Shocking statement about Pfizer…

Regulatory Submissions and Future Plans

Given these promising outcomes, Pfizer and BioNTech are moving quickly to seek authorization. "We are eager to extend the protection offered by the vaccine to this younger population, subject to regulatory approval," said Pfizer Chairman and CEO Albert Bourla.

The companies plan to submit their findings to the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other global regulatory bodies as soon as possible. Additionally, they expect to release clinical trial results for children under the age of 5 by the end of the year.

The Delta Variant and Pediatric Risks

The push to vaccinate younger children has gained urgency amid the spread of the Delta variant. "We are monitoring the spread of the Delta variant and the significant threat it poses to children," Bourla noted.

Over the summer, U.S. health professionals warned of a surge in pediatric hospitalizations driven by the Delta variant. Data released in early September by the U.S. Centers for Disease Control and Prevention (CDC) confirmed that hospitalizations among children and adolescents increased fivefold between late June and mid-August. However, the CDC also noted that the proportion of young patients suffering from severe illness remained stable during the period when the Delta variant was predominant.

Crucially, the CDC highlighted the vaccine's effectiveness in older youth, reporting that hospitalization rates were ten times higher among unvaccinated children and adolescents compared to those who had completed their full vaccination schedule.

Global Vaccination Policies

While children aged 12 to 17 have been eligible for the vaccine in the U.S. since mid-June—with 69% having received at least one dose—vaccinations for the under-12 cohort have not yet begun pending regulatory approval.

Internationally, policies vary. In France, President Emmanuel Macron addressed the topic in early September, emphasizing a cautious approach guided by scientific consensus. "Some countries have opened their doors to children under 12, but we follow the advice of experts and, for the moment, continue with those over 12," Macron stated. "There are those who are concerned, and we must listen to their concerns. As soon as the scientists tell us, 'We can open the doors to younger children,' we will."