The CDC Pushes to Vaccinate Toddlers, Again Its decision to include Covid-19 shots in children’s schedules is based on far-too-flimsy evidence. Allysia Finley hedcut By Allysia Finley

https://www.wsj.com/articles/the-cdc-pushes-to-vaccinate-toddlers-again-advisory-committee-children-schedule-covid-19-fda-risks-shot-evidence-public-health-11666529146?mod=opinion_lead_pos7

Is the Centers for Disease Control and Prevention trying to give vaccine skeptics a shot in the arm? That’s the message its Advisory Committee on Immunization Practices sent last week with its vote to add Covid-19 vaccines to childhood vaccination schedules.

Food and Drug Administration Commissioner Robert Califf stressed that the CDC isn’t mandating vaccines for kids. “Mandates are not the remit of either CDC or FDA,” he tweeted on Oct. 19. Didn’t the CDC argue the opposite in court when defending its mask requirement for public transportation?

It’s true that states and localities don’t have to follow the CDC’s recommendations when deciding which shots kids must receive to attend daycare and school, but they usually do. One CDC panelist said the vote was merely symbolic. But symbolism matters.

Why else did face masks become so controversial? Given the scant evidence supporting widespread use of nonmedical-grade masks, many conservatives perceived masking as another instance of liberals imposing scientifically baseless rituals on nonadherent Americans. The same is now true with vaccinating children.

Most conservatives don’t oppose vaccines per se. But never before has the CDC recommended, or the FDA authorized, a vaccine for children based on such thin evidence of benefits and lack of clarity on potential risks.

It’s generally accepted that kids are at much lower risk for severe Covid than adults. One study, released earlier this month, estimated that only 3 of every million kids who have been infected with Covid have died from it. Children also are much less likely to get severely sick with Covid than with some other bugs.

In Moderna’s toddler trial, no child in either the placebo or vaccine group was hospitalized with Covid, but at least 15 were for other infections including RSV, adenovirus, rhinovirus, metapneumovirus and Epstein-Barr. The two toddlers in Pfizer’s trial who were most severely ill with Covid also tested positive for other viruses, which probably exacerbated their infections.

The FDA authorized the vaccines for children primarily based on an “immunogenicity” analysis comparing their antibody levels with those of adults who received the shots. But antibodies are only one component of immunity, and the immune systems of children and adults differ in important ways. Children have stronger “innate” immune responses, which essentially carpet-bomb germs. On the other hand, children’s adaptive immunity, which operates more like tactical-weapon systems, is less developed. Children may not require the same level of antibodies to achieve the same protection as adults.

 

Normally, the FDA requires vaccines to be tested in randomized controlled trials with tens of thousands of people before approval, as it did with the original Covid vaccines for adults. Large-scale trials can help public-health authorities determine whether the benefits of vaccines outweigh the risks. But the trials on children were too small to draw conclusions.

It’s true that most kids who received vaccines in the trials didn’t experience much worse than a swollen arm, fatigue, headache or low-grade fever. On the other hand, most kids who catch Covid don’t either.

Yet some children who were vaccinated in the trials did suffer worse symptoms. About 0.8% of adolescents who received the Pfizer vaccines developed swollen lymph nodes—four times the rate in the placebo group. Then there’s the case of 12-year-old Maddie de Garay, whose second dose immediately preceded a cascade of ailments that has left her wheelchair-bound.

Twelve hours after her second dose, Maddie began to develop severe stomach pain, sensations of electric shocks down her spine, and chest pain, her mother Stephanie reported to the FDA. Maddie later developed mysterious rashes, blood in her urine, dizziness, convulsions, tinnitus, memory loss, extreme fatigue and eventually the loss of feeling from her waist down, among other debilitating conditions that hospitalized her for 64 days.

A New England Journal of Medicine write-up on the Pfizer trial, however, reported “there were no vaccine-related serious adverse events and few overall severe adverse events.” The FDA emergency-use authorization for Pfizer’s vaccines for adolescents pithily noted that one trial participant reported “generalized neuralgia” and was diagnosed with “functional abdominal pain.” That’s all?

Pfizer says it and the vaccine clinical-trial investigator “each independently evaluated this case and concluded that it isn’t related to the Pfizer-BioNTech COVID-19 vaccine. The information about the case was shared with health authorities.” The FDA didn’t respond to request for comment.

It’s impossible to conclude with any certainty whether the vaccine caused Maddie’s maladies. But it doesn’t help the credibility of public-health authorities to whitewash her case.

One reason many conservatives don’t trust Covid-19 vaccines is because they don’t trust public-health authorities. And for good reason. Since the beginning of the pandemic, these experts and officials have repeatedly shown a lack of candor and respect for the intelligence of ordinary Americans. They don’t trust Americans, and the feeling is mutual.

Adding the Covid-19 shot to the children’s vaccine schedule based on flimsy evidence risks inciting a backlash against vaccines in general. Haven’t the government scientists learned that every political action has an equal and opposite reaction?

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