Vaccine Info

SpikeVax COVID-19 Vaccine (Moderna)

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December 3, 2021
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SpikeVax COVID-19 Vaccine (Moderna, mRNA-1273) Description

The SpikeVax COVID-19 Vaccine (mRNA-1273, elasomeran) is a Messenger RNA (mRNA) vaccine against the SARS-CoV-2 betacoronavirus encoding for a prefusion stabilized form of the Spike (S) protein selected by Moderna Inc. in collaboration with U.S. NIAID Vaccine Research Center investigators. The S protein complex is necessary for membrane fusion and host cell infection.

SpikeVax's active ingredient is CX-024414 (single-stranded, 5’-capped mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the S protein of SARS-CoV-2. Moderna designs its mRNA vaccines using the virus's sequence, not on the virus itself. 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. The mRNA instructs a patient's cells to produce proteins that prevent, treat, or cure disease. Moderna says mRNA plays a fundamental role in human biology, transferring the instructions stored in DNA to make the proteins required in every living cell.

On December 18, 2020, the U.S. FDA issued an emergency use authorization (EUA) that enabled the COVID-19 Vaccine Moderna (SpikeVax) to be distributed in the U.S. for use in individuals 18 years of age and older. And on August 12, 2021, the FDA amended SpikeVax's EUA to allow for an additional dose in specific immunocompromised individuals, specifically, solid organ transplant recipients or those diagnosed with conditions considered to have an equivalent level of immunocompromised. 

The FDA announced on November 19, 2021, it amended the EUA for SpikeVax authorizing the use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. Additionally, Rituparna Das, MD, Ph.D., Moderna, presented 'Update on 50 µg Booster Dose of Moderna COVID-19 Vaccine in Individuals ≥18 Years of Age,' during the CDC vaccine advisory meeting.

The European Medicines Agency (EMA) authorized SpikeVax in January 2021. On July 23, 2021, the EMA granted an extension of indication for Spikevax (previously COVID-19 Vaccine Moderna) to include use in children aged 12 to 17 years, as well as people aged 18 and above. The EMA product number: EMEA/H/C/005791. This EMA medicinal product is subject to additional monitoring.

The Lancet Regional Health – Americas confirmed on November 25, 2021, Moderna COVID-19 vaccine effectiveness up to 5 months after the second dose was 87% against COVID-19 infection, 96% against COVID-19 hospitalization, and 98% against COVID-19 death.

SpikeVax (COVID-19 Vaccine Moderna) Accession Number: DB15654; Preferred Substance Name: CX-024414; UNII: EPK39PL4R4; MedlinePlus a621002Moderna Inc.'s 10-Q SEC filing on January 4, 2021, indicates 'mRNA is considered a gene therapy product by the U.S. FDA.' (pINN elasomeran).

SpikeVax COVID-19 Vaccine (Moderna, mRNA-1273) History

The first clinical batch of the Moderna vaccine candidate (CX-024414), funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020, and underwent analytical testing. It was shipped to the NIH on February 24th, 42 days of sequence selection. The first participant in the NIH-led Phase 1 study of the Moderna COVID-19 Vaccine (mRNA-1273) was dosed on March 16, 2020, 63 days from sequence selection to Phase 1 study dosing. On August 26, 2020, Moderna presented data from the Phase I trial at the Advisory Committee on Immunization Practices.

As of September 16, 2020, 25,296 participants enrolled in the COVE Phase 3 clinical study. And as of October 2, 2020, 19,369 participants have received their 2nd vaccination of Moderna's mRNA-1273 vaccine candidate.

With the Phase 3 dose being finalized at 100 μg, the Company said it remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021 from the Company's internal U.S. manufacturing site and strategic collaboration with Lonza.

On November 30, 2020, Moderna announced 'that the primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis. 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 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. In addition, 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 EMA published EMA/15689/2021 Committee for Medicinal Products for Human Use Assessment report for the COVID-19 Vaccine Moderna. Concentrations of lipid nanoparticles in mRNA-1647 were quantifiable (pg.#47) in most tissues examined at the first time collected (2 hours post-dose), and peak concentrations were reached between 2- and 24-hours post-dose in tissues with exposures above that of plasma. Besides injection site [muscle] and lymph nodes [proximal and distal], increased mRNA concentrations (compared to plasma levels) were found in the spleen and eye. Low levels of mRNA could be detected in all examined tissues except the kidney. This included heart, lung, testis, and brain tissues, indicating that the mRNA/LNP platform crossed the blood/brain barrier, although very low (2-4% of the plasma level). Liver distribution of mRNA-1647 is also evident in this study, consistent with the literature reports that the liver is a common target organ of lipid nanoparticles.

On September 7, 2021, Australia published updated Information on Spikevax (Moderna) COVID-19 vaccine. And on September 16, 2021, Health Canada Approved the SpikeVax vaccine. The WHO Global Advisory Committee on Vaccine Safety issued an updated statement on October 27, 2021, regarding myocarditis and pericarditis reported with COVID-19 mRNA vaccines.

Moderna, Inc. is advancing messenger RNA science to create a new transformative medicine class for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane, or secreted proteins that can have a therapeutic or preventive benefit and potentially address a broad spectrum of diseases. Headquartered in Cambridge, Mass., Moderna has been named a top biopharmaceutical employer. To learn more, visit www.modernatx.com.

SpikeVax COVID-19 Vaccine (Moderna, mRNA-1273) and Adolescents

On June 7, 2021, Moderna, Inc. announced that it is seeking conditional marketing approval for its SpikeVax COVID-19 vaccine in adolescents with the European Medicines Agency. The Company also plans to submit to the U.S. FDA an authorization request to expand the use of its vaccine to adolescents. The Company also filed for authorization with Health Canada. In addition, Moderna filed for an EMA with the U.S. FDA for adolescents ages 12 and above on August 25, 2021.

On July 23, 2021, the EMA announced its human medicines committee has recommended granting an extension of indication for the COVID-19 vaccine Spikevax to include use in children aged 12 to 17 years. On November 10, 2021, the EMA has started evaluating an application to extend the use of Moderna’s COVID-19 vaccine, Spikevax, to children aged 6 to 11.

The journal NEJM published an Orginal Article on August 11, 2021, which found the mRNA-1273 vaccine had an acceptable safety profile in adolescents. The immune response was similar to that in young adults, and the vaccine was efficacious in preventing Covid-19.

On August 17, 2021, Moderna's SpikeVax  COVID-19 vaccine was approved by the U.K.'s MHRA in 12-17-year-olds. Spikevax was authorized for those aged 12-17 years in Northern Ireland on July 23, 2021.

