Moderna COVID-19 Vaccine (mRNA-1273) Description
The Moderna COVID-19 Vaccine (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.
On December 18, 2020, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) that enables the Moderna COVID-19 Vaccine to be distributed in the USA for use in individuals 18 years of age and older.
The Moderna COVID‑19 Vaccine has not been approved or licensed by the FDA but was authorized for emergency use. There is no FDA-approved vaccine to prevent COVID‑19 at this time. The EUA for the Moderna COVID‑19 Vaccine is in effect for the duration of the COVID‑19 EUA declaration justifying emergency use of the product unless the declaration is terminated or the authorization is revoked sooner.
ModernaTX, 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 Middle Eastern Respiratory Syndrome and Severe Acute Respiratory Syndrome.
The first clinical batch, 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.
The new Phase 3 study (COVE) protocol has been reviewed by the U.S. FDA and is aligned with recent guidance on clinical trial design for COVID-19 vaccine studies. The Phase 3 COVE study is being conducted in collaboration with the NIH and the Biomedical Advanced Research and Development Authority, which began on July 27, 2020. The enrollment of approximately 30,000 participants is on track to complete in September.
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.
On October 22, 2020, Moderna stated it would determine whether to submit a dossier to the U.S. FDA requesting Emergency Use Authorization based on assessing whether the vaccine's potential benefit outweighs the potential risks once the 2-months of median safety follow-up have accrued.
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.
Moderna previously collaborated with the NIH on a vaccine for MERS-CoV, a different type of coronavirus than the current SARS-CoV-2 pandemic. This program was only at the research stage and was not tested in humans.
And on November 12, 2020, 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.
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 new 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.'
Funding from the Biomedical Advanced Research and Development Authority (BARDA) partially supported the planning for Phase 2 and Phase 3 studies of mRNA-1273 and supported the manufacturing process scale-up.
The U.S. FDA published a FAQ on January 5, 2021.
ModernaTX, 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.
Moderna COVID-19 Vaccine (mRNA-1273) Side Effects
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.
If any, side effects usually start within a day or two of getting the vaccine. They might feel like flu symptoms and might even affect your ability to do daily activities, but they should go away in a few days, says the CDC.
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.
Summary of safety data: In clinical trials, reactogenicity symptoms (side effects that happen within 7 days of getting vaccinated) were common but were mostly mild to moderate. Side effects, such as fever, chills, tiredness, and headache, were more common throughout the body after the second vaccine dose. Most side effects were mild to moderate. However, a small number of people had severe side effects—defined as side effects affecting a person’s ability to do daily activities.
The U.S. CDC publishes 'Understanding Side Effects and Adverse Events.'
Anaphylaxis, an acute and potentially life-threatening allergic reaction, has been reported following the COVID-19 vaccination. Detailed information on CDC recommendations for vaccination, including contraindications and precautions to vaccination, can be found in the Clinical Considerations for the use of mRNA COVID-19 Vaccines Currently Authorized in the USA.
Moderna COVID-19 Vaccine (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.
Moderna COVID-19 Vaccine (mRNA-1273) Distribution
In Europe, the Company stated it is working with its strategic manufacturing partners, Lonza of Switzerland and ROVI of Spain, for manufacturing and fill-finish outside the UDA. This is a dedicated supply chain to support Europe and countries other than the USA that enter into purchase agreements with Moderna.
The US government signed the distribution agreement on August 9, 2020, disclosed on October 24, 2020.
And on October 26, 2020, Moderna announced a supply agreement with the Ministry of Public Health of Qatar for mRNA-1273 to support the Ministry’s ongoing efforts to secure early access to a safe and effective COVID-19 vaccine the people of Qatar.
On October 29, 2020, Moderna, Inc. confirmed that the Ministry of Health, Labour, and Welfare of Japan and Takeda Pharmaceutical Co., Ltd. have agreed to purchase and distribute 50 million doses mRNA-1273, subject to necessary regulatory approvals.
Additionally, on November 17, 2020, Moderna announced a supply agreement with the United Kingdom government to supply mRNA-1273, its COVID-19 vaccine candidate, beginning in March 2021 if approved for use by UK regulatory authorities.
Furthermore, on November 25, 2020, the company announced that the European Commission had approved an agreement to secure 80 million doses of mRNA-1273, as part of the European Commission’s goal to secure access to a safe and effective COVID-19 vaccine for Europe. Under the terms of the proposed agreement, the European Commission has the option to increase its purchase of mRNA-1273 from 80 million doses to a total of up to 160 million doses.
