WASHINGTON: Pfizer announced Monday that its COVID-19 vaccine for children ages 5 to 11 elicited a robust and safe response in clinical trials. The pharmaceutical company said it would seek emergency use authorization (EUA) for the vaccine from the Food and Drug Administration. The EUA could be granted in a matter of weeks, which would give kids who have returned to school some degree of protection against the highly contagious Delta variant that is running rampant across America.
According to CNN, the dose for the children’s vaccine is different from that formulated for adults and teens. Clinical trials introduced varying doses and found that kids elicited a strong response to lower doses.
In the clinical trial that included more than 2,200 children, a 10-microgram dose of the vaccine given three weeks apart produced a high level of antibodies. The antibody level was comparable to the amount generated in older children who received the higher 30-microgram dose. That’s why researchers zeroed in on a 10-microgram dose for this age group, rather than the 30-microgram dose prescribed for adults and teens.
For the youngest children ― those under the age of 5 ― doctors are testing a 3-microgram dose.
Dr. Robert Frenck, a pediatric infectious disease expert affiliated with the Cincinnati Children’s Hospital Medical Center who leads vaccine trials said that the lower dose minimizes side effects, and the Pfizer drug appears to be very safe at this point.
“What we found is that the side effects in the children really mirrored exactly what we found in adults,” he told CNN. “So, the most common thing is pain at the injection site. Also having headache, and maybe fatigue. Fevers and chills were unusual — only around 10 to 11% of the children having those. Similar to the adults, or identical to the adults, is that side effects lasted a day or two and then people were back to normal.”
Frenck also commented on the reports of myocarditis in both Pfizer and Moderna vaccines.
“And so the myocarditis — which means swelling of the muscles of the heart — we have seen that as a rare side effect…,” he said. Adding that “rare” means there is a 99.9% chance myocarditis won’t happen. So far, it has been noted primarily in teenage boys who were successfully treated with Motrin. Clinical trials of children also did not encounter any cases of blood clotting, which appeared among mostly older women who got the Johnson & Johnson jab.
Frenck said it’s fine to combine the flu shot with the COVID-19 vaccine. It’s also safe for teenagers to get their meningococcal vaccine, HPV vaccine, or the TDaP (tetanus, diphtheria and pertussis), or whooping cough, vaccine at the same time, Frenck said.
Moderna has finished the enrollment of 6 to11-year-olds for its clinical trials, said Frenck, and is currently reviewing the data to evaluate the dosage of its vaccine. The adult dosage of the Moderna shot is 100 micrograms, says CNN.
Frenck said that vaccinating children will have a significant impact on controlling the pandemic. Although children under the age of 18 make up only 20% of the U.S. population, they now account for 30% of new COVID-19 cases.
He noted that while most children experience mild cases of COVID-19, they can become seriously ill and so far, 548 children have died from the disease.