COVID-19 Vaccine Moderna Description
The COVID-19 Vaccine Moderna (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 working 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. 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 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 published an update of 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 three-month refrigerated (2-8°C) stable formulation.
COVID-19 Vaccine Moderna's Accession Number: DB15654; Preferred Substance Name: CX-024414; UNII: EPK39PL4R4; MedlinePlus a621002.
COVID-19 Vaccine Moderna Cell Line
Moderna's mRNA COVID-19 Vaccine was sequenced on the computer; production did not use any cell lines; Confirmatory Lab Tests: utilized protein test and HEK293 cells.
COVID-19 Vaccine Moderna 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 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 meeting.
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.
Moderna, Inc. is advancing messenger RNA (mRNA) science to create a new class of transformative medicines 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.
COVID-19 Vaccine Moderna mRNA-1283
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.
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 in an amendment to 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.
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 the 50 µg dose level and lower. On March 10, 2021, Moderna announced that the first participants had been dosed with mRNA-1273.211 in an amendment to the ongoing Phase 2 clinical study.
Takeda TAK-919 Phase Clinical Trial
Moderna's COVID-19 vaccine, called TAK-919 in Japan, is being tested to prevent infectious diseases caused by SARS-CoV-2. This study will look at the safety and immunogenicity of 2 doses of TAK-919 (0.5 mL) by intramuscular injection in healthy Japanese male and female adults, given 28 days apart. On March 5, 2021, Moderna announced that Takeda submitted a New Drug Application to the Government of Japan’s Ministry of Health, Labour, and Welfare to import and distribute Moderna’s vaccine candidate against COVID-19 (mRNA-1273 or TAK-919) in Japan. Takeda and Moderna previously announced that Takeda would import and distribute 50 million doses of Moderna’s COVID-19 vaccine candidate starting in the first half of 2021.
Takeda is a patient-focused, values-based, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future to people worldwide.
COVID-19 Vaccine Moderna 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).
COVID-19 Vaccine Moderna and Pregnant Women
The NEJM published original research on April 21, 2021, that stated, '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 (in 9.4%) and small size for gestational age (in 3.2%).
COVID-19 Vaccine Moderna 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.
COVID-19 Vaccine Moderna Side Effects
The U.S. CDC publishes Possible Side Effects of COVID-19 vaccines on March 5, 2021. The most commonly reported side effects, which typically lasted 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, and 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.
The JAMA journal published on March 8, 2021, 98% of vaccinated individuals did not have any allergic reaction symptoms after receiving an mRNA COVID-19 vaccine. Most of the vaccine recipients with anaphylaxis had allergy histories, with 31% having prior anaphylaxis.
COVID-19 Vaccine Moderna 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.
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.
COVID-19 Vaccine Moderna 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.
Moderna announced on May 6, 2021, a new 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.
COVID-19 Vaccine Moderna 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 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.
COVID-19 Vaccine Moderna News
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) today reported financial results and 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 5, 2021 - Moderna, Inc. announced initial data from its Phase 2 study showing that a single 50 µg dose of mRNA-1273 or mRNA-1273.351 given as a booster to previously vaccinated individuals increased neutralizing antibody titer responses against SARS-CoV-2 and two variants of concern, B.1.351 (first identified in South Africa) and P.1 (first identified in Brazil).
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. These investments allow for a doubling of drug substance manufacturing at Lonza’s (SIX: LONN) Switzerland-based facility, a more than doubling of formulation, fill and finish and drug substance manufacturing at Rovi’s (BME: ROVI) Spain-based facility, as well as a 50% increase of drug substance at Moderna’s facilities in the U.S.
April 26, 2021 - Sanofi announced an agreement with Moderna, Inc. to established infrastructure and manufacturing expertise at its site in Ridgefield, NJ, to perform fill and finish of 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 the end of 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 26, 2021 - Moderna Inc. has delayed the shipment of 590,400 doses of its COVID-19 vaccine due to arrive in Canada, the federal procurement minister confirmed, reported Reuters.