And on November 29, 2020, Moderna, Inc. announced a supply agreement with the UK government for an additional 2 million doses of mRNA-1273, beginning in March 2021. The UK government has now secured 7 million doses of mRNA-1273.
An expanded supply agreement with the Ministry of Health of Israel for an additional 4 million doses of mRNA-1273 was announced on December 4, 2020. The Israeli government has now secured 6 million doses of mRNA-1273. This agreement will support the Ministry's ongoing efforts to secure early access to a COVID-19 vaccine for foIsrael'she people.
On December 7, 2020, the Canadian Government increased its confirmed order commitment by 20 million doses of Moderna’s vaccine candidate, bringing its confirmed order commitment to 40 million doses. Then, on December 23, 2020, Health Canada announced it had approved Moderna's COVID-19 vaccine for use in this country, with 168,000 vaccine doses expected to arrive by the end of 2020.
Moderna announced the Swiss Federal Government had increased its confirmed order commitment from 4.5 million to 7.5 million doses, as of December 8, 2020.
On December 11, 2020, the US government increased its order by 100 million doses. In aggregate, the USA is buying 200 million doses. Additional doses ordered today will be delivered in Q2 2021. HHS Secretary Alex Azar stated: “This new federal purchase can give Americans even greater confidence we will have enough supply to vaccinate all Americans who want it by the second quarter of 2021.”
The company confirmed an agreement with the Ministry of Health of Singapore to supply mRNA-1273 vaccines on December 14, 2020.
The European Commission exercised its option to purchase an additional 80 million doses of mRNA-1273, Moderna’s COVID-19 vaccine candidate, bringing its confirmed order commitment to 160 million doses as of December 18, 2020.
The United States Department of Defense awarded Moderna a contract worth $1,966,598,000 for an additional 100 million doses of its COVID-19 vaccine. The manufacturing will be handled in Cambridge, Massachusetts, and is expected to be fulfilled by June 30, 2021.
On January 4, 2021, Moderna provided a supply update for the Moderna COVID-19 Vaccine, increasing its base-case global production estimate from 500 to 600 million doses for 2021. Moderna said it is continuing to invest and add staff to build up to potentially 1 billion doses for 2021.
ModernaTX recently announced further progress towards ensuring the distribution, storage, and handling of the vaccine can be done using existing infrastructure. Lookup View Vial Lot Numbers and Expiration Dates.
Moderna COVID-19 Vaccine (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.
A continuous review of safety data is ongoing, and the Company has identified no new serious safety concerns. Based on prior analysis, the most common solicited adverse reactions included injection site pain, fatigue, myalgia, arthralgia, headache, and erythema/redness at the injection site. Solicited adverse reactions increased in frequency and severity in the mRNA-1273 group after the second dose.
The Package Insert is found at this link.
COVID-19 vaccination providers must document vaccine administration in their medical record systems within 24 hours of administration and use their best efforts to report administration data to the relevant system for the jurisdiction (i.e., immunization information system) as soon as practicable and no later than 72 hours after administration, stated the CDC on December 22, 2020.
Moderna COVID-19 Vaccine (mRNA-1273) Indication
Pediatric, teenager, oncology, and pregnancy efficacy verification data pending.
Kosher and Halal verification pending.
Moderna COVID-19 Vaccine (mRNA-1273) News
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 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 confirmed 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). The study was led by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
December 2, 2020 - Moderna listed a Phase 2/3, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 SARS CoV 2 Vaccine in Healthy Adolescents 12 to 17 Years of Age.
December 2, 2020 - Merck & Co announced it had sold its equity investment in Moderna Inc. Merck did not disclose the sale proceeds' details.
November 30, 2020 - Moderna announced that the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee meeting to review the safety and efficacy data package for mRNA-1273 would likely be scheduled for Thursday, December 17, 2020. The Company anticipates that the shipping of mRNA-1273 to designated distribution points throughout the U.S. will occur shortly after an Emergency Use Authorization is granted. By the end of 2020, the Company expects to have approximately 20 million doses of mRNA-1273 available in the U.S. The Company remains on track to manufacture 500 million to 1 billion doses globally in 2021.
November 29, 2020 - The UK government has now secured 7 million doses of mRNA-1273. “We appreciate the collaboration with the UK government as with many other governments and other key partners worldwide,” said Stéphane Bancel, Chief Executive Officer of Moderna.
