SpikeVax COVID-19 Vaccine (Moderna) (mRNA-1273) Description
The COVID-19 Vaccine Moderna (SpikeVax) (mRNA-1273) is an mRNA vaccine candidate against the novel coronavirus SARS-CoV-2 encoding for a prefusion stabilized form of the Spike (S) protein selected by Moderna in collaboration with investigators NIAID Vaccine Research Center.
Moderna, Inc. designs its mRNA vaccines using the virus's sequence, not on the virus itself. The Moderna mRNA platform provides significant advantages in speed and efficiency across basic science, manufacturing, and clinical development.
The S protein complex is necessary for membrane fusion and host cell infection. Therefore, it has been the target of vaccines against the coronaviruses responsible for MERS and SARS-1.
Moderna, Inc. says Messenger RNA (mRNA) plays a fundamental role in human biology, transferring the instructions stored in DNA to make the proteins required in every living cell. mRNA is a single-stranded molecule that carries genetic code from DNA in a cell’s nucleus to ribosomes, the cell’s protein-making machinery. mRNA medicine instructs a patient’s own cells to produce proteins that could prevent, treat, or cure disease—the mRNA sequence to the cells responsible for making the protein via several modalities.
On December 18, 2020, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) that enables the COVID-19 Vaccine Moderna to be distributed in the USA for use in individuals 18 years of age and older. The EAU was updated on July 7, 2021. The COVID‑19 Vaccine Moderna has not been approved or licensed by the FDA but was authorized for emergency use.
The U.S. CDC issued updated Interim Clinical Considerations for the use of mRNA COVID-19 Vaccines Currently Authorized in the United States on March 5, 2021. The U.S. CDC updated the Moderna COVID-19 Vaccine Overview and Safety overview on April 5, 2021. And on April 28, 2021, the CDC Morbidity and Mortality Weekly Report confirmed 'In a multistate network of U.S. hospitals during January–March 2021, receipt of the Moderna COVID-19 vaccine was about 94% effective against COVID-19 hospitalization among fully vaccinated adults and 64% effective among partially vaccinated adults aged ≥65 years.
On April 29, 2021, Moderna confirmed data supporting a three-month refrigerated (2-8°C) stable formulation.
On June 25, 2021, the U.S. FDA announced revisions to the patient and provider fact sheets for the Moderna (SpikeVax) COVID-19 vaccines regarding the suggested increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination.
COVID-19 Vaccine Moderna's Accession Number: DB15654; Preferred Substance Name: CX-024414; UNII: EPK39PL4R4; MedlinePlus a621002.
Moderna Inc.'s 10-Q SEC filing on January 4, 2021, indicates 'mRNA is considered a gene therapy product by the U.S. FDA.'
SpikeVax COVID-19 Vaccine (Moderna) (mRNA-1273) History
The first clinical batch of the Moderna vaccine candidate (CX-024414), funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020, and underwent analytical testing; it was shipped to the NIH on February 24th, 42 days of sequence selection. The first participant in the NIH-led Phase 1 study of the Moderna COVID-19 Vaccine (mRNA-1273) was dosed on March 16, 2020, 63 days from sequence selection to Phase 1 study dosing. On August 26, 2020, Moderna presented data from the Phase I trial at the Advisory Committee on Immunization Practices.
As of September 16, 2020, 25,296 participants enrolled in the COVE Phase 3 clinical study. And as of October 2, 2020, 19,369 participants have received their 2nd vaccination of Moderna's mRNA-1273 vaccine candidate.
With the Phase 3 dose being finalized at 100 μg, the Company said it remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021 from the Company’s internal U.S. manufacturing site and strategic collaboration with Lonza.
On November 30, 2020, Moderna announced 'that the primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis. “This positive primary analysis confirms the ability of our vaccine to prevent COVID-19 disease with 94.1% efficacy and, importantly, the ability to prevent severe COVID-19 disease. We believe that our vaccine will provide a new and powerful tool that may change the course of this pandemic and help prevent severe disease, hospitalizations, and death,” said Stéphane Bancel, CEO of Moderna.
On December 2, 2020, the company listed the TeenCove Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 Vaccine in Adolescents 12 to <18 Years Old to Prevent COVID-19.
The U.S FDA posted Moderna's Briefing Documents for the Vaccines and Related Biological Products Advisory Committee Meeting scheduled for December 17, 2020. When stratified by age group, the vaccine efficacy in this new analysis was 95.6% for 18 to <65 and 86.4% for participants ≥65 years of age.
The NEJM posted a recent study on December 17, 2020: Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults, which concluded saying 'In this small study involving older adults, adverse events associated with the mRNA-1273 vaccine were mainly mild or moderate. The 100-μg dose induced higher binding- and neutralizing-antibody titers than the 25-μg dose, which supports the use of the 100-μg dose in a phase 3 vaccine trial.'
On January 6, 2021, the European Medicines Agency published EMA/15689/2021 Committee for Medicinal Products for Human Use Assessment report for the COVID-19 Vaccine Moderna. Concentrations of lipid nanoparticles in mRNA-1647 were quantifiable (pg.#47) in most tissues examined at the first time point collected (2 hours post-dose), and peak concentrations were reached between 2- and 24-hours post-dose in tissues with exposures above that of plasma. Besides injection site [muscle] and lymph nodes [proximal and distal], increased mRNA concentrations (compared to plasma levels) were found in the spleen and eye. Low levels of mRNA could be detected in all examined tissues except the kidney. This included heart, lung, testis, and brain tissues, indicating that the mRNA/LNP platform crossed the blood/brain barrier, although very low (2-4% of the plasma level). Liver distribution of mRNA-1647 is also evident in this study, consistent with the literature reports that the liver is a common target organ of lipid nanoparticles.
