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On June 12, 2022, the U.S. Food and Drug Administration (FDA) released a long-awaited analysis of the Pfizer Inc. (PFE) and BioNTech SE (BNTX) COVID-19 vaccine for potential use in children under age 5. The analysis suggested that the vaccine appears to be safe and effective in preventing the illness in children in that age group. No new safety concerns were present in the evaluation.

The FDA’s post about Pfizer’s vaccine follows a similar posting that the FDA made earlier about Moderna’s vaccine for children under 6. The FDA is scheduled to meet on June 15 to determine whether to approve shots from either or both companies. The shots would be administered to many of the nation’s 18 million children beneath age 5, which includes babies, toddlers and preschoolers.

Key Takeaways

  • The FDA posted on June 12 an analysis suggesting that Pfizer’s COVID-19 vaccine is safe and effective for children under age 5.
  • Federal officials will vote on June 15 whether to expand Pfizer’s Emergency Use Authorization EUA to include the youngest age group to be eligible for the COVID-19 vaccine.
  • 18 million children across the U.S. could be impacted by the decision.
  • Moderna’s vaccine is also up for approval for young children.

Pfizer EUA Amendment

The FDA’s analysis follows a May 27, 2022 request by Pfizer for the FDA to amend its existing Emergency Use Authorization (EUA) for the company’s COVID-19 vaccine. Pfizer has sought to expand use of its vaccine to include a 3-dose series for children 6 months through 4 years of age.

As mentioned, there are approximately 18 million young children potentially impacted by such an amendment. Children under 5 are currently the only group in the U.S. not eligible for the Pfizer COVID-19 vaccine. If the FDA decides to amend the EUA to include young children, the U.S. Centers for Disease Control and Prevention would then take up the question of which children to recommend for vaccination.

Potential Business Impacts

The potential business impact on Pfizer is unclear regarding how its sales would be affected by an amended EUA allowing children under 5 to receive its vaccine. Though parents of young children have pressed federal officials for an approval of a COVID-19 vaccine, overall vaccination rates to prevent illnesses among kindergarten-aged children have fallen slightly since the start of the pandemic. Theoretically, a three-dose COVID-19 vaccine regimen for 18 million potential young children could yield up to 54 million doses for Pfizer.

However, if the Moderna vaccine is also approved at the same time, that could sharply decrease the number of Pfizer doses administered. Another factor is pandemic safety protocol fatigue: schools in New York, Boston, and elsewhere have dropped mask mandates for young children. Whether this trend will lead cautious parents to seek out the vaccine for their children is unclear.

Pfizer’s COVID-19 vaccine has been a boon for the company’s finances since it was approved for select use in adults. As sales of Pfizer’s COVID-19 vaccine surged in 2021, Pfizer’s fiscal year net income soared to $22.0 billion as revenue jumped 95% to 81.3 billion. In the first three months of 2021, the vaccine generated $3.5 billion in revenue. As rates of new vaccinations drop, that number could fall sharply.

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