The Australian Technical Advisory Group on Immunisation confirmed on August 27, 2021, the benefits of offering COVID-19 vaccination to all younger adolescents aged 12-15 years outweigh the known or potential risks. As such, the inclusion of this age group in the Australian COVID-19 vaccination program is advised.

Moderna announced on November 9, 2021, that it has submitted for a variation to the conditional marketing authorization with the EMA for the evaluation of a 50 µg two-dose series of SpikeVax in children ages 6-11 years.

On November 17, 2021, Moderna Inc. submitted for authorization with Health Canada for the evaluation of a 50 µg two-dose series of SPIKEVAX™ in children ages 6 to 11 years.

SpikeVax COVID-19 Vaccine (Moderna, mRNA-1273) and Cancer Patients

Two studies published by the journal Blood on April 16, 2021, evaluated immune responses to the BNT162b2 mRNA COVID-19 vaccine in patients with chronic lymphocytic leukemia and seniors diagnosed with multiple myeloma. These studies suggest that mRNA-based COVID-19 vaccines may not work as well in people with blood cancer. And on August 30, 2021, the National Comprehensive Cancer Network® published the 4th version of the NCCN: Cancer and COVID-19 Vaccination guidance.

SpikeVax COVID-19 Vaccine (Moderna, mRNA-1273) Indication For Pregnant Women

The NEJM published original research on April 21, 2021, stating, 'Preliminary findings did not show obvious safety signals among pregnant women who received mRNA COVID-19 vaccines, or neonatal outcomes. And, the EMA's PRAC concluded on October 6, 2021, that there is currently no evidence suggesting a causal relationship of menstrual disorders with the Spikevax vaccine.

SpikeVax COVID-19 Vaccine (Moderna, mRNA-1273) Indication For Breastfeeding Women

The WHO Strategic Advisory Group of Experts on Immunization Interim recommendations issued on January 26, 2021, include, but are not limited to, the vaccine that can be offered to a breastfeeding woman who is part of a group recommended for vaccination (e.g., health workers); discontinuing breastfeeding after vaccination is currently not recommended.

SpikeVax COVID-19 Vaccine (Moderna, mRNA-1273) Indication For Multiple Sclerosis Patients

A study published by the JAMA Network on August 24, 2021, found the humoral response against SARS-CoV-2 at 1 month after mRNA vaccination was appropriate under treatment with cladribine and teriflunomide and diminished/absent under treatment with anti-CD20 therapies and S1P modulators. Delaying anti-CD20 infusions by 3 to 6 months before vaccination could, however, increase the probability of developing appropriate humoral responses, especially in selected clinically and radiologically stable patients. Future studies should aim at investigating antibody dynamics over time, if and how T cell-mediated responses after vaccination are influenced by DMTs, and whether these biological measures actually reflect vaccine efficacy in terms of preventing severe SARS-CoV-2 infection.

This study's findings are similar to previous studies of immune responses in MS patients on anti-CD20 therapy after COVID-19 vaccination and in MS patients on anti-CD20 treatment who were infected with COVID-19.

SpikeVax and Fluzone High-Dose Quadrivalent Coadministration

A Phase II, open-label study to assess the safety and immunogenicity of Sanofi Pasteur Fluzone® High-Dose Quadrivalent (Influenza Vaccine), 2021–2022 Formulation, and a third dose of SpikeVax, mRNA-1273 COVID-19 vaccine, administered either concomitantly or singly in adults 65 years of age and older previously vaccinated with a 2-dose schedule of the mRNA-1273 vaccine. October 20, 2021. Results interpretation Summary: The QHD00028 study results demonstrate that QIV-HD and mRNA-1273 vaccine (100µg) can be administered safely together without evidence of immunogenicity interference, supporting existing co-administration recommendations of COVID-19 and influenza vaccines.

SpikeVax COVID-19 Vaccine (Moderna, mRNA-1273) Side Effects

The U.S. CDC published Possible Side Effects of COVID-19 vaccines on March 5, 2021. The most commonly reported side effects, typically lasting several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, swollen lymph nodes in the same arm as the injection, nausea, vomiting, and fever. Of note, more people experienced these side effects after the second dose than after the first dose, so vaccination providers and recipients need to expect that there may be some side effects after either dose, but even more so after the second dose, said the FDA.

EMA's safety committee concluded on December 3, 2021, that myocarditis and pericarditis can occur in very rare cases following vaccination with the COVID-19 vaccines Spikevax. On July 14, 2021,  the EMA published a SpikeVax vaccine safety update: Inflammation of the heart muscle (myocarditis) or membrane (pericarditis) may occur in a small number of people after vaccination with Spikevax. On October 20, 2021, the FDA announced revisions of the patient and provider fact sheets for the Moderna (SpikeVax) COVID-19 vaccines regarding the suggested increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination. On October 27, 2021, the WHO issued a similar heart health risk notice. The EMA confirmed it is reviewing heart risks related to SpikeVax vaccine recipients on October 29, 2021. On November 11, 2021, the EMA confirmed there is currently insufficient evidence of a possible link between Spikevax and very rare cases of the multisystem inflammatory syndrome.

Sweden's Health Ministry announced on October 6, 2021, it will pause the use of Moderna's COVID-19 vaccine for people born in 1991 and later after reports of possible rare side effects, such as myocarditis. Finland announced similar restrictions for men.

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 vaccine ingredient. The FDA published a FACT SHEET FOR RECIPIENTS AND CAREGIVERS. As of October 20, 2021, the FDA says, 'The warning in the Fact Sheets for Healthcare Providers Administering Vaccines notes that reports of adverse events suggest increased risks of myocarditis and pericarditis, particularly following the second dose and with the onset of symptoms within a few days after vaccination.'

Hui-Lee Wong, Ph.D., MSc, presented Surveillance Updates of Myocarditis/Pericarditis and mRNA COVID-19 Vaccination in the FDA BEST System during the VRBPAC meeting on October 14, 2021. On October 20, 2021, the ongoing analyses from the FDA and the CDC safety surveillance systems have identified increased risks of inflammatory heart conditions, myocarditis, and pericarditis, following vaccination with the Moderna COVID-19 vaccine, particularly following the second dose. Typically, the onset of symptoms has been a few days following vaccination. The observed risk is higher among males under 40 years of age, particularly males 18 through 24, than among females and older males. 