On June 1, 2021 - Moderna confirmed it had initiated the rolling submission process with the U.S. FDA for a Biologics License Application for its mRNA COVID-19 Vaccine licensure to prevent COVID-19 in individuals 18 years of age and older.
Moderna, Inc. is advancing messenger RNA science to create a new transformative medicine class for patients. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane, or secreted proteins that can have a therapeutic or preventive benefit and potentially address a broad spectrum of diseases. Headquartered in Cambridge, Mass., Moderna has been named a top biopharmaceutical employer. To learn more, visit www.modernatx.com.
SpikeVax COVID-19 Vaccine (Moderna) (mRNA-1273) and Adolescents
On June 7, 2021, Moderna, Inc. announced that it is seeking conditional marketing approval for its COVID-19 vaccine in adolescents with the European Medicines Agency. The Company also plans to submit to the U.S. FDA an authorization request to expand the use of its vaccine to adolescents. The company also filed for authorization with Health Canada.
In May 2021, the Company announced that the Phase 2/3 TeenCOVE study of Moderna’s COVID-19 vaccine in adolescents met its primary immunogenicity endpoint, successfully bridging immune responses to the adult vaccination.
On June 10, Tom Shimabukuro, M.D., MPH, MBA, with the CDC's Vaccine Safety Team, presented COVID-19 Vaccine Safety Updates. The analysis of VAERS preliminary reports of myocarditis/pericarditis is in progress; Limited outcome data suggest most patients (at least 81%) had full recovery of symptoms.
Moderna, Inc., announced on June 14, 2021, announced that it had submitted an authorization application to Swissmedic to use its COVID-19 vaccine in adolescents.
The AP reported on July 15, 2021, Dr. Marco Cavaleri, the EMA's head of vaccines strategy, said its expert committee was currently evaluating Moderna''s application to extend the use of its coronavirus vaccine for children 12 to 17 years old. “We expect that the committee will conclude by the end of next week,” he said.
On July 23, 2021, the European Medicines Agency announced its human medicines committee has recommended granting an extension of indication for the COVID-19 vaccine Spikevax (previously COVID-19 Vaccine Moderna) to include use in children aged 12 to 17 years. The vaccine is already authorized for use in people aged 18 and above.
SpikeVax COVID-19 Vaccine (Moderna) (mRNA-1273) and Cancer Patients
Two studies published by the journal Blood on April 16, 2021, evaluated immune responses to the BNT162b2 mRNA COVID-19 vaccine in patients with chronic lymphocytic leukemia and seniors diagnosed with multiple myeloma. These studies suggest that mRNA-based COVID-19 vaccines may not work as well in people with blood cancer. And could help inform the ideal time for COVID-19 vaccination of these populations.
General Principles of COVID-19 Vaccines for Immunocompromised Patients (Version 3.0; last updated April 5, 2021).
SpikeVax COVID-19 Vaccine (Moderna) (mRNA-1273) and Pregnant Women
The NEJM published original research on April 21, 2021, stating, 'Preliminary findings did not show obvious safety signals among pregnant women who received mRNA COVID-19 vaccines, or neonatal outcomes. Among 3,958 women enrolled in the V-Safe Pregnancy Registry, 827 completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth. Adverse neonatal outcomes included preterm birth (9.4%) and small size for gestational age (in 3.2%).
SpikeVax COVID-19 Vaccine (Moderna) (mRNA-1273) Indication For Breastfeeding Women
The WHO Strategic Advisory Group of Experts on Immunization Interim recommendations issued on January 26, 2021, include, but are not limited to, the vaccine that can be offered to a breastfeeding woman who is part of a group recommended for vaccination (e.g., health workers); discontinuing breastfeeding after vaccination is currently not recommended.
On July 6, 2021, the journal JAMA Pediatrics published a limited study: 'Evaluation of Messenger RNA From COVID-19 BTN162b2 and mRNA-1273 Vaccines in Human Milk.' This analysis of 13 human milk samples collected 24 hours after vaccination revealed that none of the samples showed detectable levels of vaccine mRNA in any component of the milk.
SpikeVax COVID-19 Vaccine (Moderna) (mRNA-1273) Side Effects
The U.S. CDC publishes Possible Side Effects of COVID-19 vaccines on March 5, 2021. The most commonly reported side effects, typically lasting several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, swollen lymph nodes in the same arm as the injection, nausea, vomiting, and fever. Of note, more people experienced these side effects after the second dose than after the first dose, so vaccination providers and recipients need to expect that there may be some side effects after either dose, but even more so after the second dose, said the FDA on January 6, 2021.
The FDA states people should not get the Moderna COVID-19 Vaccine if they had a severe allergic reaction after a previous dose of this vaccine or have a severe allergic reaction to any ingredient of this vaccine. The FDA published a FACT SHEET FOR RECIPIENTS AND CAREGIVERS.
As of June 25, 2021, the FDA says, 'The warning in the Fact Sheets for Healthcare Providers Administering Vaccines notes that reports of adverse events suggest increased risks of myocarditis and pericarditis, particularly following the second dose and with the onset of symptoms within a few days after vaccination.'
The EMA issued a safety update on July 14, 2021, based on new safety data, including the latest Monthly Summary Safety Report from the marketing authorization holder and data reported by patients and healthcare professionals to EudraVigilance. As of July 4, 2021, a total of 36,294 cases of suspected side effects with Spikevax were spontaneously reported to EudraVigilance from EU/EEA countries; 347 of these reported a fatal outcome. Around that time, about 35 million doses of Spikevax had been given to people in the EU/EEA.
As of July 14, 2021, the United Kingdom Medicines & Healthcare Regulatory Agency (MHRA) had received (7) Yellow Card reports of suspected adverse drug reactions related to death. And the MHRA is closely monitoring reports of anaphylaxis with the COVID-19 Vaccine Moderna and has received (26) reports of anaphylaxis in association with the vaccine.
