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WASHINGTON — A committee of experts advising the Food and Drug Administration on Tuesday recommended that regulators allow Pfizer-BioNTech’s coronavirus vaccine for 5 to 11-year-olds, bringing it a big step closer to making nearly 28 million children eligible for the vaccine.
If the FDA does, as expected, follow the panel’s advice in the coming days—and the Centers for Disease Control and Prevention agrees—the Biden administration will expand vaccine access to all but the youngest Americans, and provide booster vaccines for many.
Biden administration officials view the pediatric dose as crucial to keeping schools open and restoring a sense of normalcy to family and work life as the pandemic rapidly approaches the end of its second year. Management wants to be seen as doing everything possible to combat the virus and build on positive trends, as the Delta variant dwindles and the daily drums of infection and death dwindle.
Young children would start getting vaccinated at a time when coronavirus cases were falling sharply. But public demand for the pediatric vaccine is high, and some panel members said that although young children are less likely to become seriously ill from Covid-19, parents and doctors are concerned to protect them.
Mo., medical director at Children’s Mercy Hospital in Kansas City. Jay Portnoy said he saw critically ill children in the intensive care unit and “appalled” parents. “I’m really looking forward to being able to do something to prevent this,” he said.
The vote went 17-0 with one abstention. Federal regulators and scientists have exerted strong pressure, suggesting that 8,300 children ages 5 to 11 have been hospitalized with Covid-19, and nearly 100 have died during the pandemic.
Senior CDC vaccine officer Dr. Amanda Cohn said Covid-19 was “the eighth highest killer of children in this age group in the past year”. “Using this vaccine will prevent deaths, prevent intensive care admissions, and prevent significant long-term adverse outcomes in children.”
Data from Pfizer showed that in a clinical trial on 5 to 11 year olds, the vaccine had a 90.7 percent effectiveness rate in preventing symptomatic Covid-19. Yet many advisory board members have expressed concerns about the limited safety data, repeatedly turning to the risk of myocarditis, a rare condition involving inflammation of the heart muscle in young vaccine recipients. Myocarditis and pericarditis, inflammation of the membrane around the heart, have been linked to the Pfizer-BioNTech and Moderna vaccines, particularly in young men.
The dose of Pfizer for younger children will be one-third the strength given to those 12 years and older, with two shots given three weeks apart. Experts said this could reduce the risk of heart-related side effects.
An authorization could come in a few days if FDA regulators follow the committee’s advice, as they usually do. The Centers for Disease Control and Prevention’s own external panel of experts is scheduled to meet Tuesday and Wednesday and is also expected to approve a pediatric dose. The CDC, which sets the vaccination policy, will then likely recommend vaccinations quickly.
During a long discussion before the vote, some committee members questioned whether every child in their age group really needed the vaccine, or whether it was limited to those at high risk of severe Covid-19, an easily identifiable group with underlying conditions such as: obesity or other risk factors.
Meharry Medical College president and CEO Dr. James EK Hildreth said that since many children ages 5 to 11 may already have some immunity after contracting the virus, the need for vaccinations overall in the age group may be less urgent.
“It seems to me that in some ways we are vaccinating children to protect adults and it should be the other way around,” he said. “I believe children at highest risk should be vaccinated. But it seems a little too much for me to vaccinate all the kids to achieve that.”
Dr. Hildreth also complained that Pfizer’s pediatric research included several children from minority groups who are at greater risk of bad outcomes from Covid-19.
While some committee members said they wanted to recommend the vaccine for a narrower group of children, they were simply asked to decide whether the benefits of the pediatric vaccine outweigh the risks. An infectious diseases specialist at the Harvard TH Chan School of Public Health, Dr. “We decided to go for it with a guilty conscience,” Eric Rubin said.
A panel member who chairs the Vaccine Education Center at Children’s Hospital of Philadelphia, Dr. Paul Offit said it was “frustrating” to make public health decisions that affect millions of children, based on studies involving only a few thousand participants.
But he said: “The question is, when do you know enough? And I think we certainly know that there are many children between the ages of 5 and 11 who are predisposed to this disease, who could well get sick, be hospitalized, or die from it.”
Head of the agency’s division overseeing vaccine approvals, Dr. Peter Marks told the committee that about two million in this age group are infected and a third of those hospitalized need intensive care.
Committee members said they hoped the pediatric dose would not only keep primary school students out of the hospital, but would reduce transmission of the virus and long-term cases of Covid.
A viral disease specialist at the CDC, Dr. Fiona Havers told the panel that more than 2,000 schools were forced to close between August and October due to the outbreaks affecting more than a million students.
He said children have higher levels than adults of the neutralizing antibodies needed to prevent infection, but are at least as likely to become infected as adults. He said there are many more cases of child infection than are publicly recorded.