The WHO announced on October 27, 2021, 'Available data suggest that the immediate course of myocarditis and pericarditis following vaccination with both vaccines is generally mild and responds to treatment. Follow-up is ongoing to determine long-term outcomes. Vaccinated individuals should be instructed to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis such as new-onset and persisting chest pain, shortness of breath, or palpitations following vaccination. It is important to rule out other potential causes of myocarditis and pericarditis, including COVID-19 infection and other viral etiologies.'

SpikeVax COVID-19 Vaccine (Moderna, mRNA-1273) Ingredients

The Moderna COVID-19 Vaccine contains the following ingredients: messenger ribonucleic acid (mRNA), lipids (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate, and sucrose. This vaccine does not contain: Eggs, Preservatives, or Latex, says the CDC. In addition, although SM-102 is used in the Moderna vaccine, the vaccine does not contain chloroform

On December 22, 2020, the UAE Fatwa Council, under the chairmanship of Shaykh Abdallah bin Bayyah, issued a 'fatwa' (Islamic ruling) allowing the vaccine to be used in compliance with Islamic Sharia's objectives on the protection of the human body and other relevant Islamic rulings.

SpikeVax COVID-19 Vaccine (Moderna, mRNA-1273) Distribution and Manufacturing

The World Health Organization (WHO) and health agencies in more than 60 countries have granted emergency use authorization or emergency use listing for the use of the Moderna COVID-19 vaccine in adults, as of November 4, 2021. Since its marketing authorization in the EU from January 6, 2021, until October 29, 2021, more than 61.6 million doses of Spikevax have been administered in the EU/EEA.

The company announced product sales for the three and nine months ended September 30, 2021, were $4.8 billion and $10.7 billion, respectively, from sales of 208 million and 510 million doses of the Company's COVID-19 vaccine for the three and nine months ended September 30, 2021, respectively. In the fourth quarter of 2020, the Company delivered approximately 17 million doses to the U.S. government. 

Moderna announced an agreement with Gavi, the Vaccine Alliance, to supply up to 500 million doses of the COVID-19 Vaccine Moderna on May 3, 2021, including an initial 34 million doses to be delivered in the fourth quarter of 2021. Through this agreement retains the option to procure 466 million additional doses in 2022.

On June 2, 2021, Moderna announced a long-term supply agreement on behalf of the COVAX Facility as part of the agreement announced in May 2021. Through this agreement, UNICEF and its procurement partners, including the Pan American Health Organization, will have access to up to 34 million doses of COVID-19 Vaccine Moderna to be delivered in the fourth quarter of 2021 and up to 466 million doses in 2022.

On June 7, 2021, Moderna, Inc. and Medison Pharma announced a new agreement to commercialize the Moderna COVID-19 Vaccine across Central Eastern Europe and Israel. The agreement covers the following countries: Poland, Czech Republic, Romania, Hungary, Bulgaria, Slovenia, Slovakia, Croatia, Estonia, Latvia, Lithuania, Serbia, Ukraine, Moldova, Albania, Bosnia and Herzegovina, Kosovo, North Macedonia, Montenegro, and Israel. The EMA committee for human medicines approved a new manufacturing site to produce the Moderna COVID-19 vaccine finished product on June 11, 2021. The site, operated by Recipharm, is located in Monts, France.

Moderna announced a new Memorandum of Understanding to make up to 110 million doses of the Moderna COVID-19 vaccine available to the African Union. The Company is prepared to deliver the first 15 million doses in the fourth quarter of 2021, 35 million doses in the first quarter of 2022, and up to 60 million doses in the second quarter of 2022.

SpikeVax COVID-19 Vaccine (Moderna, mRNA-1273) CPT Code

The AMA offers a new resource to identify the appropriate CPT code combination for each patient's type and dose of a COVID-19 vaccine. The American Medical Association has updated the CPT code to reflect the booster/third dose, 0013A.

COVID-19 Vaccine Moderna Intramuscular Injection (TAK-919)

On May 21, 2021, the COVID-19 Vaccine Moderna Intramuscular Injection (TAK-919) was authorized in Japan. On July 20, 2021, Moderna announced that the Ministry of Health, Labour, and Welfare of Japan and Takeda Pharmaceutical Company Limited have agreed to purchase and distribute an additional 50 million doses of Moderna's COVID-19 vaccine and its updated variant booster vaccine candidate if authorized, to begin delivery in 2022. This new supply agreement is in addition to the prior agreement for 50 million doses in 2021, resulting in 100 million doses for Japan. 

On August 26, 2021, Japan's Health Ministry announced Takeda Pharmaceutical Company Limited has started to provide information to vaccination facilities to suspend the use of some lots of the COVID-19 Vaccine Moderna intramuscular injection. The foreign matter was mixed in a specific lot. Laboratorios Farmacéuticos ROVI, S.A. confirmed it was investigating the situation.

Moderna and Takada issued a joint statement on September 1, 2021, 'According to the root cause analysis report, conducted by ROVI, the most probable cause of the particulates identified in lot 3004667 is related to friction between two pieces of metal installed in the stoppering module of the production line due to an incorrect set-up. The two pieces are the star-wheel and the stoppers feeding device, which feed stoppers into the star-wheel. It is believed that this condition occurred during the assembling of the line before production of batch 3004667 and as a result of improper alignment during a line changeover before starting this batch. Based on the analysis conducted by ROVI, the manufacturing issue only impacted the lots included in the suspension.'

SpikeVax COVID-19 Vaccine Variants of Concern

November 26, 2021 - Moderna, Inc. announced updates to its strategy to address SARS-CoV-2 variants of concern, given the emergence of the B.1.1.529 (Omicron) variant. The company tested three existing COVID-19 vaccine booster candidates against the Omicron variant, and a new variant-specific vaccine candidate against Omicron (mRNA-1273.529).

SpikeVax COVID-19 Vaccine (Moderna, mRNA-1273)

mRNA-1283 is a next-generation vaccine candidate that encodes for the portions of the SARS-CoV-2 spike protein critical for neutralization, specifically the Receptor Binding Domain and N-terminal Domain. The encoded mRNA-1283 antigen is being developed as a potentially refrigerator-stable mRNA vaccine that will facilitate distribution and administration by healthcare providers. A Phase 1 study will evaluate three dose levels, 10 µg, 30 µg, and 100 µg, of the mRNA-1283 vaccine candidate given to healthy adults as a 2-dose series, 28 days apart, and one dose level, 100 µg, of mRNA-1283 given to healthy adults in a single dose.

