🇬🇧@COVID19Up: There seems to be a world of difference in outlook between the United States and Great Britain when it comes to the question of vaccinating children against COVID.
On Friday, the British government’s independent vaccine body announced it would not recommend vaccinating all 12-15 year olds with a COVID vaccine. “For the vast majority of children,” the Joint Committee on Vaccination and Immunisation (JCVI) noted in a press release, “SARS-CoV 2 infection is asymptomatic or mildly symptomatic and will resolve without treatment. Of the very few children aged 12 to 15 years who require hospitalization, the majority have underlying health conditions.” However, the JCVI decision may effectively be reversed in a few days by other British health officials.
Meanwhile, in the US, where the COVID vaccine is already approved for children as young as 12, the Pfizer COVID vaccine may be approved for children aged 5 to 11 by November or mid-December of this year, according to former FDA head Dr. Scott Gottlieb, who now serves on Pfizer’s board of directors. And their vaccine for children aged 2 to 5 is also moving forward, about two months behind the 5 to11 vaccine in its development.
Great Britain’s JCVI said it concluded that “the health benefits from vaccination are marginally greater than potential known harms. However, the margin of benefit is considered too small to support universal vaccination of healthy 12 to 15 year olds at this time.”
“There is evidence of an association between mRNA COVID-19 vaccines and myocarditis,” the JCVI noted. While it termed it “an extremely rare adverse event,” it also noted that “The medium-to-long term effects are unknown and long-term follow-up is being conducted.”
As noted by Sky News, Professor Adam Finn, a member of the JCVI, said the group’s decision was based on a “risk-benefit balance” which considered that there have been a “very small number of deaths in this age group from COVID”.
Finn said, “Although the vaccine works and would be beneficial in the sense of preventing infection and some severe disease from COVID, there are significant uncertainties around the safety of the vaccine that have not yet been clarified such that we can’t be sure that the risk-benefit balance is sufficiently good in favour and to the benefit of those children to recommend it.”
However, the UK’s four chief medical officers are going to review the JCVI’s position and make their own final decision, according to British press reports. So the possibility remains that in the next several days, the JCVI’s policy recommendations could be ignored and the vaccine could be approved for wide distribution among children younger than 16 in the United Kingdom.
The JCVI had previously recommended vaccines for all children aged 16-17 in the United Kingdom, but limited the jab among those aged 12-15 to those with special medical conditions thought to make them more vulnerable to COVID.
Pfizer’s Gottlieb discussed on the business cable network CNBC on August 30th how the vaccine for children aged 5 to 11 is exactly the same formulation as the one for adults, only at a lower dosage of 10 micrograms, while the adult version has a 30 microgram dose.
“So it’s effectively the same exact vaccine being used in adults, but just one-third of the dose,” said Gottlieb. “
“And so, you know, there is some ability to look at the data you have available in adults and translate that into some assumptions around how it behaves in children. Although we assume, from a regulatory standpoint, that kids under the age of 12 behave differently. The biology’s differently (sic), and that’s why you want to see separate data and that’s why you reformulate these products for a younger child, because you can’t have the expectation that a product that works in adults in one way is going to work in children in the same fashion.”
Except that seems to be exactly what Pfizer is doing, “assuming that a product that works in adults in one way is going to work in children in the same fashion.”
Gottlieb said the November-December dates for approval are “sort of an optimized scenario if everything goes right and this is an accelerated review like the other applications have been.”
But he cautioned his CNBC audience, “It could be the case that the FDA decides to wait for longer follow-up on the children in the clinical trials so that you get a longer-term view of how they perform over time, a three- to six-month follow-up, median follow-up of the kids in the clinical trial. And they’ve made some indication that they would wait a longer period of time to follow those children.”
So the FDA could wait as long as THREE to SIX MONTHS to uncover any and all long-term adverse events that might be seen in children aged 5 to 11 taking the vaccination.
It’s worth noting that it takes 4.2 years for a serious safety signal from a new drug to be detected, according to a 2017 investigation published in the Journal of the American Medical Association.
This study also found that serious safety issues were more likely to be found among drugs that received “accelerated approval.” As noted above, “an accelerated review” is what Dr. Gottlieb is hoping for in his “optimized scenario,” wherein the FDA would NOT wait those additional 3-6 months to uncover any possible safety concerns before releasing the vaccine for wide use.