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SARS-CoV-2 : THE VARIANTS TRIAL ( updated 20 April 2021)

Feb 1, 2021

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« British », « South African » or « Brazilian », who are they, and what are their capabilities?

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? 

New Update :20 April 2021 

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Is mRNA vaccine, a vaccine or gene therapy ?

Jan 28, 2021

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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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EMA/FDA update on the safety of Comirnaty® and the analysis of adverse events for Covid-19 vaccines

Mar 15, 2021

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The EMA recently issued their first update on Comirnaty® on January 28th 2021. The investigation of reports of anaphylactic reactions and the risk of death following the vaccination in frail elderly individuals by professionals did not suggest a safety concern.

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

Feb 3, 2021

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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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Male and female reproductive inclusion criteria in phase 3 studies

Feb 2, 2021

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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?