SpikeVax COVID-19 Vaccine (Moderna, mRNA-1273.351)

Moderna announced on January 25, 2021, it was advancing an emerging variant booster candidate (mRNA-1273.351) against the B.1.351 variant first identified in the Republic of South Africa. The Phase 1 clinical trial is led and funded by the NIH's National Institute of Allergy and Infectious Diseases. On April 13, 2021, new preclinical data on the Company's variant-specific booster vaccine candidates were submitted as a preprint to bioRxiv. A second multi-valent candidate (mRNA-1273.213) includes many of the mutations present in the Omicron variant that were also present in the Beta and Delta variants2. The Company has completed dosing at the 100 µg (N=584) dose level and also plans to explore the 50 µg dose level in approximately 584 participants. Moderna will rapidly expand testing of sera from completed and ongoing multi-valent booster studies to determine if these multi-valent candidates are able to provide superior neutralizing protection against Omicron.

SpikeVax COVID-19 Vaccine (Moderna, mRNA-1273.211)

A multivalent booster candidate, mRNA-1273.211, combines mRNA-1273, Moderna's authorized vaccine against ancestral strains, and mRNA-1273.211 in a single vaccine at 50 µg dose level and lower. On March 10, 2021, Moderna announced that the first participants had been dosed with mRNA-1273.211 to amend the ongoing Phase 2 clinical study. The mRNA-1273.211 includes several mutations present in the Omicron variant that were also present in the Beta variant of concern. The Company has completed dosing in a potentially pivotal safety and immunogenicity study of mRNA-1273.211 at the 50 µg (N=300) and 100 µg (N=584) dose levels

SpikeVax COVID-19 Vaccine (mRNA-1273.529)

The mRNA-1273.529 vaccine candidate is part of the Company’s strategy to advance variant-specific candidates for a subset of variants of significant concern.

SpikeVax COVID-19 Vaccine (Moderna, mRNA-1273) Dosage

Based on the results of the Phase 1 study, the data indicate that a 100 mcg dose of vaccine is generally well-tolerated across age strata, with solicited symptoms mostly mild-tomoderate in severity and self-limited duration; and Induces neutralizing Abs in the upper half of the range of convalescent serum across age strata, with the induction of Th-1 biased, CD4+ T-cells.

On August 13, 2021, Moderna announced that the U.S. FDA approved an update to the emergency use authorization for the Moderna COVID-19 vaccine to include the third dose at the 100 µg dose level for immunocompromised individuals 18 years of age or older in the U.S. who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

On September 14, 2021, the journal Science published an article: Low-dose mRNA-1273 COVID-19 vaccine generates durable memory enhanced by cross-reactive T cells. This study found a low dose of the Moderna vaccine lasts for at least six months.

The CDC's ACIP meeting presentation on September 22, 2021, '95% of VAERS reports following dose 3 of COVID-19 vaccination were nonserious.'

On October 4, 2021, the EMA's human medicines committee concluded that an extra dose of the COVID-Spikevax (Moderna) may be given to people with severely weakened immune systems, at least 28 days after their second dose. Although there is no direct evidence that the ability to produce antibodies in these patients protected against COVID-19, it is expected that the extra dose would increase protection at least in some patients.

The Company confirmed the U.S. FDA vaccine committee voted on October 17, 2021, to authorize a 3rd booster vaccination at 50 µg dose level for people aged 65 and older; people aged 18 to 64 who are at high risk of severe COVID-19; and people aged 18 to 64 whose exposure to COVID-19 puts them at risk for COVID-19 complications or severe illness. The booster dose is to be administered at least six months after completion of the primary two-dose series. The FDA authorized the booster dose on October 20, 2021. Furthermore, the FDA authorized the use of each of the available COVID-19 vaccines as a heterologous (or "mix and match") booster dose for eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine.

The first peer-reviewed study in North America funded by the Government of Canada examining the timing between the first and second doses of mRNA vaccines published on November 30, 2021, shows that a longer dose interval leads to a stronger immune response. 

SpikeVax COVID-19 Vaccine Moderna Legal Claims

Moderna Inc. published a 'Statement on Intellectual Property regarding the SpikeVax vaccine IP dispute with the U.S. government on November 11, 2021.

Moderna Inc. Financial News (Nasdaq: MRNA)

November 22, 2021 - Moderna announced its participation in the following upcoming virtual investor conferences: NASDAQ 45th Investor Conference on December 1st at 9:30 a.m. ET; Piper Sandler 33rd Annual Virtual Healthcare Conference on December 1st at 2:00 p.m. ET.

November 4, 2021 - Business Updates Third Quarter 2021 Financial Results.

September 9, 2021 - Annual R&D Day.

    SpikeVax COVID-19 Vaccine (Moderna, mRNA-1273) News

    November 25, 2021 - A new study was among the first to examine the individual effectiveness of the Moderna vaccine in a real-world setting among 222,892 persons. Overall effectiveness was 88.7% against SARS-CoV-2 infection and 93.6% against Covid-19 related death ≥7 days after the second dose. 

    November 19, 2021 - Moderna, Inc. announced that the U.S. FDA had extended the emergency use authorization of a booster dose of the Moderna COVID-19 vaccine at the 50 µg dose level to all adults aged 18 and older. This booster can be used in all individuals 18 years and older who have completed a primary vaccination with any other authorized or approved COVID-19 vaccine.

    November 12, 2021 - Health Canada announced it authorized the use of the Moderna Spikevax COVID-19 vaccine as a booster shot.

    November 9, 2021 - Moderna Inc. announced that it has submitted for a variation to the conditional marketing authorization with the EMA for the evaluation of a 50 µg two-dose series of mRNA-12731 in children ages 6-11 years.

    November 9, 2021 - The Haute Autorité de Santé has recommended the SpikeVax vaccine be available for people over 30-years-old. France initially suspended the use of the Moderna vaccine for all population groups on October 15, 2021. This vaccine obtained an extension of indication, issued by the EMA on October 25th, for the administration of a booster dose of 50 µg in people aged 18 years and over.

    November 4, 2021 - Moderna, Inc. reported financial results and provided business updates for the third quarter of the fiscal year 2021. Product sales for the three and nine months ended September 30, 2021, were $4.8 billion and $10.7 billion, respectively, from sales of 208 million and 510 million doses of the Company's COVID-19 vaccine for the three and nine months ended September 30, 2021, respectively. The increase in grant revenue of $286 million for the nine months ended September 30, 2021, was primarily driven by an increase in revenue from BARDA related to the Company's COVID-19 vaccine development. Grant revenue for the three months ended September 30, 2021, was relatively flat compared to the same period in 2020.