November 24, 2020 - Reasons for Gratitude Amid the COVID-19 Pandemic by Dr. Francis Collins, the U.S. NIH's director.
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. Stéphane Bancel, Chief Executive Officer of Moderna, added: “We will continue our ongoing dialogue with the EMA as we seek to develop a safe and effective vaccine. We are also scaling up global manufacturing with our strategic partners Lonza of Switzerland and ROVI of Spain to be able to deliver approximately 500 million doses per year and possibly up to 1 billion doses per year, beginning in 2021.”
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. “The rolling submission procedure for mRNA-1273 is based on the initially submitted data packages on the preclinical situation and quality, as well as on preliminary clinical data. In a rolling review, the data can be evaluated as soon as they become available. The companies can then submit the latest data continuously without waiting for all conclusive results."
October 29, 2020 - Stéphane Bancel, Moderna’s Chief Executive Officer, stated: “We look forward to our expected first review of our interim efficacy data, which is expected in November.”
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 27, 2020 - Moderna announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom had started the rolling review process of mRNA-1273. This rolling review process allows the MHRA to begin its independent assessment using Moderna's information and accept new evidence as it becomes available until the application is deemed complete. This process can reduce time to authorization while maintaining usual high standards of safety, efficacy, and quality.
October 22, 2020 - Moderna, Inc. announced that it had completed enrollment of 30,000 participants for the Phase 3 COVE study of mRNA-1273, its vaccine candidate against COVID-19, being conducted in collaboration with the National Institute of Allergy and Infectious Diseases. To date, more than 25,650 participants have received their second vaccination.
October 15, 2020 - A NEJM article was published: Evaluating the mRNA-1273 Vaccine against SARS-CoV-2 in Nonhuman Primates.
October 14, 2020 - Moderna, Inc. announced that it had received written confirmation from the European Medicines Agency (EMA) that mRNA-1273 is eligible for submitting an application for a European Union Marketing Authorization under the Agency’s centralized procedure. Confirmation of eligibility was given in response to submitting a letter of intent, enabling Moderna to evaluate the opportunity for submitting a Marketing Authorization Application for mRNA-1273 with the EMA.
October 13, 2020 - U.S. NIH's Director's Blog: COVID-19 Vaccine Appears Well-Tolerated and Effective in Developing Antibodies in Small Study of Older Adults.
October 13, 2020 - Moderna announced the initiation of a rolling submission to Health Canada for mRNA-1273, the Company’s vaccine candidate against COVID-19. This initiation follows positive results from a preclinical viral challenge study of mRNA-1273 and the positive interim analysis of the Phase 1 study of mRNA-1273 published in the New England Journal of Medicine.
October 2, 2020 - Moderna Inc. says the COVE Phase 3 Study enrolled 28,043 participants, and 19,369 participants have received their second vaccination.
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.
September 17, 2020 - Moderna reported COVID vaccine candidate (mRNA-1273) Phase 3 COVE study has enrolled 25,296 participants, and 10,025 participants have received their 2nd vaccination to date.
August 28, 2020 - Moderna, Inc. confirmed that the Company is engaged in discussions with the Ministry of Health, Labour, and Welfare of Japan (MHLW) to potentially purchase 40 million or more doses of the mRNA-1273 vaccine candidate. Under the terms of this arrangement, the vaccine would be supplied by Moderna, Inc. and distributed in Japan by Takeda Pharmaceutical Co., Ltd. beginning in the first half of 2021, if the vaccine receives regulatory approval.
August 26, 2020 - Moderna presented data from the Phase I trial of its mRNA-1273 vaccine candidate at the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.
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. The potential purchase agreement provides an option for the EC Member States to purchase an additional 80 million doses for a total of up to 160 million doses.
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 28, 2020 - NEJM study: Evaluation of the mRNA-1273 Vaccine against SARS-CoV-2 in Nonhuman Primates.
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. This interim analysis evaluated a two-dose vaccination schedule. Results from participants in the initial dose cohorts who received both vaccinations and were evaluated at pre-specified timepoints reaffirm the positive interim data assessment announced on May 18, 2020, and show mRNA-1273 induced rapid and strong immune responses against SARS-CoV-2.
July 14, 2020 - A Preliminary Report published by the NEJM found the mRNA-1273 vaccine-induced anti–SARS-CoV-2 immune responses in all participants, and no trial-limiting safety concerns were identified. These findings support further development of this vaccine.
