Vaccine Info

SpikeVax COVID-19 Vaccine (Moderna)

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May 13, 2022
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SpikeVax COVID-19 Vaccine (Moderna, mRNA-1273) For 2022

The SpikeVax COVID-19 Vaccine (mRNA-1273, elasomeran) is a Messenger RNA (mRNA) vaccine targeted against the SARS-CoV-2 betacoronavirus to prevent severe COVID-19. SpikeVax encodes for a prefusion stabilized form of the Spike (S) protein selected by Moderna Inc. in collaboration with U.S. NIAID Vaccine Research Center investigators. 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, but not 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 Dec. 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 Aug. 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. On Nov. 19, 2021, the FDA 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. And on Jan. 31, 2022, the FDA Approved Moderna's COVID-19 Vaccine (Spikevax) to prevent COVID-19 in individuals 18 years of age and older. On Mar. 29, 2022, the FDA authorized a second booster dose for certain people.

SpikeVax (COVID-19 Vaccine Moderna) Accession Number: DB15654; Preferred Substance Name: CX-024414; UNII: EPK39PL4R4; MedlinePlus a621002

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, MA. Moderna Inc.'s 10-Q SEC filing on Jan. 4, 2021, indicates 'mRNA is considered a gene therapy product by the U.S. FDA.' (pINN elasomeran). To learn more, visit www.modernatx.com.

SpikeVax COVID-19 Vaccine Variants of Concern (Omicron, Sublineages)

As of May 5, 2022, the U.S. NIH's OpenData Portal reported SpikeVax in vitro Therapeutic Activity against the Omicron variant. But, given the breaking nature of these releases, Omicron data should be interpreted with caution. The CDC and Scripps publish updated virus variant information in this Tracker App. And the UK's Health Security Agency publishes VoC data on this webpage.

The NEJM published an Original Article on March 2, 2022, that concluded 'a mRNA-1273 booster after the ChAdOx1 nCoV-19 or BNT162b2 primary course substantially increased protection, but that protection waned over time.' And a peer-reviewed study published on February 21, 2022, found SpikeVax's third-dose effectiveness against the Delta and Omicron variants diminished quickly.

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

The EMA confirmed on April 28, 2022, a total of 206,920 cases of suspected side effects spontaneously reported from EU/EEA countries; 1,025 of these reported a fatal outcome (by 24 April 2022), and about 155 million doses of Spikevax had been given to people in the EU/EEA. On Marc. 11, 2022, the EMA's PRAC recommended that a warning for flare-ups of capillary leak syndrome should be added to the product information for the COVID-19 vaccine Spikevax. In total, 11 reported cases of CLS were reviewed with Spikevax. At the time of the assessment, the global exposure was estimated at approximately 155 million doses.

In the Lancet Infectious Diseases journal, Hannah Rosenblum and colleagues from the U.S. report on Mar. 7, 2022, the first six months (Dec 14, 2020, to June 14, 2021) of safety monitoring of mRNA COVID-19 vaccines in individuals aged at least 16 years; show that most reported adverse events were mild and short in duration.

Myocarditis and Pericarditis Risk

On Apr. 3, 2022, the EMA confirmed the PRAC had determined the risk of myocarditis, and pericarditis is overall 'very rare', meaning that up to 1 case in 10,000. Additionally, the data show that the increased risk of myocarditis after vaccination is highest in younger males. About 155,000,000 SpikeVax doses were given to people in the EU/EEA, and 193,037 side effects were reported.

As of March 2022, the CDC says, 'Myocarditis is a rare, serious adverse event that has been reported primarily after receiving the second dose of mRNA COVID-19 vaccines, with the highest risk currently observed in males ages 12–29 years. The FDA authorized, and the ACIP and CDC have recommended Pfizer-BioNTech vaccines in children ages  5–11 years and adolescents ages 12–17 years based on the determination that the benefits of COVID-19 vaccination outweigh risks in these populations. Extending the interval between the first and second mRNA vaccine dose to 8 weeks might reduce the risk.' 

On Jan. 31, 2022, the FDA confirmed a rigorous evaluation of the post-authorization safety surveillance data about myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination with the Moderna COVID-19 Vaccine. Available data from short-term follow-ups suggest that most individuals have had resolution of symptoms. However, some individuals require intensive care support. And information is not yet available about potential long-term health outcomes. The Spikevax Prescribing Information includes a warning about these risks.

