Pfizer and BioNTech Propose Expanded COVID-19 Vaccine Trial to 44,000 Participants

Strategic Insights -

Pfizer Inc and BioNTech SE have proposed to the US Food and Drug Administration (FDA) to expand their Phase 3 pivotal COVID-19 vaccine trial to approximately 44,000 participants, increasing the diversity of the trial population. The initial target of 30,000 participants is expected to be reached by next week. The expansion will allow enrollment of individuals as young as 16 and those with chronic, stable HIV, hepatitis C, and hepatitis B. This move follows a July pledge by drugmakers to ensure diverse sets of volunteers in larger clinical trials, given COVID-19's disproportionate impact on communities of color. If successful, the companies may submit the vaccine for regulatory approval as early as October, aiming to supply up to 100 million doses by the end of 2020 and 1.3 billion by the end of 2021.

Key Takeaways:

  • Pfizer and BioNTech propose expanding their Phase 3 COVID-19 vaccine trial to 44,000 participants, an increase from the initial target of 30,000.
  • The trial expansion will allow enrollment of individuals as young as 16 and those with chronic, stable HIV, hepatitis C, and hepatitis B.
  • The companies aim to ensure a diverse set of volunteers in the trial, given COVID-19's disproportionate impact on communities of color.
  • If the trial is successful, the vaccine could be submitted for regulatory approval as early as October.
  • Pfizer and BioNTech expect to supply up to 100 million doses by the end of 2020 and 1.3 billion by the end of 2021.
  • The vaccine candidate uses chemical messenger RNA to mimic the surface of the coronavirus and teach the immune system to recognize and neutralize it.
  • The companies continue to expect a conclusive readout on efficacy by the end of October, based on current infection rates.
  • According to Pfizer's Chief Business Officer John Young, diversity in clinical trials is critical, given the disease's disproportionate impact on communities of color.

Statistics:

  • The proposed expansion will increase the trial population by 44,000 participants.
  • The initial target of 30,000 participants is expected to be reached by next week.
  • The companies aim to supply up to 100 million doses by the end of 2020.
  • By the end of 2021, the companies expect to supply up to 1.3 billion doses.
  • The vaccine candidate uses a novel mRNA technology, with no approved mRNA vaccine previously on the market.

Sources:

  • Pfizer and BioNTech joint statement on expanding the Phase 3 COVID-19 vaccine trial.
  • US Food and Drug Administration (FDA) guidelines for COVID-19 vaccine trials.
  • Congressional hearing transcript featuring Pfizer's Chief Business Officer John Young.