ALC-0315 ([(4-hydroxybutyl)azanediyl]di(hexane-6,1-diyl) bis(2-hexyldecanoate)) is a synthetic lipid. A colorless oily material, it has attracted attention as a component of the SARS-CoV-2 vaccine, BNT162b2, from BioNTech and Pfizer. Specifically, it is one of four components that form lipid nanoparticles (LNPs), which encapsulate and protect the otherwise fragile mRNA that is the active ingredient in these drugs.[1][2] These nanoparticles promote the uptake of therapeutically effective nucleic acids such as oligonucleotides or mRNA both in vitro and in vivo.[3][4]
ALC-0315 is one of the components of the BNT162b2 vaccine (0.43 mg per dose).[7] Its chemical properties as a tertiary amine mean that its cation can form an ionic bond to the messenger RNA which carries the genetic information for the SARS-CoV-2spike protein formation in the human body.[5] Importantly, once the lipid nanoparticle which encapsulates the mRNA has been absorbed into antigen-presenting cells (a process called receptor-mediated endocytosis) the more acidic environment within the endosome fully protonates the ALC-0315 as a result the nanoparticle releases its payload of mRNA.[2][8] In December 2021 there were objections raised against the use of ALC-0315 and ALC-0159 (and some other solid lipid nanoparticles) in humans by critics of mRNA-COVID-19 vaccines in Germany but the German pharmaceutical trade journal Pharmazeutische Zeitung (de) and the German investigative collective Correctiv refuted this and stated as one important reason that the European Medicines Agency has approved the vaccine and this includes all its ingredients.[9][10]
^WO application 2018081480, Ansell S.; Barbosa C. & Du X. et al., "Lipid nanoparticle formulations", published 2018-05-03, assigned to Acuitas Therapeutics, Inc.
^"Absurde Diskussion um Lipide ALC-0315 und ALC-0159". 18 January 2022. Retrieved 23 January 2022. Erstens stimmt es nicht, dass die Zusatzstoffe unerlaubt sind. Denn Comirnaty ist zugelassen und damit sind auch alle darin enthaltenen Hilfsstoffe zugelassen. [Firstly, it is not true that the additives are illegal. Because Comirnaty is approved and therefore all the additives contained in it are also approved.]
^"Faktencheck: Nein, der Biontech-Impfstoff enthält keine Inhaltsstoffe, die nicht für Menschen zugelassen sind". 23 December 2021. Retrieved 23 January 2022. Doch anders als behauptet, sind sie nicht gesundheitsschädlich, die EMA hat die Impfung und somit auch deren Bestandteile zugelassen. Dass die Bestandteile bei der Zulassung der mRNA-Impfstoffe geprüft wurden, bestätigte uns auch das Paul-Ehrlich-Institut (PEI) auf Anfrage. [But contrary to what is claimed, they are not harmful to health, the EMA has approved the vaccination and thus also its components. On request, the Paul Ehrlich Institute (PEI) also confirmed that the components were tested when the mRNA vaccines were approved.]