March 19, 2021 - CDS News reported a South Florida frontline health care worker received her first shot of the Moderna COVID-19 vaccine. She gave birth three weeks later to a healthy baby girl — with COVID-19 antibodies. Doctors believe the newborn marks the first known case of a baby born with coronavirus antibodies in the U.S., which may offer her some protection against the virus.
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, in children ages 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 Company’s 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 support 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, and 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 it is making new capital investments to increase capacity at its owned and partnered 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. The company has shipped doses to the National Institutes of Health for a Phase 1 clinical trial led and funded by the NIH’s National Institute of Allergy and Infectious Diseases. The Company also provided an update on its strategy for addressing SARS-CoV-2 variants of concern, such as a variant-specific booster candidate, mRNA-1273.351, based on the B.1.351 variant first identified in the Republic of South Africa, at the 50 µg dose level and lower; a multivalent booster candidate, mRNA-1273.211, which combines mRNA-1273, Moderna’s authorized vaccine against ancestral strains, and mRNA-1273.351 in a single vaccine at the 50 µg dose level and lower; and the third dose of mRNA-1273, the Moderna COVID-19 Vaccine, as a booster at the 50 µg dose level. The Company has already begun dosing this cohort with the booster shot.
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. 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 government and another with Colombia's government. 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. 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, now 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 29, 2021 - CNBC reported Moderna had asked the U.S. Food and Drug Administration for permission to fill its Covid-19 vaccine vials with up to five additional doses to ease a bottleneck in manufacturing, according to a person familiar with the matter. The change would allow Moderna to put 15 doses in the identical size vials now cleared to hold 10, alleviating pressure on the part of the manufacturing process known as fill/finish, said the person.
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 25, 2021 - Moderna Inc. announced results from in vitro neutralization studies of sera from individuals vaccinated with Moderna COVID-19 Vaccine showing activity against emerging strains of SARS-CoV-2. Vaccination with the Moderna COVID-19 Vaccine produced neutralizing titers against all key emerging variants tested, including B.1.1.7 and B.1.351, first identified in the UK and Republic of South Africa, respectively. The study showed no significant impact on neutralizing titers against the B.1.1.7 variant relative to prior variants. A six-fold reduction in neutralizing titers was observed with the B.1.351 variant relative to earlier variants. Despite this reduction, neutralizing titer levels with B.1.351 remain above levels expected to be protective.
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. TAK-919 is Takeda’s development code for Moderna’s COVID-19 vaccine candidate. Takeda intends to enroll 200 participants aged 20 years and above in Japan. Each participant will be assigned to receive a placebo or a 100 μg dose at both vaccinations. Participants will be followed through 12 months after the second vaccination.
January 21, 2021 - California State Epidemiologist Dr. Erica Pan issued a statement advising providers that they can immediately resume the administration of lot 41L20A of the Moderna COVID-19 vaccine, which was temporarily paused Sunday due to possible allergic reactions. Furthermore, the Workgroup plans to continue to work with specialists in the field of allergy and immunology in the coming weeks to ensure that our advice regarding the administration of COVID-19 vaccines to individuals with a history of selected forms of severe allergic reactions or anaphylaxis ensures maximum safety and that individuals who experience an adverse event suggestive of an allergic reaction receive appropriate testing and follow-up.
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. The authorization is given according to the ordinary approvals procedure. It is based on a rolling submission of data and the totality of scientific evidence shared by the Company, including a data analysis from the pivotal Phase 3 clinical study announced on November 30, 2020. The Swiss Federal Government has secured 7.5 million doses of the COVID-19 Vaccine Moderna, with the first deliveries are expected to begin in Switzerland in January 2021.
