Moderna COVID-19 vaccine

Moderna COVID-19 Vaccine, codenamed mRNA-1273, is a COVID-19 vaccine developed by the United States National Institute of Allergy and Infectious Diseases (NIAID), the Biomedical Advanced Research and Development Authority (BARDA), and Moderna. It is administered by two 0.5 mL doses given by intramuscular injection given four weeks apart.[11]

"Moderna vaccine" redirects here. For other Moderna vaccination topics, see Moderna.

Moderna COVID-19 vaccine
Vials of Moderna COVID-19 vaccine
Vaccine description
Target diseaseCOVID-19
TypemRNA
Clinical data
Pronunciation/məˈdɜːrnə/ mə-DUR-nə[1]
Other namesmRNA-1273, CX-024414, COVID-19 Vaccine Moderna, COVID-19 mRNA Vaccine Moderna
License data
Routes of
administration		Intramuscular
ATC code
  • None
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DrugBank
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 COVID-19 Portal

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. It is one of the two RNA vaccines developed and deployed in 2020 against COVID-19, the other being the Pfizer–BioNTech vaccine.

On 18 December 2020, mRNA-1273 was issued an Emergency Use Authorization by the United States Food and Drug Administration (FDA).[6][12][13][14] It was authorized for use in Canada on 23 December 2020,[2][3] in the European Union on 6 January 2021,[9][15][10] and in the United Kingdom on 8 January 2021.[16]

Design

In January 2020, Moderna announced development of an RNA vaccine, named mRNA-1273, to induce immunity to SARS-CoV-2.[17][18][19] Moderna's technology uses a nucleoside-modified messenger RNA (modRNA) compound which is named mRNA-1273. Once it is inside of a human cell, the mRNA links up with the cell's endoplasmic reticulum. The mRNA-1273 is encoded to tell the cell to make a specific protein using the cell's normal manufacturing process. Once it is expelled from the cell, it is eventually detected by our immune system which begins generating efficacious antibodies. Because the "blueprints" for the antibody are already part of your immune system, the manufacturing time is much shorter. Upon the announcement Moderna's shares rose dramatically, and the CEO and other corporate executives began large program sales of their shareholdings.[20] The drug delivery system of mRNA-1273 uses a PEGylated lipid nanoparticle drug delivery (LNP) system.[21]

Composition

The vaccine contains the following ingredients[22]

Clinical trials

Phase I / II

In March 2020, the Phase I human trial of mRNA-1273 began in partnership with the US National Institute of Allergy and Infectious Diseases.[24] In April, the U.S. Biomedical Advanced Research and Development Authority (BARDA) allocated up to $483 million for Moderna's vaccine development.[25] Plans for a Phase II dosing and efficacy trial to begin in May were approved by the U.S. Food and Drug Administration (FDA).[26] Moderna signed a partnership with Swiss vaccine manufacturer Lonza Group,[27] to supply 300 million doses per annum.[28]

On 25 May 2020, Moderna began a Phase IIa clinical trial recruiting 600 adult participants to assess safety and differences in antibody response to two doses of its candidate vaccine, mRNA-1273, a study expected to complete in 2021.[29] 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.[30]

On 9 July, Moderna announced an in-fill manufacturing deal with Laboratorios Farmacéuticos Rovi, in the event that its vaccine is approved.[31]

On 14 July 2020, Moderna scientists published preliminary results of the Phase I dose escalation clinical trial of mRNA-1273, showing dose-dependent induction of neutralizing antibodies against S1/S2 as early as 15 days post-injection. Mild to moderate adverse reactions, such as fever, fatigue, headache, muscle ache, and pain at the injection site were observed in all dose groups, but were common with increased dosage.[32][33] The vaccine in low doses was deemed safe and effective in order to advance a Phase III clinical trial using two 100-μg doses administered 29 days apart.[32]

In July 2020, Moderna announced in a preliminary report that its Operation Warp Speed candidate had led to production of neutralizing antibodies in healthy adults in Phase I clinical testing.[32][34] "At the 100-microgram dose, the one Moderna is advancing into larger trials, all 15 patients experienced side effects, including fatigue, chills, headache, muscle pain, and pain at the site of injection."[35] The troublesome higher doses were discarded in July from future studies.[35]

Phase III

Moderna and the National Institute of Allergy and Infectious Diseases began a Phase III trial in the United States on 27 July, with a plan to enroll and assign 30,000 volunteers to two groups — one group receiving two 100-μg doses of mRNA-1273 vaccine and the other receiving a placebo of 0.9% sodium chloride.[36] As of 7 August, over 4,500 volunteers had enrolled.

