Food and Drug Administration advisors unanimously recommended Pfizer's and Moderna's Covid vaccines for young children on Wednesday, prodding the vaccine stocks to rise.
The Vaccines and Related Biological Products Advisory Committed voted 21-0, saying the benefits of the vaccines outweigh the risks. The full agency will now weigh the matter before deciding on the companies' applications. From there, the Centers for Disease Control and Prevention will be able to tweak its guidance on vaccine administration.
Despite the unanimous endorsements, there were split views among the panelists regarding the ultimate need to broadly vaccinate children under age 6. Panelist Dr. Paul Offit noted there have been 422 Covid deaths among children under 5 years old.
"The number of people struck by lightning each year is 270," he said. "We're talking about a very rare event. We'd be talking about vaccinating close to 20 million children to prevent 200-300 deaths. It's a matter how an individual weighs the risks and benefits."
But fellow panelist Dr. Arthur Reinhold said there are vaccines to prevent less deadly viruses.
"We nevertheless try to vaccinate a large portion of the population, if not everyone," he said.
On today's stock market, vaccine stocks jumped. Moderna stock surged 5.7% to close at 128.53. Pfizer stock rose 1.2% to finish at 48.51. Shares of Pfizer's partner BioNTech ended the regular session up 2.4% to 137.99. The three were flat to slightly up after hours.
Vaccine Stocks: Different Strategies
Now, the FDA will decide on the two vaccine regimens. Moderna's could be given to children under the age of 6. Pfizer tested its shot in children 6 months to under 5 years of age.
Both use messenger RNA technology. But Moderna tested a two-shot series at one-quarter the dose given to adults. Pfizer studied three shots at one-tenth the adult vaccine level. Moderna's vaccine was 37%-51% effective, depending on age. Preliminary, Pfizer's was 76%-82% effective. But Pfizer has yet to reach the 21 Covid cases within a week of the third shot it needs to finalize its data.
Pfizer switched tactics after its two-dose vaccine offered little protection against omicron in children age 2-5. Panelist Offit suggested someday Pfizer's regimen could be a four-dose series. He said the public messaging needs to be clear that children won't be fully vaccinated without the third shot.
Dr. William Gruber, Pfizer's senior vice president of vaccine clinical research and development, said two doses creates a basis for effective protection. The third dose builds on that.
Side Effects Continue To Challenge
Side effects are also a challenge facing vaccine stocks.
Dr. Cody Meissner, another panelist, said only a small number of children under the age of 6 have received these vaccines.
"The safety is not as well established as it is in adolescents and adults," he said. "It's so important to continue to follow the safety profile of these vaccines."
In older boys and young men, there have been incidents of heart inflammation, called myocarditis, after receiving the messenger RNA-based vaccines. So far, the risk of myocarditis does not appear to be heightened for this age group. But there are other risks.
But in children 6-23 months, four recipients of Moderna's vaccine experienced febrile seizures. One of those incidents was determined to be related to the vaccine. Up to 5% of young children experience febrile seizures and the cause is often unknown.
Others argued children usually experience less severe Covid than adults.
"We've got to be transparent about the real risk of Covid-19 for children," panelist Dr. James Hildreth said. "Tens of millions of children in this age group have gotten Covid and been just fine."
Follow Allison Gatlin on Twitter at @IBD_AGatlin.