SpikeVax COVID-19 Vaccine (Moderna) (mRNA-1273) Ingredients
The Moderna COVID-19 Vaccine contains the following ingredients: messenger ribonucleic acid (mRNA), 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. This vaccine does not contain: Eggs, Preservatives, or Latex, says the CDC. In addition, although SM-102 is used in the Moderna vaccine, the vaccine does not contain chloroform.
On December 22, 2020, the UAE Fatwa Council, under the chairmanship of Shaykh Abdallah bin Bayyah, issued a 'fatwa' (Islamic ruling) allowing the coronavirus vaccines to be used in compliance with Islamic Sharia’s objectives on the protection of the human body and other relevant Islamic rulings.
SpikeVax COVID-19 Vaccine (Moderna) (mRNA-1273) Distribution
In the fourth quarter of 2020, the Company delivered approximately 17 million doses to the U.S. government. For the first quarter of 2021, the Company delivered approximately 88 million doses to the U.S. government and approximately 14 million doses to other customers. Through April 12, 2021, Moderna cumulatively delivered approximately 132 million doses globally, including approximately 117 million doses to the U.S. government and approximately 15 million doses delivered from Moderna’s ex-U.S. supply chain. The Company remains on track to deliver the second 100 million doses to the U.S. government by the end of May 2021, followed by another 100 million additional doses by the end of July 2021.
Moderna announced an agreement with Gavi, the Vaccine Alliance, to supply up to 500 million doses of the COVID-19 Vaccine Moderna on May 3, 2021, including an initial 34 million doses to be delivered in the fourth quarter of 2021. Through this agreement retains the option to procure 466 million additional doses in 2022.
On June 2, 2021, Moderna announced a long-term supply agreement on behalf of the COVAX Facility as part of the agreement announced in May 2021. Through this agreement, UNICEF and its procurement partners, including the Pan American Health Organization, will have access to up to 34 million doses of COVID-19 Vaccine Moderna to be delivered in the fourth quarter of 2021 and up to 466 million doses in 2022.
And on June 2, 2021, Moderna announced an additional agreement with Lonza to support drug substance manufacturing at Lonza’s Geleen site in the Netherlands, contributing to the supply of an additional 300 million doses of Moderna’s updated booster variant vaccine candidate, if authorized, per year, at a 50 µg dose. In addition to previously announced investments in drug substance manufacturing with ROVI in Granada, Spain, Moderna expects to supply the equivalent of 600 million 50 µg doses per year from production within the European Union before the end of 2021.
Also, on June 2, 2021, Moderna and UNICEF announced that they had signed a long-term agreement for the supply of COVID-19 vaccine on behalf of the COVAX Facility as part of the agreement announced in May 2021. As a result, UNICEF and its procurement partners, including the Pan American Health Organization, will have access to up to 34 million doses of COVID-19 Vaccine Moderna in the fourth quarter of 2021 and up to 466 million doses through this long-term agreement in 2022.
On June 7, 2021, Moderna, Inc. and Medison Pharma announced a new agreement to commercialize the Moderna COVID-19 Vaccine across Central Eastern Europe and Israel. The agreement covers the following countries: Poland, Czech Republic, Romania, Hungary, Bulgaria, Slovenia, Slovakia, Croatia, Estonia, Latvia, Lithuania, Serbia, Ukraine, Moldova, Albania, Bosnia and Herzegovina, Kosovo, North Macedonia, Montenegro, and Israel.
The EMA committee for human medicines approved a new manufacturing site to produce the Moderna COVID-19 vaccine finished product on June 11, 2021. The site, operated by Recipharm, is located in Monts, France.
On June 16, 2021, that the U.S. government had purchased an additional 200 million doses of Moderna’s COVID-19 vaccine. As of June 14, Moderna has supplied 217 million released vaccine doses to the U.S. government.
On June 22, 2021, Moderna announced that the European Commission had purchased an additional 150 million doses of Moderna’s COVID-19 vaccine. This purchase brings the European Commission’s confirmed order commitment to 460 million doses.
On July 12, 2021, Moderna confirmed a supply agreement with the government of Argentina for 20 million doses of Moderna’s COVID-19 vaccine or its updated variant booster vaccine candidate, if authorized, to begin delivery in the first quarter of 2022.
Moderna, Inc. announced on July 22, 2021, a new supply agreement with Taiwan for 20 million doses of Moderna’s COVID-19 vaccine and its updated variant booster vaccine candidate, if authorized, to begin delivery in 2022 and an additional 15 million doses in 2023. This new supply agreement is in addition to the prior agreement for 5 million doses in 2021.
SpikeVax COVID-19 Vaccine (Moderna) (mRNA-1273) CPT Code
The AMA offers a new resource to identify the appropriate CPT code combination for each patient's type and dose of a COVID-19 vaccine.
COVID-19 Vaccine Moderna Intramuscular Injection (TAK-919)
On May 21, 2021, the COVID-19 Vaccine Moderna Intramuscular Injection (TAK-919) was authorized in Japan.
On July 20, 2021, Moderna announced that the Ministry of Health, Labour, and Welfare of Japan and Takeda Pharmaceutical Company Limited have agreed to purchase and distribute an additional 50 million doses of Moderna’s COVID-19 vaccine and its updated variant booster vaccine candidate if authorized, to begin delivery in 2022. This new supply agreement is in addition to the prior agreement for 50 million doses in 2021, resulting in a total of 100 million doses for Japan.