    October 31, 2021 - Moderna, Inc. provided an update that the U.S. FDA has notified the Company that it will require additional time to complete its assessment of Moderna’s EUA request for the use of the Moderna COVID-19 vaccine (mRNA-1273) at the 100 µg dose level in adolescents 12 to 17 years of age.

    October 25, 2021 - Moderna Inc. announced positive interim data from the Phase 2/3 study, called the KidCOVE study, of mRNA-1273, the Company's vaccine candidate against COVID-19, in children 6 to under 12 years of age. This interim analysis showed a robust neutralizing antibody response after two doses of mRNA-1273 at the 50 µg dose level with a favorable safety profile. 

    October 21, 2021 - Jacqueline Miller, M.D., FAAP, presented 'Safety and Immunogenicity of a 50 µg Booster Dose of Moderna COVID-19 Vaccine' during the CDC ACIP meeting.

    October 20, 2021 - The U.S. FDA took action to expand the use of a booster dose for COVID-19 vaccines in eligible populations. The use of a single booster dose of the Moderna COVID-19 Vaccine that may be administered at least 6 months after completion of the primary series to certain individuals.

    October 16, 2021 - The WSJ reported the U.S. FDA is reviewing the SpikeVax vaccine's risk of generating inflammatory heart conditions.

    October 14, 2021 - Moderna, Inc. confirmed that the U.S. Food and Drug Administration's Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended an Emergency Use Authorization (EUA) for a booster dose of the Moderna COVID-19 vaccine (mRNA-1273). The 19 VRBPAC members unanimously recommended this EUA. The Company estimates that booster at the 50 µg dose level could result in up to 1 billion additional doses.

    October 13, 2021 - The U.S. FDA announced in a 45-page document VRBPAC Briefing Document dated October 14, 2021, that there had been concerns over the reduced effectiveness of the Moderna (SpikeVax) COVID-19 vaccine against the symptomatic disease, which could naturally lead to a further drop in efficacy when used against severe cases. 

    October 12, 2021 - New VRBPAC Briefing Document was posted by Moderna ahead of the U.S. FDA vaccine committee meeting scheduled for 10/14/21.

    October 8, 2021 - Media sources reported the country of Iceland has paused administering the SpikeVax vaccine.

    October 7, 2021 - Helsinki Times reported Finland has followed Sweden and will pause administering the SpikeVax vaccine to men below the age of 30 due to a rare side effect. 

    October 5, 2021 - The U.S. NIH confirmed people who received low doses of the Moderna COVID-19 vaccine had strong immune memories of the virus six months after being fully vaccinated. And those carrying cross-reactive T cells from earlier exposure to other coronaviruses had greater immune responses after vaccination.

    October 1, 2021 - The Swedish Public Health Agency recommended that the regions in Sweden give half a dose of Moderna's vaccine to certain individuals.

    September 21, 2021 - New York-based Feinstein Institutes for Medical Research announced it had administered the extra SpikeVax vaccine dose to people living with an organ (liver or kidney) transplant who are enrolled in phase 3 clinical trial.

    September 17, 2021 - The U.S. CDCDC'sew MMWR: Comparative Effectiveness of Moderna, Pfizer-BioNTech, and Janssen Vaccines in Preventing COVID-19 Hospitalizations Among Adults Without Immunocompromising Conditions. Among U.S. adults without immunocompromising conditions, vaccine effectiveness against COVID-19 hospitalization during March 11–August 15, 2021, was higher for the Moderna (93%) than the Pfizer-BioNTech (88%) and the Janssen vaccine (71%).

    September 16, 2021 - Moderna, Inc. announced Health Canada has approved the New Drug Submission for SPIKEVAX™ (elasomeran mRNA vaccine), which has been known as COVID-19 Vaccine Moderna, for active immunization to prevent COVID-19 in individuals 12 years of age and older.

    September 15, 2021 - Moderna, Inc. highlighted a new analysis suggesting that the Moderna COVID-19 vaccine is highly effective against circulating variants of concern. Additionally, the Company shared a new analysis of follow-up through 1 year in the Phase 3 COVE study suggesting a lower risk of breakthrough infection in participants vaccinated more recently (median 8 months after the first dose) compared to participants vaccinated last year (median 13 months after the first dose).

    September 9, 2021 - Moderna, Inc. announced significant advances across its portfolio of mRNA pipeline programs presented at the CoCompany'sifth annual R&D Day today.

    September 9, 2021 - AuAustralia'sovernment announced more than 450,000 doses of the Pfizer vaccine have arrived from the U.K. as part of a dose-sharing agreement between our two countries. The first of four million to arrive from the U.K. this month will be batch-tested by the Therapeutic Goods Administration. Later, Australia will send four million doses from supplies to the U.K. in December 2021.

    September 8, 2021 - The EMA published SpikeVax Vaccine Safety Updates.

    September 6, 2021 - JaJapan'sinistry of Health, Labour, and Welfare announced a death case report (third case) after inoculation with the Moderna COVID-19 vaccine. However, there was no report of foreign matter contamination.

    September 3, 2021 - Moderna, Inc. announced it has submitted for conditional marketing approval with the European Medicines Agency to evaluate booster doses of the Moderna COVID-19 vaccine (mRNA-1273) at the 50 µg dose level.

    September 1, 2021 - Moderna Inc. and Takada jointly announced, 'A' this time, there is no evidence that the two tragic deaths following the administration of the Moderna COVID-19 vaccine (from lot 3004734) were in any way related to administration of the vaccine. The relationship is currently considered to be coincidental. However, it is important to conclude a formal investigation to confirm this.'

    'ugust 25, 2021 - Moderna, Inc. announced it had completed the rolling submission process for its Biologics License Application (BLA) to the U.S. FDA for the full licensure of the Moderna COVID-19 Vaccine for active immunization to prevent COVID-19 in individuals 18 years of age and older. As part of the completed BLA submission, Moderna has requested Priority Review designation. The FDA Fast Track designation received on May 12, 2020, has permitted Moderna to submit sections of the BLA on a rolling basis. Moderna announced the initiation of the BLA submission on June 1, 2021. 

    August 24, 2021 - The EMA approved an additional manufacturing site to produce Spikevax, the COVID-19 vaccine developed by Moderna. The site, located in Bloomington, Indiana, is operated by Catalent. The site will perform finished product manufacturing. In addition to the new manufacturing facility for this vaccine, CHMP has also approved several alternative sites responsible for batch control/testing and packaging of the finished product manufactured by Catalent.

    August 17, 2021 - The U.K. confirmed the Spikevax vaccine (formerly COVID-19 Vaccine Moderna) is authorized for use in 12- to 17-year-olds. This Conditional Marketing Authorization extension is valid in Great Britain only and was approved via the European Commission Decision Reliance Route.

