A third three-microgram (µg) dose of the Pfizer-BioNTech COVID-19 vaccine elicited a strong immune response in children 6 months to younger than 5 years old, according to topline safety, immunogenicity, and vaccine efficacy data the companies released May 23.
In the phase 2-3 trial, 1,678 children received a third 3-µg vaccine dose at least two months after the second dose, during a time when the omicron SARS-CoV-2 variant was predominant. Three vaccine doses were well tolerated, no new safety signals were identified, and most adverse events were mild or moderate.
Preliminary vaccine efficacy data show the vaccine was 80.3 percent effective at preventing symptomatic infections in children 6 months to younger than 5 years of age. This descriptive analysis was based on 10 symptomatic COVID-19 cases identified from seven days after the third dose and accrued by April 29. Following trial protocol, researchers will perform a formal analysis after 21 cases have accrued from seven days after the third dose, and final vaccine efficacy data will be shared, once available.
Pfizer applied in February for emergency use authorization (EUA) from the Food and Drug Administration (FDA) for two doses of the 3-µg COVID-19 vaccine series for children 6 months to younger than 5 but later asked the agency to delay review until data from all three doses were available. Pfizer and BioNTech plan to submit the new data on three doses to FDA this week.
FDA on May 23 revised the dates of its upcoming Vaccines and Related Biological Products Advisory Committee (VRBPAC) meetings. In April, the agency had announced tentative meeting dates pending more information about expected EUA submissions.
On June 14, VRBPAC and FDA will review Moderna’s EUA request for its COVID-19 vaccine for those ages 6 to 17. On June 15, VRBPAC and FDA will review Moderna’s EUA request for children ages 6 months through 5 years and Pfizer-BioNTech’s EUA request for children ages 6 months through 4 years, based on expected completion of an EUA submission.
CDC Expands Eligibility for COVID-19 Booster Shot
Following a meeting of its Advisory Committee on Immunization Practices, the Centers for Disease Control and Prevention (CDC) on May 19 expanded eligibility of COVID-19 vaccine booster doses to include everyone 5 and older. This comes after FDA authorized a booster dose of the Pfizer COVID-19 vaccine for children ages 5 through 11 on May 17.
Citing a steady increase in cases, CDC also strengthened its recommendation that those 12 and older who are immunocompromised and those 50 and older receive a second booster dose at least four months after their first booster dose.
Third Round of No-Cost, At-Home COVID-19 Tests Available
The Biden administration announced May 17 that Americans can request a third round of no-cost, at-home COVID-19 tests. Individuals can request eight tests at COVIDTests.gov or by calling 800.232.0233 (TTY 888.720.7489) from 8 am to midnight ET, seven days a week.
Individuals with disabilities may email DIAL@usaginganddisability.org or contact the Disability Information and Access Line at 888.677.1199, Monday to Friday, from 9 am to 8 pm ET, for assistance ordering tests.
Individuals living at multi-unit addresses might encounter difficulties ordering tests if those living in other units at the address already have placed orders. In those cases, individuals can file a service request or call 800.ASK.USPS (800.275.8777) for assistance.
National Academy of Medicine Seeks Input on Health Workforce Well-Being Plan
The National Academy of Medicine seeks public input on the draft National Plan for Health Workforce Well-Being developed by its Collaborative on Clinician Well-Being and Resilience.
Fueled by the health workforce crisis that came to a head during the COVID-19 pandemic, the National Plan intends to drive collective action to strengthen health workforce well-being and restore the nation’s health by:
- creating and sustaining positive work and learning environments and culture;
- investing in measurement, assessment, strategies, and research;
- supporting mental health and reducing stigma;
- mitigating compliance, regulatory, and policy barriers for daily work;
- engaging effective technology tools;
- institutionalizing well-being as a long-term value; and
- recruiting and retaining a diverse and inclusive health workforce.
Users can submit feedback on the draft plan by May 28, at 3 am ET (May 27, at midnight PT).
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.