SpikeVax COVID-19 Vaccine (Moderna) (mRNA-1273)
mRNA-1283 is a next-generation vaccine candidate that encodes for the portions of the SARS-CoV-2 spike protein critical for neutralization, specifically the Receptor Binding Domain (RBD) and N-terminal Domain (NTD). The encoded mRNA-1283 antigen is being developed as a potentially refrigerator-stable mRNA vaccine that will facilitate distribution and administration by healthcare providers. A Phase 1 study will evaluate three dose levels, 10 µg, 30 µg, and 100 µg, of the mRNA-1283 vaccine candidate given to healthy adults as a 2-dose series, 28 days apart, and one dose level, 100 µg, of mRNA-1283 given to healthy adults in a single dose.
SpikeVax COVID-19 Vaccine (Moderna) (mRNA-1273.351)
Moderna announced on January 25, 2021, it was advancing an emerging variant booster candidate (mRNA-1273.351) against the B.1.351 variant first identified in the Republic of South Africa. The company moves mRNA-1273.351 into preclinical studies and a Phase 1 study in the U.S. to evaluate the immunological benefit of boosting with strain-specific spike proteins. Moderna expects that its mRNA-based booster vaccine (whether mRNA-1273 or mRNA-1273.351 will be able to increase further neutralizing titers in combination with all of the leading vaccine candidates. The Phase 1 clinical trial is led and funded by the NIH’s National Institute of Allergy and Infectious Diseases.
Moderna announced that the first participants had been dosed with mRNA-1273.351 to amend the ongoing Phase 2 clinical study on March 10, 2021.
On April 13, 2021, new preclinical data on the Company’s variant-specific booster vaccine candidates have been submitted as a preprint to bioRxiv. Both mRNA-1273.351 and mRNA-1273.211 increase neutralizing titers against SARS-CoV-2 variants of concern in Balb/c mice. Specifically, this preclinical data confirms improved neutralizing titers with the mRNA-1273.351 vaccine primary series.
SpikeVax COVID-19 Vaccine (Moderna) (mRNA-1273.211)
A multivalent booster candidate, mRNA-1273.211, combines mRNA-1273, Moderna’s authorized vaccine against ancestral strains, and mRNA-1273.211 in a single vaccine at 50 µg dose level and lower. On March 10, 2021, Moderna announced that the first participants had been dosed with mRNA-1273.211 to amend the ongoing Phase 2 clinical study.
SpikeVax COVID-19 Vaccine (Moderna) (mRNA-1273) Dosage
Based on the results of the Phase 1 study, the data indicate that a 100 mcg dose of vaccine is generally well-tolerated across age strata, with solicited symptoms mostly mild-tomoderate in severity and self-limited duration; and Induces neutralizing Abs in the upper half of the range of convalescent serum across age strata, with the induction of Th-1 biased, CD4+ T-cells. The 100 mcg dose was evaluated in the Phase 3 study. The Package Insert is found at this link.
On July 9, 2021, a non-peer-reviewed study published by the journal Nature stated, 'Quarter-dose of Moderna COVID vaccine still rouses a big immune response.'
On July 22, 2021, the Taiwan Central Epidemic Command Center pointed out that the interval between the first dose and second dose of the Moderna COVID-19 vaccine at this phase was extended to 10-12 weeks for some groups of people.
SpikeVax COVID-19 Vaccine (Moderna) (mRNA-1273) News
July 16, 2021 - UC San Fransico published a press statement - 'Messenger RNA vaccines against COVID-19 were not detected in human milk, according to a small study offering early evidence that the vaccine's mRNA is not transferred to an infant.
July 14, 2021 - The EMA issued a report as of July 4, 2021, a total of 36,294 cases of suspected side effects with Spikevax were spontaneously reported to EudraVigilance from EU/EEA countries; 347 of these reported a fatal outcome.
July 14, 2021 - Yale Medicine published - Comparing the COVID-19 Vaccines: How Are They Different?
July 9, 2021 - The United Kingdom Medicines & Healthcare Regulatory Agency (MHRA) received (6) Yellow Card reports of suspected adverse drug reactions to the SpikeVax vaccine. These patients died shortly after vaccination. In addition, the MHRA had received 24 reports of anaphylaxis in association with the SpikeVax vaccine.
July 6, 2021 - The U.S. CDC published Use of mRNA COVID-19 Vaccine After Reports of Myocarditis Among Vaccine Recipients: Update from the Advisory Committee on Immunization Practices — United States, June 2021.
July 4, 2021 - About 2.5 million doses of Moderna (mRNA-1273) COVID-19 vaccines supplied through the COVAX Facility’s dose-sharing mechanism and donated by the United States started being distributed by the Government of Pakistan to vaccinate priority groups across the country, in line with the National Deployment and Vaccination Plan.
June 25, 2021 - The FDA revised the patient and provider fact sheets regarding the suggested increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination.
June 22, 2021 - Moderna announced that the European Commission had purchased additional doses of Moderna’s COVID-19 vaccine. Under the terms of the agreement, delivery of Moderna’s updated variant booster vaccine candidate will begin in 2022. Purchase under this agreement is subject to regulatory approval of the booster vaccine candidates by the European Medicines Agency.
June 15, 2021 - Moderna, Inc., and Magenta Investments (United Arab Emirates (UAE)) announced a new agreement to distribute the Moderna COVID-19 Vaccine and Moderna’s updated variant booster candidates once authorized, in the UAE in 2021 and 2022.
June 11, 2021 - Moderna, Inc. and Tabuk Pharmaceutical Manufacturing Company announced an agreement to commercialize the Moderna COVID-19 Vaccine and future variant-specific booster candidates in the Kingdom of Saudi Arabia.
June 10, 2021 - Moderna announced that it had requested an emergency use authorization for its COVID-19 vaccine in adolescents with the U.S. FDA. Previously, the Phase 2/3 study of its COVID-19 vaccine in adolescents has met its primary immunogenicity endpoint, successfully bridging immune responses to the adult vaccination. In the study, no cases of COVID-19 were observed in participants who had received two doses of the Moderna COVID-19 vaccine using the primary definition.
