FDA deciding on Pfizer, Moderna vaccines for children under 5

WASHINGTON – The Food and Drug Administration is meeting Wednesday to decide whether the Pfizer and Moderna vaccines should be approved for children under 5. 

As CBS2’s Natalie Duddridge reports, if approved, kids could get shots as early as next week. 

Parents of some of the youngest Americans – preschoolers, toddlers and babies – have been eagerly awaiting vaccine authorization for kids 6 months to 5 years old. 

“At least we know that something could protect us. We both had COVID before,” one mother said. “Especially since they lifted the mask put it back again. It keeps going back and forth.” 

“We’re here today requesting emergency use authorization,” said Carla Vinaia of Moderna. 

An FDA panel heard virtually from Moderna and Pfizer researchers Wednesday morning. 

“Totality of evidence supports benefits of mRNA in infants toddlers and young children outweigh potential risks,” Vinaia said. 

The panel looked at many factors, including the rate of hospitalization and death in children. 

“Beginning with Delta wave, then Omicron wave, we have seen substantial increase in number of infections among these children,” said Dr. Evan Anderson, a professor of pediatrics and medicine. 

One person told the panel there have been 442 deaths in children under 4 attributed to COVID as of May 28. By way of comparison, the H1N1 outbreak in 2009-2010, there were 78 deaths. 

Preliminary data shows Pfizer is more than 80% effective in preventing symptomatic infection with no side effects, while data shows Moderna’s vaccine is 51 percent effective in preventing illness in children between six months and 2, and 37% effective in 2-5 year olds. 

The vaccination includes a primary series of two doses. Health officials also reviewed dosage suggestions. The Pfizer vaccine for children aged 6 months to 4 is one tenth the strength of the adult version. It would require three doses. 

Moderna’s vaccine for 6 months-5 year olds has a higher concentration of mRNA vaccine, and would require two shots. 

It’s unclear how much demand there is for this youngest age group. Only 29% of children under 12 have been vaccinated since they became eligible for Pfizer’s shot in November. 

“Only if their families desire it, but not mandated to go to any events,” said father Chien Kwok. “You can see that parents, when given a free choice, determines it’s very low percentage.” 

Tuesday, the FDA voted to grant emergency use authorization for Moderna’s vaccine for children 6-17

If the under 5 group is authorized, the White House says it has a plan to make vaccines available next week starting June 21. 

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