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A Wall Street Journal (WSJ) editorial board member Monday called into question the motives behind the U.S. Food and Drug Administration’s (FDA) decision to extend Emergency Use Authorization of Pfizer and Moderna’s COVID-19 vaccines to toddlers and infants as young as 6 months old, writing that the decision was motivated by politics and pressure rather than science.
In her WSJ opinion piece — “Why the Rush for Toddler Vaccines?” — Allysia Finley wrote:
“The FDA standard for approving vaccines in otherwise healthy people, especially children, is supposed to be higher than for drugs that treat the sick.
“But the FDA conspicuously lowered its standards to approve COVID vaccines for toddlers. Why?”
Finley started her piece with a quote from President Biden, which praised the FDA’s recommendation: “This is a very historic milestone. The United States is now the first country in the world to offer safe and effective COVID-19 vaccines for children as young as six months old.”
She responded, writing, “In fact, we don’t know if the vaccines are safe and effective.”
“The rushed FDA action was based on extremely weak evidence. It’s one thing to show regulatory flexibility during an emergency. But for children, Covid isn’t an emergency.
“The FDA bent its standards to an unusual degree and brushed aside troubling evidence that warrants more investigation.”
“Mr. Biden’s hypocrisy is hard to stomach,” she wrote, listing many reasons for caution in vaccinating young children against COVID-19, including:
- Children are at low risk of dying from COVID-19: Only 209 kids between 6 months and 4 years old have died from COVID-19 — about 0.02% of all virus deaths in the U.S. About half as many toddlers were hospitalized with COVID-19 between October 2020 and September 2021 as were hospitalized with the flu during the previous winter.
- The two children in Pfizer’s trial who got sickest with COVID-19 also tested positive for other viruses. It’s possible that many hospitalizations attributed to COVID-19 this winter were instigated or exacerbated by other viruses.
- The FDA authorized vaccines for toddlers based on a comparison of the antibodies they generated to the original Wuhan variant with those in young adults who had received two doses. But two doses offer little if any protection against Omicron infection in adults, and even protection against hospitalization is only around 40% to 60%.
- Vaccinated toddlers in Pfizer’s trial were more likely to get severely ill with COVID-19 than those who received a placebo. Most children who developed multiple infections during the trial were vaccinated.
“FDA granted the Pfizer and Moderna vaccines for toddlers an emergency-use authorization allowing the agency to expedite access for products that ‘prevent serious or life-threatening diseases or conditions,’” wrote Finley.
“While adult COVID vaccines clearly met this standard in late 2020, the toddler vaccines don’t.”
As to why the FDA “rushed” and “bent its standards,” Finley suggested, “perhaps [the FDA] felt pressure from the White House as well as anxious parents.”
White House COVID-19 response coordinator Ashish Jha repeatedly told parents that he expected vaccines for toddlers would be available in June, she wrote.