January 11, 2021 - Moderna, Inc. announced that it is expanding its pipeline of innovative vaccines with three new development programs based on its infectious disease vaccine portfolio's clinical success to date. Stéphane Bancel, Moderna’s chief executive officer, stated, “Even as we have shown that our mRNA-based vaccine can prevent COVID-19, this has encouraged us to pursue more ambitious development programs within our prophylactic vaccines modality. Today we are announcing three new vaccine programs addressing seasonal flu, HIV, and the Nipah virus, some of which have eluded traditional vaccine efforts and all of which we believe can be addressed with our mRNA technology.
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 7, 2021 - The US CMS published: Medicare Part B Payment for COVID-19 Vaccines and Certain Monoclonal Antibodies during the Public Health Emergency.
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. Stella Kyriakides, Commissioner for Health and Food Safety, said: “We are all in this together and united. This is why we have negotiated the broadest vaccine portfolio in the world for all our Member States. Today we are authorizing a second safe and effective vaccine from Moderna, which together with BioNTech-Pfizer, will ensure that 460 million doses will be rolled out with increasing speed in the EU, and more will come. Member States have to ensure that the pace of vaccinations follows suit. Our efforts will not stop until vaccines are available for everyone in the EU.”
January 6, 2021 - Moderna, Inc. announced that the European Commission had granted conditional marketing authorization for COVID-19 Vaccine Moderna, allowing vaccination programs using the Moderna vaccine to be rolled out across the European Union.
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.'
January 4, 2021 - Moderna, Inc. announced that Israel’s Ministry of Health (MOH) had given the authorization to import the COVID-19 Vaccine Moderna in Israel.
January 4, 2021 - Moderna said it expects about 100 million doses to be available in the USA by the end of the first quarter of 2021, with 200 million doses total available by the second quarter. Moderna reported that approximately 18 million doses had been supplied to the U.S. Government to date. Additional vaccine doses have also been supplied to the Canadian government following Health Canada's Interim Order's authorization on December 23, 2020.
January 1, 2021 - The U.S. CDC published Information about the Moderna COVID-19 Vaccine.
December 31, 2020 - Reports of possible allergic reactions to the COVID-19 vaccines produced by Pfizer-BioNTech and Moderna, both recently approved for emergency use by the U.S. Food and Drug Administration, have raised public concern. A team of experts led by allergists at Massachusetts General Hospital (MGH) has now examined all relevant information to reassure that the vaccines can be administered safely, even to people with food or medication allergies. The group’s review is published in the Journal of Allergy and Clinical Immunology: In Practice. This review summarizes vaccine allergy epidemiology and proposes risk stratification schema: (1) for individuals with different allergy histories to safely receive their first COVID-19 vaccine and (2) for individuals who develop a reaction to their first dose of COVID-19 vaccine.
December 30, 2020 - NEJM editorial: A New Vaccine to Battle Covid-19, by Barton F. Haynes, M.D.
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. Aside from transient local and systemic reactions, no safety concerns were identified. The investigational vaccine known as mRNA-1273 was 94.1% efficacious in preventing symptomatic coronavirus disease 2019 (COVID-19), according to preliminary results from a Phase 3 clinical trial reported in the New England Journal of Medicine. The vaccine also demonstrated efficacy in preventing severe COVID-19. Investigators identified no safety concerns and no evidence of vaccine-associated enhanced respiratory disease.
December 29, 2020 - Moderna, Inc. announced, 'To provide an additional layer of COVID-19 protection as Moderna workers conduct essential services in developing, manufacturing and delivering a COVID-19 vaccine, Moderna is making its vaccine available to its workers, contractors, and board members in the U.S. under Emergency Use Authorization. The program will extend to our team's adult household members to reduce the risk of absenteeism and disruption due to a COVID-19 infection in an adult household member. Participation in the program is confidential and entirely voluntary.'
December 29, 2020 - Moderna, Inc. confirmed that the Company is engaged in discussions with South Korea's government to potentially provide 40 million or more doses of the Moderna COVID-19 Vaccine to support South Korea’s aim of providing vaccines to the public as soon as possible. Under the terms of the proposed agreement, the distribution would begin in the second quarter of 2021.
