Pfizer reports strong COVID vaccine protection in kids under 5, will file with FDA

In closely watched developments, especially among parents and healthcare providers, Pfizer and BioNTech today announced strong efficacy for a three-dose regimen of the child-sized dose of their mRNA vaccine in kids ages 6 months to 4 years old.

Moving forward with 3-dose series

The new findings come more than 3 months after the two companies abruptly delayed submitting the emergency use authorization (EUA) application for the vaccine to allow them more time to evaluate whether a two- or three-dose primary series would be best.

The 3-microgram dose for the smallest children is one-tenth of the adult dose and was selected for its safety, tolerability, and immunogenicity. Earlier trials, however, found that the reduced dose didn't prompt a significant immune response in children 2 years and older, suggesting that a third dose may be needed.

In a statement today, the companies said the third dose was well tolerated among 1,678 children under age 5, with a safety profile that was similar to placebo. Vaccine efficacy was 80.3% at a time when the Omicron variant was dominant.

Ugr Sahin, MD, BioNTech's chief executive officer and cofounder, said officials from the two companies are preparing documents and expect to submit the EUA application to the US Food and Drug Administration (FDA) later this week, with submission to the European Medicines Agency and other regulatory agencies in the coming weeks.

Given the new timeline for expected submissions, the FDA today said its vaccine advisory group will meet on Jun 14 to discuss Moderna's EUA request for kids ages 6 through 17. The Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet on Jun 15 to talk about both Moderna's EUA request for kids age 6 months through 5 years and Pfizer-BioNTech's EUA request for kids 6 months through 4 years.

FDA to examine variant-specific vaccine

The FDA also said VRBPAC will meet on Jun 28 to assess whether COVID-19 vaccines should be modified to match circulating SARS-CoV-2 strains and, if so, which strain should be selected for the fall of 2022.

In addition, on Jun 7, VRBPAC will meet to discuss an EUA from Novavax for its adjuvanted, recombinant spike protein nanoparticle COVID-19 vaccine in adults. The next day, the group is slated to discuss updates to Moderna and Pfizer-BioNTech EUA's to include younger populations.

Peter Marks, MD, PhD, who directs the FDA's Center for Biologics Evaluation and Research, said there are a number of anticipated submissions and scientific questions that will benefit from VRBPAC discussions. He said the schedule is tentative and that the agency is committed to a thorough and transparent process.

"We intend to move quickly with any authorizations that are appropriate once our work is completed," he added.

In other US developments:

  • The nation's COVID-19 activity continues to rise steadily, with the 7-day average for new daily cases at 109,249 cases and 309 daily deaths, according to a Washington Post Over the past week, cases rose 21%, hospitalizations were up 5%, and deaths increased 4%.

  • With rising cases in Philadelphia, the school district on May 20 announced it will resume universal mask wearing effective today. It said it based the step on a recommendation from the Philadelphia Department of Public Health.

World Health Assembly meets this week

In global news, for the first time since the start of the pandemic, the World Health Assembly (WHA) is meeting in person in Geneva this week. Participants have been asked to wear masks and take rapid antigen tests each day. The WHA, made up of health officials from 194 member states, is the WHO's main decision-making body.

Some of the agenda items include examining the WHO's role in responding to health emergencies, influenza preparedness, and polio eradication.

In his opening address to the group yesterday, WHO Director-General Tedros Adhanom Ghebreyesus, PhD, said although the world has made progress against COVID-19, cases are increasing in nearly 70 countries across all WHO regions and against a backdrop of decreased testing.

"This virus has surprised us at every turn—a storm that has torn through communities again and again, and we still can't predict its path, or its intensity," he said. "We lower our guard at our peril."

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