Independent profile — not affiliated with Moderna
Moderna
Moderna, Inc. of Cambridge, Massachusetts makes the Spikevax and mNEXSPIKE COVID-19 vaccines, the mRESVIA RSV vaccine and the mFLUSIVA influenza vaccine. This page gathers Moderna's own contact and side-effect reporting channels, HRSA's published routes and statistics for COVID-19 vaccine injury claims (the CICP), FDA approvals and label actions, and the company's patent and securities litigation, all from primary sources read on 2026-10-03. USAComplaints has no approved complaints about Moderna, and the page contains no medical advice.
Independent Sources
Shown for context — not merged with USAComplaints' own numbers.
Contacts
- Official website: https://www.modernatx.com/
- Moderna WeCare, U.S. (customer support, medical information, product inquiries; also the number prin: 1-866-663-3762
- Moderna WeCare email (customer support, medical information, product inquiries): [email protected]
- Moderna Adverse Event Intake Portal (linked from the Moderna Contact page under 'Report a side effec: https://patientsafety.modernatx.com/
- Moderna, Inc. principal corporate office telephone (SEC filings): (617) 714-6500
- Privacy requests (Moderna privacy statement): [email protected]
Locations
| Type | Address |
|---|---|
| Headquarters | 325 Binney Street Cambridge MA 02142 |
Questions about a Moderna vaccine? Contact, side-effect reporting and injury-compensation routes
This page is about Moderna, Inc. of Cambridge, Massachusetts, the maker of the Spikevax and mNEXSPIKE COVID-19 vaccines, the mRESVIA RSV vaccine and the mFLUSIVA influenza vaccine. It collects the company's own contact channels and the U.S. government routes for reporting a side effect and for asking about injury compensation, all read on 2026-10-03. It contains no medical advice: questions about a vaccine, a symptom or a medical decision belong with a healthcare provider, and VAERS says "If you are experiencing a medical emergency, seek immediate assistance from a healthcare provider or call 9-1-1."
- Contacting Moderna. Moderna's Contact page says "For inquiries regarding customer support, medical information or product inquiries connect with us via Moderna WeCare" and lists telephone 1 866 MODERNA (1-866-663-3762) and email [email protected]. The same page also lists a "Speak Up Line" for "an ethical or compliance concern regarding Moderna's business activities" and has a "Report a side effect" line: "Online: Moderna's Adverse Event Intake Portal or U.S. HHS's Vaccine Adverse Event Reporting System".
- Reporting a suspected side effect. The current Spikevax, mNEXSPIKE, mRESVIA and mFLUSIVA FDA-approved prescribing information say "To report SUSPECTED ADVERSE REACTIONS, contact ModernaTX, Inc. at 1-866-663-3762 or VAERS at 1-800-822-7967" (the Spikevax label gives https://vaers.hhs.gov; the mFLUSIVA label gives www.vaers.hhs.gov). The mFLUSIVA information for recipients says "You may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or https://vaers.hhs.gov" and gives 1-866-MODERNA (1-866-663-3762) for additional questions; Moderna's own mFLUSIVA page repeats the VAERS line. The Spikevax label's counseling section says to "report any adverse events to their healthcare provider or to the Vaccine Adverse Event Reporting System". The VAERS site says "Anyone can report an adverse event to VAERS" and "Vaccine manufacturers are required to report to VAERS all adverse events that come to their attention." The VAERS page adds "If you need further assistance with reporting to VAERS, please email [email protected] or call 1-800-822-7967." VAERS also cautions that "VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness." Moderna's privacy statement notes that it "cannot comply with a consumer's request to amend or remove information that was provided to Moderna by a healthcare professional or a consumer regarding an adverse drug event due to legal obligations."
