Male and female reproductive inclusion criteria in phase 3 studies


 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?


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


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:


What should we know about COVID new variants?


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?


Is mRNA vaccine, a vaccine or gene therapy ?


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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