COVID-19 vaccines for children under 12 likely approved later this year, FDA says

COVID-19 vaccines that will be safe enough to use on children ages 12 and under will likely not be approved until later this year, according to a U.S. Food and Drug Administration stakeholder meeting held on July 6.

Dir. of FDA’s Center for Biologics Evaluation and Research, Dr. Peter Marks, said that while the vaccine has proven effective and safe for young people 12 and older, the parameters that determine the safety of those same vaccines in children below 12 takes longer. 

"There are trials now undergoing, in the two to 11 age range, as well as some even in the youngest children of only a few months to two years. Those results will be in later this year. They take a little longer to do because we are requiring longer follow-up to make sure that the safety is adequate." 

Alongside the FDA, the American Academy of Pediatrics is also monitoring the efficacy of COVID-19 vaccines in younger children while also working to combat misinformation surrounding children and vaccine safety. 

FILE - 13-year-old celebrates being inoculated by Nurse Karen Pagliaro at Hartford Healthcare's mass vaccination center at the Connecticut Convention Center in Hartford, Connecticut on May 13, 2021.

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"AAP’s experts are continuing to work with CDC and FDA to monitor the situation but given all the data that AAP’s experts have seen, we still continue to strongly recommend vaccination of individuals 12 and older for COVID-19," James Baumberger, Senior Dir. of Federal Advocacy at AAP, said during the stakeholder meeting. "And not only do we need to continue to, in our view, be supportive of this vaccine, we have lots of work to do to combat vaccine hesitancy and as Dr. Woodcock and others alluded to, a lot of misinformation that is circulating about the safety and efficacy of not only COVID vaccines but of other routine childhood vaccinations." 

In May, the FDA authorized emergency use of Pfizer’s COVID-19 vaccine in kids as young as 12. 

Pfizer’s vaccine had already been used for months in people 16 and older, and advisers at the U.S. Centers for Disease Control and Prevention had also concluded the same dose adults use is safe and strongly protective in those 12 to 15 years old. 

The two-dose vaccine made by Pfizer and its German partner BioNTech was studied in more than 2,000 kids ages 12 to 15. There were no cases of COVID-19 among vaccinated kids compared with 16 in the group given dummy shots. Kids also developed higher levels of virus-fighting antibodies than vaccinated adults. 

RELATED: FDA to decide on full approval of Pfizer COVID-19 vaccine by January 

Side effects are the same as what adults experienced, mostly sore arms and flu-like fever, chills or aches that signal the immune system is revving up. 

CDC’s advisers did caution that those temporary shot reactions may be even more common if people get a COVID-19 shot at the same time as another routine vaccination. 

Similarly, Moderna requested the FDA grant emergency use authorization for its COVID-19 vaccine in adolescents in early June. Currently, the two-dose vaccine is authorized for use in the U.S. for those 18 years and older. 

The request follows promising data from a Phase 2 /3 TeenCOVE study involving 3,732 teens ages 12 to 18 that found the vaccine produced immune responses similar to those observed in adults. Additionally, Moderna said that no cases of COVID-19 were observed in participants who had received two doses of the jab. 

RELATED: COVID-19 becoming ‘pandemic of the unvaccinated’, CDC director says 

With the highly contagious delta variant surging in several areas of the U.S., federal health officials continue to urge people who have not been vaccinated to get their free shot as soon as possible. 

Local officials have even reinstated preventative health measures to combat the spread of the newest variant. 

In California, Los Angeles County will again require masks indoors, even in people who have been vaccinated. Over the past three weeks, COVID-19 cases have doubled across Kaiser Permanente’s 36 California hospitals, to more than 400. 

Cases in the U.S. are up around 70% over the last week and hospital admissions have climbed about 36%, with deaths up by 26%, the CDC said Friday. 

RELATED: US surgeon general calls COVID-19 misinformation ‘serious threat’ 

Some hospitals are reporting record or near-record patient volumes. But even for those that aren't, this round of the pandemic is proving tougher in some ways, hospital and health officials said. Staff members are worn out, and finding traveling nurses to boost their ranks can be tough. 

"I really think of it as a war and how long can you stay on the front line," said Dr. Mark Rosenberg, president of the American College of Emergency Physicians. "And how many times do you want to go back for another tour of duty. Eventually, you just don’t want to do it." 

Despite the discouraging surges in new cases, COVID-19 deaths and newly confirmed infections across the U.S. are still dramatically lower than they were over the winter. But for the first time since then, cases are rising in all 50 states. And the nation's vaccination drive has slowed to a crawl, with only about 48% of the population fully protected. 

CDC Director Dr. Rochelle Walensky warned that the outbreak in the U.S. is becoming "a pandemic of the unvaccinated" because nearly all hospital admissions and deaths are among those who hadn’t been immunized. 

The Associated Press and FOX News contributed to this report. This story was reported out of Los Angeles.