July 9, 2020 - Moderna, Inc. announced a collaboration for large-scale, commercial fill-finish manufacturing of Moderna’s mRNA vaccine candidate against COVID-19 (mRNA-1273) at ROVI’s facility in Madrid, Spain.
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.
July 1, 2020 - Inside Moderna: The COVID Vaccine Front-Runner With No Track Record and an Unsparing CEO.
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. As part of the agreement, Catalent will provide manufacturing operations at the site to support the production of an initial 100 million doses of the vaccine candidate intended to supply the U.S. market starting in the third quarter of 2020.
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. This study showed that mRNA-1273 vaccination induces both potent neutralizing antibody and CD8 T cell responses and protects against SARS-CoV-2 infection in the lungs and mice's noses without evidence of immunopathology.
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. The randomized, 1:1 placebo-controlled trial is expected to include approximately 30,000 participants enrolled in the U.S. and are expected to collaborate with the National Institute of Allergy and Infectious Diseases.
June 2, 2020 - Moderna, Inc. announced new research to be highlighted at the Company’s third annual Science Day. The program is designed to provide insight into the continued diverse efforts underway at Moderna and with collaborators to understand better how to use mRNA as medicine. It underscores the Company’s continued commitment to basic science and innovation.
May 29, 2020 - Moderna, Inc. announced that the first participants in each age cohort had been dosed in the Company’s Phase 2 study of its mRNA vaccine candidate (mRNA-1273) against the novel coronavirus SARS-CoV-2.
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. “These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 µg,” said Tal Zaks, M.D., Ph.D., Chief Medical Officer.
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). Previously, on May 6th, the FDA said it completed the review of the Investigational New Drug (IND) application for mRNA-1273, allowing it to proceed to a Phase 2 study, which is expected to begin shortly. Moderna said it is finalizing the protocol for a Phase 3 study, expected to begin in the early summer of 2020.
May 8, 2020 - 'If Moderna’s coronavirus vaccine proves to work, the company anticipates working “very closely” with the U.S. government to determine 'who' will get the first mRNA-1273 doses, CEO Stephane Bancel told CNBC.
May 7, 2020 - Stéphane Bancel, Moderna’s Chief Executive Officer, said in a press statement, “The imminent Phase 2 study start is a crucial step forward as we continue to advance the clinical development of mRNA-1273, our vaccine candidate against SARS-CoV-2. Intending to start the mRNA-1273 pivotal Phase 3 study early this summer, Moderna is now preparing to potentially have its first Biologics License Application approved as soon as 2021."
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 IND application to the U.S. FDA for the company’s mRNA vaccine candidate (mRNA-1273) against the SARS-CoV-2 coronavirus 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 23, 2020 - The USA Today reports the Seattle volunteers who got shots in the first trial of a possible coronavirus vaccine are now getting the second shot — an indicator the early trial is progressing well. The doctors at Kaiser Permanente's Vaccine Treatment and Evaluation Unit in Seattle don’t know the results of the first round of tests, said Lisa Jackson, who is leading the study.
April 16, 2020 - Moderna, Inc. announced an agreement for a commitment of up to $483 million from the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), to accelerate the development of the Company’s mRNA vaccine candidate (mRNA-1273) against the novel coronavirus SARS-CoV-2.
March 27, 2020 - The NIH announced that Emory University in Atlanta would begin enrolling healthy adult volunteers ages 18 to 55 years in the NIH-led Phase 1 study of mRNA-1273.
March 16, 2020 - Moderna, Inc. announced that the first participant had been dosed in the Phase 1 study of the Company’s mRNA vaccine (mRNA-1273) against the novel coronavirus (SARS-CoV-2). The National Institutes of Health are conducting this Phase 1 study under its own Investigational New Drug application.
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 23, 2020 - Moderna, Inc. announced a new collaboration to develop an mRNA vaccine against the novel coronavirus SARS-CoV-2.
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. At that time, the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, disclosed their intent to run a Phase 1 study using the mRNA-1273 vaccine in response to the coronavirus threat, and Moderna mobilized toward clinical manufacture. This batch's manufacture was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).
Moderna COVID-19 Vaccine (mRNA-1273) Definition
Messenger RNA, or 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. Reaching different types of cells requires different delivery methods, says the company.
Moderna COVID-19 Vaccine (mRNA-1273) Clinical Trials
Clinical Trial NCT04470427: A Phase 3 Study to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1273 Vaccine in Adults Aged 18 Years and Older to Prevent COVID-19 -- Last Update Posted: October 28, 2020.