June 8, 2021 - The EMA confirmed it has started evaluating an application to extend the use of the COVID-19 Vaccine Moderna to include young people aged 12 to 17.
June 7, 2021 - CBS TV in San Francisco reported 'Vaccine breakthrough cases occur in only a small percentage of vaccinated people. Napa County has identified 32 breakthrough cases in which fully vaccinated residents became symptomatic and tested positive for COVID19–out of more than 71,371 residents (.04%) who were fully vaccinated.
June 2, 2021 - Moderna, Inc. announced that it has entered into an additional agreement with Lonza to support drug substance manufacturing for its global supply chain at Lonza’s Geleen site in the Netherlands.
June 1, 2021 - The U.S. NIH announced a Phase 1/2 clinical trial in which adult volunteers who have been fully vaccinated against COVID-19 will receive booster doses of the Moderna vaccine to determine the safety and immunogenicity of mixed boosted regimens.
May 25, 2021 - Moderna, Inc. announced that the Phase 2/3 study of its COVID-19 vaccine in adolescents had met its primary immunogenicity endpoint. Safety data continues to accrue, and the study continues to be monitored by an independent safety monitoring committee. In addition, all participants will be monitored for 12 months after their second injection to assess long-term protection and safety. Consequently, these data are subject to change based on ongoing data collection.
May 24, 2021 - Moderna, Inc. and Aldevron, LLC announced their expanded collaboration supporting the Moderna COVID-19 Vaccine and additional programs in Moderna’s clinical development pipeline. Specifically, Aldevron will supply plasmid DNA to serve as the genetic template for generating the COVID-19 mRNA vaccine and other investigational programs. Aldevron’s 600 employees support thousands of scientists who are developing revolutionary treatments for millions of people.
May 22, 2021 - Moderna and Samsung Biologics announced a Manufacturing Services and Supply Agreement in which Samsung Biologics will provide large-scale, commercial fill-finish manufacturing for mRNA-1273, Moderna’s COVID-19 vaccine.
May 22, 2021 - Moderna, Inc. announced two Memoranda of Understanding (MoU) with the government of South Korea: one MoU with the Korea National Institute of Health (KNIH), an agency of the Korea Centers for Disease Control and Prevention Agency for a new collaboration on mRNA vaccine research in South Korea; and an additional MoU with the Ministry of Trade, Industry and Energy of the Republic of Korea, the Ministry of Health and Welfare of the Republic of Korea to explore local manufacturing opportunities for mRNA vaccines in South Korea.
May 21, 2021 - Takeda announced that the Ministry of Health, Labour, and Welfare had granted special approval for the emergency use of Moderna’s mRNA COVID-19 vaccine, TAK-919, now known as COVID-19 Vaccine Moderna Intramuscular Injection, in Japan.
May 20, 2021 - Japanese regulators recommended the approval of the mRNA COVID-19 vaccine developed by Moderna Inc.
May 20, 2021 - The journal Clinical Infectious Diseases published a new study: Circulating SARS-CoV-2 Vaccine Antigen Detected in the Plasma of mRNA-1273 Vaccine Recipients. This study's findings include 'SARS-CoV-2 proteins were measured in longitudinal plasma samples collected from 13 participants who received two doses of mRNA-1273 vaccine. 11 of 13 participants showed detectable levels of SARS-CoV-2 protein as early as day one after the first vaccine injection. Clearance of detectable SARS-CoV-2 protein correlated with production of IgG and IgA.'
May 12, 2021 - Moderna, Inc. announced a new supply agreement with the government of Australia for 25 million doses. This includes 10 million doses of Moderna’s COVID-19 vaccine against the ancestral strain (mRNA-1273) to be delivered in 2021 and 15 million doses of Moderna’s updated variant booster vaccine candidate to be delivered in 2022.
May 6, 2021 - Moderna, Inc. (Nasdaq: MRNA) reported financial results, provided business updates for the first quarter of 2021, and highlighted pipeline progress. Total revenue was $1.9 billion for the three months ended March 31, 2021, compared to $8 million for the same period in 2020. Total revenue increased in the first quarter of 2021, resulting from a full quarter of commercial sales of the Company’s COVID-19 vaccine in the U.S. and an initial ramp-up of international sales. A total of 102 million doses were recognized as revenue. Product sales were $1.7 billion for the three months ended March 31, 2021, from sales of the Company’s COVID-19 vaccine. The increase in grant revenue of $190 million was primarily driven by an increase in revenue from BARDA related to the Company’s COVID-19 vaccine development.
May 6, 2021 - Moderna announced a supply agreement with the Swiss Federal Government for 7 million doses of booster vaccine in 2022, with an additional option for another 7 million doses for delivery during the second half of 2022 or the first quarter of 2023. Swissmedic, the Swiss Agency for Therapeutic Products, authorized the COVID-19 Vaccine Moderna in Switzerland on January 12, 2021.
May 3, 2021 - Moderna confirmed an agreement with Gavi to deliver up to 500 million doses of the COVID-19 Vaccine Moderna. Gavi retains an option to procure 466 million additional doses in 2022.
April 29, 2021 - Moderna, Inc. announced it is making new funding commitments to increase supply at its owned and partnered manufacturing facilities, which it expects will increase global 2022 capacity to up to 3 billion doses of its COVID-19 vaccine, depending upon the mix between the authorized Moderna COVID-19 Vaccine at the 100 μg dose level and potentially lower doses of the Company’s variant booster candidates and pediatric vaccines, if authorized.
April 26, 2021 - Sanofi announced an agreement with Moderna, Inc. to establish infrastructure and manufacturing expertise at its site in Ridgefield, NJ, to fill and finish up to 200 million doses of Moderna’s COVID-19 vaccine, starting in September 2021.