    August 16, 2021 - Moderna confirmed the Government of Canada would purchase up to 105 million doses of MoModerna'sOVID-19 vaccine and its booster vaccine candidate, if authorized, for delivery through 2024. The agreement provides for 20 million doses each year in 2022 and 2023, with an option for an additional 15 million doses each year. For 2024, the agreement provides an option for up to 35 million doses.

    August 15, 2021 - A non-peer-reviewed study found binding and neutralizing antibodies correlated with COVID-19 risk and vaccine efficacy and likely have utility in predicting mRNA-1273 vaccine efficacy against COVID-19.

    August 13, 2021 - PoPoland'sealth ministry confirmed people under 18 could be vaccinated with MoModerna'spikevax.

    August 11, 2021 - The New England Journal of Medicine reported the Teen Cove clinical trial results.  A total of 3732 participants were randomly assigned to receive mRNA-1273 (2489 participants) or a placebo (1243 participants). Concluding that the mRNA-1273 vaccine had an acceptable safety profile in adolescents. The immune response was similar to that in young adults, and the vaccine was efficacious in preventing Covid-19.

    August 10, 2021 - Moderna, Inc. announced a Memorandum of Understanding with the government of Canada to build a state-of-the-art messenger RNA (mRNA) vaccine manufacturing facility in Canada, including access to MoModerna'sRNA development engine.

    August 9, 2021 - The Therapeutic Goods Administration granted provisional approval to Moderna Australia Pty Ltd for its COVID-19 vaccine Spikevax (elasomeran), making it the fourth COVID-19 vaccine to receive regulatory approval in Australia.

    August 5, 2021 - Moderna, Inc. reported financial results and provided business updates for the second quarter of the fiscal year 2021. Total revenue increased in 2021, resulting from commercial sales of the CoCompany'sOVID-19 vaccine and grant revenue to a lesser extent. Product sales for the three and six months ended June 30, 2021, were $4.2 billion and $5.9 billion, respectively. The increases in grant revenue of $101 million and $291 million for the three and six months ended June 30, 2021, respectively, were primarily driven by increases in revenue from BARDA related to the CoCompany'sOVID-19 vaccine development.

    July 30, 2021 - The EMA estimated that in the third quarter of 2021, the U.S. supply chain would provide 40 million doses of the SpikeVax vaccine for the European market.

    July 29, 2021 - The U.K. published a summary of clinical care guidelines.

    July 23, 2021 - Moderna, Inc. announced that the European Medicines AgAgency'sommittee for Medicinal Products for Human Use adopted a positive opinion recommending marketing authorization for MoModerna'sOVID-19 vaccine (Spikevax) to include adolescents 12 years of age and older.

    July 16, 2021 - Ireland confirmed the medicine protocol is a specific written instruction for the administration of Spikevax® (COVID‐19 Vaccine Moderna) to vaccine recipients by healthcare professionals included in Statutory Instruments S.I. No. 698 of 2020, S.I. No. 81 of 2021 and S.I. No. 245 of 2021 who are registered with their respective regulatory body and students in healthcare professions.

    July 16, 2021 - U.C. San Fransico published a press statement - 'M'ssenger RNA vaccines against COVID-19 were not detected in human milk, according to a small study offering early evidence that the vavaccine'sRNA is not transferred to an infant.

    July 14, 2021 - The EMA issued a report as of July 4, 2021, a total of 36,294 cases of suspected side effects with Spikevax were spontaneously reported to EudraVigilance from EU/EEA countries; 347 of these reported a fatal outcome.

    July 14, 2021 - Yale Medicine published - Comparing the COVID-19 Vaccines: How Are They Different?

    July 9, 2021 - The United Kingdom Medicines & Healthcare Regulatory Agency (MHRA) received (6) Yellow Card reports of suspected adverse drug reactions to the SpikeVax vaccine. These patients died shortly after vaccination. In addition, the MHRA had received 24 reports of anaphylaxis in association with the SpikeVax vaccine.

    July 6, 2021 - The U.S. CDC published Use of mRNA COVID-19 Vaccine After Reports of Myocarditis Among Vaccine Recipients: Update from the Advisory Committee on Immunization Practices — United States, June 2021.

    July 4, 2021 - About 2.5 million doses of Moderna (mRNA-1273) COVID-19 vaccines supplied through the COVAX FaFacility'sose-sharing mechanism and donated by the United States started being distributed by the Government of Pakistan to vaccinate priority groups across the country, in line with the National Deployment and Vaccination Plan.

    June 25, 2021 - The FDA revised the patient and provider fact sheets regarding the suggested increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination. 

    June 22, 2021 -  Moderna announced that the European Commission had purchased additional doses of MoModerna'sOVID-19 vaccine. Under the terms of the agreement, delivery of MoModerna'spdated variant booster vaccine candidate will begin in 2022. Purchase under this agreement is subject to regulatory approval of the booster vaccine candidates by the European Medicines Agency.

    June 15, 2021 - Moderna, Inc., and Magenta Investments (United Arab Emirates (UAE)) announced a new agreement to distribute the Moderna COVID-19 Vaccine and MoModerna'spdated variant booster candidates once authorized, in the UAE in 2021 and 2022.

    June 11, 2021 - Moderna, Inc. and Tabuk Pharmaceutical Manufacturing Company announced an agreement to commercialize the Moderna COVID-19 Vaccine and future variant-specific booster candidates in the Kingdom of Saudi Arabia.

    June 10, 2021 - Moderna announced that it had requested an emergency use authorization for its COVID-19 vaccine in adolescents with the U.S. FDA. Previously, the Phase 2/3 study of its COVID-19 vaccine in adolescents has met its primary immunogenicity endpoint, successfully bridging immune responses to the adult vaccination. In the study, no cases of COVID-19 were observed in participants who had received two doses of the Moderna COVID-19 vaccine using the primary definition.

    June 8, 2021 - The EMA confirmed it has started evaluating an application to extend the use of the COVID-19 Vaccine Moderna to include young people aged 12 to 17.

    June 7, 2021 - CBS TV in San Francisco reported 'V'ccine breakthrough cases occur in only a small percentage of vaccinated people. Napa County has identified 32 breakthrough cases in which fully vaccinated residents became symptomatic and tested positive for COVID19–out of more than 71,371 residents (.04%) who were fully vaccinated.

    June 2, 2021 - Moderna, Inc. announced that it has entered into an additional agreement with Lonza to support drug substance manufacturing for its global supply chain at LoLonza'seleen site in the Netherlands.