- COVID-19 vaccine injury claims go to the CICP, not the VICP. HRSA's FAQ says "COVID-19 vaccines are covered countermeasures under the Countermeasures Injury Compensation Program (CICP), not the National Vaccine Injury Compensation Program (VICP)." HRSA's VICP page repeats it: "For claims associated with the COVID-19 vaccine or other COVID-19 related countermeasures, please file your Request for Benefits with the Countermeasures Injury Compensation Program." The VICP list of covered vaccines that I read names routine vaccines such as MMR, HPV and seasonal influenza; it does not list an RSV vaccine, and I did not find an HRSA page stating which program covers mRESVIA. HRSA's VICP page says the VICP "covers all seasonal influenza vaccines"; I did not find an HRSA page that names mFLUSIVA, so the VICP line is the place to ask which program applies to it. HRSA's VICP line (1-800-338-2382, [email protected]) can say.
- How the CICP works (HRSA's words). The CICP "provides compensation for covered serious injuries or deaths that occur as the result of the administration or use of certain countermeasures. Compensation may include unreimbursed medical expenses (expenses that health insurance did not cover), lost employment income, and the survivor death benefit." The deadline: "You must file a Request for Benefits Package within one year of receiving or using the countermeasure that you believe caused the injury." A complete package includes the Request for Benefits form, an Authorization for Use or Disclosure of Health Information form for each provider, proof the countermeasure was administered (for example "a CDC COVID-19 vaccine card") and medical records. Claims go through the HRSA Injury Compensation Programs website or by mail to "Health Resources and Services Administration, Countermeasures Injury Compensation Program, 5600 Fishers Lane, Room 14W-18, Rockville, MD 20857"; "The CICP does not accept Request for Benefits packages or Letters of Intent via email or fax." Status questions: 1-855-266-2427 or [email protected] (no personal or medical information by email). HRSA also says the CICP "is the payer of last resort" and "is not authorized to provide reimbursement for attorneys' fees." A claimant who disagrees with a decision "can ask for reconsideration": HRSA's filing-process page says a request "must be received in writing within 60 days of the CICP's determination of ineligibility" and be mailed to the Associate Administrator, Healthcare Systems Bureau, 5600 Fishers Lane, Room 14W-37, Rockville, MD 20857.
- Letter of Intent (deadline protection). HRSA's FAQ says a requester can file by "filling out the Request for Benefits Form ... or submitting a Letter of Intent to the CICP. The letter of intent is only accepted for the purposes of meeting the filing deadline. All Request for Benefits Forms or Letters of Intent must be filed within one (1) year of receiving the countermeasure that is alleged to have caused the injury. All requesters who have submitted Letters of Intent must still file Request Forms as soon as possible." Per HRSA, a Letter of Intent "should include your full name and a statement that demonstrates your intent to submit a Request for Benefits" without Social Security numbers or medical, legal or financial documents, and goes by U.S. mail or private courier to the CICP address above or through the CICP online portal; "CICP does not accept Letters of Intent via fax or email."
- What the CICP counts and does not count. HRSA says it pays for injuries that "are found to be directly caused by" a covered countermeasure or meet an injury table, and that "Temporal association between the administration or use of the covered countermeasure and onset of the injury ... is not sufficient, by itself, to prove that an injury is the direct result of a covered countermeasure." Program statistics as of September 1, 2026 are in the complaint-record section below.
- PREP Act liability protection. HHS's ASPR page says a PREP Act declaration "provides immunity from liability (except for willful misconduct)" for claims of loss caused by the administration or use of covered countermeasures. The twelfth amendment to the COVID-19 declaration (effective January 1, 2025) extends PREP Act coverage "through December 31, 2029", and the ASPR page I read lists no later amendment. HRSA's FAQ says that if all requirements of the declaration are met, a covered person "is immune from liability except for 'willful misconduct'". This describes the program as the agencies publish it; whether it applies to a particular claim is a legal question for a court or a lawyer.
- Looking up what FDA has approved. FDA keeps a page with package inserts and approval letters for each product (links in the government-actions section below). The package inserts, not this page, are the authoritative text on indications, warnings and dosing.
- Privacy. Moderna's privacy statement (it shows "Effective September 2023") lists [email protected] for unsubscribe requests and links a request web page for access, correction and deletion requests; its California section says "You may exercise your Right to Know and Right to Deletion by visiting our request web page or calling (844) 971-2551."
