An expert panel on Wednesday recommended that Pfizer’s Covid-19 vaccine be offered to adolescents between the ages of 12 and 15, opening the door to vaccinating this age group in coming weeks — and before the start of the next school year.
The Advisory Committee on Immunization Practices voted 14 to 0 in support of the recommendation, making the Pfizer vaccine the first to be offered to children under the age of 16. (One member recused herself because she had conducted clinical trials on Covid vaccines.) Other vaccine manufacturers are conducting studies in children as well and are expected to seek authorizations when they complete the work.
The committee advises the Centers for Disease Control and Prevention on vaccine policy. CDC Director Rochelle Walensky adopted the recommendation later Wednesday, clearing the way for vaccine clinics to begin to vaccinate 12-to-15-year-olds.
“This is another way to get closer to ending this horrible pandemic,” said Camille Kotton, a transplant medicine specialist from Massachusetts General Hospital who is on the committee.
The company also applauded the decision.
“Adolescents make up a significant portion of the total global population and can develop Covid-19 disease, which can sometimes be severe, and can spread the virus to others,” said Bill Gruber, Pfizer senior vice president of vaccine clinical research and development. “The decisions from health authorities this week bring us one step closer to protecting adolescents and achieving herd protection.”
Members of the committee’s Covid vaccine work group presented data on the disease burden American children have faced in the pandemic, saying an estimated 22.2 million aged 5 to 17 have contracted Covid and 127 children have died. CDC epidemiologist Sara Oliver noted that while that number appears low, with that many deaths Covid would have ranked in the top 10 causes of death among children in 2019, the last year for which cause of death data are available.
Oliver also reported that more children aged 12 to 17 were hospitalized for Covid than were hospitalized with H1N1 flu during that 2009 pandemic, or were hospitalized with flu in the past three flu seasons. The work group looking at the issue concluded Covid infection in adolescents was of sufficient public health importance that vaccination of this group is warranted.
Data presented to the committee suggested the vaccine is protective in this age group, which generated higher antibody levels than people aged 16 to 25 who were also given the vaccine. In a trial of 2,260 adolescents, there were 18 confirmed Covid infections among children in the placebo arm of the trial, and none among those who received vaccine.
The vaccine was, however, quite reactogenic, meaning many of the children who received it reported some side effects — though they were mostly mild. Nearly 20% reported having fever after the second dose, and in one case, a child experienced a high fever, 104.7 Fahrenheit — the only so-called Grade 4 side effect reported in the trial. Grade 4 side effects are considered very serious and require medical care.
The most common side effects were injection site pain, fatigue, and headache, with 91% of vaccine recipients in the study reporting that constellation of symptoms, though they resolved within a day or two. A small number of the vaccine recipients developed lymphadenopathy — swelling of lymph nodes — after vaccination that was deemed to have been caused by the vaccine. No other unusual side effects were seen to be linked to receipt of the vaccine, the committee was told.
During the meeting, the CDC revealed it was waiving the recommendation that people not receive another vaccine within two weeks — either side — of getting a Covid-19 shot. The new policy would allow adolescents and adults, many of whom have fallen behind in getting regular vaccinations during the pandemic, to catch up when they get their Covid shots.
CDC staff explained the original recommendation was made out of an abundance of caution, not because there was evidence to suggest getting a Covid shot at the same time as other vaccines would be unsafe or would erode the efficacy of any of the vaccines.
But a number of members of the committee expressed concern about the idea, given the newness of the Covid vaccines and the lack of clinical trials to date to see if co-administration would have any impact on the amount of protection generated by the vaccines. Several pointed in particular to concerns about administering at the same time vaccines that are known to be reactogenic — likely to induce side effects in a fair percentage of people who receive them. Sandra Fryhofer, a nonvoting member of the committee who represents the American Medical Association, worried in particular that getting shingles vaccine and Covid vaccine at the same time could be unpleasant.
“I’m concerned about a double whammy of side effects,” she said.
The CDC staff amended the language of the recommendation to note that it is not known if reactogenicity would be increased by coadministration of vaccine and vaccine providers could consider that issue when recommending whether a person should be offered two or more vaccines at the same time.
This article has been updated to reflect the fact that the CDC director adopted the committee’s recommendation.
Let’s all hope that this vaccine is as safe in children as it has been in older adults. It’s a shame that the FDA does not appear to have utilized all of the available safety data, in particular from the two Pfizer-supported large population studies conducted in Israel and published in the New England Journal of Medicine and the Lancet. These studies disturbingly reported only effectiveness estimates, and not safety estimates. In particular, the two-dose regimen allows comparison of the rates of rare adverse effects between the three weeks after the first dose and the three weeks after the second dose. Significantly different rates would not be expected in the same people if the vaccine is not responsible. For example, 90% of myocarditis cases reported in Israel after the Pfizer vaccine occurred after the second dose, according to a leaked report from the Israel Ministry of Health, and the cases were almost entirely in those under 30 (https://www.timesofisrael.com/israel-said-probing-link-between-pfizer-shot-and-heart-problem-in-men-under-30/).
This sort of analysis would obviate the need to estimate the VAERS reporting rates and background rates. It’s not clear to me why the FDA didn’t require this analysis. If anybody has a good explanation, please share it.
Not mentioned in this STAT article was the very low confidence the Pfizer data on adverse events in adolescents demonstrated. This is as shown by the lowest GRADE rating on whether the data addressed the outcome. Despite the adolescent trial being very underpowered and having very low safety certainty by GRADES criteria the CDC ACIP approved the use of the vaccine. Nothing in the Pfizer data confers safety. That will be determined once low risk adolescents start getting the vaccine. So if the CDC ACIP along with the FDA allows a vaccine that is not proven safe by its manufacturer biased trial data to be widely administered who is running the show here? STAT needs to dive deeper into this because this is not science nor is it evidence based medicine.
100x more likely to get a serious reaction from the vaccine than from COVID itself. No long term studies on impact to these kids but sure go ahead and pump them up!
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