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CDC advisors recommend Pfizer’s low-dose COVID vaccine for children: Shots

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Pfizer-BioNTech’s infant COVID-19 vaccine is a lower-dose formulation of the company’s adult vaccine. It was found to be safe and 90.7% effective in preventing COVID-19.

Paul Hennessy / SOPA Images / LightRocket via Getty

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Paul Hennessy / SOPA Images / LightRocket via Getty

Pfizer-BioNTech’s infant COVID-19 vaccine is a lower-dose formulation of the company’s adult vaccine. It was found to be safe and 90.7% effective in preventing COVID-19.

Paul Hennessy / SOPA Images / LightRocket via Getty

Children ages 5 to 11 may soon receive a low-dose COVID-19 vaccine from Pfizer-BioNTech. Advisors to the Centers for Disease Control and Prevention unanimously voted to recommend vaccinations to approximately 28 million US children in that age group on Tuesday.

If the recommendations, as expected, from the CDC’s director, Dr. Rochelle Walensky, advocated, the children could start vaccinating in the next few days.

The vaccine is one third of the adult dose and the vaccine is given in two doses three weeks apart. The lower dose was chosen to minimize side effects while still producing strong immunity, says Pifzer.

Prior to the committee’s vote at the start of the advisory session on Tuesday, Walensky called it “a monumental day” when she asked the panel to consider the unprecedented tolls of COVID-19 on children. the The latest data from CDC show 172 children ages 5-11 have died of COVID-19 and more than 8,300 have been hospitalized.

“We also know that beyond the clinical effects of COVID on children, there were adverse social and mental health effects that we are only just beginning to fully understand,” said Walensky on handing over her responsibility to the panel. “It is our ongoing responsibility to ensure that as many people as possible are vaccinated and protected from COVID-19.”

Her statements left little doubt that she supported a broad recommendation to vaccinate all children between the ages of 5 and 11. Your decision is expected shortly.

During a briefing Monday, White House COVID-19 Response Coordinator Jeffrey Zients said the government had bought enough of the low-dose children’s vaccine for everyone in that age group. Zients said the company started filling and labeling the vials and started shipping 15 million doses when the Food and Drug Administration approved the vaccine last Friday.

The federal vaccine distribution program “will be fully operational by next Monday, November 8,” Zients said, with some doses potentially available by the end of this week.

The vaccine will be supplied to pediatricians and general practitioners, as well as community health centers, pharmacies, tribal health centers and other providers, Zients said. School vaccine administration sites are also being added in some areas.

Some school districts have scheduled vaccinations before the Thanksgiving holiday. And some clinics say they are ready to start recording on Wednesday.

Parents don’t need a doctor’s prescription to get a vaccine, Zients said, although parents with questions may want to discuss the vaccine with a trusted healthcare provider.

During the CDC Advisory Committee on Immunization Practices meeting on Tuesday, the panel members reviewed and discussed the science behind the FDA’s approval of the vaccine in all children ages 5-11. This approval was primarily based on a Pfizer BioNTech study involving 4,600 children worldwide, of whom approximately 3,100 received the low-dose vaccine and approximately 1,500 a placebo.

These studies showed that the vaccine was about 91% effective against COVID-19. The immune system response to the vaccine, as measured by antibodies, was similar to the response seen in 16 to 25 year olds.

Counselors spent much of their time evaluating the public health need for a vaccine for children against a disease that is not as often severe or fatal as it is in adults. In the end, the prevalence of COVID-19 in the US and the number of serious cases and deaths led them to recommend universal use of the vaccine in the 5-11 year old age group.

The latest CDC data from September 2021 shows that 38% of children ages 5-11 have antibodies to the virus that causes COVID-19, suggesting they have become infected. Dr. Jefferson Jones, a CDC medical officer, said young children are at least as likely to be infected as adults. More than 1.9 million cases have been reported in 5 to 11 year olds.

In total, more than 8,300 children, ages 5 to 11, have been hospitalized with COVID-19 or a related disease called MIS-C, a serious multi-organ condition that can be fatal. The age group 5-11 had the highest number of MIS-C cases in children.

Hospitalization rates for COVID-19 in this age group were similar to those for influenza in recent years, according to Jones. The severity was similar in children with COVID-19 and those with influenza who had to be hospitalized.

Hospitalization rates for COVID-19 are three times higher for non-Hispanic black, non-Hispanic American Indian / Alaskan, and Hispanic children compared to non-Hispanic white children, Jones said.

A relatively rare side effect that sparked significant discussion at Tuesday’s meeting is myocarditis, a type of inflammation of the heart. It also occurs as a complication of several viral infections, including COVID-19, and is most commonly seen in adolescent boys and young men. It usually clears up within weeks or a few months.

The CDC has confirmed 877 cases of myocarditis after the Pfizer or Moderna vaccine in people aged 30 or younger, but there were no deaths, said Dr. Matthew Oster, who studies myocarditis for the CDC and is a pediatric cardiologist at Children’s Hospital of Atlanta. He explained that COVID-19 itself can cause myocarditis or other heart-related problems, including MIS-C, which commonly affects the heart.

“The bottom line is, getting COVID is a lot riskier to your heart than getting this vaccine, in my opinion,” Oster said.

In terms of safety, some who testified during a public comment period, as well as other commentators, have questioned whether the study used by the FDA to issue the emergency clearance is large enough to reassure parents that the vaccine is safe in young children is.

In response, Dr. Doran Fink, The FDA’s Assistant Clinical Director, Vaccines and Related Products Division, said at the meeting that the size of the safety database for this age group is “at the high end – or even beyond – the size of the safety database that has supported licensing for other preventive measures Infectious Disease Vaccines. “

Vaccinations of 5-11 year olds starting this month could prevent 600,000 cases of COVID-19 by next March, according to CDC models, said Dr. Sara Oliver from the CDC. Vaccinating 5 to 11 year olds “would diminish, but not eliminate” the possibility that a new variant might emerge, she said.

Given that some parents are reluctant to vaccinate their children right away, Dr. Counselor Matthew Daley: “We hear you loud and clear.”

“Of course you only want what is best for your child,” he said. “I encourage you to speak to your general practitioner or pediatrician [so] they can get away with you. “

Jane Greenhalgh contributed to this report.

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