Government actions: FDA approvals, labeling and the COVID-19 emergency authorization
The items below are FDA actions recorded on FDA's own pages and letters, read on 2026-10-03. They are regulatory records, not findings of wrongdoing, and nothing here is medical advice.
- mFLUSIVA (Influenza Vaccine, mRNA), approved August 5, 2026. FDA's page (content current as of 09/02/2026) lists "STN: BLA 125869/0 Proper Name: Influenza Vaccine, mRNA Tradename: MFLUSIVA Manufacturer: ModernaTX, Inc." and says it "is approved for use in persons 50 years of age and older." FDA's letter of August 5, 2026, addressed to ModernaTX, Inc. at 325 Binney Street, approves the Biologics License Application "received December 5, 2025" under "U.S. License No. 2256" and says "The indication for persons 65 years of age and older is approved under accelerated approval pursuant to section 506(c) of the Federal Food, Drug, and Cosmetic Act (FDCA)"; the package insert (Revised 8/2026, "Initial U.S. Approval: 2026") adds "Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial." FDA's page also lists a Clinical Review and a Summary Basis for Regulatory Action dated August 5, 2026. The indication line on FDA's web page says only "approved for use in persons 50 years of age and older"; the accelerated-approval wording is in the approval letter and the package insert. Moderna's release of August 5, 2026 calls mFLUSIVA its "fifth approved product globally and fourth FDA-approved product", says the company "expects supply to be available in select retailers in the coming weeks" and expects availability for eligible populations "for the 2026-2027 respiratory virus season" (the company's statements; this page does not say whether a particular pharmacy has it in stock). mCOMBRIAX, the flu plus COVID combination vaccine described in Moderna's Form 10-Q as approved in Europe, is a separate product; no FDA approval of mCOMBRIAX was identified in the FDA pages read on 2026-10-03.
- Spikevax (COVID-19 Vaccine, mRNA). FDA's page (content current as of 08/27/2026) lists STN 125752, "Manufacturer: Moderna Tx, Inc", and says Spikevax "is approved for use in individuals who are: 65 years of age and older, or 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19." The package inserts show "Initial U.S. Approval: 2022". FDA's letter of August 27, 2026 approved a supplement "to include the 2026-2027 Formula and associated labeling revisions."
- mNEXSPIKE (COVID-19 Vaccine, mRNA). FDA's page lists STN 125835, ModernaTX, Inc., and says MNEXSPIKE "is approved for use in individuals who are: 65 years of age and older, or 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19." The page lists approval letters dated May 30, 2025 (with a "Summary Basis for Regulatory Action") and August 27, 2026 (2026-2027 Formula). Moderna's Form 10-Q says it "launched commercial sales of mNEXSPIKE in the third quarter of 2025".
- mRESVIA (Respiratory Syncytial Virus Vaccine). FDA's page lists STN 125796 and says MRESVIA is indicated for the prevention of lower respiratory tract disease caused by RSV in "Individuals 60 years of age and older" and "Individuals 18 through 59 years of age who are at increased risk". The package insert shows "Initial U.S. Approval: 2024". By an FDA letter of August 7, 2026 FDA approved a supplement "to describe in Section 8.4 (Pediatric Use) the observed imbalance in severe and/or hospitalized RSV lower respiratory tract disease among participants who were vaccinated from 5 months through 7 months of age and RSV-seronegative at baseline." The revised label (8/2026) says "Safety and effectiveness of MRESVIA in individuals younger than 18 years of age have not been established." and describes that imbalance in infants in a dose-ranging study; the indications quoted above are for adults.