The COVE study is designed to primarily evaluate the efficacy, safety, and immunogenicity of mRNA-1273 to prevent COVID-19 for up to 2-years after the second dose of mRNA-1273. Last updated on October 28, 2020.
The Phase 3 study protocol has been reviewed by the U.S. Food and Drug Administration (FDA) and is aligned with recent FDA guidance on clinical trial design for COVID-19 vaccine studies.
The randomized, 1:1 placebo-controlled trial is expected to include approximately 30,000 participants at the 100 µg dose level in the U.S. The primary endpoint will be the prevention of symptomatic COVID-19 disease. Key secondary endpoints include preventing severe COVID-19 disease and preventing infection by SARS-CoV-2.
The primary endpoint is the prevention of symptomatic COVID-19 disease.
Key secondary endpoints include preventing severe COVID-19 disease and preventing infection by SARS-CoV-2. The trial will continue to accrue additional data relevant to safety and efficacy even after a EUA is submitted.
The COVE study includes more than 7,000 Americans over the age of 65. It also includes more than 5,000 Americans under the age of 65.
Additionally, high-risk chronic diseases put Americans at increased risk of severe COVID-19, such as diabetes, severe obesity, and cardiac disease.
These medically high-risk groups represent 42% of the total participants in the Phase 3 COVE study.
The study also included communities that have historically been under-represented in clinical research and have been disproportionately impacted by COVID-19.
The study includes more than 11,000 participants from communities of color, representing 37% of the study population, which is similar to U.S. diversity at large. This includes more than 6,000 participants who identify as Hispanic and more than 3,000 participants who identify as Black or African American.
Estimated Study Completion Date: October 27, 2022.
Clinical Trial NCT04649151: A Study to Evaluate the Safety, Reactogenicity, and Effectiveness of mRNA-1273 Vaccine in Adolescents 12 to <18 Years Old to Prevent COVID-19 (TeenCove)--Last Update Posted January 14, 2021
The purpose of the TeenCove study is to seek an indication for use of the mRNA-1273 vaccine in adolescents of 12-17 years old. Study volunteers will participate and be followed by medical staff for a total of 13 months.
Estimated enrollment will consist of 3,000 adolescents 12 to <18 Years Old.
Clinical Trial NCT04405076: A Phase 2a, Randomized, Observer-Blind, Placebo-Controlled, Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 SARS-COV-2 Vaccine in 600 Adults Aged 18 Years and Older -- Last Update Posted July 10, 2020
The first cohort of healthy adults ages 18-54 years (n=300) in the Phase 2 study of mRNA-1273 is fully enrolled, 13 days after the first participant was dosed.
The sentinel participants in the cohort of older adults ages 55 years and above (n=50) are fully enrolled. This Phase 2 study, conducted by Moderna, evaluates the safety, reactogenicity, and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart.
The Company intends to enroll 600 healthy participants across two cohorts of adults ages 18-54 years (n=300) and older adults ages 55 years and above (n=300). Each participant will be assigned to receive a placebo, a 50 μg, or a 100 μg dose at both vaccinations. Participants will be followed through 12 months after the second vaccination.
Estimated Primary Completion Date: March 2021.
Clinical Trial NCT04283461: - Phase I, Open-Label, Dose-Ranging Study of the Safety and Immunogenicity of 2019-nCoV Vaccine (mRNA-1273) in Healthy Adults -- Last Update Posted: December 21, 2020.
This is a phase I, open-label, dose-ranging clinical trial in males and non-pregnant females, starting at 18 years of age, inclusive, who are in good health and meet all eligibility criteria.
Enrollment will occur at up to 3 domestic clinical research sites. 120 will be enrolled into one of thirteen cohorts (10 micrograms [mcg], 25 mcg, 50 mcg, 100 mcg, and 250 mcg). Subjects will receive an intramuscular (IM) injection (0.5 milliliters [mL]) of mRNA-1273 on Days 1 and 29 in the deltoid muscle and will be followed through 12 months post-second vaccination (Day 394).
Follow-up visits will occur 1, 2, and 4 weeks post each vaccination (Days 8, 15, 29, 36, 43, and 57), as well as 3, 6, and 12 months post-second vaccination (Days 119, 209, and 394). The primary objective is to evaluate the safety and reactogenicity of a 2-dose vaccination schedule of mRNA-1273, given 28 days apart, across 5 dosages in healthy adults.
Estimated Study Completion Date: November 22, 2021.