Updated 6/18/2022 3:34pm ET: The Centers for Disease Control and Prevention have now recommended the use of Moderna and Pfizer-BioNTech’s COVID-19 vaccines for children ages 6 months to 5 years. The CDC’s Advisory Committee on Immunization Practices (ACIP) today voted unanimously to recommend both vaccines after a two-day meeting to review and discuss the data. CDC Director Rochelle Walensky quickly signed her recommendation this afternoon, marking the final step in the regulatory process. The administration of both vaccines can now begin. Distribution has already begun and the vaccines should be available at thousands of pediatric offices, pharmacies, health centers, local health departments, clinics and other locations this week, according to the CDC.
“We know millions of parents and caregivers are eager to get their young children vaccinated, and today’s decision lets them do that,” Walensky said in a statement. “I encourage parents and carers to reach out to their doctor, nurse or local pharmacist with any questions they may have to learn more about the benefits of vaccination and the importance of protecting their children through vaccination.”
Updated 06/17/2022 09:25 ET: Two COVID-19 vaccines for infants and young children ages 6 months to less than 5 years are now approved for use by the U.S. Food and Drug Administration. The regulator granted the approvals early Friday after the agency’s committee of experts unanimously confirmed the approvals on Wednesday.
“Many parents, caregivers and doctors have been waiting for a vaccine for younger children, and this action will help protect children up to 6 months of age,” said FDA Commissioner Robert M. Califf a statement Friday. “As we have seen with older age groups, we expect that younger children’s vaccines will provide protection against the most serious consequences of COVID-19, such as hospitalization and death.”
The approved vaccines are both Moderna’s mRNA-based vaccines, now approved for children aged 6 months to 17 years, and Pfizer-BioNTech’s vaccine, now approved for children aged 6 months to 4 years . Although both have been approved and unanimously supported by the FDA’s expert advisors, the two vaccines are very different. Most importantly, the advisors had far more concerns about the efficacy and three-month three-dose treatment of Pfizer-BioNTech’s vaccine than Moderna’s two-dose treatment.
Below, Ars provides parents with a guide to key information about these vaccines, including why they are needed, the process ahead, detailed data on the vaccines, and comments from FDA advisors.
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Original story 6/15/2022 8:07pm ET: A panel of experts advising the Food and Drug Administration unanimously voted Wednesday to approve two COVID-19 vaccines for children under the age of 5. If the FDA approves the vaccines, it will be the first time in more than two years. year of the pandemic that vaccines against COVID-19 will be available for this age group – the last group still to be vaccinated.
The need for vaccines
Although children in this young age group have a relatively lower risk of serious illness and death from COVID-19 compared to older groups, they can become seriously ill and die from the infection. As of last month, 45,000 children under the age of 5 have been hospitalized for COVID-19 during the pandemic; About 50 percent of these hospital admissions occurred during the Omicron wave. Of the children who end up in the hospital, about 63 percent have no underlying medical conditions that put them at higher risk of severe COVID-19. And about a quarter of hospital patients require critical care.
So far, 475 children under the age of 5 have died from COVID-19 during the pandemic, making COVID-19 far more deadly than other diseases we routinely vaccinate young children against, including influenza, measles, chickenpox, hepatitis A and rotavirus.
“I think we have to be careful not to go numb to the number of pediatric deaths because of the overwhelming number of elderly deaths,” Peter Marks, the FDA’s top vaccines regulator, said today. “Every life matters.”
Marks made the comments earlier today at the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) all-day meeting. The independent experts reviewed data on Moderna’s vaccine for infants 6 months to children under 6 years of age and Pfizer-BioNTech’s vaccine for infants 6 months to children under 5 years of age.
The committee voted unanimously — 21 to 0 — for FDA approval of Moderna’s vaccine for infants and young children. In a second vote, they also voted unanimously — 21 to 0 — for FDA approval of Pfizer’s BioNTech vaccine for infants and young children.
These votes are the first steps in a four-step process to get these vaccines into tiny arms. In the second step, the FDA must decide whether to grant approval for both vaccines. The agency is under no obligation to follow VRBPAC’s advice, but normally does and is widely expected to do so here, likely by the end of Thursday.
The third step is for the Centers for Disease Control and Prevention to convene its advisory committee of independent vaccine experts Advisory Committee on Vaccination Practices (ACIP), who will review the data again and vote on whether to recommend the use of the vaccines. ACIP is scheduled to meet to discuss and vote on these vaccines Friday 17th June and Saturday 18th June. If ACIP members vote to have the CDC recommend the use of these vaccines, then the fourth and final step will be approval from CDC Director Rochelle Walensky. At this point management can begin.
In terms of vaccine distribution, the Biden administration has already allocated a stash of 10 million doses — some Moderna doses and some Pfizer-BioNTech doses — for states to pre-order. If or when the FDA approves the vaccines, these orders can be shipped to states. If all goes according to plan, orders for cans are expected to arrive in the States this weekend. Assuming Walensky endorses the use of the vaccines, federal officials expect vaccine administration to begin “in earnest” beginning Tuesday, March 21.
In the meantime, parents who want to finally protect their young children from the devastating pandemic virus must carefully decide which of the two vaccination options is right for their children. Both vaccines are simply smaller doses of the companies’ mRNA-based vaccines that are already approved for older age groups. However, when compared to each other, they have significant differences in dosage, timing of dosing, estimate of efficacy, and side effects.
While VRBPAC members overwhelmingly supported approval of both vaccines, they also expressed reservations about the longer three-dose, three-month regimen of the Pfizer-BioNTech vaccine and the highly preliminary vaccine estimates.
Here’s an overview of the two vaccines, the data we have on them, and what VRBPAC members thought.
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