Pfizer’s test results that its COVID-19 vaccine is safe and effective among children ages 5 to 11 provides a glimmer of hope to parents desperate to get their younger children protected against the virus.
The vaccine manufacturer’s announcement, which didn’t include specific data from the trial, comes as COVID-19 has taken a greater toll on the pediatric population in recent weeks than previously in the pandemic.
Both child cases and hospitalizations have reached new heights amid the delta variant’s spread and the back-to-school season. Surges have forced several schools to quarantine students and staff or shut down altogether, stifling hopes to keep all students in in-person classes.
The uptick has raised the pressure on Food and Drug Administration (FDA) officials to authorize a vaccine for children younger than 12.
With the Pfizer results and the FDA’s previous statement that it will review submitted data “likely in a matter of weeks rather than months,” experts say the emergency authorization for the age group could come as early as next month. But they cautioned that the timing is far from certain.
Jeffrey Gerber, an attending physician in the division of infectious diseases at Children’s Hospital of Philadelphia, said Pfizer’s announcement “sounds promising” to protect children, noting that widening eligibility among school children would be “a game changer.”
“Nothing is perfect — including COVID vaccines — but they are the most important line of defense,” he said in a statement to The Hill. “It would not only directly protect the kids but also further reduce the number of people in whom virus can spread. This helps us all.”
Gerber, who is heading the clinical trial of the Moderna vaccine in kids under 12 at the Philadelphia hospital, said it’s “not possible to precisely predict” the timing of the authorization.
But if the FDA granted the Pfizer-BioNTech regimen to be given to children ages 5 to 11 at the end of October, it’s possible most kids could be vaccinated by January.
“So, practically speaking, we’re talking about the prospect of having all school-aged kids fully vaccinated when school opens after the winter holidays,” he said. “That is, if we can make it easy for them to get it and their parents choose for their children to be vaccinated.”
For children younger than 5, however, experts don’t expect vaccines to become available until sometime next year.
Pfizer announced that children ages 5 to 11 showed “robust neutralizing antibody responses” after receiving one-third of the COVID-19 vaccine dosage for adults and teenagers. The trial with 2,268 participants in the age group found the dose’s side effects comparable to what those aged 16 to 25 experienced.
“These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency,” Pfizer CEO Albert Bourla said in a statement, without providing a specific timeline.
Former FDA Commissioner Scott Gottlieb noted that Pfizer’s announcement “came a little earlier than some were expecting” on CNBC’s “Squawk Box.”
“Depending on how long the FDA takes to review the application – whether it’s a four-week review or a six-week review – you could have a vaccine available to children as early as probably by the end of October, perhaps it slips a little bit into November.”
President BidenJoe BidenHouse clears bill to provide veterans with cost-of-living adjustment On The Money — Dems dare GOP to vote for shutdown, default To reduce poverty, stop burdening the poor: What Joe Manchin gets wrong about the child tax credit MORE’s chief medical adviser, Anthony FauciAnthony FauciThe Hill’s Morning Report – Presented by Alibaba – Democrats return to disappointment on immigration ‘Highest priority’ is to vaccinate the unvaccinated, Fauci says Sunday shows – Boosters in the spotlight MORE, expressed optimism that the Pfizer vaccine eligibility will extend to children aged 5 to 11 next month, saying Monday on MSNBC that he “think there’s a really good chance it will be before Halloween.”
The FDA has received several calls to prioritize authorizing a vaccine for children younger than 12, including from more than 100 lawmakers and the American Academy of Pediatrics (AAP) last week. The federal agency responded in a statement earlier this month saying it is working “around the clock” to allow vaccines for these children but cannot provide a certain timeline, adding it would “follow the science.”
Parents are growing more anxious as pediatric cases and hospitalizations climb to record levels.
The AAP has said cases have grown “exponentially,” with more than 243,000 infections confirmed in the week ending Sept. 9 — the most recent week of data. That data represented the second highest weekly count throughout the pandemic, during which children made up 28.9 percent of cases, despite making up 22.2 percent of the population.
Pediatric hospitalizations have also soared, with the weekly average number of current child patients reaching 5.77 times higher in early September than in early July, according to federal data. At the same time, children’s hospitals have also seen an influx in cases of a respiratory virus called RSV that usually hits in fall and winter.
Although the AAP considers COVID-19 hospitalization and death “uncommon in children” even among the delta variant, the virus is not without consequences, as some infected children have developed multisystem inflammatory syndrome and “long” COVID-19.
The AAP has said it does not recommend off-label use of COVID-19 vaccine in children younger than 12 and encouraged physicians to wait for the final trial results.
However, children not yet eligible for the COVID-19 vaccine are not left without protections, said Kawsar Talaat, an associate professor of international health at the Johns Hopkins Bloomberg School of Public Health.
Precautions, like masking, ventilation and vaccination among adults in contact with children can lessen the chance of COVID-19 spread and allow schools to stay in session safely, she said.
“I think there’s lots of things that we can do to protect kids now and allow the process to move with speed but with due diligence and making sure all the I’s are dotted and the T’s are crossed,” she said.
But Talaat, who helped enroll children in the Pfizer trial, said that locations with high vaccination rates have seen lower pediatric cases and hospitalization, noting it will “decrease … even further” with a vaccine for most school-aged children. But areas with lower vaccination rates may continue to see surges if the adults and children there don’t get vaccinated.
Centers for Disease Control and Prevention Director Rochelle WalenskyRochelle WalenskyFDA panel endorses COVID-19 booster shots for older Americans, rejects widespread use Watch live: White House COVID-19 response team holds briefing The Hill’s Morning Report – Presented by National Industries for the Blind – Tight security for Capitol rally; Biden agenda slows MORE said last month that “large-scale quarantines” and outbreaks are “generally occurring” in schools that are not following her agency’s guidance for masking and for all eligible students and teachers to be vaccinated.
“The problem is in places that are not highly vaccinated, whether they would be willing to vaccinate children or not, because if they’re not vaccinating themselves, you gotta wonder if … people are not going to vaccinate their kids,” Talaat said.