Covid Vaccines and Their Excipients | Covid-19 Vaccines

Covid Vaccines and Their Excipients

Over the past 18 months a series of vaccines have been developed against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or COVID-19 virus. They represent a complete departure from traditional vaccines and rely on new technology platforms, deliveries (injectable and intranasal) and ingredients (for listings of ingredients in traditional, fully-approved vaccines, see). These include nucleic acid (DNA and mRNA), virus-like particle, peptide, viral vector (replicating and non-replicating), recombinant protein, live attenuated virus and inactivated virus approaches. Globally, some 300 experimental COVID-19 vaccines are being developed.

Public information on the specific SARS-CoV-2 antigen(s) used in vaccine development is limited. Most candidates for which details are available aim to induce neutralizing antibodies against the viral spike (S) protein, preventing uptake via the human ACE2 receptor. However, it remains unclear how different forms and/or variants of the S protein used in different candidates relate to each other, or to the genomic epidemiology of the disease.

The published compositions of the major vaccines include:

Pfizer-BioNTech vaccine: messenger ribonucleic acid (mRNA), lipids, potassium chloride, monobasic potassium phosphate, sodium chloride, dibasic sodium phosphate dihydrate, and sucrose. The nanolipids used as vehicle for delivery include: ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and cholesterol.

Moderna vaccine: messenger ribonucleic acid (mRNA), lipids, tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate, and sucrose. The nanolipid components include: the aminolipid SM-102 [Heptadecan-9-yl 8-{(2-hydroxyethyl)[6-oxo-6-(undecyloxy)hexyl]amino}octanoate], 1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000 [PEG2000-DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]).

Janssen vaccine: recombinant, replication-incompetent adenovirus type 26 expressing the SARS-CoV-2 spike protein, citric acid monohydrate, trisodium citrate dihydrate, ethanol, 2-hydroxypropyl-β-cyclodextrin (HPBCD), polysorbate 80, and sodium chloride.

Oxford-AstraZeneca vaccine: recombinant, replication-deficient chimpanzee adenovirus vector, histidine, histidine hydrochloride monohydrate, sodium chloride, magnesium chloride hexahydrate, disodium edetate (EDTA), sucrose, ethanol absolute, polysorbate 80 and water.

Sputnik V vaccine: adenovirus viral vector vaccine. The components include: tris(hydroxymethyl)aminomethane, sodium chloride, sucrose, magnesium chloride hexahydrate, Disodium EDTA dihydrate, polysorbate 80, ethanol 95%, and water. No adjuvants and no other components or ingredients are included in this vaccine.

CoronaVac, or Sinovac COVID-19 vaccine: Inactivated SARS-CoV-2 Virus, aluminum hydroxide, disodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate monohydrate, sodium chloride and water.

The above Covid-19 vaccines are all experimental and are not yet approved by authorities as is required for regular drugs. Their use is authorized under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID19) by the World Health Organization (WHO), the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) or other agencies (for a listing see).

The sudden, huge global surge for the supply of the vaccines has created major ingredient shortages, particularly for some of the nanolipid components that were not widely used in the past. Manufacturers are scrambling to meet the demand and have exhausted their capacities. Many report lack of inventory and have announced new product deliveries for only 2022 and beyond. CarboMer is one of the few manufacturers that is able to supply the nanolipid and other critical products in these challenging times.