FDA Says Pfizer-BioNTech Covid-19 Vaccine Safe And Effective For Children Under 5
Staff for the US Food and Drug Administration (FDA), said on Sunday that the Covid-19 vaccine made by Pfizer and BioNTech is safe and effective for children under the age of 5. Staff members said the vaccine is effective in producing a virus-blocking response without any major safety concerns, now the results will be studied by a group of independent advisers for the FDA.
Independent experts working for the agency will review a request for emergency use authorization for the vaccine in children under the age of 5. The group will also review a similar request from Moderna for the use of their vaccine for children under the age of 6.
After the advisers make their recommendations, the FDA will then decide whether or not to follow the panel’s advice, which it likely will. If the agency approves, and the Centers for Disease Control and Prevention (CDC) do the same, the vaccines could be available for young children and infants as soon as the beginning of next week.
According to the FDA, “overall preliminary data indicated the vaccine was 80.4% effective in preventing symptomatic covid-19. The rate was 75.6% for babies and toddlers six to 23 months old, and 82.4% for children 2-to-4-years-old.
It’s still too soon, however, to reach definitive conclusions on the vaccine’s effectiveness.”
“Side effects were minimal and included irritability and drowsiness for children 6-to-23-months-old, and pain at the injection site and fatigue for children 2 to 4. Babies and children younger than 5 — a group numbering 19 million — remain the only age group in the United States not yet eligible for a coronavirus vaccine.”
The FDA also emphasized with these findings that they believe vaccines for the youngest group of Americans are critical for navigating the rest of the pandemic.
“Given the uncertainty of the pandemic and likely continued virus transmission in coming months, deployment of the vaccine for use among children 6 months through 4 years of age will likely have a beneficial effect on COVID-19 associated morbidity and mortality in this age group,” the agency said.
Assuming that both Pfizer and Moderna receive an emergency use authorization, most children will likely be able to receive their shots at their pediatricians office, however, many states and communities are already gearing up to set up vaccine clinics and make the shots available throughout local pharmacies.
Sallie Permar, an expert in pediatric vaccines, said that her facility will offer both vaccine options to ideally make it easier for the parents to choose what they want their child to receive.
“While there may be some confusion over the difference between the two vaccines, offering both gives you more flexibility. Parents can weigh all the information and decide,” she explained.
Eric Mastrota is a Contributing Editor at The National Digest based in New York. A graduate of SUNY New Paltz, he reports on world news, culture, and lifestyle. You can reach him at eric.mastrota@thenationaldigest.com.
