The United States Centers for Disease Control and Prevention (CDC) approved booster vaccines against covid-19 for children aged 5 to 11 years following the recommendation of independent single-dose vaccine advisors additional Pfizer/BioNTech vaccine after a first round.
On Thursday, CDC vaccine advisers voted 11-1, with 1 abstaining, to support the recommendation for a booster dose of the Pfizer/BioNTech vaccine against Covid-19, which the US Food and Drug Administration ( FDA, in English) authorized earlier this week.
The recommendation they voted for was: “A single booster dose of the Pfizer/BioNTech vaccine against covid-19 is recommended for persons aged 5 to 11 years at least 5 months after the initial series, according to the Authorization for use of FDA emergency.
The CDC’s Advisory Committee on Immunization Practices (ACIP) endorsed the booster for children at least five weeks after they received their two-dose series. This would be a third dose for healthy children and a fourth dose for immunocompromised children.
The committee voted in favor of the booster after hearing details about Pfizer’s request to the FDA to expand access to boosters for this age group. Decreasing antibody levels have been observed in children who received a primary vaccination series and booster doses achieved higher antibody levels than those observed after the primary series.
The company said data from its clinical trials showed that the booster vaccine increased antibodies that fight the omicron variant by 36-fold in this age group. The trial that included 4,500 children ages 5 to 11 saw no new safety concerns, according to the company.
“Overall, the benefits of COVID-19 vaccines continue to outweigh the risks, as we continue to see, regardless of which age group is highlighted, that receiving the primary series of COVID-19 vaccines remains critically important for prevention of serious morbidity and mortality from COVID-19, and general booster doses of COVID-19 vaccine have been shown to increase protection against all outcomes in people older than 12 years,” said Dr. Sara Oliver, a pediatric infectious disease specialist and leader of the ACIP COVID-19 Vaccine Task Force.
“Children aged 5 to 11 years are likely to benefit from a booster dose of the covid-19 vaccine,” added Oliver.
The impact of omicron on children
Hospitalizations for covid in the US rose 10% last week 0:45The omicron variant of the coronavirus has been tough on children. Studies by 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 dropped significantly during the surge in omicron cases, falling from 68% to around 12% against infection. Two doses of the vaccine seemed to keep children out of the hospital.
While not at the same levels as during the omicron wave, COVID-19 cases among children have been on the rise. The number of new COVID-19 cases among children in the US grew nearly 76% last week compared to the previous two weeks, the American Academy of Pediatrics said Monday.
According to the latest CDC report, 1,547 children have died of covid-19 in the US and 364 of them were in the age range of 5 to 11 years.
The American Academy of Pediatrics says nearly 13.2 million children in the US have tested positive for Covid-19 during the pandemic, with more than 5.3 million of those cases this year. Those numbers are likely underestimates, as testing is down in much of the country.
Vaccination is an important protection for children
Booster dose in children increases antibodies against omicron, says Pfizer 0:46Looking at electronic health records, with more than 700,000 doses administered, no real safety issues were found.
Anaphylaxis rates in children 5 to 11 years of age after receiving the Pfizer vaccine were comparable to rates seen in people 12 years of age and older. In the three months after the initial series of vaccines, there were 10 potential cases of myocarditis or pericarditis, both types of heart inflammation, but four of those cases were determined to be unrelated to vaccination, the CDC said in its filing.
“The big picture is that mRNA vaccination-associated myocarditis relative to viral myocarditis tends to be clinically mild and patients have a good prognosis and fairly short recovery period,” Dr. Tom Shimabukuro of the CDC.
The rates were also lower in this age group than those seen in adolescence. The rate was also lower after a booster dose.
Children who experienced a problem with the vaccine were considered non-severe cases, as they only experienced pain at the injection site. This was similar to the reaction of adults after their second dose.
The risk of dying from COVID-19 for children aged 12 years and older in February 2020 was 20 times higher among unvaccinated children, compared to those with the primary vaccine series and a booster dose.
Although scientists initially believed that COVID-19 did not affect children as much as adults, deaths from COVID-19 in children ages 5 to 11 were higher than those from other childhood 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, which indicates that most parents accept vaccination against hepatitis A, meningococcus, chickenpox, rubella and rotavirus. , although deaths from these diseases are relatively rare,” he said. Dr. Matt Daley, chair of the COVID-19 Vaccines Task Force and Principal Investigator at the Kaiser Permanente Colorado Institute for Health Research.
Parents should also keep in mind that a child who contracts COVID-19 can, like adults, develop prolonged COVID-19, Daley said, even after a child has a mild case of COVID-19. Long-term symptoms of covid-19 can last for years after the initial infection. People who were previously vaccinated were less likely to have symptoms 12 to 20 weeks after infection compared to those who were not vaccinated, the CDC said.
Children ages 5 to 11 were also the most vulnerable age group for developing multisystem inflammatory syndrome in children, also known as MIS-C, a rare but serious condition linked to COVID-19. Among this age group, there have been 3,800 cases of MIS-C and 16 deaths, according to the CDC presentation.
“The data do not suggest potential safety concerns regarding a Pfizer/BioNTech COVID-19 vaccine booster for children aged five to seven years beyond those previously identified in older age groups,” said Dr. Helen Keipp Talbot in his presentation of safety findings to the committee.
Talbot was the only expert who voted against the booster dose for this age group. While he is in favor of vaccinating children against COVID-19, he believes public health leaders should focus on the low vaccination rate among this age group rather than focus on boosters.
“I really want kids to be vaccinated,” said Talbot, an associate professor of medicine at Vanderbilt University. “We really need to put our time and effort into educating the 70% that haven’t been (vaccinated). Boosters are great once we get everyone through their first round and I think that needs to be a priority.”
In the age group 5 to 11 years, only 35% of children have received a dose and only 28% are fully vaccinated according to the CDC.
After the ACIP vote, CDC Director Dr. Rochelle Walensky will decide whether to sign the ACIP recommendation.
Walensky, who delivered a keynote address at the meeting, advocated for more people of all ages to get vaccinated against Covid-19.
“There are too many who are not being protected as we face another surge in cases and hospitalizations,” he told the committee. “We all hoped we would never see the death toll rise this high, reaching a number that was unfathomable when we first learned about this virus.”
“The sadness I feel for the lives lost, the families devastated and the communities changed is profound,” Walensky added. “We have the tools we need to protect these people from serious illness and prevent more tragic deaths.”
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