COVID: FDA expert panel blesses vaccine for kids 5-11

A panel of medical experts advising the U.S. Food and Drug Administration concluded Tuesday that the benefits of vaccinating 5-11 year-old children with Pfizer’s COVID-19 vaccine at a third of the dosage given teens and adults outweighs the risks of rare but potentially dangerous side effects like heart inflammation.

The FDA’s Vaccines and Related Biological Products Advisory Committee’s decision is a key step in authorizing the shots for elementary school-aged children. Its recommendations aren’t binding but are typically followed by the FDA. The Centers for Disease Control and Prevention’s advisory committee is expected to consider the matter Nov. 2-3 and authorization could follow soon after.

“Our hospital has been full for the last month or so with children who’ve been been critically ill — not all of them have COVID but many of them do, we had a lot of them in the intensive care unit,” said panelist Dr. Jay Portnoy, pediatrics professor at Children’s Mercy Hospital in Kansas City, Missouri. “I’m looking forward to being able to actually do something to prevent that.”

Seventeen of the panel’s 18 voting members concluded the benefits of the shots for children outweigh the risks. Dr. Michael Kurilla, a director at the National Institutes of Health, abstained. He questioned whether the estimated 40% of children in that age group who’ve recovered from COVID-19 would benefit from the two-dose vaccine, and said he resented the voting question preventing a more limited approval.

“It’s likely one dose at best is probably more than sufficient for them,” Kurilla said.

The vote was eagerly anticipated by many parents worried about their kids getting COVID-19. Belinda Macauley of Thousand Oaks said she hasn’t been able to take her 8-year-old daughter out to movies or restaurants because of the risk of COVID-19.

“My daughter will get it the first day it’s authorized,” Macauley told the committee during the online hearing. “We welcome the additional protection of the vaccine to help her and other kids regain a more normal life.”

But others with concerns about the vaccines’ risks greeted their authorization for kids with apprehension, fearing their kids will be forced to get the shots to attend schools. Gov. Gavin Newsom earlier this month said California will add COVID-19 to the list of illnesses California school children are required to be vaccinated against after they receive full FDA approval.

Several California school districts, including Oakland, Hayward, Piedmont and West Contra Costa Unified in the Bay Area and Los Angeles and Culver City already are moving to require pupils to have the shots this fall.

Amy Alvo of Ontario, Calif., said her healthy, athletic 17-year-old daughter had an adverse reaction to a single dose of the Pfizer vaccine in March, and was hospitalized with a neurological reaction to the shot the next day after feeling faint. Her right arm continues to shake uncontrollably, doctors have no answers and Alvo said her daughter’s school denied her a medical exemption and is requiring her to have the second shot.

“California is now mandating the vaccine and Abby’s school is requiring her to be fully vaccinated by November,” Alvo said. “I failed my daughter in allowing her to get this vaccine now she has neurological damage. Don’t allow the same thing to happen to other children.”

Pfizer’s vaccine is the most widely used in the U.S. — more than 105 million Americans have been fully vaccinated with two shots of it, compared with almost 70 million with the similar two-dose Moderna and 15 million of the single-dose Johnson & Johnson vaccine.

Pfizer’s is the only COVID-19 vaccine the FDA has allowed for children under 18, and the only one the FDA fully approved for those 16 and older. It is available under emergency use authorization, an expedited safety and efficacy review, for kids 12-15. Pfizer is seeking to expand that authorization to children 5-11, but at a third of the dosage given adolescents and adults.

Dr. William C. Gruber, Pfizer’s senior vice president of vaccine clinical research, said the drug maker’s trials in kids 5-11 found the dosage 90.7% effective in preventing COVID-19 in participants, with no reported incidences of heart inflammation or allergic reaction.

“We think we have optimized the immune response and minimized the reactions,” Gruber said.

Children 5-11 years of age have accounted for approximately 8.7% of reported COVID-19 cases in the U.S. overall and currently account for approximately 39% of all pediatric COVID-19 cases, one of the highest of any age group. Of the 722,000 U.S. COVID-19 deaths, 146 were kids 5-11, the FDA said. About 4,300 kids under 18 have been hospitalized for COVID-19, about a third were otherwise healthy.

Federal health authorities haven’t confirmed any deaths in any age group due to the Pfizer vaccine. Isolated tragedies, such as the sudden death of a 13-year-old Michigan boy in June just days after his second shot, remain inconclusive — the Saginaw County Health Department said Tuesday there’s been no determination of his cause of death yet.

The committee was asked to weigh whether the risks from the vaccine, however rare, outweigh those from COVID-19, given they are least likely to suffer severe disease from the virus, whose victims are overwhelmingly elderly, but are still sometimes hospitalized and killed by it.

That question, panelists said, isn’t easy to answer. COVID-19 can lead to a host of complications even in children, including heart inflammation. The FDA presented analyses of risk and benefit that showed the benefit outweighed risk when COVID-19 was prevalent, but not when virus transmission was low. Panelists noted there’s no way to predict how prevalent the virus will be in the future.

“I do believe children at highest risk do need to be vaccinated,” said Dr. James Hildreth, president of Meharry Medical College in Nashville. “But vaccinating all the children is a bit tough for me.”