Infectious Disease

The CDC Panel recommends the Pfizer BioNTech vaccine for children between 12 and 15 years of age

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Beers, Oliver, Slavitt and Woodworth do not report any relevant financial information.

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A CDC advisory panel on Wednesday approved the use of the Pfizer-BioNTech COVID-19 vaccine in children ages 12-15, lowering the age of availability for the country’s only coronavirus vaccine for children.

The Advisory Committee on Immunization Practices voted 14-0 in favor of the recommendation, with a rejection due to a conflict of interest. The vote took place 2 days after the EUA (Emergency Use Authorization) approval for the vaccine was extended to the younger age group.

Source: Adobe Stock.

A CDC advisory committee recommended that the Pfizer BioNTech vaccine be used in children aged 12 to 15 years. Source: Adobe Stock.

“This is really an exciting development that will allow us to protect large numbers of children and help them regain their lives after a really difficult year,” said the President of the American Academy of Pediatrics (AAP) Lee Savio Beers, MD, FAAP, said in a statement.

The vaccine was previously available to people aged 16 and over through an EUA issued in December. Pfizer and BioNTech last month asked the FDA to expand the EEA based on Phase 3 data showing the messenger RNA-based vaccine is safe and effective in children ages 12-15 . Much of this data was presented during Wednesday’s meeting.

According to the EUA, the vaccination schedule for children aged 12 to 15 is the same as for the older, previously approved age group: two doses of 0.3 ml each with an interval of 3 weeks.

Co-administration
In a new policy statement, the AAP said COVID-19 vaccines can be given at the same time – or within 14 days – as other vaccines. Likewise, Kate Woodworth, MD, MPH, During a presentation on clinical considerations, the CDC’s Maternal and Child Health COVID-19 team said that COVID-19 vaccines can be given “now regardless of the timing” with other vaccines in both children and adults.

This contradicts a previous recommendation not to give COVID-19 vaccines within 14 days of other vaccines – a recommendation made out of caution rather than safety or immunogenicity, Woodworth said.

A number of ACIP voting and non-voting members expressed surprise at the new guidelines, saying there was insufficient data to change the previous recommendation. Other members noted that the pandemic has disrupted other vaccination efforts, leaving many children with routine vaccinations that may now be offered at the same time as a COVID-19 vaccine.

“I am very reassured by the AAP statement of support,” he said Sandra A. Fryhofer, MD, who represents the American Medical Association at ACIP meetings.

A CDC slide presented during the meeting said: “Although data are not available for COVID-19 vaccines given concurrently with other vaccines, extensive experience with non-COVID-19 vaccines has shown that immunogenicity and side effect profiles for vaccines are generally similar when administered concurrently as if they were administered alone. “

The ACIP did not vote on the new language regarding the timing of the COVID-19 vaccination with other vaccines. A CDC slide said that vendors deciding whether to give a COVID-19 vaccine at the same time as another vaccine “could consider whether the patient is late with the recommended vaccines and the reactogenicity profile of the vaccines or is in danger of default. ”

Higher proportion of cases
In a presentation Sara Oliver, MD, MSPH, The head of ACIP’s COVID-19 Vaccines Working Group noted that the proportion of U.S. cases among teenagers has increased in recent weeks as older Americans continue to be vaccinated. In April, for example, 9% of new cases occurred in children between the ages of 12 and 17 – a larger proportion than in adults aged 65 and over, according to Oliver.

In the past two months, the COVID-19 hospitalization rate among adolescents has also “gradually increased,” said Oliver. In addition, between January 1 and April 30, 127 children ages 12-17 died of COVID-19 – which “may seem low,” Oliver said, but would become one of the top ten causes of death in 2019, the last such data were available for children counting years.

According to more recent data from the AAP, more than 72,000 new pediatric COVID-19 cases were reported in the week ending May 6, accounting for 24% of all new cases in the United States.

Oliver noted that transmission of SARS-CoV-2 in children is rare but is more likely to occur in high schools than primary schools. As part of the two EUAs, all students can now receive the Pfizer BioNTech vaccine.

“This will help us close a difficult chapter for many children and families,” said the White House COVID-19 Senior Advisor Andy Slavitt tweeted.

The White House previously said that vaccinating children ages 12-15 would be an integral part of its effort to get 160 million Americans vaccinated by July 4th.

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