Moderna Announces Advancements in mRNA Platform Science for Application Across Multiple Diseases at Science and Technology Day - Seite 3

In addition to the clinical benefits of stabilizing mRNA integrity, manufacturing protocols that limit the formation of lipid-mRNA adducts can improve product shelf-life. It thus remains critical to ensure robust analytical methods and stringent manufacturing controls to ensure mRNA stability and high activity in LNP delivery systems. Moderna's adduct formation research has led to the development of manufacturing processes designed to identify and mitigate lipid-driven impurities that would otherwise disrupt mRNA translation and reduce product shelf-life. As a result, new manufacturing controls have resulted in improved shelf-life, improved product activity, and higher storage temperatures.

With hundreds of millions of COVID-19 vaccines administered, numerous observational studies and in-depth animal research, current data supports the safety of vaccination relative to fertility, pregnancy, and breastfeeding. In addition to examination of real-world and observational data, Moderna reviewed guidelines from several health agencies, including the United States Centers for Disease Control and Prevention (CDC), the United Kingdom (UK) Health Security Agency, the European Medicines Agency (EMA)'s COVID-19 Task Force (ETF), the UK Joint Committee on Vaccination and Immunisation (JCVI). Taken together, current data supports the safety of COVID-19 vaccination for pregnant or breastfeeding women and suggests no safety concerns in regard to fertility. Currently there is no evidence that COVID-19 vaccines cause fertility problems in women or men. Observational data from vaccinated pregnant women has not shown an increase in adverse pregnancy outcomes and no increased risk for miscarriage has been seen.

Observational data from women who were breastfeeding after COVID-19 vaccination have not shown a risk for adverse effects in breastfed newborns/infants. As per the CDC, COVID-19 vaccination is recommended for people who are pregnant, breastfeeding, trying to get pregnant now, or might become pregnant in the future.

Biodistribution of Moderna's vaccine

To further characterize Moderna's IM vaccines, biodistribution studies were conducted to demonstrate where mRNA goes in the body after injection. Studies demonstrate that injected mRNA remains predominantly at the injection site and in nearby draining lymph nodes. Furthermore, consistent with its transient nature, mRNA is undetectable in the body 5 days after injection, with minimal mRNA detectable after only 3 days.

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