Pfizer Shares Jump on Positive COVID-19 Vaccine Trial Data for Adolescents

Strategic Insights -

Pfizer has published promising follow-up data from a late-stage trial of its coronavirus vaccine in adolescents, showing a 100% efficacy rate in those between 12 and 15 years of age. The data demonstrates the vaccine's safety and effectiveness in this age group, which has seen a rise in COVID-19 cases in some regions. The company plans to submit the data to the US FDA for expanded approval of the vaccine, which was granted Emergency Use Authorization earlier this year.

Key Takeaways:

  • The vaccine showed a 100% efficacy rate in adolescents between 12 and 15 years of age, measured seven days through over four months after the second dose.
  • No serious safety concerns were noted in the phase 3 trial, with a favourable safety profile and robust neutralizing antibody responses elicited using a two-dose regimen of 10 µg doses.
  • Pfizer plans to submit the data to the US FDA for expanded approval of the vaccine, based on the Emergency Use Authorization it was granted earlier this year.
  • The company has already submitted data to the FDA from a late-stage trial of the Comirnaty vaccine in children between 5 and 11 years of age, showing a favourable safety profile and robust neutralizing antibody responses.
  • CEO Albert Bourla stated that the additional data provide further confidence in the vaccine's safety and effectiveness profile in adolescents, especially as rates of COVID-19 are climbing in this age group in some regions.
  • Pfizer shares were marked 0.4% higher in early trading, extending the stock's six-month gain to around 26.2%.
  • The company's third-quarter earnings were stronger-than-expected, with revenues nearly doubling from last year to $24.1 billion.
  • Around $13 billion of the topline came from vaccine sales, and Pfizer lifted its vaccine sales estimate to around $36 billion.
  • The company sees adjusted earnings in the region of $4.13 to $4.18 per share, up from its prior forecast of $3.95 to $4.05 per share.

Statistics:

  • 100% efficacy rate in adolescents between 12 and 15 years of age (measured seven days through over four months after the second dose)
  • No serious safety concerns noted in the phase 3 trial
  • 0.4% higher in early trading, extending the stock's six-month gain to around 26.2%
  • $24.1 billion in revenues (nearly double from last year)
  • $13 billion in vaccine sales (around 54% of total topline)
  • $36 billion estimated vaccine sales
  • $4.13 to $4.18 per share (adjusted earnings forecast)
  • $3.95 to $4.05 per share (prior adjusted earnings forecast)

Sources:

  • Pfizer
  • The Street
  • AP News
  • BioNTech
  • US FDA