    June 1, 2021 - The U.S. NIH announced a Phase 1/2 clinical trial in which adult volunteers who have been fully vaccinated against COVID-19 will receive booster doses of the Moderna vaccine to determine the safety and immunogenicity of mixed boosted regimens.

    May 25, 2021 - Moderna, Inc. announced that the Phase 2/3 study of its COVID-19 vaccine in adolescents had met its primary immunogenicity endpoint. Safety data continues to accrue, and the study continues to be monitored by an independent safety monitoring committee. In addition, all participants will be monitored for 12 months after their second injection to assess long-term protection and safety. Consequently, these data are subject to change based on ongoing data collection.

    May 24, 2021 -  Moderna, Inc. and Aldevron, LLC announced their expanded collaboration supporting the Moderna COVID-19 Vaccine and additional programs in MoModerna'slinical development pipeline. Specifically, Aldevron will supply plasmid DNA as the genetic template for generating the COVID-19 mRNA vaccine and other investigational programs. AlAldevron's00 employees support thousands of scientists who are developing revolutionary treatments for millions of people.

    May 22, 2021 - Moderna and Samsung Biologics announced a Manufacturing Services and Supply Agreement in which Samsung Biologics will provide large-scale, commercial fill-finish manufacturing for mRNA-1273, MoModerna'sOVID-19 vaccine.

    May 22, 2021 - Moderna, Inc. announced two Memoranda of Understanding (MoU) with the government of South Korea: one MoU with the Korea National Institute of Health (KNIH), an agency of the Korea Centers for Disease Control and Prevention Agency for a new collaboration on mRNA vaccine research in South Korea; and an additional MoU with the Ministry of Trade, Industry and Energy of the Republic of Korea, the Ministry of Health and Welfare of the Republic of Korea to explore local manufacturing opportunities for mRNA vaccines in South Korea.

    May 21, 2021 - Takeda announced that the Ministry of Health, Labour, and Welfare had granted special approval for the emergency use of MoModerna'sRNA COVID-19 vaccine, TAK-919, now known as COVID-19 Vaccine Moderna Intramuscular Injection, in Japan. 

    May 20, 2021 - Japanese regulators recommended approving the mRNA COVID-19 vaccine developed by Moderna Inc.

    May 20, 2021 - The journal Clinical Infectious Diseases published a new study: Circulating SARS-CoV-2 Vaccine Antigen Detected in the Plasma of mRNA-1273 Vaccine Recipients. This ststudy'sindings include 'S'RS-CoV-2 proteins were measured in longitudinal plasma samples collected from 13 participants who received two doses of mRNA-1273 vaccine. 11 of 13 participants showed detectable levels of SARS-CoV-2 protein as early as day one after the first vaccine injection. Clearance of detectable SARS-CoV-2 protein correlated with production of IgG and IgA.'

    'ay 12, 2021 - Moderna, Inc. announced a new supply agreement with the government of Australia for 25 million doses. This includes 10 million doses of MoModerna'sOVID-19 vaccine against the ancestral strain (mRNA-1273) to be delivered in 2021 and 15 million doses of MoModerna'spdated variant booster vaccine candidate to be delivered in 2022.

    May 6, 2021 - Moderna, Inc. (Nasdaq: MRNA) reported financial results, provided business updates for the first quarter of 2021, and highlighted pipeline progress. Total revenue was $1.9 billion for the three months ended March 31, 2021, compared to $8 million for the same period in 2020. Total revenue increased in the first quarter of 2021, resulting from a full quarter of commercial sales of the CoCompany'sOVID-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 the CoCompany'sOVID-19 vaccine sales. The increase in grant revenue of $190 million was primarily driven by an increase in revenue from BARDA related to the CoCompany'sOVID-19 vaccine development.

    May 6, 2021 - Moderna announced a supply agreement with the Swiss Federal Government for 7 million booster vaccine doses in 2022, with an additional option for another 7 million doses for delivery during the second half of 2022 or the first quarter of 2023. Swissmedic, the Swiss Agency for Therapeutic Products, authorized the COVID-19 Vaccine Moderna in Switzerland on January 12, 2021.

    May 3, 2021 - Moderna confirmed an agreement with Gavi to deliver up to 500 million doses of the COVID-19 Vaccine Moderna. Gavi retains an option to procure 466 million additional doses in 2022. 

    April 29, 2021 - Moderna, Inc. announced it is making new funding commitments to increase supply at its owned and partnered manufacturing facilities, which it expects will increase global 2022 capacity to up to 3 billion doses of its COVID-19 vaccine, depending upon the mix between the authorized Moderna COVID-19 Vaccine at the 100 μg dose level and potentially lower doses of the CoCompany'sariant booster candidates and pediatric vaccines, if authorized.

    April 26, 2021 - Sanofi announced an agreement with Moderna, Inc. to establish infrastructure and manufacturing expertise in Ridgefield, NJ, to fill and finish up to 200 million doses of MoModerna'sOVID-19 vaccine, starting in September 2021.

    April 13, 2021 - Moderna, Inc. announced clinical and supply updates on its COVID-19 Vaccine program. New results from a preclinical study of the CoCompany'sOVID-19 variant-specific vaccine candidates showed that the CoCompany'sariant-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, 'A'tibody Persistence through 6 Months after the Second Dose of mRNA-1273 Vaccine for Covid-19.' 'A'though 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.'

    'pril 5, 2021 - The U.S. CDC published the Moderna COVID-19 Vaccine Overview and Safety update.

    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.

    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 cacandidate'safety and immunogenicity in adult volunteers.

    March 29, 2021 - The U.S. CDC reported, 'P'ospective cohorts of 3,950 health care personnel, first responders, and other essential and frontline workers completed weekly SARS-CoV-2 testing for 13 consecutive weeks. Under real-world conditions, mRNA vaccine effectiveness of full immunization (≥14 days after the second dose) was 90% against SARS-CoV-2 infections regardless of symptom status; vaccine effectiveness of partial immunization (≥14 days after the first dose) before the second dose) was 80%.

    March 29, 2021 - Moderna, Inc. announced that the Company had shipped the 100-millionth dose of its COVID-19 vaccine to the U.S. Government. The Company expects to meet its commitment dates to the U.S. Government for all currently ordered doses of the Moderna COVID-19 Vaccine, including delivering the second 100 million doses by the end of May 2021 and the third 100 million doses by July 2021. 