In September 2020, Moderna published the detailed study plan for the clinical trial.[37] On 30 September, CEO Stéphane Bancel said that, if the trial is successful, the vaccine might be available to the public as early as late March or early April 2021.[38] As of October 2020, Moderna had completed the enrollment of 30,000 participants needed for its Phase III trial.[39] The US National Institutes of Health announced on 15 November 2020 that overall trial results were positive.[40]

On 30 December 2020, Moderna published results from the Phase III clinical trial, indicating 94% efficacy in preventing COVID-19 infection.[41][42][43] Side effects included flu-like symptoms, such as pain at the injection site, fatigue, muscle pain, and headache.[42] The clinical trial is ongoing and is set to conclude in late-2022[44]

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".[45]

Since September 2020, Moderna has used Roche Diagnostics' Elecsys Anti-SARS-CoV-2 S test, authorized by the US Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA) on 25 November 2020. According to an independent supplier of clinical assays in microbiology, "this will facilitate the quantitative measurement of SARS-CoV-2 antibodies and help to establish a correlation between vaccine-induced protection and levels of anti-receptor binding domain (RBD) antibodies". The partnership was announced by Roche on 9 December 2020.[46]

A review by the FDA in December 2020, of interim results of the Phase III clinical trial on mRNA-1273 showed it to be safe and effective against COVID-19 infection resulting in the issuance of an EUA by the FDA.[12]

It remains unknown whether the Moderna vaccine candidate is safe and effective in people under age 18 and how long it provides immunity.[42]

In January 2021, Moderna announced that it would be offering a third dose of its vaccine to people who were vaccinated twice in its phase I trial. The booster would be made available to participants six to twelve months after they got their second doses. The company said it may also study a third shot in participants from its Phase III trial, if antibody persistence data warranted it.[47][48][49]

In January 2021, Moderna started development of a new form of its vaccine that could be used as a booster shot against the virus mutation found in South Africa.[50][51] It also started testing to see if a third shot of the existing vaccine could be used to fend off the virus variants.[51]

Storage requirements
Moderna vaccine being stored in a conventional medical freezer

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 30 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).[52][42] Low-income countries only have cold chain capacity for refrigerator storage.[53][54]

Efficacy

The interim primary efficacy analysis was based on the per-protocol set, which consisted of all participants with negative baseline SARS-CoV-2 status and who received 2 doses of investigational product per schedule with no major protocol deviations. The primary efficacy endpoint was vaccine efficacy (VE) in preventing protocol defined COVID-19 occurring at least 14 days after dose 2. Cases were adjudicated by a blinded committee. The primary efficacy success criterion would be met if the null hypothesis of VE ≤30% was rejected at either the interim or primary analysis. The efficacy analysis presented is based on the data at the first pre-specified interim analysis timepoint consisting of 95 adjudicated cases.[55] The data are presented below.

Interim analysis a for primary efficacy endpoint, COVID-19 starting 14 days after the 2nd dose, per-protocol set[55]
Primary endpoint: COVID-19 Cases n (%)
Incidence per 1000 person-years		 Vaccine efficacy
(95% confidence interval)
Vaccine group (N = 13,934) Placebo group (N = 13,883)
All participants 5 cases in 13,934 (<0.1%)

1.840

 90 cases in 13,883 (0.6%)

33.365

 94.5% (86.5-97.8%)
Participants 18–64 years of age 5 cases in 10,407 (<0.1%)

2.504

 75 cases in 10,384 (0.7%)

37.788

 93.4% (83.7-97.3%)
65 and older 0 cases in 3,527 15 cases in 3,499 (0.4%) 100%
Chronic lung disease 0/661 6/673 100%
Significant cardiac disease 0/686 3/678 100%
Severe obesity (BMI>40) 1/901 11/884 91.2% (32-98.9%)
Diabetes 0/1338 7/1309 100%
Liver disease 0/93 0/90
Obesity (BMI>30) 2/5269 46/5207 95.8% (82.6-99%)

