Pharmaceutical giant Pfizer admits in documents submitted to the Food and Drug Administration (FDA) that clinical trials conducted to de...
Pharmaceutical giant Pfizer admits in documents submitted to the Food and Drug Administration (FDA) that clinical trials conducted to determine long-term myocarditis risks in children are too short.
This information, which has not been made public by the company or the FDA, appears on page 11 of an FDA advisory committee briefing last October, in which Pfizer admitted its sample size of clinical trial volunteers was too small to detect myocarditis risks in children 5 to 12 years old.
The statement was buried in the briefing documents for Pfizer’s vaccine for kids under 12 years old. It reads: “The number of participants in the current clinical development program is too small to detect any potential risks of myocarditis associated with vaccination. Long-term safety of COVID-19 vaccine in participants 5 to <12 years of age will be studied in 5 post-authorization safety studies, including a 5-year follow-up study to evaluate long-term sequelae of post-vaccination myocarditis or pericarditis.”
In its overall risk-benefit conclusions, Pfizer stated that the number of participants in their current clinical development program is too small to detect any potential risks of myocarditis that is associated with vaccinations.
Despite this, the FDA still decided to issue emergency use authorization (EUA) for the Pfizer COVID-19 vaccine to be administered to children between the ages of five and eleven.
Meanwhile, the FDA delayed a similar EUA for Moderna, saying that they need to conduct a more thorough examination into the risk of myocarditis as the company’s vaccine formulation contains tromethamine – a drug that is used to treat metabolic acidosis, which usually occurs after heart bypass surgeries or cardiac arrests.
Parents question COVID vaccines for kids
Many American parents don’t plan on getting their kids vaccinated right away. The Centers for Disease Control and Prevention already extended Pfizer’s COVID vaccine eligibility to kids ages five to eleven, with other vaccines not far behind.
However, only about a third of parents with children in this age group plan on vaccinating their kids right away.
Their hesitation is understandable. Dr. Lee Savio Beers, president of the American Academy of Pediatrics said: “As parents, it’s our job to understand the health decisions that we’re making for our kids. There’s quite a bit of [Covid vaccine] information out there – much of it misinformation – which can be a little hard to filter through.”
COVID impacts children less than adults, and when they do get infected, they experience only very mild symptoms or none at all. Many parents also expressed their concern about the speed at which the vaccines were developed and the processes that were used to monitor their progress.
Kids will generally experience adverse effects from COVID vaccines similar to teens and adults, but with less severity, according to the FDA. This means that children may experience pain at the injection site, fatigue or headaches after their second dose, but they are less likely to get knocked out from the side effects.
Pfizer’s vaccines have a lower dosage for young children, with as little as 10 micrograms for kids ages five to 11 as opposed to the 30 micrograms for adults. The company found that at this dose, they get high levels of antivirus protection and low levels of side effects in younger children.
Still, parents should be concerned about the long-term side effects of COVID vaccines on their kids. While a report from the FDA found zero deaths or significant adverse events in Pfizer’s early vaccine trials for kids, the fact that the company admitted it needs more time to study the vaccine’s effects in kids is concerning.
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