Previously, researchers with the U.S. CDC conducted an Original Investigation published in the JAMA Network on Jan. 25, 2022, that found 1,991 cases of myocarditis (0.00004%) were reported, with 1,626 (0.000008%) meeting the case definition. Of all patients with myocarditis, the median age was 21 years; 82% were male, with a median time to symptom onset of two days, generally after a second mRNA dose. Furthermore, the CDC stated this heart health risk should be considered in the context of future COVID-19 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 Oct. 14, 2021. On Oct. 20, 2021, the ongoing analyses from the FDA and the CDC safety surveillance systems identified increased risks of inflammatory heart conditions, myocarditis, and pericarditis, following vaccination with the Moderna COVID-19 vaccine, particularly following the second dose.

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

Moderna's SpikeVax vaccine is offered in various dose regimens, subject to country-based authorizations. The European Centre for Disease Prevention and Control and the EMA’s COVID-19 task force concluded on Apr. 6, 2022, that it is too early to consider using the fourth dose of mRNA COVID-19 vaccines (Spikevax) in the general population. The U.K.'s JCVI endorses the 5th vaccination for certain people with blood cancer aged 12+. 

In the U.S., the FDA's Mar. 29, 2022's recommendation is for certain people is to receive a 3-dos primary series followed by two booster doses, for a potential of 5 total doses. On Mar. 18, 2022, the CDC added considerations for an 8-week interval between certain people's first and second doses. On March 17, 2022, Moderna announced that it had submitted a request to the U.S. FDA for an amendment to the EUA to allow for the 4th dose of its COVID-19 vaccine (mRNA-1273) in adults. And Moderna confirmed a 25 µg two-dose primary series is suggested for children. On Mar. 29, 2022, the U.S. FDA authorized a second booster dose of the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals. 

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 analyzed. 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 Mar. 16, 2020, 63 days from sequence selection to Phase 1 study dosing. On Aug. 26, 2020, Moderna presented data from the Phase I trial at the Advisory Committee on Immunization Practices.

The EMA authorized SpikeVax in Jan. 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 and people aged 18 and above. The EMA product number: EMEA/H/C/005791. This EMA medicinal product is subject to additional monitoring. On Sept. 7, 2021, Australia published updated Information on Spikevax (Moderna) COVID-19 vaccine. And on Sept. 16, 2021, Health Canada Approved the SpikeVax vaccine. 

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

 Moderna has received regulatory authorizations for the use of the 100 µg Moderna COVID vaccine primary series for adolescents 12 to 17 years of age in more than 40 countries.

Moderna Tweeted on May 13, 2022, @Swissmedic authorized the use of our mRNA COVID19 vaccine in a two-dose series of 50 µg per dose for active immunization to prevent COVID-19 in children aged 6 to 11 years. This approval follows similar authorizations in more than 35 countries, including Australia, Canada, the European Union, and the UK. The EMA’s human medicines committee recommended granting an extension of indication for the COVID-19 vaccine Spikevax (50 µg compared with 100 µg) to include use in children aged 6 to 11 on Feb. 24, 2022. Canada issued a similar authorization on March 17, 2022.

Moderna, Inc. announced on April 28, 2022, that it has submitted a request for EUA for its COVID-19 vaccine (mRNA-1273) in children six months to under two years and two years to under six years of age to the U.S. FDA and that similar requests are underway with international regulatory authorities.

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

On December 11, 2021, an observational study found that most patients with myeloid malignancies, including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), converted to seropositivity after two doses of the mRNA vaccine. Antibody titer levels increased dramatically following the 2nd vaccine dose, indicating the potential utility for serial vaccination (i.e., additional dosing) in poorly-responsive patients. mRNA-273 SARS-CoV-2 vaccine appears to induce a strong humoral response in this population of patients with AML and MDS.

Breastcancer.org stated on March 28, 2022, people diagnosed with cancer developed COVID-19 antibodies after receiving the Moderna vaccine, but at lower levels than people who hadn’t been diagnosed with cancer.

