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Male and female reproductive inclusion criteria in phase 3 studies

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 In the BioNtech/Pfizer protocol C4591001 for the Phase 3 study of Comirnaty (below), the Appendix 4 describes strict male and female reproductive inclusion criteria.

Are all these precautions standard precautions in all vaccine trials?

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Pregnancy/fertility data in the clinical trials of the mRNA vaccines

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Questions have been recently raised related to the fertility of women receiving the Covid-19 Vaccine.

We present what is known to date on the fertility/pregnancy outcomes of women receiving the Covid19 vaccines in the two Phase 2/3 trials today approved by several regulatory agencies (e.g EMA, FDA) to protect patients from Covid19:

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What should we know about COVID new variants?

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The emergence of new SARS-CoV-2 variants coincided with an outbreak of infections in Britain, South Africa and Brazil. Now these variants are spreading around the world. What are they, and what are their dangers?

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Is mRNA vaccine, a vaccine or gene therapy ?

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Vaccination with mRNA has nothing to do with gene therapy

Gene therapy introduces genetic material in order to correct or replace a defective gene, as a treatment of genetic disease or a cancer.

Whereas, mRNA vaccine enables cells to temporarily express the Spike protein at their surface. 

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