Dr. Havers added that Kovid-19 hospitalization rates in the 5-11 age group are three times higher for Black, Hispanic and Native American children than for white children.
What You Need to Know About Covid-19 Booster Shots
The FDA has allowed booster shots for millions of buyers. Pfizer-BioNTech, modern and Johnson and Johnson vaccines. Pfizer and Moderna recipients who qualify for support include people aged 65 and over and young adults at high risk of serious Covid-19 due to medical conditions or where they work. Eligible Pfizer and Moderna recipients can receive a boost for at least six months after their second dose. All Johnson & Johnson recipients will be eligible for a second shoot at least two months after the first.
Yeah. The FDA has updated its mandate to allow medical providers to empower people with a different vaccine than the one they originally received. “Mix and Match.” You can get a booster for any other vaccine, whether you’ve received Moderna, Johnson & Johnson, or Pfizer-BioNTech. The regulators did not recommend any vaccine over the other as a booster. They also remained silent on whether it would be preferable to use the same vaccine whenever possible.
The CDC said conditions that qualify a person for a booster shot include: hypertension and heart disease; diabetes or obesity; cancer or blood diseases; weakened immune system; chronic lung, kidney, or liver disease; dementia and some disabilities. Pregnant women and current and former smokers are also eligible.
The FDA has allowed boosters for workers whose jobs put them at risk of exposure to potentially infectious humans. The CDC says the group includes: emergency health workers; education workers; food and agricultural workers; manufacturing workers; correction workers; US Postal Service employees; public transport workers; grocery workers.
Yeah. The CDC says the Covid vaccine can be administered regardless of the timing of other vaccines, and many pharmacy sites allow people to schedule a flu shot at the same time as a booster dose.
presented at CDC data on blood samples From young children who stated that 42 percent had antibodies to the coronavirus, many raised questions about whether they were infected without showing any symptoms, and enhanced natural immunity. Dr. Havers warned that the children tested are already under clinical care, and may not be representative of the general pediatric population.
“During the delta wave, we saw the highest rates of hospitalizations in the 5 to 11-year-olds in September,” he said. “Obviously, there are many vulnerable children out there who are vulnerable to serious illness.”
It’s unclear how many parents will quickly outgrow their primary school students if given the opportunity. Surveys have shown that roughly a third are willing to do so right away, while a third prefer to wait. As federal regulators cleared Pfizer vaccines for adolescents aged 12 to 15 in May, 46 percent are fully vaccinated, compared to about 69 percent of adults.
Many panel members said the data on safety and efficacy were convincing enough for the government to recommend vaccines and give parents a choice.
However, the National Institutes of Health official who did not participate in the vote, Dr. Michael G. Kurilla said the government has taken a “one size fits all” approach.
“I think for many children who are already experiencing Covid, they are probably adequately protected. “One dose may be enough,” he said. “I think the situation is very different for high-risk children.”
The voting took place in a very tense atmosphere. As of Tuesday, approximately 140,000 public opinion on the matter has been formally submitted to the agency. In contrast, only 66 reviews were submitted before the panel of recommended boosters for adult recipients of the Moderna and Johnson & Johnson vaccines.
Over the weekend, panel members were flooded with messages in an organized email campaign urging them to vote against proposing authorization. The CDC warned members of its expert panel Tuesday afternoon that they could be targeted by a similar “false information campaign.”
Dr. Marks said that although the public has “strong feelings” about the empowerment, the committee was only asked if they should authorize the shootings, whether they should authorize it.
But panelist and chief of the pediatric infectious diseases division at Tufts Children’s Hospital, Dr. H. Cody Meissner said he feared government-level instructions would be followed too quickly before sufficient safety data had been collected. And others have questioned how well the government is tracking negative side effects, despite assurances that any alarming patterns will be detected.
FDA scientists say benefits of curbing Covid-19 with pediatric dose overall outweighed the risks It is one of the most worrisome side effects. Even in a scenario where the risk of infection is low, such as in June, the benefits of the vaccine could be greater because those hospitalized with Covid-19 tend to be sicker and longer for longer than those with vaccine-triggered myocarditis, they said.
Pfizer officials released safety data for nearly 4,500 children aged 5 to 11, who were split into two roughly equal-sized groups. The first group was followed for about two months, the second for about two and a half weeks. None of the children participating in Pfizer’s clinical trial developed myocarditis or pericarditis, but this was expected given the small size of the clinical trial and the rarity of these conditions.
Federal health officials said cases of heart disease tend to be mild and improve quickly, and that young people can also develop myocarditis from the virus itself.
Pfizer sought to reassure the panel that pharmacists and other service providers would be able to handle the shootings of the children. Company officials said they will be color-coded to reduce the risk of confusion.
Apoorva Mandavilli contributed news from New York and Carl Zimmer of New Haven, Conn.
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