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

On January 26, 2022, the BMJ reported More than 36,000 reports of menstrual changes or unexpected vaginal bleeding following covid-19 vaccination (55% Comirnaty) have so far been made to the yellow card surveillance scheme run by the UK Medicine and Healthcare Products Regulatory Agency (MHRA). But as cycles naturally vary in women and the MHRA does not collect comparison data from unvaccinated people, these data cannot be used to establish whether menstrual changes increase after COVID-19 vaccination. However, a similar signal appeared in the U.S. VAERS. The CDC publishes data on COVID-19 during Pregnancy: Severity of Maternal Illness.

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 one month after mRNA vaccination was appropriate under treatment with cladribine and teriflunomide and diminished/absent under treatment with anti-CD20 therapies and S1P modulators. However, delaying anti-CD20 infusions by 3 to 6 months before vaccination could increase the probability of developing appropriate humoral responses, especially in clinically and radiologically stable patients. Therefore, future studies should investigate antibody dynamics over time, if and how DMTs influence T cell-mediated responses after vaccination, and whether these biological measures reflect vaccine efficacy in 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 Co-Administration

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 the 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) 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) CPT Code

The AMA offers resources to identify the appropriate CPT code combination for each patient's type and dose of a COVID-19 vaccine. The updated CPT code for the booster/third dose, 0013A, 0011A, and other codes are listed on this CMS page.

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

On February 3, 2022, Takeda announced it continues to distribute Moderna's COVID-19 vaccine in Japan. To date, 50 million doses of Moderna's COVID-19 vaccine have been imported to Japan. Takeda has started importation and distribution of an additional 93 million booster doses from the beginning of 2022 for a total distribution of 143 million doses. 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.

Moderna's Pan-Respiratory Annual Booster Vaccine 

Moderna's product strategy includes developing a pan-respiratory annual booster vaccine. The Company believes it could be the first to market with a COVID + Flu + RSV booster vaccine. A pan-respiratory annual single booster vaccine to cover multiple viruses could create value for the healthcare system through compliance, convenience to the customer (one vs. three injections), and reduction in vaccine administration cost. "Best-case scenario will be the fall of' 23,' Moderna CEO Stephane Bancel told a virtual World Economic Forum roundtable session on January 17, 2022.

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. The trial will enroll approximately 210 healthy adult volunteers at four clinical research sites in the U.S. (Atlanta, Cincinnati, Nashville, and Seattle).

SpikeVax COVID-19 Vaccine (Moderna, mRNA-1273.213)

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 variants. The Company has completed dosing at the 100 µg (N=584) dose level and 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.

Moderna Bivalent Booster Candidate (mRNA-1273.214)

Moderna's Omicron-specific bivalent booster candidate (mRNA-1273.214) combines Moderna's Omicron-specific booster candidate (mRNA-1273.529) and mRNA-1273. On March 10, 2022, Moderna announced that the first participant had been dosed in the Phase 2/3 study. The Company expects initial data on mRNA-1273.214 in June 2022 to inform the selection of its candidate for the Northern Hemisphere fall 2022 booster.

Moderna Multivalent Booster Candidate (mRNA-1273.211)

The bivalent booster candidate, mRNA-1273.211, combines mRNA-1273, Moderna's authorized vaccine against ancestral strains, in a single vaccine at a 50 µg dose level and lower. The mRNA-1273.211 includes several mutations present in the Omicron variant that were also present in the Beta variant of concern. On April 15, 2022, a non-peer-reviewed study found the mRNA-1273.211 booster (50 and 100-µg) elicited higher neutralizing antibody responses against the ancestral SARS-CoV-2 and the Beta variant than that after the second mRNA‑1273 dose. The safety and reactogenicity profile of the mRNA-1273.211 booster (50-µg) was comparable to mRNA-1273 (50-µg). Moderna is evaluating an updated bivalent booster incorporating more Omicron-specific mutations (mRNA-1273.214) in a Phase 2/3 clinical study.

Moderna Omicron-Specific Booster Vaccine Candidate (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. On March 10, 2022, the first participant had been dosed in the Phase 2 study of mRNA-1273.214, which combines Moderna's Omicron-specific booster candidate (mRNA-1273.529) and mRNA-1273. Moderna is also evaluating mRNA-1273.529 in a Phase 2 study in the U.S. Separately, the Company is evaluating mRNA-1273.529 in a Phase 3 study in the UK, in collaboration with the National Institute for Health Research.

