hopes rose last month that the youngest children would be covered soon, after regulators pressured Pfizer-BioNTech to submit preliminary results of its three-dose trial. While waiting for final results in three doses, the FDA wanted to start the vaccine campaign with two doses.
However this effort has failed When new data from Pfizer covering more Omicron fluctuations convincingly show that two doses do not adequately protect against symptomatic infection.
Now, more detailed results from Pfizer and Moderna’s trials are happening more or less simultaneously. Both companies don’t yet know whether their vaccines will be effective enough for the youngest age group, but both say their research shows they’re safe.
Moderna’s chief medical officer, Dr. “We haven’t seen anything negative at this time, so we’re relying on the safety profile,” Paul Burton said in an interview.
Amy Rose, Pfizer’s spokesperson, said that after careful research, Pfizer-BioNTech has selected the “safest and most tolerable dose” for young children. The companies said they were hopeful that a three-shot regimen would provide strong protection for children under the age of 5. Pfizer tests a dose of 10 micrograms for 5 to 11-year-olds, a third of adults and teens. dosing; and 3 micrograms for children under 5 years old.
Moderna recommends significantly higher dosing than Pfizer in all three pediatric age groups: 100 micrograms, full adult dose for 12 to 17 year olds; 50 micrograms for children 6 to 11 and 25 micrograms for children younger than 6 years. Regulators are likely to review the firm’s data for all three age groups at the same time.
Dr. “We’re really behind these doses,” Burton said. While federal officials say the efficacy of both Pfizer’s and Moderna’s vaccines diminishes over time, Some studies of adults suggested Moderna’s protection lasts longer. Dr. “I think he’s running low,” Burton said.
He said preliminary results showed that the 50 microgram dose of Moderna induced a “strong immune response” in children aged 6 to 11 years. high, increases antibody levels.
Recently retired as senior vaccine regulator at the FDA, Dr. Philip Krause said the agency spent significant time last year worrying about the safety of Moderna’s vaccine for those under 18, with some studies showing a higher risk of myocarditis from the company’s vaccine. More from Pfizer.
“The question is always: What dose elicits an immune response that we think might be protective?” said. “You can’t actually test to understand the rate of myocarditis, because it’s rare, but ‘What are we sacrificing in the immune response by lowering the dose and do we think it matters?’ you may ask.”
Partly because of concerns about myocarditis, The CDC has recently encouraged some people aged 12 and overMen and women ages 12 to 39, especially, wait eight weeks between first and second Pfizer or Moderna shots. Studies have shown that young men and boys are at risk of developing side effects.
Dr. Burton said the research in general, including recent research, has proven reassuring. British data showed that myocarditis is very rare and typically mild in both Pfizer and Moderna recipients.
But drug safety expert at the University of Pittsburgh, Dr. Walid F. Gellad said it remains unclear whether a high dose of Moderna would increase the risk of myocarditis in young children. He and other experts said the company’s pediatric studies were likely too small to determine the risk of side effects.
Moderna’s new move comes after several studies that raise questions about the protection that two doses of the Pfizer-BioNTech vaccine provide for children ages 5 to 11. Researchers at the New York State health department recently found Protection against infection from the two doses was significantly reduced within weeks.
CDC researchers found separately During the Omicron wave, the efficacy of two doses of Pfizer vaccine against moderate forms of the disease in children aged 5 to 11 years dropped significantly.
The studies have sparked a debate among vaccine experts about whether a stronger dose would be better or whether these children need a third dose. Power-up shots are now authorized for anyone 12 years and older. Pfizer expects results from a three-dose regimen study for younger children next month.
Dr. For 5- to 11-year-olds, the Pfizer dose may be too weak, but scientists aren’t sure yet, Gellad said. He said he expects regulators to be particularly careful considering higher doses for younger children, given the relatively low risk of contracting Covid and becoming seriously ill at this time.
Among all the questions, one thing is clear: Going back and forth about which vaccine is best for young children can deter vaccination.
Those considering vaccination find comfort in the certainty, said Alison M. Buttenheim, a behavioral health specialist at the University of Pennsylvania. Otherwise, “that will pave the way for you to just say ‘I’ll wait,'” she said. “A lot of people are uncomfortable with advancing science.”
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