- Myocarditis and pericarditis warning. In an FDA Safety Communication dated June 25, 2025, FDA said it "has required and approved updates to the Prescribing Information for Comirnaty ... manufactured by Pfizer Inc. and Spikevax ... manufactured ModernaTX, Inc. to include new safety information about the risks of myocarditis and pericarditis following administration of mRNA COVID-19 vaccines." The updated warning says "the observed risk of myocarditis and pericarditis following vaccination with mRNA COVID-19 vaccines has been highest in males 12 through 24 years of age", with an estimated unadjusted incidence in the 7 days after the 2023-2024 Formula of "approximately 8 cases per million doses in individuals 6 months through 64 years of age and approximately 27 cases per million doses in males 12 through 24 years of age." The current Spikevax label highlights repeat that warning.
- Emergency use authorization ended. FDA's page for the Moderna COVID-19 Vaccine says: "On August 27, 2025, the Food and Drug Administration revoked the emergency use authorization (EUA) of Moderna COVID-19 Vaccine. Spikevax ... is approved for use by FDA." Moderna's Form 10-K says the same: "In August 2025, the FDA revoked the EUA for emergency use of our COVID vaccine."
- Texas Attorney General investigation (announced May 1, 2023). The Texas Attorney General's press release of May 1, 2023 says Attorney General Paxton "launched an investigation into the pharmaceutical companies Pfizer, Moderna, and Johnson & Johnson concerning whether they engaged in gain-of-function research and misled the public about doing so", and that he is also investigating whether the companies "misrepresented the efficacy of their Covid-19 vaccines and the likelihood of transmitting Covid-19" in violation of the Texas Deceptive Trade Practices Act and the potential manipulation of vaccine trial data. The release links a civil investigative demand addressed to Moderna. An investigation announcement states subjects of inquiry, not findings; the release contains no settlement, penalty or admission, and I did not find a later Moderna-specific outcome in the sources opened on 2026-10-03, so this page does not say whether the investigation is pending, closed or modified. Moderna's Form 10-K Item 3 and Form 10-Q Part II Item 1, as read for this page, do not describe it.
- Other government matters. In the sources checked on 2026-10-03, the legal-proceedings sections of Moderna's Form 10-K for 2025 (Item 3) and Form 10-Q for the quarter ended June 30, 2026 (Part II, Item 1, and Note 12) describe patent disputes and a shareholder securities case (see the litigation section) and do not describe an FTC or state attorney general enforcement action. A search of the California Attorney General's data-breach list for the organization name "moderna" returned "There are currently no published reported breaches." These are scoped checks of the sources named, not a statement about every agency or state.
Who Moderna is and what it sells
Moderna, Inc. is listed by SEC EDGAR (CIK 1682852) as a Delaware corporation with its business address at 325 Binney Street, Cambridge, Massachusetts 02142 and the ticker MRNA on Nasdaq. Its Form 10-K for 2025 (filed 2026-02-20; I found no 10-K/A for that year in EDGAR's recent-filings list) says: "We were incorporated under the laws of the State of Delaware on July 22, 2016. We are the successor in interest to Moderna LLC ... Moderna LLC was the successor in interest to Moderna Therapeutics, Inc., a Delaware corporation incorporated in 2009 as Newco LS18, Inc. by Flagship Pioneering. In August 2018, we changed our name from Moderna Therapeutics, Inc. to Moderna, Inc." It describes itself as "a biotechnology company advancing a new class of medicines made of messenger RNA (mRNA)" and reports about 4,700 full-time employees in 18 countries as of December 31, 2025 (the company's figure).
Products. The Form 10-Q for the quarter ended June 30, 2026 (filed 2026-07-31, before the FDA's August 5 mFLUSIVA approval) says Moderna has "four approved products": Spikevax and mNEXSPIKE (COVID-19 vaccines), mRESVIA (an RSV vaccine) and mCOMBRIAX, a flu plus COVID combination vaccine "approved in Europe for individuals 50 years of age and older"; it adds that mCOMBRIAX "had not been commercialized" as of June 30, 2026. On August 5, 2026 FDA approved the influenza vaccine mFLUSIVA (see the government-actions section), which Moderna's August 5, 2026 release calls its "fifth approved product globally and fourth FDA-approved product" (mCOMBRIAX, per the 10-Q, being approved in Europe). FDA's product pages list mNEXSPIKE, mRESVIA and mFLUSIVA as products of ModernaTX, Inc. and Spikevax with the manufacturer shown as "Moderna Tx, Inc"; the mFLUSIVA recipient information says "Manufactured for: Moderna US, Inc. Princeton, NJ 08540". The 10-Q says "In the U.S., our COVID and RSV vaccines are sold primarily to wholesalers and distributors, and to a lesser extent, directly to retailers and healthcare providers," so most people receive them through a pharmacy, clinic or other provider rather than from Moderna.