    March 28, 2021 - U.K. minister of Culture Secretary Oliver Dowden stated MoModerna'sOVID-19 vaccine is expected to be rolled out within weeks across the United Kingdom, reported the BBC.

    March 16, 2021 - Moderna Inc. announced that the first participants had been dosed in the Phase 2/3 study, called the KidCOVE study, of mRNA-1273, the CoCompany'saccine candidate against COVID-19 children 6 months to less than 12 years. The study is being conducted in collaboration with the U.S. National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority.

    March 15, 2021 - The JAMA published a new study: Immunogenicity of a Single Dose of SARS-CoV-2 Messenger RNA Vaccine in Solid Organ Transplant Recipients. Transplant recipients receiving anti–metabolite maintenance immunosuppression therapy were less likely to develop an antibody response than those not receiving such immunosuppression therapy (37% vs. 63%, respectively; adjusted incidence rate ratio [IRR], 0.22 [95% CI, 0.15-0.34], P < .001).

    March 15, 2021-- Moderna, Inc. announced that the first participants had been dosed in the Phase 1 study of mRNA-1283, the next-generation COVID-19 vaccine candidate.

    March 10, 2021 - Moderna, Inc. announced that the first participants had been dosed with the CoCompany'sodified 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, to help smarter COVID-19 vaccine management. Central to the effort will be a pilot of open, standardized, technology-enabled vaccine distribution approaches to improve supply chain visibility and foster near real-time tracking of vaccine administration.

    March 4, 2021 - The NEJM published an ORIGINAL ARTICLE: Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. CONCLUSIONS - The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease. Aside from transient local and systemic reactions, no safety concerns were identified.

    March 4, 2021 - The EMA announced the latest safety data for this vaccine are in line with the known benefit-risk profile; the outcomes of the related assessments are presented in this update. The benefits of COVID-19 Vaccine Moderna in preventing COVID-19 continue to outweigh any risks, and there are no recommended changes regarding the use of this vaccine. EMEMA'sharmacovigilance 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 KoKorea'sovernment to distribute 40 million doses of COVID-19 Vaccine Moderna.

    February 17, 2021 - Moderna, Inc. announced that the European Commission (E.C.) 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 E.E.C.'sonfirmed order commitment to 310 million doses for delivery in 2021. Under the terms of the agreement, the E.C. can purchase an additional 150 million doses to be delivered in 2022.

    February 11, 2021 - Moderna, Inc. announced that the U.S. government had purchased an additional 100 million doses of MoModerna'sOVID-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 9, 2021 - Moderna, Inc. announced supply agreements with TaTaiwan'snd CoColombia'sovernments. 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.

    January 29, 2021 - Media reported the World Health Organization reversed its guidance on pregnant women receiving the coronavirus vaccine created by Moderna, saying it recommends the jab for expectant persons. The WHO says, 'W'ile pregnancy puts women at higher risk of severe COVID-19, very little data are available to assess vaccine safety in pregnancy.

    January 21, 2021 - Moderna Inc. announced that the first participant had been dosed in the Phase 1/2 study of MoModerna'saccine candidate against COVID-19 (mRNA-1273 or TAK-919) Japan, led by Takeda Pharmaceutical Co., Ltd.

    January 8, 2021 - Moderna, Inc. announced that the U.U.K.'sedicines 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 MoModerna'supply in Great Britain and is based upon the U.K. Commission on Human MeMedicines'dvice.

    January 6, 2021 - The European Commission has granted conditional marketing authorization for the COVID‑19 vaccine developed by Moderna, the second COVID-19 vaccine authorized in the E.U.

    January 6, 2021 - The U.S. FDA published 'T'e 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.'

    'ecember 30, 2020 - NEJM article: Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease. In addition, aside from transient local and systemic reactions, no safety concerns were identified. 

    December 29, 2020 - The U.S. Department of Defense announced it had awarded Moderna a contract worth $1,966,598,000 for an additional 100 million doses of its COVID-19 vaccine.

    December 18, 2020 - The U.S. FDA issued an emergency use authorization for the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.

    December 17, 2020 - A ststudy'sesults 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.

    December 15, 2020 - Presented by the Orthodox Union and the Rabbinical Council of America: our poskim conclude that, according to the advice of your personal health care provider, the Torah obligation to preserve our lives and the lives of others requires us to vaccinate for COVID-19 as soon as a vaccine becomes available.

    December 11, 2020 - Moderna, Inc. announced that the U.S. government had exercised its option to purchase an additional 100 million doses of mRNA-1273, MoModerna'sOVID-19 vaccine candidate, bringing its confirmed order commitment to 200 million doses. In addition, the U.S. government retains the option to purchase up to an additional 300 million doses.

    December 10, 2020 - Moderna Inc. announced that the first adolescent participants had been dosed in the Phase 2/3 study of mRNA-1273 in adolescents ages 12 to less than 18.

    November 16, 2020 - Moderna, Inc. announced that the independent, NIH-appointed Data Safety Monitoring Board for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%. 

    October 29, 2020 - Takeda Pharmaceutical announced that it would import and distribute 50 million doses of MoModerna'sOVID-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 JaJapan'sinistry of Health Labour and Welfare.

    August 11, 2020 - Moderna announced that the U.S. government had secured 100 million doses of mRNA-1273 as part of the U.S. gogovernment'soal of securing early access to safe and effective COVID-19 vaccines for Americans. This award of up to $1.525 billion is for manufacturing and delivering 100 million doses of mRNA-1273.

    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 mRNA vaccine candidate mRNA-1273.

    May 12, 2020 - Moderna, Inc. announced that the U.S. FDA had granted Fast Track designation for the CoCompany'sRNA 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 MoModerna'sRNA vaccine (mRNA-1273) against the novel coronavirus (SARS-CoV-2) and additional Moderna products in the future.

    April 16, 2020 - Moderna, Inc. announced an agreement for a commitment of up to $483 million from the Biomedical Advanced Research and Development Authority to accelerate the cocompany'sRNA vaccine candidate (mRNA-1273) against the novel coronavirus SARS-CoV-2.

    February 24, 2020 - Moderna, Inc. announced that it had released the first batch of mRNA-1273, the vaccine against the novel coronavirus, for human use.

    January 13, 2020 - The U.S. National Institutes of Health and MoModerna'snfectious disease research team finalized the sequence for mRNA-1273, the vaccine against the novel coronavirus.

    SpikeVax COVID-19 Vaccine (Moderna) (mRNA-1273) Clinical Trials 

    Moderna continues to run clinical trials to evaluate the safety, immunogenicity, and reactogenicity of its COVID-19 vaccine.

    Clinical Trials