Vaccine Info

SpikeVax COVID-19 Vaccine (Moderna)

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August 10, 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 the SARS-CoV-2 virus.

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. And on June 17, 2022, the FDA authorized a version of SpikeVax for infants and young children.

SpikeVax (elasomeran mRNA vaccine) 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 Omicron BA.x Sublineages

As of Aug. 4, 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.

SpikeVax Bivalent Vaccine (mRNA-1273.211)

The EMA has started a rolling review for a bivalent vaccine version. This means a new version of SpikeVax will target two strains of SARS-CoV-2, in this case, the original strain and the Omicron variant of concern. 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).

SpikeVax Bivalent Vaccine (mRNA-1273.211)

On July 29, 2022, Moderna announced that the U.S. government had secured a contract for 66 million doses, including an award of up to $1.74 billion, of Moderna's COVID-19 vaccine booster candidate, mRNA-1273.222, a bivalent booster candidate containing Spikevax™ plus the Omicron BA.4/5 strain mRNA. The contract includes options to purchase up to an additional 234 million doses of COVID-19 vaccine booster candidates from Moderna.

SpikeVax Side Effects

The EMA confirmed as of May 29, 2022, a total of 219,135 cases of suspected spontaneous side effects were reported from EU/EEA countries; 1,059 of these reported a fatal outcome. As of May 15, 2022, about 152 million doses of Spikevax had been given to people in the EU/EEA.

SpikeVax Heart Risk

Dr. Tom Shimabukuro, MPH, MBA, with the U.S. CDC COVID-19 Vaccine Coordination Unit, confirmed on June 7, 2022, on slide #27, that the 'current evidence supports a causal, but rare, association between mRNA COVID-19 vaccination and myocarditis and pericarditis.' 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 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.

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. 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 Dosage

Moderna's SpikeVax vaccine is offered in various dose regimens, subject to country-based authorizations. 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.

SpikeVax 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 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. On June 14, 2022, the FDA Vaccines and Related Biological Products Advisory Committee reviewed these presentations. The U.S. CDC director issued her approval for infants and toddlers to receive 2 or 3 doses of SpikeVax.

On July 22, 2022, the EMA's Committee for Medicinal Products for Human Use adopted a positive opinion recommending a variation to the authorization to include a booster dose of Spikevax at the 50 µg dose level for adolescents (12-17 years) at least three months after completion of the primary series. 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.

The Therapeutic Goods Administration in Australia granted provisional registration on July 18, 2022, for the use of Spikevax, in a two-dose series of 25 µg per dose for active immunization to prevent COVID-19 in children aged 6 months to 5 years. This approval follows similar authorizations in more than 35 countries, including Australia, Canada, the European Union, and the UK. Canada issued a similar authorization on March 17, 2022.

SpikeVax 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 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.

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 Multiple Sclerosis

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

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 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 TAK-919

On May 31, 2022, Moderna and Takeda announced the marketing authorization in Japan for Spikevax will transfer from Takeda to Moderna in Japan as of August 2022. 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.

Pan-Respiratory Booster 

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 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 mRNA-1273.351

Moderna announced on January 25, 2021, that 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 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 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 July 11, 2022, the Company announced among participants without prior infection that bivalent mRNA-1273.214 resulted in significantly higher neutralizing titers against BA.4/5 compared to the currently authorized booster, with a geometric mean ratio of 1.69 (95% CI: 1.51-1.90)1. One month after the booster, BA.4/5 neutralizing titers were 776 (95% CI: 719, 838) for mRNA-1273.214 and 458 (95% CI: 421, 499) for the currently authorized booster. The BA.4/5 geometric mean fold rise (GMFR) from pre-booster levels was 6.3-fold (95% CI: 5.7, 6.9) for mRNA-1273.214 recipients, and 3.5-fold (95% CI: 3.2, 3.9) for mRNA-1273 recipients. Consistent results were demonstrated across subgroups, including those aged 65 and older.

On June 8, 2022, Moderna announced a 50 µg booster dose of mRNA-1273.214 met all pre-specified endpoints in the 437 study participants, including superior neutralizing antibody response (geometric mean ratio) against the Omicron variant one month after administration when compared to the original mRNA-1273 vaccine.

Moderna 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 was 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 Availability

As of August 10, 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 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.

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

August 3, 2022 - Moderna announced product sales for the second quarter of 2022 were $4.7 billion, increased by $334 million, or 8%, compared to the same period in 2021, primarily driven by a higher average selling price due to customer mix. The company reiterates advance purchase agreements for expected delivery in 2022 of approximately $21 billion

July 29, 2022 - Moderna Inc. announced a new contract valued at up to $1.74 billion with the U.S. government for additional vaccines.

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.

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 News

    August 9, 2022 - Moderna, Inc. announced an amendment to its agreement with the European Commission (EC) to convert contractually agreed doses of Moderna's COVID-19 vaccine (Spikevax, mRNA-1273) to the Company's Omicron-containing bivalent vaccines for supply in 2022, pending regulatory approval. In addition, the EC has agreed to purchase an additional 15 million doses of Omicron-containing vaccine booster candidates.

    July 18, 2022 - Moderna, Inc. announced Australia granted provisional registration for the use of Spikevax in children aged 6 months to 5 years.

    July 11, 2022 -  Moderna, Inc. announced new clinical data on its bivalent Omicron (BA.1) booster candidate, mRNA-1273.214. One month after administration in previously vaccinated and boosted participants, a 50 µg booster dose of mRNA-1273.214 elicited significantly higher neutralizing antibody responses against the Omicron subvariants BA.4 and BA.5 compared to the currently authorized booster (mRNA-1273) regardless of prior infection status or age (adults over 18, greater or less than 65 years old).

    June 17, 2022 - “As with all vaccines for any population, when authorizing COVID-19 vaccines intended for pediatric age groups, the FDA ensures that our evaluation and analysis of the data is rigorous and thorough,” commented Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a press statement.

    June 10, 2022 - The EMA published Clinical Data supporting updated information for healthcare professionals on the efficacy of Spikevax against the Delta variant.

    June 8, 2022 - Moderna announced the mRNA-1273.214 vaccine candidate Exhibited an 8-Fold Boost in Neutralizing Geometric Mean Titers Against Omicron Among Baseline Seronegative Participants. Stéphane Bancel, Chief Executive Officer of Moderna commented:. "Looking at these data alongside the durability we saw with our first bivalent booster candidate, mRNA-1273.211, we anticipate more durable protection against variants of concern with mRNA-1273.214, making it our lead candidate for a Fall 2022 booster. We are submitting our preliminary data and analysis to regulators with the hope that the Omicron-containing bivalent booster will be available in the late summer. Taken together, our bivalent booster candidates demonstrate the power of Moderna's mRNA platform to develop vaccines that meet immediate, global public health threats."

    June 2, 2022 - Moderna, Inc. announced an agreement with the European Commission to amend their originally agreed contractual delivery schedules of SpikeVax vaccines; doses scheduled for delivery in the second quarter of 2022 to be delivered later in the calendar year 2022 or in 2023. 

    May 27, 2022 - Around 620,000 doses of Moderna’s SpikeVax vaccine stored in Switzerland have expired. Of these, 200,000 are in cantonal refrigerators and 420,500 are being held by the army.

    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 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 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 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