Lucien Wiggins, 12, arrived at Tufts Children’s Hospital in an ambulance on June 7th. He had chest pain, dizziness, and high levels of protein in the blood, which could indicate an inflammation of the heart. The symptoms had started the day before, the morning after his second vaccination with the Pfizer BioNTech mRNA shot.
For Dr. Sara Ross, head of the pediatric intensive care unit at Boston Hospital, the event confirmed a doubt it had allayed: Did the country try its luck vaccinating children against Covid when the disease was relatively mild in young people? – and the skepticism about vaccines was terrifying?
“I have been practicing in the pediatric intensive care unit for nearly 15 years and have never looked at a single patient with a vaccine-related complication,” Ross told KHN. “Our safety standards seem to be different for all other vaccines we children expose.”
Of course, cases of myocarditis like Lucien’s were rare and the side effects reported, although sometimes severe, generally resolve with pain relievers and sometimes with infusions of antibodies. And Covid infection itself is far more likely to cause myocarditis than a vaccine, even in younger people.
Lucien went home after two days of intravenous ibuprofen infusion in the intensive care unit. Most of the approximately 800 cases of heart problems of all ages reported to a state vaccine safety database as of May 31, were similar. The pattern of these cases – most occurred in young men after the second Pfizer or Moderna vaccination – suggested that the disease was caused by the vaccine and was not accidental.
At a time when vaccination campaigns are waning, leading conservatives openly spreading disinformation about vaccines, and scientists fear a possible spike in cases in the fall or winter, side effects in young people are puzzling health officials.
On Friday, the Centers for Disease Control and Prevention’s Vaccine Advisory Committee will meet to discuss the possible link and whether it makes sense to change its recommendations for vaccinating teenagers with the Pfizer vaccine, which the Food and Drug administration approved last month for children aged 12 and older. Similar approval for the Moderna vaccine is pending, and both companies are conducting clinical trials testing their vaccines in children 6 months and older.
At an FDA advisory committee meeting last week, vaccine experts suggested that the agency require drug companies to conduct larger and longer clinical trials for the younger age groups. Some said the FDA shouldn’t allow younger children to be vaccinated for up to a year or two.
Interestingly, Lucien and his mother, Beth Clarke, of Rochester, New Hampshire, disagreed. Her son’s reaction was “strange,” she said, but “I’d rather he get a side effect” [that doctors] can help get as covid and possibly die. And that’s how he feels, which is more important. He thinks all of his friends should get it. “
The data on the impact of Covid on young people is a bit chaotic, but at least 300 Covid-related deaths and thousands of hospital admissions have been reported in children under 18, making Covid’s toll as big or greater than any childhood illness for which a vaccine is currently available. The American Academy of Pediatrics wants children to receive the vaccine, provided tests show that it is safe.
However, healthy people under the age of 18 have generally not experienced any major effects of Covid, and the number of serious cases in young people has decreased as more adults are vaccinated. Unlike other pathogens like the flu, children generally don’t infect older, vulnerable adults. Under the circumstances, said Dr. Cody Meissner – who was advised on Lucien’s case as head of pediatric infectious diseases at Tufts – the benefits of the Covid vaccination could not outweigh the risks for children at this point.
“We all want a pediatric vaccine, but I’m worried about the safety problem,” Meissner told members of the advisory commission last week. An Israeli study found a five to 25 fold increase in heart disease in men aged 16 to 24 who were vaccinated with the Pfizer vaccine. Most recovered within a few weeks. Two deaths occurred in vaccinated men who were apparently unrelated to the vaccine.
Young people could experience long-term consequences such as scarring, irregular heartbeat or even early heart failure from the suspected vaccine side effect, said Meissner, so it makes sense to wait until the severity of the problem becomes clearer.
“Could the disease come back this fall? For sure. But in my opinion the probability is rather low. And our first mandate is not to harm, ”he said.
Ross said the biggest pandemic threats to children who have experienced their intensive care unit are drug overdoses and mental illness caused by shutting down normal life.
“Small children are not carriers of disease, nor are they driving the spread of the epidemic,” said Ross. Finally, while everyone should be vaccinated against Covid, the use of the vaccines should not be extended to children without full safety data, she said.
The government could approve vaccination against Covid in children without immediately recommending it, noted Dr. Eric Rubin, an advisory committee member and editor-in-chief of the New England Journal of Medicine. “In September when the kids are back to school the people are inside and the vaccination rates are very low in certain parts of the country, who knows what things will be like? Maybe we want this vaccine. “
Moderna and Pfizer started testing their vaccines in younger children this summer. A Pfizer spokesman said the company expects to vaccine about 2,250 children aged 6 months to 11 years as part of its study; Moderna said it would vaccinate around 3,500 children ages 2-11.
Some members of the FDA advisory committee suggested that up to 10,000 children be included in each study. But Marion Gruber, director of the FDA’s vaccine admissions office, pointed out that even such large studies wouldn’t necessarily find a side effect as rare as what appears to be myocarditis.
At some point, federal agencies and the public will have to decide how much risk they are willing to accept from vaccines versus the risk of a Covid virus that continues to spread and mutate around the world, said Dr. Paul Offit, director of the Vaccine Education Center at Philadelphia Children’s Hospital.
“We will need a heavily vaccinated population for years or maybe decades,” Offit said at the meeting. “It’s hard to imagine that we won’t have to vaccinate children in the future.”
Ross argued that it makes more sense to selectively vaccinate children who are most at risk of developing severe Covid disease, such as obese people or diabetes. But asking questions about the vaccination program yourself can be a burdened decision, she said. While the authorities have a duty to speak openly about the safety of vaccines, they also have a responsibility not to frighten the public in ways that discourage them from seeking protection.
A 10-day hiatus in the Johnson & Johnson vaccination campaign in April while authorities investigated an association with an occasionally fatal bleeding disorder caused a sharp drop in public confidence in the vaccine, although authorities only had 28 cases on 8 by the end of May , 7 million US recipients of the vaccine. With the decreasing appetite for the Johnson & Johnson vaccine, there is a risk that millions of doses will exceed their expiration dates in refrigerators across the country.
Paying too much attention to potential harm from the Pfizer and Moderna vaccines to children could have a tragic outcome, said Dr. Saad Omer, director of the Yale Institute for Global Health and an expert on vaccination hesitation. “Very soon we could be in a situation where we really need to vaccinate this population, but it will be too late because you have already conveyed the message that we shouldn’t,” he said.
At some point, maybe next year, K-12 mandates could be called for, said Dr. Sean O’Leary, Professor of Pediatric Infectious Diseases at the University of Colorado. “So much misinformation and propaganda is being spread that people are reluctant to go there to continue drilling the hornet’s nest,” he said. But once there is robust safety data for children, “if you think about it, there is no logical or ethical reason why you shouldn’t do this.”
This story was produced by KHN, an editor of California Healthline, an editorially independent service of the California Health Care Foundation.
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