Entities. Exhibit 21.1 to the Form 10-K, listing Moderna, Inc.'s principal affiliates as of December 31, 2025, includes ModernaTX, Inc. (Delaware) and Moderna US, Inc. (Delaware). FDA letters on the vaccines' biologics license applications are addressed to ModernaTX, Inc. at 325 Binney Street.
Recent corporate filings. Moderna's recent Form 8-K filings include one filed March 5, 2026 reporting a March 3, 2026 patent-litigation settlement (see the litigation section), the completion on September 1, 2026 of a private offering of $3,000,000,000 aggregate principal amount of 0.00% Convertible Senior Notes due 2032, and a September 30, 2026 announcement that Juan Andres will become Chief Operating Officer effective October 5, 2026. These are investor matters; they do not change the consumer routes above.
Other businesses with similar names. This page covers only Moderna, Inc. A BBB search on 2026-10-03 also returned unrelated businesses such as Moderna Contractors LLC (Port Arthur, TX), Moderna Tea and Moderna Laser (Las Vegas, NV) and Moderna Relocation (Pittsburgh, PA), and this site's older complaint archive contains posts about unrelated businesses such as Modernage Furniture. None of those is connected to Moderna, Inc. on the basis of the pages I read.
Complaint and review record (as displayed 2026-10-03)
This site. USAComplaints has no approved complaint posts about Moderna, Inc. The search for "Moderna" in our database returned only posts about unrelated businesses with similar names (for example Modernage Furniture and Modern Auto Sales).
BBB. The "BBB profile for Moderna Inc, Cambridge, MA" is a listing under "Administrative Services" that is not BBB Accredited and shows a BBB rating of A+. As displayed on 2026-10-03 its complaints tab says "This business has 0 complaints" and its reviews tab says "This business has 0 reviews". The listing shows a street address (200 Technology Square) and a category that differ from Moderna's headquarters address on its own Contact page, so I treat it as an incomplete listing. The listing also names "Mr. Stephen Hodge, President" as business management (the SEC filings and the Wentz docket spell the executive's surname "Hoge") and shows "Number of Employees: 1", whereas the 10-K reports about 4,700 full-time employees (the company's figure); these are fields as BBB displays them, and this site has not verified them. BBB's raw page data gives a file-opened date of 2018-02-20, a business start of 2009-04-15 and an incorporation date of 2009-04-15.
Trustpilot. The page for modernatx.com shows "Unclaimed profile", 0 reviews and 0 reviews in the last 12 months as displayed on 2026-10-03.
ComplaintsBoard. A site search for "moderna" on 2026-10-03 returned posts about other businesses (a furniture retailer, pharmacies) and no business page for Moderna, Inc.
Government compensation-program data (HRSA CICP, aggregate data as of September 1, 2026). HRSA reports claims by the countermeasure the requester alleges, not by manufacturer: "The CICP does not maintain its aggregated data concerning alleged countermeasures, including vaccines, by specific manufacturer or trade name." For all COVID-19 countermeasures HRSA reports 14,206 claims filed, of which 11,145 allege injuries or deaths from COVID-19 vaccines and 3,061 allege injuries or deaths from other COVID-19 countermeasures (including claims where the type was unclear at submission). Of those 14,206, 6,084 were pending review or in review and 8,122 had decisions. Of the decisions, 120 were found eligible for compensation (63 compensated, 53 pending a benefits determination, 4 with no eligible reported expenses) and 8,002 were denied: 3,387 because requested medical records were not submitted, 2,711 for a missed filing deadline, 1,640 because the standard of proof was not met and/or a covered injury was not sustained, and 264 as not a CICP-covered product or not specified. HRSA cautions that it "reports data based on the alleged countermeasure(s) and the alleged injuries that requesters list" and that these may not match the medical documentation. These figures cannot be attributed to Moderna, Pfizer or any single manufacturer.