April 20, 2021 - Moderna, Inc. announced a new supply agreement with Israel for 2022.
April 13, 2021 - Moderna, Inc. announced clinical and supply updates on its COVID-19 Vaccine program. New results from a preclinical study of the Company’s COVID-19 variant-specific vaccine candidates showed that the Company’s variant-specific booster vaccine candidates (mRNA-1273.351 and mRNA-1273.211) increase neutralizing titers against SARS-CoV-2 variants of concern. To date, the Company has delivered approximately 132 million doses of the Moderna COVID-19 Vaccine globally.
April 6, 2021 - The NEJM published a new study, 'Antibody Persistence through 6 Months after the Second Dose of mRNA-1273 Vaccine for Covid-19.' 'Although the antibody titers and assays that best correlate with vaccine efficacy are not currently known, antibodies that were elicited by mRNA-1273 persisted through 6 months after the second dose, as detected by three distinct serologic assays. Our data show antibody persistence and thus support the use of this vaccine in addressing the Covid-19 pandemic.'
April 5, 2021 - The U.S. CDC published an update of the Moderna COVID-19 Vaccine Overview and Safety.
April 2, 2021 - The U.S. CDC published: Interim Estimates of Vaccine Effectiveness of Moderna COVID-19 Vaccines in Preventing SARS-CoV-2 Infection Among Health Care Personnel, First Responders, and Other Essential and Frontline Workers — Eight U.S. Locations, December 2020–March 2021. Prospective cohorts of 3,950 health care personnel, first responders, and other essential and frontline workers completed weekly SARS-CoV-2 testing for 13 consecutive weeks. Under real-world conditions, mRNA vaccine effectiveness of full immunization (≥14 days after the second dose) was 90% against SARS-CoV-2 infections regardless of symptom status; vaccine effectiveness of partial immunization (≥14 days after the first dose) before the second dose) was 80%.
April 1, 2021 - The U.S. FDA announced two revisions regarding the number of doses per vial available for the Moderna COVID-19 Vaccine. The first revision clarifies the number of doses per vial for the currently available vials, in that the maximum number of extractable doses is 11, with a range of 10-11 doses. The second revision authorizes the availability of an additional multi-dose vial. Each vial contains a maximum of 15 doses, with a range of 13-15 doses that can potentially be extracted.
March 31, 2021 - The U.S. NIH confirmed an investigational vaccine designed to protect against the B.1.351 SARS-CoV-2 variant had been administered as part of a new Phase 1 clinical trial evaluating the vaccine candidate’s safety and immunogenicity in adult volunteers.
March 29, 2021 - The U.S. CDC reported, 'Prospective cohorts of 3,950 health care personnel, first responders, and other essential and frontline workers completed weekly SARS-CoV-2 testing for 13 consecutive weeks. Under real-world conditions, mRNA vaccine effectiveness of full immunization (≥14 days after the second dose) was 90% against SARS-CoV-2 infections regardless of symptom status; vaccine effectiveness of partial immunization (≥14 days after the first dose) before the second dose) was 80%.
March 29, 2021 - Moderna, Inc. announced that the Company had shipped the 100-millionth dose of its COVID-19 vaccine to the U.S. Government. The Company expects to meet its commitment dates to the U.S. Government for all currently ordered doses of the Moderna COVID-19 Vaccine, including delivering the second 100 million doses by the end of May 2021 and the third 100 million doses by July 2021.
March 28, 2021 - UK minister of Culture Secretary Oliver Dowden stated Moderna's COVID-19 vaccine is expected to be rolled out within weeks across the United Kingdom, reported the BBC.
March 16, 2021 - Moderna Inc. announced that the first participants had been dosed in the Phase 2/3 study, called the KidCOVE study, of mRNA-1273, the Company’s vaccine candidate against COVID-19 children 6 months to less than 12 years. The study is being conducted in collaboration with the US National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority.
March 15, 2021 - The JAMA published a new study: Immunogenicity of a Single Dose of SARS-CoV-2 Messenger RNA Vaccine in Solid Organ Transplant Recipients. Transplant recipients receiving anti–metabolite maintenance immunosuppression therapy were less likely to develop an antibody response than those not receiving such immunosuppression therapy (37% vs. 63%, respectively; adjusted incidence rate ratio [IRR], 0.22 [95% CI, 0.15-0.34], P < .001).
March 15, 2021-- Moderna, Inc. announced that the first participants had been dosed in the Phase 1 study of mRNA-1283, the next-generation COVID-19 vaccine candidate.
March 10, 2021 - Moderna, Inc. announced that the first participants had been dosed with the Company’s modified COVID-19 vaccines, designed to address the potential need for booster vaccine candidates, mRNA-1273.351 and mRNA-1273.211, in an amendment to the ongoing Phase 2 clinical study.
March 4, 2021 - Moderna and IBM announced their intentions to explore technologies, including artificial intelligence, blockchain, and hybrid cloud, that could help smarter COVID-19 vaccine management. Central to the effort will be a pilot of open, standardized, technology-enabled vaccine distribution approaches to improve supply chain visibility and foster near real-time tracking of vaccine administration.
March 4, 2021 - The NEJM published an ORIGINAL ARTICLE: Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. CONCLUSIONS - The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease. Aside from transient local and systemic reactions, no safety concerns were identified.
March 4, 2021 - The EMA announced the latest safety data for this vaccine are in line with the known benefit-risk profile; the outcomes of the related assessments are presented in this update. The benefits of COVID-19 Vaccine Moderna in preventing COVID-19 continue to outweigh any risks, and there are no recommended changes regarding the use of this vaccine. EMA’s Pharmacovigilance Risk Assessment Committee carries out the assessments based on all available data.
