Moderna COVID-19 vaccine
The Moderna COVID‑19 vaccine, sold under the brand name Spikevax, is a COVID-19 vaccine developed by the American company Moderna, the United States National Institute of Allergy and Infectious Diseases (NIAID), and the Biomedical Advanced Research and Development Authority (BARDA). Depending on the jurisdiction, it is authorized for use in humans aged six months,[48] twelve years, or eighteen years and older. It provides protection against COVID-19, which is caused by infection by the SARS-CoV-2 virus.[42][2][22][14]
"Moderna vaccine" redirects here. For other Moderna vaccination topics, see Moderna.Vaccine description
- AU: S4 (Prescription only)[10][11][7][8][12][13][14][15][16][17][18][19]
- BR: Approved (BA.4/5 and XBB.1.5)[20][21]
- CA: ℞-only / Schedule D[4][22][23][24][25][26][27][28]
- UK: Marketing authorization granted[29][30][31][32]
- US: ℞-only with standing order;[33][34][35][36] Spikevax approved for those aged 18+;[37][1][38] Emergency Use Authorization for those aged six months and older[37][39][40][41][42][43]
- EU: Marketing authorization granted[2][44][45][46][47]
- Full list of Moderna vaccine authorizations
It is designed to be administered in two or three 0.5-mL doses given by intramuscular injection, primarily into the deltoid muscle, at an interval of at least 28 days apart.[33][49][50][51] The World Health Organization advises an eight-week interval between doses to optimize efficacy. Additional booster doses are approved in some regions to maintain immunity. Clinical trials and real-world data have demonstrated the vaccine's high efficacy, with significant effectiveness observed two weeks post-administration of the second dose, offering 94% protection against Covid and robust defense against severe cases. The vaccine's efficacy spans various demographics, including age, sex, and those with high-risk medical conditions.
It is an mRNA vaccine composed of nucleoside-modified mRNA (modRNA) encoding a spike protein of SARS-CoV-2, which is encapsulated in lipid nanoparticles.[52] In August and September 2022, bivalent versions of the vaccine (Moderna COVID-19 Vaccine, Bivalent) containing elasomeran/elasomeran 0-omicron (Spikevax Bivalent Zero/Omicron)[53] were authorized for use as booster doses in individuals aged 18 or older in the United Kingdom,[54][55] Switzerland,[56] Australia,[57] Canada,[58][59] the European Union,[2] and the United States.[60][61][62][63][64][65] The second component of the version of the bivalent vaccine used in the United States[66] is based on the Omicron BA.4/BA.5 variant,[60] while the second component of the bivalent vaccine version used in other countries is based on the Omicron BA.1 variant.[2][53][55][54][59] The vaccine's effectiveness against variants has been extensively studied, indicating varying degrees of protection. For instance, during the prevalence of the Delta variant, effectiveness against infection slightly decreased over time. The vaccine's longevity and continuous protection are under study, with ongoing research focusing on its duration of effectiveness, which remains partially undetermined as of the latest updates.
The safety profile of the vaccine is favorable, with common side effects including injection site pain, fatigue, and headaches. Severe reactions like anaphylaxis are exceedingly rare. Concerns regarding myocarditis, have been identified but are typically mild and manageable. The vaccine's formulation utilizes mRNA technology, encapsulated within lipid nanoparticles to ensure cellular uptake and immune system response.
Pharmacology
Moderna's technology uses a nucleoside-modified messenger RNA (modRNA) compound codenamed mRNA-1273. The mRNA-1273 drug delivery system uses a PEGylated lipid nanoparticle drug delivery (LNP) system.[97] Once the compound is inside a human cell, the mRNA links up with the cell's endoplasmic reticulum. The mRNA-1273 is encoded to trigger the cell into making a specific protein using the cell's normal manufacturing process. The vaccine encodes a version of the spike protein with a modification called 2P, in which the protein includes two stabilizing mutations in which the original amino acids are replaced with prolines, developed by researchers at the University of Texas at Austin and the National Institute of Allergy and Infectious Diseases' Vaccine Research Center.[98][99][100] Once the protein is expelled from the cell, it is eventually detected by the immune system, which begins generating efficacious antibodies.
The vaccine contains the following ingredients:[42][41]
The active ingredient is an mRNA sequence containing a total of 4101 nucleotides that encodes the full-length SARS-CoV-2 spike (S) glycoprotein,[101] with two mutations (K986P and V987P) designed to stabilize the pre-fusion conformation. The sequence is further optimized by:[102][103]
A putative sequence of the vaccine has been published on a forum for professional virologists, obtained by direct sequencing of residual vaccine material in used vials.[104]
The vaccine mRNA is dissolved in an aqueous buffer containing tromethamine, tromethamine hydrochloride, sodium acetate, and sucrose.[33] The mRNA is encapsulated in lipid nanoparticles that stabilize the mRNA and facilitate its entry into cells.[52] The nanoparticles are manufactured from the following lipids:
History
Original version
In January 2020, Moderna announced development of an RNA vaccine, codenamed mRNA-1273, to induce immunity to SARS-CoV-2.[122][123][124]
Moderna received US$955 million from the Biomedical Advanced Research and Development Authority (BARDA), an office of the US Department of Health and Human Services. BARDA funded 100% of the cost of bringing the vaccine to FDA licensure.[125][126]
The United States government provided $2.5 billion in total funding for the Moderna COVID‑19 vaccine (mRNA-1273).[127] Private donors also made contributions to the vaccine's development. The Dolly Parton COVID-19 Research Fund contributed $1 million.[128]