Babies, toddlers, preschool kids and their protection from COVID-19 are front of mind again for federal health advisers this week.
The Vaccines and Related Biological Products Advisory Committee, which advises the U.S. Food and Drug Administration, is scheduled to meet Tuesday and Wednesday to consider the Pfizer BioNTech and Moderna COVID-19 vaccines for children.
The vaccines’ trials for babies and children were among many led by investigators at Cincinnati Children’s Hospital Medical Center’s Gamble Vaccine Research Center.
“Both the Pfizer and Moderna COVID vaccines have been shown to be safe and effective for young children,” said Dr. Grant Paulsen, who was principal site investigator for the Pfizer and Moderna COVID vaccine clinical trials in kids ages 6 months to 11 years old at Cincinnati Children’s.
The FDA’s advisory group will consider amending the emergency use authorization of the Moderna COVID-19 mRNA vaccine to include the primary vaccination series to children and teenagers 5 to 17 years old on Tuesday. On Wednesday, the committee will discuss changing the emergency use authorization of the Moderna vaccine to include the primary series for infants and children 6 months through 5 years old, and the emergency use authorization of the Pfizer-BioNTech vaccine to include administering it to infants and children 6 months through 4 years old.
Kids’ vaccination rates are low
The youngest age groups that currently qualify for a COVID-19 vaccine series have been the least vaccinated against the pandemic virus. In the 16-county region, just over a quarter of the area’s 242,000 children aged 5-17 have been fully vaccinated, an Enquirer analysis of data from the Centers for Disease Control and Prevention show. The rate is less than half the region’s overall vaccination rate of 58.7%,
Paulsen said side effects from both vaccines in babies and young children were mostly mild or moderate, and neither trial showed new safety concerns. Both vaccines are greatly reduced doses from those given to older people but generated protective antibodies generally the same as those given to young adults, he said.
“Assuming that one or both of the COVID vaccines are approved for young children, I would encourage parents to vaccinate their children,” he said.
Hospitals, health departments prepare for infant vaccine distribution
Cincinnati Children’s has been administering Pfizer-BioNTech COVID-19 vaccines since they were approved for the oldest kids and is making plans for vaccinating the youngest children, should the vaccinations be approved.
For that to happen, the FDA would have to give the go-ahead. After that, the Centers for Disease Control and Prevention makes its recommendations based on its Advisory Committee on Immunization Practices recommendations.
Susan Wade-Murphy, a registered nurse who oversees COVID-19 vaccine clinics for Cincinnati Children’s as assistant vice president of patient services, said if all of that occurs, the vaccines will be available by appointment for the newest age group.
They’d be administered at Cincinnati Children’s Burnet Campus in Avondale and Liberty Campus in Butler County. Patients, family groups or adult individuals will be given the vaccine in an individual exam room and will have to wait 15 minutes before leaving to make sure no major side effects occur after vaccination, Wade-Murphy said.
“Our focus on ensuring a safe and developmentally supportive vaccine environment will continue,” she said.
Hamilton County has 10 vaccine nurses, down from 40 at the height of the pandemic. But in anticipation of the authorization, the county’s remaining nurses all have pediatric experience, health commissioner Greg Kesterman said.
“We have been excited for months for the opportunity to provide vaccine to those youngsters in our population,” he said. “We are mostly watching the FDA committees and are excited to see the data coming out showing that it’s effective and safe.”
Kesterman said there will likely be a good mix of individuals who wish to vaccinate their child through a pediatrician and some who will use the public health department for shots in young children should approval be granted.
In Clermont County, health officials have ordered an initial 200 Pfizer vaccines in preparation of the age-extended emergency-use authorization.
“We don’t know what the demand will be out there. We don’t know if parents will choose to go to their pediatrician’s office,” said Maalinii Vijayan, assistant health commissioner for Clermont County Public Health. “So that’s why we made the decision and that’s how we are preparing for it.”
Kesterman and Vijayan both said there would be a short period, from around a couple days to 10 days, between FDA and CDC approval and when the vaccine would actually be available for the new age group to receive.
“This is a great next step,” Vijayan added. “We all know COVID-19 is not going to go away completely.”
Isn’t COVID-19 rare in children?
While the COVID-19 infection is usually much less severe in children when compared to adults, Paulsen said, “some kids can get very sick and need to be admitted to the hospital.” The vaccines reduce the risk of severe infection and death.
And severe cases have not eluded kids nationwide, the latest American Academy of Pediatrics and Children’s Hospital Association report shows.
- More than 1,000 children in the U.S. have died of COVID-19 since the pandemic began.
- More than 43,000 children in the U.S. have been hospitalized with the infection.
- More than 13.4 million kids have been diagnosed with COVID-19.
Fourth vaccine also nears approval
In addition to an age expansion for some vaccines, the FDA has recommended approval of a fourth vaccine, produced by Novavax, though authorization may be delayed as the agency seeks to review new changes to the biotechnology company’s manufacturing process, a spokesman said Wednesday.
If approved, Novavax would become the second non-messenger RNA (or mRNA) vaccine approved. Vaccines developed by Pfizer and Moderna are mRNA-based, which is a type of protein production. A third vaccine developed by Johnson & Johnson is a non-mRNA vaccine with a more traditional development but recently had its emergency use authorization restricted by the FDA due to risks of a rare clotting condition called thrombosis.
Novavax is seeking authorization for individuals 18 and older and is studying its effectiveness in children aged 12 to 17.
Health officials hope approval could convince individuals weary of mRNA-produced vaccines to finally get their shots.
“There are certainly a portion of the population that has just been generally nervous about vaccines in general. I don’t think this will sway them,” Kesterman said. “But there is certainly another portion of the population that had some concerns about the way previous vaccines were made and the way they were perceived as rushed. So this could be an option for those that fall into that category.”
The CDC would need to sign off on the vaccine before shots are administered.