How can Pfizer Covid vaccine be approved in fall 2021 when its trials–which include no pregnant or breastfeeding women–won’t be finished until May 2023?-ClinicalTrials.gov

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“Estimated [Pfizer] Study Completion Date: May 2, 2023.”..Excluded from ongoing Pfizer study: “Women who are pregnant or breastfeeding."… “FDA officials familiar with the process predict that full approval of at least Pfizer’s vaccine could come in September or October [2021]."…8/1/21, “FDA Under Pressure to Grant Full Approval to Covid-19 Vaccines," Wall St. Journal

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As of 7/22/21, “Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals,” clinicaltrials.gov

“Sponsor: BioNTech SE

Collaborator: Pfizer

Information provided by (Responsible Party): BioNTech SE…

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Study Design…

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Actual Study Start Date: April 29, 2020

Estimated Primary Completion Date: Nov. 2, 2021

Estimated Study Completion Date: May 2, 2023…

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Eligibility Criteria…

Inclusion Criteria:…

Note that participants <18 years of age cannot be enrolled in the EU….

• Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures….
• Capable of giving personal signed informed consent

Exclusion Criteria:…

• Women who are pregnant or breastfeeding.
• Previous vaccination with any coronavirus vaccine.
• Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study….
• Phases 1 and 2 only: Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).
• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
• Receipt of medications intended to prevent COVID 19.
• Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19

• Phase 1 only: Individuals at high risk for severe COVID-19, including those with any of the following risk factors:
  • Hypertension
  • Diabetes mellitus
  • Chronic pulmonary disease
  • Asthma
  • Current vaping or smoking
  • History of chronic smoking within the prior year
  • BMI >30 kg/m2
  • Anticipating the need for immunosuppressive treatment within the next 6 months
• Phase 1 only: Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (eg, healthcare worker, emergency response personnel)."...

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