Food and Drug Administration staffers said Pfizer's and Moderna's pediatric Covid vaccines are safe and effective, but both vaccine stocks toppled Monday.
The analysis comes ahead of a key meeting Tuesday and Wednesday in which a panel of advisors to the FDA will weigh the merits and risks of vaccinating children as young as 6 months against Covid. Pfizer and BioNTech hope to vaccinate children under 5. Moderna tested its shot in children 17 and under.
After the advisory committee meeting, the full FDA will decide on the matter. If the agency authorizes one or both vaccines, the Centers for Disease Control and Prevention will have the chance to tweak its guidance on administering the shots.
But on today's stock market, both vaccine stocks skidded, reflecting a broad dive in the market amid inflation worries. Pfizer shares fell 4.1% to 47.91 and BioNTech stock fell 7.1% to 133.62. Moderna stock tumbled 7.9% to 117.13.
Vaccine Stocks: Inoculating Young Children
In the briefing documents, FDA staffers said the Pfizer-BioNTech vaccine was as effective in children younger than age 5 as it was in people age 16-25. The companies tested three doses at one-tenth the size of the vaccine given to older children and adults.
Overall, the vaccine proved more than 80% effective at preventing symptomatic Covid. It was 75.6% protective in children 6-23 months and 82.4% protective for older toddlers.
Moderna tested a two-shot approach at one-quarter the dosage given to adults. It was 36.8% effective in children under the age of 2. In children 2-5 years old, the regimen was 50.6% protective. Moderna noted it tested the vaccine while the omicron variant was dominant.
But in both cases — and bearishly for vaccine stocks — the FDA said the data wasn't enough to make a decision on the overall effectiveness of the jabs. Still, the agency lent its support to vaccinating young children, the last group in the U.S. to become eligible for Covid shots.
"Given the uncertainty of the Covid-19 pandemic and likelihood of continued (viral) transmission during the ensuing 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 FDA said in its Pfizer-BioNTech briefing.
Parents Might Not Be On Board
FDA authorization doesn't guarantee parents will get on board, however.
In the June IBD/TIPP Poll, 27% of respondents said they had children or grandchildren under the age of 5. Slightly more than half, 51%, said they were comfortable vaccinating young children.
The FDA didn't note any new safety issues in the briefing documents. But the number of children tested was so small, it would be hard to detect the rarest side effects, the FDA said.
Both vaccine stocks have trended sideways this year following massive gains in 2020-21.
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