March 4, 2021 - South Korea-based GC Pharma announced that it would support Moderna and the Republic of Korea's government to distribute 40 million doses of COVID-19 Vaccine Moderna. The Korea Diseases Control and Prevention Agency previously announced that it would import 40 million doses of COVID-19 Vaccine Moderna in Korea from the second quarter of 2021. Under the terms of its agreement with Moderna, GC pharma is responsible for local regulatory activities. Under the terms of its agreement with the Korean government, GC Pharma, with the support of the Korean government authorities, is responsible for distribution activities in South Korea.
February 24, 2021 - Moderna, Inc. announced making new capital investments to increase its owned and partner manufacturing facilities. It expects to increase global 2022 capacity to approximately 1.4 billion doses of the COVID-19 vaccine, assuming a 100 μg dose. The investments will enable additional production of the current Moderna COVID-19 Vaccine and provide flexibility in addressing potential vaccine boosters that may need to address emerging variants of SARS-CoV-2.
February 24, 2021 - Moderna, Inc. announced that it has completed manufacturing clinical trial material for its variant-specific vaccine candidate, mRNA-1273.351, against the SARS-CoV-2 variant known as B.1.351.
February 17, 2021 - Moderna, Inc. announced that the European Commission (EC) purchased an additional 150 million doses of the COVID-19 Vaccine Moderna, scheduled to be delivered in the third and fourth quarter of 2021. This brings the EC's confirmed order commitment to 310 million doses for delivery in 2021. Under the terms of the agreement, the European Commission can purchase an additional 150 million doses to be delivered in 2022.
February 16, 2021 - Moderna, Inc. announced a supply update for the Moderna COVID-19 Vaccine in the USA, reporting that 45.4 million doses have been supplied to the U.S. Government to date. Approximately 25.5 million doses of the Moderna COVID-19 Vaccine have been administered in the U.S., according to the U.S. Centers for Disease Control and Prevention. An additional 33.2 million doses of Moderna COVID-19 Vaccine have been filled in vials and are at various final production and testing stages before release to the U.S. Government.
February 12, 2021 - The NY Times reported the U.S. FDA informed Moderna that it could increase the number of vaccines in each produced vial by up to 40%.
February 11, 2021 - Moderna, Inc. announced that the U.S. government had purchased an additional 100 million doses of Moderna’s COVID-19 Vaccine, bringing its confirmed order commitment to 300 million doses. Moderna has supplied 41 million released doses of the vaccine to the U.S. government to date.
February 11, 2021 - Moderna, Inc. announced that the Qatar Ministry of Public Health had issued an emergency use authorization for COVID-19 Vaccine Moderna. The approval is based on the totality of scientific evidence shared by the Company, including a data analysis from the pivotal Phase 3 clinical study announced on November 30. Additionally, Qatar has secured COVID-19 Vaccine Moderna access through a supply agreement announced on October 26, 2020.
February 9, 2021 - Moderna, Inc. announced supply agreements with Taiwan's and Colombia's governments. The COVID-19 Vaccine Moderna is not currently approved for use in Taiwan or Colombia, and the Company will work with regulators to pursue necessary approvals before distribution.
February 3, 2021 - Moderna, Inc. announced that the Singapore Health Sciences Authority had approved its mRNA vaccine's interim authorization against COVID-19 (COVID-19 Vaccine Moderna) for use under the Pandemic Special Access Route.
February 3, 2021 - Moderna, Inc. announced the Swiss Federal Government had increased its confirmed order commitment from 7.5 million to 13.5 million doses of the COVID-19 Vaccine Moderna in Switzerland. The additional 6 million doses announced today will be delivered beginning in the summer of 2021, with an option to receive doses in the first half of 2022. In addition, Moderna explores potential vaccine boosters to address emerging variants.
February 1, 2021 - Researchers from the Icahn School of Medicine at Mount Sinai in New York published a non-peer-reviewed report that found the antibody response to the first vaccine dose in individuals with pre-existing immunity is equal to or even exceeds the titers found in naïve individuals after the second dose. This study also showed that the reactogenicity is significantly higher in individuals who have been infected with SARS-CoV-2 in the past.
January 29, 2021 - Media reported the World Health Organization reversed its guidance on pregnant women receiving the coronavirus vaccine created by Moderna, saying it recommends the jab for expectant persons. The WHO says, 'While pregnancy puts women at higher risk of severe COVID-19, very little data are available to assess vaccine safety in pregnancy.
January 26, 2021 - The WHO Strategic Advisory Group of Experts (SAGE) on Immunization has issued Interim recommendations using the Moderna mRNA-1273 vaccine against COVID-19. The vaccine is safe and effective in people with known medical conditions associated with increased risk of severe diseases, such as hypertension, diabetes, asthma, pulmonary, liver, kidney disease, and chronic infections, stable and controlled.
January 21, 2021 - Moderna Inc. announced that the first participant had been dosed in the Phase 1/2 study of Moderna’s vaccine candidate against COVID-19 (mRNA-1273 or TAK-919) Japan, led by Takeda Pharmaceutical Co., Ltd.
January 17, 2021 - California State Epidemiologist Statement Recommending Providers Pause Administration of Single Lot of Moderna COVID-19 Vaccine.
January 12, 2021 - Moderna, Inc. announced that Swissmedic, the Swiss Agency for Therapeutic Products, has authorized the COVID-19 Moderna Vaccine in Switzerland.
January 8, 2021 - Moderna, Inc. announced that the UK’s Medicines and Healthcare products Regulatory Agency has approved its mRNA vaccine COVID-19 Vaccine Moderna for use under Regulation 174. The temporary authorization permits COVID-19 Vaccine Moderna's supply in Great Britain and is based upon the UK Commission on Human Medicines' advice.
January 6, 2021 - The European Commission has granted a conditional marketing authorization (CMA) for the COVID‑19 vaccine developed by Moderna, the second COVID-19 vaccine authorized in the EU.
