Moderna COVID-19 vaccine
The Moderna COVID-19 vaccine (pINN: elasomeran, codenamed mRNA-1273, and commercialized under the trade name Spikevax) was developed by Moderna, the National Institute of Allergy and Infectious Diseases (NIAID), and the Biomedical Advanced Research and Development Authority (BARDA). In certain countries, it is legal to use in persons above the age of twelve, as well as for those under the age of twelve. In certain jurisdictions, it is approved for use in persons aged twelve and up, while in others, it is approved for use in people aged eighteen and up to protect against COVID-19, which is caused by infection with the SARS-CoV-2 virus. It is intended to be given in two 0.5 mL intramuscular injections with a 29-day interval. It's an RNA vaccine made up of nucleoside-modified mRNA (modRNA) that encodes a SARS-CoV-2 spike protein and is encapsulated in lipid nanoparticles. Many governments have given it permission to be used at some degree. Moderna's second COVID19 vaccine (mRNA-1283) began phase I clinical trials on March 15, 2021.
Medical uses
COVID19 is prevented by using the Moderna COVID19 vaccine, which protects against infection by the SARS-CoV-2 virus. The vaccination is injected into the deltoid muscle intramuscularly. There are two dosages in the first course. A 28-day gap between dosages is recommended by the World Health Organization (WHO). The effects of the initial dose might last up to 10 weeks, according to the data. As a result, the WHO recommends postponing the second dosage by up to 12 weeks in order to ensure high coverage of the first dose in high-priority groups and minimize fatalities in areas where supplies are low.
Efficacy
Approximately two weeks following the first dosage, evidence of vaccination effectiveness emerges. Full vaccination was evaluated at 94.1 percent effectiveness two weeks after the second dose: at the end of the vaccine trial that resulted to emergency authorisation in the US, there were eleven instances of COVID19 in the vaccine group (out of 15,181 individuals) against 185 cases in the placebo group (15,170 people) . Furthermore, in the vaccination group, there were zero occurrences of severe COVID19, compared to eleven in the placebo group. For a respiratory virus vaccine, this effectiveness has been described as "astonishing" and "borderline historic," and it is comparable to the efficacy of the Pfizer–BioNTech COVID-19 vaccine.
Participants with medical comorbidities associated with a high risk of severe COVID19 had similar efficacy estimates across age ranges, sexes, racial and ethnic groupings, and participants with medical comorbidities associated with a high risk of severe COVID19. The researchers only looked at those who were at least 18 years old. Children ages 0–11 (KidCOVE) and 12–17 (12–17) are being studied to determine effectiveness and safety (TeenCOVE) A second study conducted by the US Centers for Disease Control and Prevention (CDC) on nearly 4,000 health care workers, first responders, and other essential and frontline workers between December 2020 and March 2021 found that mRNA vaccine effectiveness of full immunization against SARS-CoV-2 infections was 90% in real-world conditions, regardless of symptoms. As of April 2021, the vaccine's length of protection remains unknown, and a two-year follow-up research is being conducted to find out.
Specific populations
There is less information on the Moderna COVID19 vaccine's safety in pregnant women. Pregnant women were either excluded from the research or had their vaccinations stopped after a positive pregnancy test. Animal studies revealed no safety issues, and clinical trials to assess the safety and effectiveness of COVID19 vaccinations in pregnant women are now underway.
Adverse effects
"The safety data indicated a positive safety profile," according to the World Health Organization (WHO), and the vaccine's AE (adverse event) profile "did not highlight any significant safety concerns." Pain at the injection site, tiredness, headache, myalgia (muscle pain), and arthralgia were the most prevalent side effects (joint pain). Anaphylaxis (a severe allergic reaction) has been recorded in 2.5 instances per million doses delivered, according to the US Centers for Disease Control and Prevention (CDC), which recommends a 15-minute observation period following injection. In rare occasions, delayed cutaneous responses resulting in rash-like erythemas have been reported at injection sites, however they are not considered severe or contraindications to future immunization. Local unfavorable erythema occurs in around 10.8% of cases, with redness extending to a diameter of 100mm or more in 1.9 percent of instances. The US Centers for Disease Control and Prevention (CDC) verified on June 23, 2021 that myocarditis or pericarditis occurred in around 13 of every 1 million young individuals, primarily males over the age of 16, who got the Moderna or Pfizer–BioNTech vaccination. With proper treatment and rest, the majority of those who are afflicted recover rapidly.
