FDA endorses Moderna, Pfizer vaccines for infants

FILE - A vial of the Moderna COVID-19 vaccine is displayed on a counter at a pharmacy in Portland, Ore. on Dec. 27, 2021. A government advisory panel met Tuesday, June 14, 2022, to decide whether to recommend a second brand of COVID-19 vaccine for school-age children and teens. The Food and Drug Administration's outside experts will vote on whether Moderna's vaccine is safe and effective enough to give kids ages 6 to 17. If the panel endorses the shot and the FDA agrees, it would become the second option for those children, joining Pfizer's vaccine.(AP Photo/Jenny Kane, File)

FILE – A vial of the Moderna COVID-19 vaccine is displayed on a counter at a pharmacy in Portland, Ore. on Dec. 27, 2021. (AP Photo/Jenny Kane, File)

UPDATED 10:01 AM PT – Thursday, June 16, 2022

Moderna plans to study its COVID-19 vaccine in infants as young as 3-months-old. The biotech company announced Wednesday that it will enroll as many as 700 babies in their experiment, dubbed Baby Cove, in September. The babies will reportedly receive two doses of Moderna’s vaccine within an eight-week period.

The announcement comes as the FDA declared Moderna and Pfizer’s vaccines to be safe and effective for children 6-months to 6-years-old, which means this is one step closer to full FDA authorization. During a Wednesday hearing, an FDA committee unanimously endorsed both vaccines after a testimony from a panel of medical experts and representatives from both companies.

“I do believe the benefits far outweigh the risks that were involved and personally, I really do believe this recommendation does fill a significant unmet need for a really ignored younger population in need of options,” said Dr. Michael Nelson, an FDA committee member. “Families will now have a choice that they did not have before, and I fully believe in the intelligence of families to make the right choice for their family and children.”

The committee endorsed the Moderna and Pfizer vaccines while citing a recent report from the CDC, purportedly showing an increase in COVID deaths amongst infants and young children.

“Unfortunately, infants and young children can and do die with COVID,” said Dr. Evan Anderson of the Emory School of Medicine. “As of June 2, more than 440 infants and young children aged zero through four have died with COVID as documented by CDC. This is a tremendous burden of disease.”

The hearing ended with the committee expressing concerns about “vaccine hesitancy” due to reports about adverse side effects such as paralysis tied to COVID-19 vaccines. Other adverse symptoms include swollen lymph nodes, appendicitis and herpes.

“I have a lot of concern that many of these kids will not get the third dose,” expressed Dr. Jeannette Lee, another FDA committee member. “As we know, it’s a struggle to get people in for two. We’ve already seen with the boosters for adults, lots of people don’t take them. And so my concern is that you have to give them three doses to really get what you need. I’m just concerned that that some won’t.”

The decision is now in the hands of CDC advisers who will vote on Saturday whether to sign-off on authorizing both vaccines. If authorized, the vaccines could be made available for young children as soon as next week.

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Amber Coakley
Author: Amber Coakley

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