January 6, 2021 - The U.S. FDA published 'The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older.'
December 30, 2020 - NEJM article: Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease. In addition, aside from transient local and systemic reactions, no safety concerns were identified.
December 29, 2020 - The US Department of Defense announced it had awarded Moderna a contract worth $1,966,598,000 for an additional 100 million doses of its COVID-19 vaccine.
December 23, 2020 - Health Canada authorized the second COVID-19 vaccine manufactured by Moderna. Health Canada received Moderna’s submission on October 12, 2020.
December 19, 2020 - The CDC's Advisory Committee on Immunization Practices voted to support the U.S. FDA's emergency authorization of Moderna's COVID-19 Vaccine (mRNA-1273) the afternoon of December 19, 2020.
December 18, 2020 - The U.S. Food and Drug Administration issued an emergency use authorization for the second vaccine to prevent COVID-19 caused by SARS-CoV-2. The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.
December 17, 2020 - A study's results published by the NEJM concluded stating: Solicited adverse events were predominantly mild or moderate in severity and most frequently included fatigue, chills, headache, myalgia, and pain at the injection site. Such adverse events were dose-dependent and were more common after the second immunization. Binding-antibody responses increased rapidly after the first immunization. By day 57, among the participants who received the 25-μg dose, the anti–S-2P geometric mean titer (GMT) was 323,945 among those between the ages of 56 and 70 years and 1,128,391 among those who were 71 years of age or older; among the participants who received the 100-μg dose, the GMT in the two age subgroups was 1,183,066 and 3,638,522, respectively. After the second immunization, serum neutralizing activity was detected in all the participants by multiple methods.
December 15, 2020 - Presented by the Orthodox Union and the Rabbinical Council of America: our poskim conclude that, according to the advice of your personal health care provider, the Torah obligation to preserve our lives and the lives of others requires us to vaccinate for COVID-19 as soon as a vaccine becomes available.
December 11, 2020 - Moderna, Inc. announced that the U.S. government had exercised its option to purchase an additional 100 million doses of mRNA-1273, Moderna’s COVID-19 vaccine candidate, bringing its confirmed order commitment to 200 million doses. In addition, the U.S. government retains the option to purchase up to an additional 300 million doses.
December 10, 2020 - Moderna Inc. announced that the first adolescent participants had been dosed in the Phase 2/3 study of mRNA-1273, the Company’s vaccine candidate against COVID-19, in adolescents ages 12 to less than 18.
December 2, 2020 - Merck & Co announced it had sold its equity investment in Moderna Inc. Merck did not disclose the sale proceeds' details.
November 16, 2020 - Moderna, Inc. announced that the independent, NIH-appointed Data Safety Monitoring Board for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%.
October 29, 2020 - Moderna announced it had received $1.1 billion of customer deposits for the future supply of the mRNA-1273 vaccine candidate in Q3 2020, recorded as deferred revenue.
October 29, 2020 - Takeda Pharmaceutical announced that it would import and distribute 50 million doses of Moderna’s COVID-19 vaccine candidate, mRNA-1273, starting in the first half of 2021, pending licensure in Japan. This effort is part of a three-way agreement among Takeda, Moderna, and the Government of Japan’s Ministry of Health Labour and Welfare.
October 27, 2020 - Moderna announced that the Medicines and Healthcare products Regulatory Agency in the United Kingdom had started the rolling review process of mRNA-1273.
August 11, 2020 - Moderna announced that the U.S. government had secured 100 million doses of mRNA-1273 as part of the U.S. government’s goal of securing early access to safe and effective COVID-19 vaccines for the American people. This award of up to $1.525 billion is for manufacturing and delivering 100 million doses of mRNA-1273, including incentive payments for timely delivery of the product.
July 26, 2020 - Moderna, Inc. announced a modification to its contract with the Biomedical Advanced Research and Development Authority for an additional commitment of up to $472 million to support late-stage clinical development, including the expanded Phase 3 study of the mRNA vaccine candidate mRNA-1273.
July 14, 2020 - Moderna, Inc. announced the publication of an interim analysis of the open-label Phase 1 study of its mRNA-1273 vaccine candidate in The New England Journal of Medicine.
June 25, 2020 - Moderna and Catalent, Inc. announced a collaboration for large-scale, commercial fill-finish manufacturing of Moderna’s mRNA-based COVID-19 vaccine candidate at Catalent’s biologics facility in Indiana.
May 18, 2020 - Moderna announced positive interim clinical data of mRNA-1273, its vaccine candidate against novel coronavirus (SARS-CoV-2), from the NIAID's Phase 1 study.
May 12, 2020 - Moderna, Inc. announced that the U.S. FDA had granted Fast Track designation for the Company’s mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2).
May 1, 2020 - Moderna, Inc. and Lonza Ltd. today announced a 10-year strategic collaboration agreement to enable larger-scale manufacture of Moderna’s mRNA vaccine (mRNA-1273) against the novel coronavirus (SARS-CoV-2) and additional Moderna products in the future.
April 16, 2020 - Moderna, Inc. announced an agreement for a commitment of up to $483 million from the Biomedical Advanced Research and Development Authority to accelerate the company’s mRNA vaccine candidate (mRNA-1273) against the novel coronavirus SARS-CoV-2.
February 24, 2020 - Moderna, Inc. announced that it had released the first batch of mRNA-1273, the vaccine against the novel coronavirus, for human use.
January 13, 2020 - The U.S. National Institutes of Health and Moderna’s infectious disease research team finalized the sequence for mRNA-1273, the vaccine against the novel coronavirus.
SpikeVax COVID-19 Vaccine (Moderna) (mRNA-1273) Clinical Trials
Moderna continues to run clinical trials to evaluate the safety, immunogenicity, and reactogenicity of its COVID-19 vaccine.