The US Centers for Disease Control and Prevention signed off on boosters for 5- to 11-year-olds following the independent vaccine advisers recommendation for an additional dose of the Pfizer/BioNTech Covid-19 vaccine following a primary series.
The CDC’s vaccine advisers voted 11-1, with 1 abstention Thursday to support recommending a booster dose, which the US Food and Drug Administration authorized earlier this week.
The recommendation they voted on was: “A single Pfizer/BioNTech Covid-19 vaccine booster dose is recommended for persons ages 5-11 years at least 5 months after the primary series, under the FDA’s Emergency Use Authorization.”
The CDC’s Advisory Committee on Immunization Practices endorsed the booster for children at least five months after they received their two-dose series. This would be a third dose for healthy children and a fourth dose for children who are immunocompromised.
The committee voted for the booster after hearing details about Pfizer’s application to the FDA to expand access to the boosters for this age group. Waning antibody levels have been seen in children who have received a primary vaccination series, and booster doses achieved antibody levels higher than what was seen after the primary series.
The company said data from its clinical trials showed it raised Omicron-fighting antibodies by 36 times in this age group. The trial that included 4,500 children ages 5 through 11 saw no new safety issues, according to the company.
“Overall, the benefits of Covid vaccines continue to outweigh the risks as we continue to see, regardless of what age group is highlighted, receipt of the Covid vaccine primary series continues to be critically important for the prevention of severe Covid-19 morbidity and mortality and overall Covid-19 vaccine booster doses have been shown to increase protection against all outcomes in those 12 and over,” said Dr. Sara Oliver, a pediatric infectious disease specialist and the lead for the Covid-19 vaccines ACIP Work Group. “It’s likely that children ages 5 through 11 would benefit from a Covid-19 vaccine booster dose.”
The Omicron variant of the coronavirus has been tough on kids. Studies from the New York State Department of Health and the CDC found that the effectiveness of two doses of Pfizer’s vaccine for children ages 5 to 12 fell significantly during the Omicron surge, falling from 68% to about 12% against infection. Two doses of the vaccine did seem to keep kids out of the hospital.
While not at the same levels as during the Omicron wave, Covid-19 cases among children have been increasing. The number of new Covid-19 cases among children in the US grew nearly 76% last week from two weeks prior, the American Academy of Pediatrics said Monday.
According to the latest report from the CDC, 1,547 children have died of Covid-19 in the US and 364 of them were in the 5-11 year-old age range.
The American Academy of Pediatrics says that almost 13.2 million kids in the US have tested positive for Covid-19 during the pandemic, with more than 5.3 million of those cases coming this year. Those numbers are probably undercounted, as testing has fallen off in much of the country.
Looking at electronic health records, with more than 700,000 doses administered, there were no real safety problems found with the Pfizer vaccine in children, according to a presentation given to the committee.
Anaphylaxis rates in children ages 5-11 following the Pfizer vaccination were comparable to the rate seen in people ages 12 and older. In the three months after the initial vaccine series, there were 10 potential cases of myocarditis or pericarditis, both types of heart inflammation, but four of those cases were determined not be related to the vaccination, the CDC said in its presentation.
“The general picture is that myocarditis associated with mRNA vaccination relative to viral myocarditis tends to be clinically mild and patients have good prognosis and a fairly short recovery period,” the CDC’s Dr. Tom Shimabukuro told the committee.
The rates were also lower in this age group than were seen in adolescence. The rate was also lower after a booster dose.
Most children, if they experienced any problems with the vaccine were considered non-serious, like pain at the injection site. This was similar to adults’ reaction after their second dose.
Vaccination is an important protection for children. The risk of dying from Covid-19 for children 12 years and older in February of 2020 was 20 times higher among unvaccinated children, compared to those with the primary vaccine series and a booster dose.
While scientists initially believed that Covid-19 didn’t impact children nearly as much as it did adults, deaths from Covid-19 in 5 -11-year-olds were greater than for a number of other pediatric vaccine preventable diseases. In 2020, it was one of the leading causes of death for children in this age range.
“It’s important to highlight that vaccine coverage for these other conditions, these other diseases, is relatively high, indicating that most parents accept vaccination for Hepatitis A, meningococcal, varicella, rubella and rotavirus even though deaths from these diseases are relatively rare,” said Dr. Matt Daley, who is chair of the COVID 19 vaccines workgroup and a senior investigator with the Institute for Health Research Kaiser Permanente Colorado.
Parents should also keep in mind that a child who gets Covid-19 can, like adults, develop long-Covid, Daley said, even after a child has a mild case of Covid-19. Long Covid symptoms can last for years after the initial infection. People who were previously vaccinated were less likely to have symptoms between 12 and 20 weeks after infection compared to those that were unvaccinated, the CDC said.
Children ages 5 - 11 were also the most vulnerable age group to develop multisystem inflammatory syndrome in children, also known as MIS-C, a rare but serious Covid-19-related condition. Among this age group, there have been 3,800 MIS-C cases and 16 deaths, according to the CDC’s presentation.
“Data do not suggest potential safety concerns regarding a Pfizer/BioNTech COVID-19 vaccine booster for children five to seven years of age beyond those previously identified in older age groups,” said Dr. Helen Keipp Talbot in her safety findings presentation to the committee.
Talbot was the one expert who voted against the booster dose for this age group. While she is in favor of vaccinating children against Covid-19, she thinks public health leaders should concentrate on the low vaccination rate among this age group instead of focusing on boosters.
“I really want children to be vaccinated,” said Talbot, an associate professor of medicine at Vanderbilt University. “We really need to spend our time and effort on educating the 70% who have not been (vaccinated). Boosters are great once we’ve got everyone their first round and I think that needs to be a priority.”
In the 5-11 age group, only 35% of children have had one dose and only 28% are fully vaccinated according to the CDC.
Following the ACIP vote, CDC Director Dr. Rochelle Walensky will decide whether to sign off on the ACIP recommendation.
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Walensky, who gave opening remarks in the meeting advocated for more people of all ages to get the Covid-19 vaccine.
“There are too many who do not have the protection necessary as we face yet another increase in cases and hospitalizations,” she told the committee. “We all hoped to never see the death tolls rise this high, reaching a number that was unfathomable when we first learned of this virus.”
“The sadness I feel for lives lost, the families devastated and the communities changed is steep,” Walensky added. “We have the tools we need to protect these people from severe disease and prevent any more tragic deaths.”