Manufacturing
An insulated shipping container with Moderna vaccine boxes ensconced by cold packs

Moderna is relying extensively on contract manufacturing organizations to scale up its vaccine manufacturing process. Moderna has contracted with Lonza Group to manufacture the vaccine at facilities in Portsmouth, New Hampshire in the United States, and in Visp in Switzerland, and is purchasing the necessary lipid excipients from CordenPharma.[56] For the tasks of filling and packaging vials, Moderna has entered into contracts with Catalent in the United States and Laboratorios Farmacéuticos Rovi in Spain.[56]

Purchase commitments

In June 2020, Singapore signed a pre-purchase agreement for Moderna, reportedly paying a price premium in order to secure early stock of vaccines, although the government declined to provide the actual price and quantity, citing commercial sensitivities and confidentiality clauses.[57][58]

On 11 August 2020, the US government signed an agreement to buy 100 million doses of Moderna's anticipated vaccine,[59] which the Financial Times said Moderna planned to price its vaccine between $50–60 per course.[60] On November 2020, Moderna has stated that it will charge governments who purchase its vaccine between $25 and $37 per dose while the EU is seeking a price of under $25 per dose for the 160 million doses it plans to purchase from Moderna.[61][62]

In 2020, Moderna also obtained purchase agreements for mRNA-1273 with the European Union for 160 million doses and with Canada for up to 56 million doses.[63][64] On 17 December, a tweet by the Belgium Budget State Secretary revealed the EU would pay US$18 per dose, while The New York Times reported that the US would pay US$15 per dose.[65]

Authorizations

Expedited
U.S. military personnel being administered the Moderna vaccine
Kamala Harris, Vice President of the United States, receiving her second dose of the Moderna vaccination in January 2021.

As of December 2020, mRNA-1273 was under evaluation for emergency use authorization (EUA) by multiple countries which would enable rapid rollout of the vaccine in the United Kingdom, the European Union, Canada, and the United States.[66][67][68][69]

On 18 December 2020, mRNA-1273 was authorized by the United States Food and Drug Administration (FDA) under an EUA.[6][8][12] This is the first product from Moderna that has been authorized by the FDA.[70][13]

On 23 December 2020, mRNA-1273 was authorized by Health Canada.[2][3] Prime Minister Justin Trudeau previously stated that deliveries would begin within 48 hours of approval and that 168,000 doses would be delivered by the end of December.[71]

On 5 January 2021, mRNA-1273 was authorized for use in Israel by its Ministry of Health.[72]

On 3 February 2021, mRNA-1273 was authorized for use in Singapore by its Health Sciences Authority, with the first shipment expected to arrive in March.[73]

Standard

On 6 January 2021, the European Medicines Agency (EMA) recommended granting conditional marketing authorization[9][74] and the recommendation was accepted by the European Commission the same day.[10][15]

On 12 January 2021, Swissmedic granted temporary authorization for the Moderna COVID-19 mRNA Vaccine in Switzerland.[75][76]

Society and culture

Controversies

In May 2020, after releasing partial and non-peer reviewed results for only 8 of 45 candidates in a preliminary pre-Phase I stage human trial directly to financial markets, the CEO announced on CNBC an immediate $1.25 billion rights issue to raise funds for the company, at a $30 billion valuation,[77] while Stat said, "Vaccine experts say Moderna didn't produce data critical to assessing COVID-19 vaccine".[78]

On 7 July, disputes between Moderna and government scientists over the company's unwillingness to share data from the clinical trials were revealed.[79]

Pregnant and breastfeeding women were excluded from the initial trials used to obtain Emergency Use Authorization,[80] though trials in those populations are expected to be performed in 2021.[81]

Moderna also faced criticism for failing to recruit people of color in clinical trials.[82]

Patent litigation

The PEGylated lipid nanoparticle (LNP) drug delivery system of mRNA-1273 has been the subject of ongoing patent litigation with Arbutus Biopharma, from whom Moderna had previously licensed LNP technology.[21][83] On 4 September 2020, Nature Biotechnology reported that Moderna had lost a key challenge in the ongoing case.[84]

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