Pressure on the Food and Drug Administration (FDA) is shifting to vaccine licensing for children under 12, now that the Pfizer vaccine has been fully approved for adults.
With children returning to school and the enraged delta variant, some experts and lawmakers are calling for the agency to act more urgently and to clarify the timetable for authorizing a COVID-19 vaccine for children, as it currently does not. none are available for children 12.
More than 100 House lawmakers wrote to the FDA last week asking for an update on their child immunization schedule, given the current “alarming” situation.
“He [FDA] it seems to ignore the urgency felt by millions of parents with young children about vaccination, ”he receives. Ro Khanna
Rohit (Ro) KhannaOvernight Health Care: NIH Director Says Israeli Data Builds Case for Drivers | Biden walks well on vaccine mandates Lawmakers ask FDA about vaccination schedule for children More than 100 lawmakers ask FDA about vaccination schedule for children Republicans are looking for a full tape behind the sting of vaccines ‘Exxon MORE (D-California), one of the leaders of the letter, tweeted Wednesday. “His communication has been very poor. Parents need a timeline. “
Lee Savio Beers, president of the American Academy of Pediatrics (AAP), also wrote to the FDA earlier this month, pressuring it to move “aggressively,” to authorize vaccines for children. ” as fast as possible”.
A complicated factor is the potential for rare cases of vaccine-related cardiac inflammation, known as myocarditis, in younger people.
Beers wrote that there is “justifiable concern” about these cases, but that they are “extremely rare” and are likely to occur within four weeks of vaccination.
And, instead, the delta variant is causing an increase in COVID-19 cases. Although children tend to perform better than older people, they are not fully immune.
The AAP reported 180,000 new cases of COVID-19 in children and adolescents in the week ending August 19.
“In our view, the increase in the Delta variant changes the risk-benefit analysis for vaccine authorization in children,” Beers wrote.
In an interview, Khanna said “confusion” was added to this week’s timeline when Francis Collins, the director of the National Institutes of Health, and Anthony Fauci
Anthony Fauci Sunday shows the preview: the bombing in Kabul produces an evacuation effort blow; US orders strikes at ISIS-K Overnight Health Care: Biden has received an inconclusive intellectual report on the origin of COVID-19. Biden officials weigh a shorter schedule for MORE reinforcing shots, seems to have given different estimates of when an authorization could occur.
Collins told NPR: “I don’t see the approval of children aged 5 to 11 coming long before the end of 2021.”
Fauci, meanwhile, told NBC that permission for children could arrive “hopefully in mid-fall and early winter.”
“There has to be a congressional briefing on what the timeline is and what they expect,” Khanna told The Hill.
Asked to clarify Collins and Fauci’s deadlines, NIH spokeswoman Renate Myles said the two schedules are “roughly” the same. “Dr. Collins said (in several iterations) that he sees approvals for vaccines for children ages 5 to 11 coming before the end of the year, though not long before, “Myles wrote in an email.” Half of autumn or early winter (November / December) is roughly the same estimate, just a different choice of words. “
Data from trials in children have yet to be submitted to the FDA before an authorization can occur. Collins told NPR that Pfizer data could arrive “in late September.”
Peter Marks, a senior FDA official, also said earlier this month that data for children ages 5 to 11 could arrive “in early fall,” but “it will take at least a few weeks to review them.” “. The number of security questions could determine how long the process takes, he said.
“If there’s any kind of security issue that concerns us, we may have to go back to an advisory committee because we want to make sure that when these things are allowed, people feel really comfortable that it can be used,” he said. Marks said, at an event organized by the COVID-19 Vaccine Education and Equity Project.
Data for children under 5 is expected to arrive later than data from 5-11, perhaps “later this fall in early winter,” Marks said.
“We are very aware that people are very eager to vaccinate their children,” Marks acknowledged. “We just have to make sure that when we put our primer on, our FDA is the emergency use authorization or the approval of something, we’re really sure it has met our safety, effectiveness standards. and quality “.
The bets were illustrated Thursday by a letter from Mark Wietecha, CEO of the Children’s Hospital Association. “With pediatric volumes at capacity or near and next school season demand is expected to increase, there may not be enough bed capacity or expert staff to care for children and families in need,” he warned in the letter a President Biden
Joe BidenUS tells Americans to leave Kabul airport “immediately” and “credible” threat “Britain and France will propose a safe zone in Kabul for people trying to flee Afghanistan.
Wietecha called for a number of steps, including the release of additional funds for children’s hospitals, but also noted the authorization of a vaccine.
“We ask that you continue to prioritize the development and deployment of a vaccine for children under 12 so that all children have a chance to protect themselves from the virus,” he wrote.