F.D.A. Panel recommends vaccine for children 5 to 11

WASHINGTON – A committee of experts advising the Food and Drug Administration on Tuesday recommended regulators authorize Pfizer-BioNTech's coronavirus vaccine for 5-11 year olds, bringing about 28 million children a big step closer to being used for Syringes to be considered.

When the F.D.A. In the coming days, following the advice of the panel, as expected – and the Centers for Disease Control and Prevention agree – the Biden administration will expand vaccine access to all but the youngest Americans while providing booster shots for many.

Biden administration officials see the pediatric dose as critical to keeping schools open and restoring a sense of normalcy in family and work life as the pandemic rages towards the end of their sophomore year. The government wants to be seen doing everything in its power to fight the virus and build on positive trends as the Delta variant dies down and the daily drumming of infections and deaths fades.

Younger children would start vaccinating at a time when coronavirus cases are falling sharply. However, public demand for a pediatric vaccine has been high, and some members of the panel said that while young children are less likely to get Covid-19, parents and doctors alike are careful to keep them safe.

Dr. Jay Portnoy, a medical director at Children's Mercy Hospital in Kansas City, Missouri, said he saw critically ill children in intensive care and "scared" parents. "I'm looking forward to actually doing something to prevent that," he said.

The vote was 17-0 in favor, with one abstention. Federal regulators and scientists made a strong push, arguing that 8,300 children between the ages of 5 and 11 were hospitalized with Covid-19 and nearly 100 had died over the course of the pandemic.

Covid-19 is "the eighth highest killing of children in this age group in the past year," said Dr. Amanda Cohn, a top C.D.C. Vaccine officer. "Using this vaccine will prevent deaths, will prevent I.C.U. Intake and will prevent significant long-term side effects in children. "

Data from Pfizer showed the vaccine had a 90.7 percent rate of effectiveness in preventing symptomatic Covid-19 in a clinical study of 5-11 year olds. Nonetheless, many members of the Advisory Committee raised concerns about limited safety data and repeatedly addressed the risk of myocarditis, a rare disease involving inflammation of the heart muscle, in young vaccine recipients. Myocarditis and pericarditis, an inflammation of the lining of the heart, have been linked to the Pfizer-BioNTech and Moderna vaccines, particularly in younger men.

The Pfizer dose for younger children would be a third of the strength given to people 12 years and older, with two syringes three weeks apart. Experts have said this could reduce the risk of the heart-related side effects.

When F.D.A. Regulators follow the committee's advice as they normally do, approval could be in a matter of days. The Centers for Disease Control and Prevention's own committee of external experts is scheduled to meet on Tuesday and Wednesday and is also expected to endorse a pediatric dose. The C.D.C., which sets vaccine policy, would then likely recommend the introduction of vaccinations quickly.

During a long debate leading up to the vote, some committee members wondered whether every child in the age group really needed the vaccine or whether it should be restricted to those at high risk for severe Covid-19 – an easily identifiable group with underlying conditions like obesity or other risk factors.

Dr. James E. K. Hildreth, the president and executive director of Meharry Medical College, said the need for comprehensive vaccination may be less urgent in the age group, as many children between the ages of 5 and 11 may already have some immunity after contracting the virus.

"It just seems to me that in a way we are vaccinating children to protect the adults, and it should be the other way around," he said. “I believe that children at the highest risk need to be vaccinated. But vaccinating all children to achieve that seems like a little too much to me. "

Dr. Hildreth also lamented the fact that Pfizer's pediatric study included few children from minority groups who are at greater risk for poor outcomes from Covid-19.

While some committee members said they wanted to recommend the vaccine for a closer group of children, they were asked to simply decide whether the benefits of a pediatric syringe outweigh the risks. "We made the decision to do so with a heavy conscience," says Dr. Eric Rubin, Infectious Disease Expert at Harvard T.H. Chan School of Public Health.

Updated

Oct. 28, 2021, 4:26 p.m. ET

Dr. Paul Offit, a panel member who directs the Vaccine Education Center at Children's Hospital of Philadelphia, said it was "nerve-wracking" making public health decisions that affect millions of children based on studies with just 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 prone to this disease and get sick very easily and / or be hospitalized or die from it. "

Dr. Peter Marks, who heads the agency's division that oversees vaccine approvals, told the committee that nearly two million in this age group are infected and that a third of hospital patients require intensive care.

Committee members said they hoped a pediatric dose would not only keep elementary school students away from the hospital but also reduce transmission of the virus and cases of long-term Covid.

Dr. Fiona Havers, a viral disease specialist at C.D.C., told the panel that more than 2,000 schools closed between early August and October due to outbreaks that affected more than a million students.

Children have higher levels of the neutralizing antibodies than adults, which are essential for preventing infection, she said, but they are at least as likely as adults to be infected, she said. She said there seem to be many more cases of infection in children than are publicly recorded.

Covid-19 hospitalization rates in the 5-11 year old age group are three times higher among black, Hispanic, and Native American children than white children, added Dr. Havers added.