December 29, 2020 - The US Department of Defense announced on December 29, 2020; it had awarded Moderna, Inc. a contract worth $1,966,598,000 for an additional 100 million doses of its COVID-19 vaccine (mRNA-1273). Moderna is expected to be fulfilled this purchase order by June 30, 2021.
December 29, 2020 - Moderna, Inc.. announced that Stéphane Bancel, Chief Executive Officer, will participate virtually in the Goldman Sachs 13th Annual Healthcare CEOs Unscripted Conference on January 5th, 2021, at 8:00 a.m. ET.
December 26, 2020 - The first wave of Moderna COVID-19 vaccine shipments has been delivered to Yokota Air Base, Japan. “Our plan to administer the doses is working through a structured tier system, which will make sure to prioritize our people appropriately,” said Capt. Alexander Tran, 374th Medical Group chief of in-patient pharmacy services. “This stratification will initially include first responders, public safety personnel, and the healthcare workers who are able and opting-in to receive the vaccine.”
December 23, 2020 - The U.S. CDC published 'General Information about the Moderna COVID-19 Vaccine.'
December 23, 2020 - Health Canada authorized the second COVID-19 vaccine in Canada, manufactured by Moderna. Health Canada received Moderna’s submission on October 12, 2020. After a thorough, independent review of the evidence, it has been determined that the Moderna vaccine meets the Department’s stringent safety, efficacy, and quality requirements.
December 22, 2020 - The U.S. CDC published COVID-19 Vaccine (Moderna) Administration Resources.
December 20, 2020 - Early Release: The Advisory Committee on Immunization Practices’ Interim Recommendation for the use of Moderna COVID-19 Vaccine — United States, December 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. Use of all COVID-19 vaccines authorized under a EUA, including the Moderna COVID-19 vaccine, should be implemented in conjunction with ACIP’s interim recommendations for allocating initial supplies of COVID-19 vaccines.
December 19, 2020 - The U.S. CDC's Coronavirus Disease (COVID-19) Vaccine review meeting presentation materials were published online.
December 18, 2020 - The U.S. Food and Drug Administration issued an emergency use authorization for the second vaccine for the prevention 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 - The Commissioner of the US Food and Drug Administration Stephen M. Hahn M.D. wrote 'Following today’s positive advisory committee meeting outcome regarding the Moderna COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified the U.S. CDC and Operation Warp Speed so that they can execute their plans for timely vaccine distribution.'
December 17, 2020 - Moderna, Inc. announced the U.S. FDA's Vaccines and Related Biological Products Advisory Committee recommended that the FDA grant an Emergency Use Authorization (EUA) for the Company’s COVID-19 vaccine candidate mRNA-1273. Twenty VRBPAC members recommended for EUA, 0 members voted against, and 1 abstained.
December 17, 2020 - The U.S. FDA posted the Vaccines and Related Biological Products Advisory Committee Meeting presentations on December 17, 2020. ModernaTX, Inc sponsors the mRNA-1273 experimental vaccine candidate.
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 17, 2020 - The EMA Committee has scheduled an extraordinary meeting on January 6, 2021, to conclude its assessment, if possible. Once the CHMP recommends a marketing authorization, the European Commission will fast-track its decision-making process to grant valid marketing authorization in all EU and the EEA Member States within days.
December 15, 2020 - Presented by the Orthodox Union and the Rabbinical Council of America: the conclusion of our poskim is 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 14, 2020 - The Centers for Disease Control and Prevention posted the ACIP meeting agenda for Atlanta, Georgia, on December 19 and 20, 2020.
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. 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 8, 2020 - Moderna announced the Swiss Federal Government had increased its confirmed order commitment from 4.5 million to 7.5 million doses of Moderna’s vaccine candidate against COVID-19, mRNA-1273.
December 7, 2020 - Moderna announced that the Canadian Government had increased its confirmed order commitment by 20 million doses of Moderna’s vaccine candidate against COVID-19, mRNA-1273, bringing its documented order commitment to 40 million doses.
