“This is a very historic milestone, a monumental step forward“, the president declared last week Joe Biden after the Food and Drug Administration approved Pfizer and Moderna vaccines for toddlers. “The United States is now the first country in the world to offer safe and effective Covid-19 vaccines for babies as young as 6 months“. In fact, we do not know if vaccines are safe and effective. The FDA’s hasty action was based on extremely weak evidence. One thing is to show regulatory flexibility during an emergency. But for children, Covid is not an emergency. The FDA has bent its standards to a. unusual level and disregarded the worrying evidence that warrants further investigation.
As originally done for adults, the FDA has granted Pfizer and Moderna vaccines to young children an emergency use permit that allows the agency to speed up access to products that “prevent serious or life-threatening diseases or conditionsWhile Covid vaccines for adults clearly met this standard by the end of 2020, vaccines for young children do not.
Only 209 children between the ages of 6 months and 4 years have died from Covid: about 0.02% of all deaths from the virus in the United States. About half of the young children were hospitalized with Covid between October 2020 and September 2021 compared to those hospitalized with influenza. during the previous winter. More children were hospitalized during the Omicron wave last winter, but hospitalization rates were still roughly in line with the 2019-2020 flu season. None of the approximately 5,400 young children in Moderna’s trial have been hospitalized because of Covid. Still, at least 15 have been hospitalized for non-Covid infections.
Covid or other viruses?
The two children in the Pfizer trial who became most ill from Covid also tested positive for other viruses. It is possible that many admissions attributed to Covid this winter have actually been triggered or exacerbated by other viruses. Doctors had warned that children more “immunologically naive“They would have risked getting sick when the schools reopened and the blockade was lifted. Evidence supporting the efficacy of Moderna and Pfizer vaccines in adults, at least at the time of approval, was also much stronger. Both studies were large and robust enough to demonstrate 95% efficacy against infections with a strong degree of safety. In contrast, the FDA approved vaccines for young children based on a comparison of the antibodies they generated from the original Wuhan variant with those from young adults who received two doses. However, two doses provide little or no protection against Omicron infection in adults, and the protection against hospitalization is also only about 40% -60%.
The Moderna study showed at least a modest effect against Omicron symptomatic infection: 37% in children aged 2 to 5 years and 51% in children aged 6 months to 2 years. Pfizer claimed that their vaccine was 80% effective, but that is misleading. First, Pfizer has violated several clinical trial conventions. Its original protocol consisted of only two doses, but failed to generate the antibody levels required for FDA approval. Then Pfizer added a third dose, which the FDA generously allowed. Normally, the agency does not allow drug manufacturers to make a price correction when a process ends in failure.
Pfizer therefore plans to track at least 21 cases to establish a significant efficiency measure. By comparison, Moderna monitored more than 250 cases. Nevertheless, Pfizer suspended its data collection on April 29, the day after Moderna announced that it had submitted its application for an emergency use permit, even though only 10 cases were registered after the third dose. It’s hard not to conclude that Pfizer cut corners to avoid being beaten by Moderna. However, as a result, too few cases have been documented to measure the efficacy of the Pfizer vaccine with any degree of certainty. However, Pfizer said their vaccine was 80% effective. Modern scientists must simmer. A Pfizer spokesman says the FDA was more interested in data on “immunogenicity“Of the vaccine rather than effect among young children and will make another effect analysis after several cases have accumulated.
The most concerned vaccinated children in Pfizer’s study were more likely to become seriously ill with Covid than those given placebo. Pfizer said the most serious cases were not “clinically significant “whatever that means, but this was another reason why the FDA should have required longer follow-up before approving the vaccine.
Also of concern was the fact that most of the children who developed multiple infections during the trial were vaccinated. This warranted further studies, as experimental vaccines against other diseases sometimes increase susceptibility to infections.
Researchers also find that adults with triple vaccine previously infected with the Wuhan variant have a weaker immune response to Omicron, making them more susceptible to re-infection. This phenomenon, called “immunological imprinting“, Could explain why children who received three Pfizer injections were more likely to become re-infected.
The FDA ignored the risk that inoculating children against a variant that no longer circulates could weaken their immune response to Micron and its derivatives. There is a reason why vaccine trials usually take a decade. Some steps can be accelerated, but extensive follow-up is often required to ensure that potential side effects are not overlooked.
The FDA’s standard for approving vaccines for otherwise healthy people, especially children, should be higher than for drugs that treat the sick. But the FDA has dramatically lowered its standards for approving Covid vaccines for toddlers. Why? Maybe he felt the pressure from the White House and anxious parents. White House Covid Response Coordinator Ashish Jha he repeatedly told the parents that he expected vaccines for young children to be approved and available in June. We remember how Mr Biden accused Donald Trump of lobbying the FDA to speed up the approval of the Covid vaccine by suggesting that they may be available before the November 2020 election.
Sir. The hypocrisy of the bite is hard to digest. The FDA, to its credit, accelerated Covid treatments and vaccines when they were desperately needed. But the kids would have been better off if the FDA had spent more time making sure the vaccines were actually safe and effective, even if that meant America would not be the first.