What you should know about Covid-19 booster shots

Who is entitled to a booster vaccination?

The F.D.A. has authorized booster vaccinations for millions of recipients of Pfizer BioNTech, Moderna, and Johnson & Johnson vaccines. Pfizer and Moderna recipients eligible for a booster include those 65 years of age and younger and younger adults who are at high risk of severe Covid-19 due to medical conditions or their job. Eligible Pfizer and Moderna recipients can receive a booster vaccination at least six months after their second dose. All Johnson & Johnson recipients are entitled to a second admission at least two months after the first.

Can I exchange Covid vaccines for a booster?

Yes sir. The F.D.A. has updated its approvals to allow medical providers to replenish people with a different vaccine than the one they originally received, a strategy known as "mix and match". Whether you received Moderna, Johnson & Johnson, or Pfizer-BioNTech, you can get a booster shot with any other vaccine. Regulators have not recommended any vaccine over any other than a booster. They have also remained silent about whether it is preferable to stick with the same vaccine whenever possible.

Which underlying diseases qualify for a booster vaccination?

The C.D.C. has said that the conditions that qualify a person for a booster vaccination include: high blood pressure and heart disease; Diabetes or obesity; Cancer or blood diseases; weakened immune system; chronic lung, kidney, or liver disease; Dementia and certain disabilities. Pregnant women as well as current and former smokers are also eligible.

Which professions are suitable for boosters?

The F.D.A. Approved booster vaccination for workers whose workplace presents a high risk of exposure to potentially infectious people. The C.D.C. says the group includes: emergency medical personnel; Educational workers; Food and agricultural workers; Manufacturing workers; Correction worker; US Post Office Workers; Public transport employees; Grocery store employees.

Can I get a flu vaccination at the same time as a Covid vaccination or a booster vaccination?

Yes sir. The C.D.C. says the Covid vaccine can be given regardless of timing of other vaccines, and many pharmacies allow people to schedule a flu shot at the same time as a booster dose.

The C.D.C. Also presented data on blood samples from young children suggesting 42 percent had antibodies to coronavirus, raising the question of whether many were infected with no symptoms and had developed natural immunity. Dr. Havers warned that the children tested were already in clinical treatment and may not constitute the general pediatric population.

"We saw the highest hospitalization rates in the 5-11 age group in September during the Delta Wave," she said. "There are clearly still many vulnerable children out there who are prone to serious illness."

It is unclear how many parents would have their elementary school children vaccinated quickly if they had the chance. Surveys have shown that around a third would like to do this immediately, while a third would rather wait and see. Since federal regulators approved Pfizer vaccinations for teenagers ages 12-15 in May, 46 percent have been fully vaccinated, compared with about 69 percent of adults.

Many members of the panel said the safety and efficacy data were convincing enough for the government to offer shots and give parents a choice.

But dr. Michael G. Kurilla, an official with the National Institutes of Health who abstained, said the government has a "one size fits all" approach.

“I think that for many children who have already experienced Covid, they are probably more than adequately protected. One dose can be enough, ”he said. "I think it's very different with the high-risk children."

The vote took place in a highly charged atmosphere. By early Tuesday, nearly 140,000 public comments on the matter had been formally submitted to the agency. In contrast, only 66 comments were received before the panel recommended booster vaccinations for adult recipients of the Moderna and Johnson & Johnson vaccines.

Over the weekend, panel members were inundated with messages in an organized email campaign asking them to vote against the recommendation of authorization. The C.D.C. warned members of its own panel of experts Tuesday afternoon that they could potentially be targeted by a similar “misinformation campaign”.

Dr. Marks said that while the public had "strong feelings" about approval, the committee was only asked if they should allow shots, not if they should be ordered.

Dr. However, H. Cody Meissner, a panelist and chief of the pediatric infectious diseases division at Tufts Children's Hospital, said he feared state mandates would follow too soon before adequate safety data could be gathered. And others questioned how well the government is tracking adverse side effects, despite assurances that worrying patterns would be detected.

F.D.A. Scientists said the benefits of averting Covid-19 with a pediatric dose generally outweigh the risks of the most worrisome side effects. Even in a scenario where the risk of infection was low, like in June, the benefit of the vaccine could be greater, as those hospitalized with Covid-19 tend to be sicker and longer than those with one triggered by the vaccine Myocarditis, they said.

Pfizer officials described safety data from approximately 4,500 children, ages 5-11, split into two roughly equal cohorts. The first group was followed for about two months, the second for about two and a half weeks. None of the children involved in Pfizer's clinical study developed myocarditis or pericarditis, but this was to be expected given the small size of the clinical study and the rarity of these disorders.

Federal health officials have said that cases of heart disease are usually mild and go away quickly, and that younger people can develop myocarditis from the virus itself too.

Pfizer tried to reassure the panel that pharmacists and other providers would be able to handle child syringes. They would be color-coded to reduce the risk of confusion, company officials said.

Apoorva Mandavilli provided coverage from New York and Carl Zimmer from New Haven, Conn.