Pharmacology
Moderna's technique makes use of mRNA-1273, a nucleoside-modified messenger RNA (modRNA) molecule. Once inside a human cell, the compound's mRNA binds to the cell's endoplasmic reticulum. The mRNA-1273 coding instructs the cell to use its regular manufacturing process to produce a specific protein. Researchers from the University of Texas at Austin and the National Institute of Allergy and Infectious Diseases' Vaccine Research Center developed a vaccine that encodes a version of the spike protein with a modification known as 2P, in which the protein includes two stabilizing mutations in which the original amino acids are replaced with prolines. Once the protein has been released from the cell, the immune system detects it and begins producing effective antibodies. A PEGylated lipid nanoparticle drug delivery (LNP) technology is used in the mRNA-1273 drug delivery system.
Manufacturing
Moderna and Catalent formed a collaboration in June 2020, with Catalent filling and packaging the vaccine candidate. In addition, Catalent will handle storage and distribution. In the event that the vaccine is authorized, Moderna announced an in-fill production contract with Laboratorios Farmacéuticos Rovi on July 9, 2020. To scale up its vaccine production method, Moderna relies heavily on contract manufacturing firms. The first phase of the procedure, the synthesis of DNA plasmids (to be used as a template for mRNA synthesis), was handled by Aldevron of Fargo, North Dakota. Moderna partnered with Lonza Group to produce the vaccine at facilities in Portsmouth, New Hampshire, and Visp, Switzerland, and acquired the required lipid excipients from CordenPharma for the rest of the process. [58] Moderna produces the vaccine in its own facilities in Norwood, Massachusetts, in addition to using CMOs. Moderna signed contracts with Catalent in the United States and Laboratorios Farmacéuticos Rovi in Spain to fill and package vials (fill and finish). Moderna extended its deal with Catalent in April 2021 to enhance production output at the latter's Bloomington, Indiana factory. Catalent will be able to produce up to 400 vials per minute and fill an additional 80 million vials per year as a result of the expansion. Moderna said later that month that it will spend billions of dollars to expand vaccine manufacturing, perhaps doubling output by 2022, and claimed that it would produce no less than 800 million doses in 2021. Part of the rise in output can be ascribed to the company's advancements in manufacturing processes.
Moderna's announcement came after preliminary results from the Pfizer-BioNTech vaccine candidate, BNT162b2, with Moderna demonstrating similar efficacy but requiring storage at 2–8 °C 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. Low-income nations often have just ordinary refrigerator storage capacity, not ultracold freezer storage. The US Food and Drug Administration amended the emergency use authorisation for the Pfizer vaccine in February 2021, allowing undiluted frozen vials of the vaccine to be transported and kept at between 25 and 15 °C for up to two weeks before use.
"While differences in LNP formulations or mRNA secondary structures may account for the thermostability differences [between Moderna and BioNtech], many experts suspect both vaccine products will eventually prove to have similar storage requirements and shelf lives under various temperature conditions," according to a report published in Nature in November 2020.
Brand names
During development and testing, the code name was mRNA-1273, the proposed international nonproprietary name (pINN) was elasomeran, and the brand name was Spikevax.
Economics
Singapore signed a pre-purchase deal for Moderna in June 2020, allegedly paying a higher price to obtain early vaccination supply, however the government refuses to reveal the exact price and amount, citing commercial sensitivities and confidentiality restrictions. The US government agreed to acquire 100 million doses of Moderna's upcoming vaccine on August 11, 2020, according to the Financial Times, which claimed Moderna planned to charge US$50–60 each course. Moderna said in November 2020 that it will charge governments between US$25 and US$37 each dosage for its vaccine, while the European Union is seeking a price of less than US$25 per dose for the 160 million doses it expects to buy from Moderna.
Moderna has secured purchase agreements for mRNA-1273 with the European Union for 160 million doses and Canada for up to 56 million doses in 2020. The European Union will pay US$18 each dosage, according to a tweet from Belgium's Budget State Secretary on December 17, while the US will pay US$15 per dose, according to The New York Times. Prime Minister Justin Trudeau had earlier stated that delivery would begin within 48 hours of permission and that 168,000 doses would be given by the end of December, as of the authorisation in Canada on December 23, 2020.
The first cargo landed in Singapore on February 17, 2021. Moderna forecasted sales of its COVID-19 vaccine at US$18.4 billion in February 2021.
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