Moderna COVID-19 Vaccine

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Moderna COVID-19 vaccine

It is codenamed mRNA-1273 and sold under the brand name Spikevax, is a COVID-19 vaccine developed by Moderna, the United States National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA). It is used in people aged 18 years and older to provide protection against infection by the SARS-CoV-2 virus, which causes COVID-19. It is designed to be administered as two 0.5 mL doses given by intramuscular injection at an interval of four weeks apart.


It is an RNA vaccine composed of nucleoside-modified mRNA (modRNA) encoding a spike protein of SARS-CoV-2, which is encapsulated in lipid nanoparticles.

The Moderna COVID‑19 vaccine is authorized for use at some level in 53 countries including the United States, Canada, the European Union, the United Kingdom, Israel, and Singapore.

On 15 March 2021, Moderna's second COVID‑19 vaccine (mRNA-1283) started phase I clinical trials.

Medical uses

The Moderna COVID‑19 vaccine is used to provide protection against infection by the SARS-CoV-2 virus in order to prevent COVID‑19.

Efficacy

Evidence of vaccine efficacy starts about two weeks after the first dose. High efficacy is achieved with full immunization, two weeks after the second dose, and was evaluated at 94.1%: at the end of the vaccine study that led to emergency authorization in the USA, there were eleven cases of COVID‑19 in the vaccine group (out of 15,181 people) versus 185 cases in the placebo group (15,170 people). Moreover, there were zero cases of severe COVID‑19 in the vaccine group, versus eleven in the placebo group. This efficacy has been described as "astonishing" and "borderline historic" for a respiratory virus vaccine, and it is similar to the efficacy of the Pfizer–BioNTech COVID-19 vaccine.

Efficacy estimates were similar across age groups, sexes, racial and ethnic groups, and participants with medical comorbidities associated with high risk of severe COVID‑19. Only individuals aged 18 or older were studied. Studies are underway to gauge efficacy and safety in children aged 0–11 (KidCOVE) and 12–17 (TeenCOVE).

A further study conducted by the CDC between December 2020 and March 2021, on nearly four thousand health care personnel, first responders, and other essential and frontline workers concluded that under real-world conditions, mRNA vaccine effectiveness of full immunization (14 days or more after second dose) was 90% against SARS-CoV-2 infections, regardless of symptoms, and vaccine effectiveness of partial immunization (14 days or more after first dose but before second dose) was 80%.

The duration of protection provided by the vaccine is not known as of April 2021, and a two-year follow up study is underway to determine this.

Chemistry

The vaccine contains the following ingredients:

  • nucleoside-modified messenger RNA encoding the SARS-CoV-2 spike glycoprotein (S) stabilized in its prefusion configuration;
  • lipids:
    • SM-102,
    • polyethylene glycol [PEG] 2000-dimyristoyl glycerol [DMG],
    • cholesterol,
    • and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC];
  • tromethamine;
  • tromethamine hydrochloride;
  • acetic acid;
  • sodium acetate;
  • and sucrose.

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.

Manufacturing

In June 2020, Moderna entered a partnership with Catalent in which Catalent will fill and package the vaccine candidate. Catalent will also provide storage and distribution.
On 9 July 2020, Moderna announced an in-fill manufacturing deal with Laboratorios Farmacéuticos Rovi, in the event that its vaccine is approved.
Moderna is relying extensively on contract manufacturing organizations to scale up its vaccine manufacturing process. In May 2021, it was revealed that the first step of the process—synthesis of DNA plasmids (to be used as a template for synthesis of mRNA)—has been handled from the beginning by a contractor called Aldevron in Fargo, North Dakota. For the remainder of the process, Moderna contracted with Lonza group to manufacture the vaccine at facilities in Portsmouth, New Hampshire in the United States, and in Visp in Switzerland, and purchased the necessary lipid excipients from CordenPharma. Besides CMOs, Moderna also manufactures the vaccine at its own production facility in Norwood, Massachusetts.
For the tasks of filling and packaging vials (fill and finish), Moderna entered into contracts with Catalent in the United States and Laboratorios Farmacéuticos Rovi in Spain. In April 2021, Moderna expanded its agreement with Catalent to increase manufacturing output at the latter's plant in Bloomington, Indiana. The expansion will allow Catalent to manufacture up to 400 vials per minute and fill an additional 80 million vials per year. Later that month, Moderna announced its plans to spend billions of dollars to boost production of their vaccines, potentially tripling its output in 2022, claiming as well that it would make no less than 800 million doses in 2021. The increase in production is in part attributed to improvements made by the company in manufacturing methods.
The Moderna news followed preliminary results from the Pfizer-BioNTech vaccine candidate, BNT162b2, with Moderna demonstrating similar efficacy, but requiring storage at the temperature of a standard medical refrigerator of 2–8 °C (36–46 °F) for up to thirty days or −20 °C (−4 °F) for up to four months, whereas the Pfizer-BioNTech candidate requires ultracold freezer storage between −80 and −60 °C (−112 and −76 °F). Low-income countries usually have cold chain capacity for only standard refrigerator storage, not ultracold freezer storage. In February 2021, the restrictions on the Pfizer vaccine were relaxed when the US Food and Drug Administration (FDA) updated the emergency use authorization (EUA) to permit undiluted frozen vials of the vaccine to be transported and stored at between −25 and −15 °C (−13 and 5 °F) for up to two weeks before use.
In November 2020, Nature reported that "While it's possible that differences in LNP formulations or mRNA secondary structures could account for the thermostability differences [between Moderna and BioNtech], many experts suspect both vaccine products will ultimately prove to have similar storage requirements and shelf lives under various temperature conditions."


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