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CDC Advisers Recommend Pfizer’s Low-Dose Childhood COVID Vaccine: Shots

CDC Advisers Recommend Pfizer's Low-Dose Childhood COVID Vaccine: Shots

Pfizer-BioNTech’s early childhood COVID 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 early childhood COVID 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 be able to receive a low-dose COVID-19 vaccine made by Pfizer-BioNTech. Advisors to the Centers for Disease Control and Prevention voted unanimously on Tuesday to recommend the injections for the roughly 28 million children in this age group.

If the recommendations are endorsed by CDC Director Dr. Rochelle Walensky, as expected, children can start getting their injections within days.

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

Before the committee’s vote, at the start of Tuesday’s advisory meeting, Walensky called this “a monumental day,” while urging the panel to reflect on the unprecedented toll COVID-19 is taking on children. had. The CDC’s Latest Data show that 172 children aged 5-11 have died from COVID-19 and more than 8,300 have been hospitalized.

“We also know that in addition to the clinical impact of COVID on children, there are also harmful social and mental health effects that we are only now beginning to fully understand,” Walensky said when she gave her briefing to the panel. “It is our ongoing responsibility to ensure that as many people as possible are vaccinated and protected against COVID 19.”

Her statements left little doubt that she supports a broad recommendation to vaccinate all children ages 5-11. Her decision is expected soon.

At a briefing on Monday, Jeffrey Ziess, White House’s COVID-19 response coordinator, said the government has bought enough of the low-dose childhood vaccine for everyone in this age group. Zients said the company began filling and labeling the vials and began shipping 15 million doses when the FDA approved the vaccine last Friday.

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

The vaccine will be shipped to the offices of pediatricians and primary care physicians, Zients said, as well as community health centers, pharmacies, tribal health centers and other suppliers. It will also include school-based vaccine administration sites in some areas.

Some school districts have already scheduled vaccinations for the Thanksgiving holiday. And some clinics say they are ready to start the injections 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 health care provider.

At Tuesday’s meeting of the CDC’s Advisory Committee on Immunization Practices, panelists reviewed and discussed the science behind the FDA’s approval of the vaccine on Friday in all children ages 5-11. That authorization was based largely on a Pfizer-BioNTech study of 4,600 children worldwide, of whom about 3,100 received the low-dose vaccine and about 1,500 a placebo.

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

The consultants spent a lot of time weighing the need for a pediatric public health vaccine against a disease that is not as often serious or fatal as in adults. Ultimately, the nationwide prevalence of COVID-19 and the number of serious cases and deaths led them to recommend universal use of the vaccine in the 5-11 age group.

The most recent CDC data from September 2021 shows that 38% of children in the age group 5-11 have antibodies to the virus that causes COVID-19, indicating they are infected. dr. Jefferson Jones, a CDC medical offering, said that young children are infected at least as often as adults. More than 1.9 million cases have been reported in 5- to 11-year-olds.

In total, more than 8,300 children aged 5-11 have been hospitalized with COVID-19 or a related illness called MIS-C, a serious condition that affects multiple organs and can be fatal. The age group 5-11 had the highest incidence of MIS-C among children.

The hospitalization rates for COVID-19 in this age group are comparable to what has been seen for flu in recent years, Jones said. Severity was similar for children with COVID-19 and those with flu who required hospitalization.

Hospital admissions for COVID-19 are three times higher for non-Hispanic black, non-Hispanic American Indian/Alaska Native and Hispanic children compared to non-Hispanic white children, Jones said.

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

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

“The bottom line is that getting COVID is, I think, much riskier for the heart than getting this vaccine,” Oster said.

On the safety side, some who testified during a public comment period, as well as other commentators, have questioned whether the study used by the FDA to grant emergency use approval is large enough to assure parents that the vaccine is safe. is in young children.

In answer, dr. doran fink, deputy clinical assistant director of the vaccines and related products division for the FDA, told the meeting that the size of the safety database for this age group is “at the higher end — or even greater — of the size of the safety database that can support the licensure of other people.” preventive vaccines for infectious diseases.”

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

Recognizing that some parents are hesitant to get their children vaccinated right away, said Dr. Matthew Daley, a member of the consulting firm, “We hear you loud and clear.”

“Of course you only want the best for your child,” he said. “I encourage you to talk to your GP or pediatrician, [so] they can walk through this with you.”

Jane Greenhalgh contributed to this report.

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