Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, MPH, on June 18 endorsed the Advisory Committee on Immunization Practices’ recommendation that children ages 6 months to 5 years old receive a Moderna or Pfizer-BioNTech COVID-19 vaccine.
CDC urged parents and caregivers to register their children for v-safe, a vaccine safety monitoring program that conducts health check-ins through text messages and web surveys.
This decision comes after the Food and Drug Administration (FDA) on June 17 authorized emergency use of the Pfizer-BioNTech and Moderna COVID-19 vaccines for children.
FDA amended the emergency use authorization (EUA) for the Moderna vaccine, previously authorized for adults ages 18 and older, to include individuals 6 months to 17 years old.
Children 6 months to 5 years old are authorized to receive a primary series of two 25-microgram (µg) doses, one month apart. Moderna also received emergency use authorization for a 50 μg two-dose regimen for children ages 6 to 11 years old and a 100 μg two-dose regimen for adolescents ages 12 to 17. The vaccine is authorized for a third primary series dose in individuals who are immunocompromised.
In an analysis of 5,400 children ages 6 months to 5 years:
- among participants 6 through 23 months old, 64 percent of whom had blinded follow-up for more than two months after the second dose, the vaccine was 50.6 percent effective in preventing COVID-19; and
- among participants 2 through 5 years old, 72 percent of whom had blinded follow-up for more than two months after the second dose, the vaccine was 36.8 percent effective in preventing COVID-19.
Among 320 children ages 6 to 11, Moderna reported an immune response similar to that of adults ages 18 to 25 in a previous study that determined the vaccine to be effective. Notably, an additional analysis of the occurrence of COVID-19 cases was determined not to be reliable due to the low number of COVID-19 cases in study participants.
Among 340 adolescents ages 12 to 17, Moderna reported an immune response comparable to that of adults in a previous study. In the 42 percent of participants who had two or more months of blinded follow-up after the second dose, the vaccine was 93.3 percent effective in preventing COVID-19.
The Pfizer vaccine, previously authorized for individuals age 5 and older, received EUA for use in children ages 6 months to 4 years. This 3-µg vaccine is administered in a series of two doses three weeks apart, followed by a third dose administered at least eight weeks after the second dose.
Pfizer compared the immune response of approximately 80 children ages 6 to 23 months and approximately 140 children ages 2 to 4 years to the immune response of approximately 170 older participants in a previous study; the children had a comparable immune response. An additional analysis of the occurrence of COVID-19 cases was determined not to be reliable due to the low number of COVID-19 cases in study participants
White House to Support COVID-19 Vaccines for Children
President Joe Biden on June 9 announced an operational plan for administering COVID-19 vaccines to children under age 5.
The administration initially will procure 10 million doses; to ensure access for health care providers in small practices and rural settings, vaccines will arrive in packages of 100 doses. Vaccines will be available through pediatricians, pharmacies, and more than 120 children’s hospitals. The administration will provide federal funding to state and local health departments to host vaccination clinics.
Additionally, the administration will leverage the Women, Infants, and Children Program; Head Start Program; Maternal, Infant, and Early Childhood Home Visiting Program; Department of Housing and Urban Development programs; and Medicaid and the Children’s Health Insurance Program to promote vaccination. The administration also plans to partner with the COVID-19 Community Corps, along with numerous trade associations and community groups.
Pfizer: Paxlovid Fails to Alleviate COVID-19 Symptoms
Pfizer released new study data showing that its antiviral drug Paxlovid failed to alleviate COVID-19 symptoms in patients at standard risk of developing severe COVID-19. Researchers also observed a nonsignificant 70 percent relative risk reduction in hospitalizations or deaths and a nominally significant 62 percent decrease in COVID-19-related medical visits per day across all patients.
FDA authorized Paxlovid in December 2021 to treat mild to moderate COVID-19 in patients at risk of progression to severe disease. Although data from standard-risk patients are not all statistically significant, Pfizer will include available data in a new drug application to FDA this month for Paxlovid use in high-risk patients. Because of the low rate of hospitalization or death observed in the standard-risk patient population, Pfizer will cease enrollment in the study.
FDA Authorizes First COVID-19 Test that Differentiates COVID-19 Strains
FDA on June 10 issued an EUA for the Laboratory Corporation of America (Labcorp) VirSeq SARS-CoV-2 NGS Test on the PacBio Sequel II sequencing system. This next-generation sequencing (NGS)–based test is the first COVID-19 test authorized to identify and differentiate SARS-CoV-2 Phylogenetic Assignment of Named Global Outbreak lineages.
The VirSeq SARS-CoV-2 test is authorized for use at Labcorp-designated laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 to meet the requirements to perform high-complexity testing. The test is intended for health care providers who believe, based on patients’ medical history and other diagnostic information, that strain-specific information could help determine appropriate patient treatment.
Visit the America’s Essential Hospitals coronavirus resource page for more information about the pandemic.
Contact Senior Director of Policy Erin O’Malley at email@example.com or 202.585.0127 with questions.