SpikeVax COVID-19 Vaccine (Moderna, mRNA-1273) Availability For 2022

As of May 12, 2022, Moderna's SpikeVax was available in Poland, Czech RepublicCaribbeanDenmark, Romania, Hungary, Bulgaria, Slovenia, Slovakia, Croatia, Estonia, Latvia, Lithuania, Serbia, Ukraine, Moldova, Albania, Bosnia-Herzegovina, Kosovo, North Macedonia, Montenegro, Israel, France, the African Union,  AustralianSpain, Switzerland, South Korea, the United Kingdom, Switzerland, and was Approved in the U.S. And 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.

And Moderna announced on January 23, 2022, that about 807 million doses of Moderna's COVID-19 vaccine shipped globally in 2021.

SpikeVax COVID-19 Vaccine Moderna Legal Claims

Feb. 28, 2022 - Arbutus Biopharma Corporation and Genevant Sciences filed a lawsuit in the U.S. District Court for the District of Delaware against Moderna, Inc. and a Moderna affiliate seeking damages for infringement of U.S. Patent Nos. 8,058,069, 8,492,359, 8,822,668, 9,364,435, 9,504,651, and 11,141,378 in the manufacture and sale of MRNA-1273, Moderna’s vaccine for COVID-19. The patents relate to nucleic acid-lipid particles and lipid vesicles and compositions and methods for their use.

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)

May 4, 2022 - The company announced total revenue was $6.1 billion for the first quarter of 2022, compared to $1.9 billion for the same period in 2021. Product sales for the first quarter of 2022 were $5.9 billion from sales of the Company's COVID vaccine, compared to $1.7 billion in 2021.

March 24, 2022 - Moderna increased its 2022 Advance Purchase Agreement revenue forecast from $19 billion to $21 billion.

February 24, 2022 - Moderna announced the Full-year 2021 revenues of $18.5 billion, GAAP net income of $12.2 billion, and GAAP diluted EPS of $28.29. Product sales for 2021 were $17.7 billion from sales of 807 million doses of the Company's COVID-19 vaccine.

    SpikeVax COVID-19 Vaccine (Moderna, mRNA-1273) News: 2020 - 2022

    May 11, 2022 - The NEJM reported a phase 2/3 study found two 50-μg doses of the mRNA-1273 vaccine were found to be safe and effective in inducing immune responses and preventing Covid-19 in children 6 to 11 years of age; these responses were noninferior to those in young adults. 

    April 28, 2022 - "We are proud to share that we have initiated our EUA submission for authorization for our COVID-19 vaccine for young children," said Stéphane Bancel, CEO of Moderna. "We believe mRNA-1273 will be able to safely protect these children against SARS-CoV-2, which is so important in our continued fight against COVID-19 and will be especially welcomed by parents and caregivers."

    April 19, 2022 - Moderna announced the first bivalent booster vaccine candidate, mRNA-1273.211, demonstrated superiority against Beta, Delta, and Omicron variants of concern one month after administration. This vaccine candidate is not targeted specifically against the Delta or Omicron variants.

    April 8, 2022 - Moderna and ROVI Pharma Industrial Services, S.A.U. announced a recall of one lot (lot #000190A) of the Moderna COVID-19 vaccine (Spikevax®). The lot is being recalled due to a foreign body being found in one vial in the lot manufactured at the Company’s contract manufacturing site, ROVI, in Spain. The impacted vial was punctured and was not administered.

    March 31, 2022 - The U.S. NIH began a clinical trial evaluating second COVID-19 booster shots in adults.

    March 23, 2022 - Moderna confirmed it would submit a request for authorization of a 25 μg two-dose primary series of mRNA-1273 for children six months to under six years of age to the U.S. FDA, European Medicines Agency, and other global regulators in the coming weeks.

    March 21, 2022 - Moderna, Inc. announced a new supply agreement with the Swiss Federal Government for 7 million doses of Moderna's COVID-19 booster vaccine and an additional option of seven million doses for delivery in 2023 and 2024.

    March 17, 2022 - Moderna, Inc. announced that it has submitted a request to the U.S. FDA to allow for the fourth dose of its COVID-19 vaccine (mRNA-1273) in adults who have received an initial (3rd) booster of any of the authorized or approved COVID-19 vaccines. 

