Miljöpåverkan
Schimpans-adenovirusvektor, kodar för SARS-CoV-2 spike-protein, rekombinant
Miljörisk:
Användning av vacciner bedöms inte medföra någon miljöpåverkan.
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Detaljerad miljöinformation
According to the EU EMA guideline for Environmental Risk Assessment of pharmaceuticals (Ref. 1) and guidance for Environmental Classification of Pharmaceuticals in www.fass.se (Ref. 2), in the case of products containing vitamins, electrolytes, amino acids, peptides, proteins, carbohydrates and lipids as active pharmaceutical ingredient(s), an ERA may consist of a justification for not submitting ERA studies, e.g. due to their nature they are unlikely to result in a significant risk to the environment. The same applies to vaccines and herbal medicinal products.
Enligt den europeiska läkemedelsmyndigheten EMA:s riktlinjer för miljörisk-bedömningar av läkemedelssubstanser (EMA/CHMP/SWP/4447/00), är vitaminer, elektrolyter, aminosyror, peptider, proteiner, kolhydrater, lipider, vacciner och växtbaserade läkemedel undantagna då de inte bedöms medföra någon betydande risk för miljön.
Also, a full assessment has been conducted according to the European Union (EU) Directive 2001/18/EC to identify and evaluate potential adverse effects on human health (other than the intended recipients) and the environment, which may result from the placing on the market of the genetically modified organism (GMO). This has concluded that the overall risk from Vaxzevria is negligible.
This justifies the phrase:
Användning av vacciner bedöms inte medföra någon miljöpåverkan.
(Use of vaccines has been considered to result in insignificant environmental impact.)
References
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Committee for Medicinal Products for Human Use (CHMP); Guideline on the Environmental Risk Assessment of Medicinal Products for Human Use. 1 June 2006, Ref EMEA/CPMP/SWP/4447/00.
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Environmental Classification of Pharmaceuticals in www.fass.se – Guidance for Pharmaceutical Companies. (2012 v2).