December 4, 2020 - Moderna, Inc. announced an expanded supply agreement with the Ministry of Health of Israel for an additional 4 million doses of the mRNA-1273 vaccine. The Company has already initiated the rolling regulatory review process with the Ministry of Health in Israel.
December 3, 2020 - Moderna provided an update on the clinical development and production of mRNA-1273, its vaccine candidate against COVID-19. A letter to the editor was published in the New England Journal of Medicine reporting that participants in the Phase 1 study of mRNA-1273, its COVID-19 vaccine candidate, retained high levels of neutralizing antibodies through 119 days following the first vaccination (90 days following second vaccination).
December 2, 2020 - Merck & Co announced it had sold its equity investment in Moderna Inc. Merck did not disclose the sale proceeds' details.
November 17, 2020 - Moderna, Inc., announced that the European Medicines Agency human medicines committee had started a rolling review of mRNA-1273, the Company’s vaccine candidate against COVID-19, following the confirmation of eligibility of mRNA-1273 for submission on October 14, 2020.
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%.
November 13, 2020 - The Swiss therapeutics products agency Swissmedic has started reviewing the anti-Covid 19 vaccine from Moderna in the rolling submission procedure.
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.
October 15, 2020 - A NEJM article was published: Evaluating the mRNA-1273 Vaccine against SARS-CoV-2 in Nonhuman Primates.
September 29, 2020 - Moderna, Inc. announced the publication of the second interim analysis of the open-label Phase 1 study of mRNA-1273, its vaccine candidate against COVID-19, in The NEJM. This interim analysis found that both the 25 µg and 100 µg dose levels were generally well-tolerated in both age cohorts. Immune responses were dose-dependent, with the 100 µg dose eliciting higher binding and neutralizing antibody titers, supporting the selection of the 100 µg dose for further study in the Phase 3 trial.
August 24, 2020 - Moderna announced that the Company had concluded advanced exploratory talks with the European Commission (EC) to supply 80 million doses of mRNA-1273, Moderna’s vaccine candidate against COVID-19 disease.
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 the manufacturing and delivery of 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 Company’s 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.
July 8, 2020 - Moderna, Inc. announced that it had completed enrollment for both cohorts of the Phase 2 study of its coronavirus vaccine candidate, mRNA-1273. Moderna has finalized the Phase 3 study protocol based on feedback from the U.S. Food and Drug Administration.
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 (mRNA-1273) at Catalent’s biologics facility in Indiana.
June 17, 2020 - Reuters reported Israel had signed an agreement with Moderna for the future purchase of its potential COVID-19 vaccine.
June 11, 2020 - A non-peer-reviewed study of Moderna Inc.'s COVID-19 vaccine candidate in mice lends some assurance that it will not increase the risk of more severe disease and that one 1-dose may provide protection against the novel coronavirus.
June 11, 2020 - Moderna announced progress on the late-stage development of mRNA-1273, the Company’s mRNA vaccine candidate against COVID-19. Moderna has finalized the Phase 3 study protocol based on the U.S. FDA's feedback.
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 27, 2020 - Moderna, Inc. announced that it had submitted an application to the U.S. FDA to evaluate mRNA-1273 in Phase 2 and late-stage studies if supported by safety data from the Phase 1 study led by the National Institute of Allergy and Infectious Diseases.
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 development of 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 Company’s vaccine against the novel coronavirus, for human use. Vials of mRNA-1273 have been shipped to the National Institute of Allergy and Infectious Diseases, a part of the National Institutes of Health, to be used in the planned Phase 1 study in the U.S.
January 13, 2020 - The U.S. National Institutes of Health (NIH) and Moderna’s infectious disease research team finalized the sequence for mRNA-1273, the Company’s vaccine against the novel coronavirus.
COVID-19 Vaccine Moderna Clinical Trials
Moderna continues to run clinical trials to evaluate the safety, immunogenicity, and reactogenicity of its COVID-19 vaccine.