    March 17, 2022 - Health Canada authorized the use of the Moderna Spikevax (50 mcg) COVID-19 vaccine in children 6 to 11 years of age. After a thorough and independent scientific review of the evidence, the Department has determined that the benefits of this vaccine for children between 6 and 11 years of age outweigh the risks.

    March 16, 2022 - Moderna, Inc. announced an agreement with the Ministry of Health, Labour, and Welfare of Japan to supply an additional 70 million doses of Moderna's COVID-19 booster vaccine or an updated booster vaccine candidate, if authorized, for anticipated delivery in the second half of 2022.

    March 2, 2022 - A peer-reviewed analysis of Vaccine Adverse Event Reporting System data showed neurologic adverse events after COVID-19 vaccination were rare.

    March 2, 2022 - Following Australia's TGA’s provisional approval, ATAGI issued guidelines recommending Moderna’s COVID-19 vaccine (Spikevax) in children aged 6 to 11 years. 

    February 15, 2022 - The journal Radiology published an editorial: Post-Vaccine Myocarditis: A Risk Worth the Reward? 'While the prevalence of mRNA vaccine-associated myocarditis is now reasonably well characterized, the pattern and extent of myocardial injury compared to other forms of myocarditis remain poorly understood.'

    February 14, 2022 - AMA Chief Experience Officer Todd Unger and Sandra Fryhofer, MD, AMA's liaison to the CDC's Advisory Committee on Immunization Practices discuss expanded intervals between vaccine doses and not needing to delay vaccine or booster shots after receiving certain COVID treatments.

    February 4, 2022 - The CDC Director Dr. Rochelle Walensky commented, "If you have been waiting for approval before getting vaccinated, now is the time to join the nearly 212 million Americans who have already completed their primary series. CDC continues to recommend that people remain up to date on their COVID-19 vaccines, including getting a booster shot when eligible."

    February 4, 2022 - The U.S. CDC's Advisory Committee on Immunization Practices conducted a digital meeting reviewing the SpikeVax vaccine. These presentations included but were not limited to, updates on myocarditis and pericarditis following Moderna COVID-19 vaccination, presented by Tom Shimabukuro, MD, MPH, MBA; and an Overview of BLA for Use of Moderna's COVID-19 Vaccine (Spikevax) in Individuals ≥18 Years of Age, presented by Rituparna Das, MD, Ph.D. The data presented did not include Delta or Omicron virus variant impact.

    January 31, 2022 - The U.S. FDA announced the Approval of the SpikeVax vaccine, granted to ModernaTX, Inc. Acting FDA Commissioner Janet Woodcock, M.D., stated in a press release, "While hundreds of millions of doses of Moderna COVID-19 Vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated." 

    January 26, 2022 - The NEJM confirmed the 100-μg booster doses of the mRNA-1273, mRNA-1273.211, and mRNA-1273.213 vaccines all generated nearly identical ID50 geometric mean titers against the omicron variant (range, 2115 to 2228); these titers were 2.5 to 2.6 times higher than those assessed after the 50-μg booster dose of the mRNA-1273 vaccine and 1.4 to 1.5 times higher than the peak titers against the D614G variant 1 month after the second dose in the COVE trial. The strong boosting of neutralization of the omicron variant was similar to the strong boosting of neutralization of the delta and beta variants.

    January 12, 2022 - The NEJM published a peer-review study that observed limited waning in vaccine effectiveness against Covid-19–related hospitalization and death at 20 weeks or more after vaccination with two doses of BNT162b2 vaccine. Waning was greater in older adults and in those in a clinical risk group.

    December 7, 2021 - The EMA and the ECDC confirmed the evidence from studies on heterologous vaccination suggests that the combination of viral vector vaccines and mRNA vaccines produces good levels of antibodies against the COVID-19 virus (SARS-CoV-2) and a higher T-cell response than using the same vaccine (homologous vaccination) whether in a primary or booster regimen. The heterologous regimens were generally well tolerated.

    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.

    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's ACIP meeting.

    October 14, 2021 - Moderna, Inc. confirmed that the U.S. FDA's VRBPAC recommended an Emergency Use Authorization for a booster dose of the Moderna COVID-19 vaccine.

    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.

    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.

    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.

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

    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.

    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 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 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.

    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).

    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