VAERS. The VAERS site says its reports "may contain information that is incomplete, inaccurate, coincidental, or unverifiable" and cannot by themselves show that a vaccine caused an event. This page does not summarize VAERS counts for Moderna products.
Lawsuits and court records
Moderna's SEC filings describe mainly patent disputes between companies and one shareholder securities case. They are business and investor disputes, not consumer injury cases. In the sources checked on 2026-10-03 (Form 10-K Item 3 and the Form 10-Q for the quarter ended June 30, 2026, Note 12 and Part II, Item 1), no consumer product-liability class action against Moderna was described. This is a scoped statement about those filings.
Securities case (Wentz v. Moderna, Inc.). A putative shareholder class action, No. 1:24-cv-12058 (D. Mass.), was filed in August 2024 against Moderna and certain officers over statements about its RSV vaccine (mRNA-1345, now mRESVIA). The Form 10-K says the plaintiff's August 25, 2025 amended complaint narrowed the class period to February 15, 2024 to May 31, 2024 and that Moderna filed a motion to dismiss on October 24, 2025. These are allegations. The case entry below summarizes the docket entries read on 2026-10-03, including a Magistrate Judge's Report and Recommendations on the motion to dismiss (ECF 94, August 31, 2026) that I could not read.
Arbutus/Genevant settlement. The Form 8-K of March 5, 2026 says that on March 3, 2026 Moderna entered a settlement agreement "to resolve all patent infringement litigation between Moderna and Arbutus/Genevant pending in the U.S. and internationally", with "a $950 million noncontingent lump sum payment" by July 8, 2026. It also says Moderna may appeal to the Federal Circuit on whether 28 U.S.C. section 1498 bars the claims for doses sold to the U.S. Government under a particular contract; if Moderna does not prevail on that issue, "Moderna will make an additional $1.3 billion contingent lump sum payment". The Form 10-Q says Moderna has appealed and recorded no accrual for the additional amount.
Patent disputes where Moderna is the plaintiff. The Form 10-K says Moderna sued Pfizer and BioNTech in 2022 (D. Mass. and in European courts) over its mRNA platform patents; the U.S. case "has been stayed pending the outcome of two Inter Partes Review proceedings", and in March 2025 the PTAB "found the patents invalid" and Moderna appealed. In July 2024 the High Court of England and Wales ruled one European patent valid and infringed; the Form 10-K reports later appeals and hearings in several countries.
Patent claims against Moderna. The Form 10-Q lists suits by GSK (two complaints in D. Del. and two in the Unified Patent Court), Northwestern University, Bayer CropScience and Monsanto, mNG Bio, BioNTech, CureVac and, since July 2026, Sanofi subsidiaries Translate Bio and Sanofi Vaccines US (D.N.J.); the 10-K says the GSK trials are set for July 19, 2027 (COVID) and August 23, 2027 (RSV). Each seeks a judgment of infringement and damages; these are allegations and several are at an early stage.
Bayer patent case: motion to dismiss denied. Bayer CropScience LLC, Monsanto Company and Monsanto Technology, LLC v. Moderna US, Inc., Moderna, Inc. and ModernaTX, Inc., No. 1:26-cv-00012 (D. Del.), is a complaint for patent infringement filed January 6, 2026. The CourtListener docket entry dated September 28, 2026 reads: "MEMORANDUM OPINION AND ORDER, Denying 22 MOTION to Dismiss for Failure to State a Claim. Signed by Judge William C. Bryson on 09/28/2026." The docket also records that the case was reassigned to Judge Bryson of the U.S. Court of Appeals for the Federal Circuit. I did not read the opinion. A denied motion to dismiss is a ruling on the pleadings, not a finding of infringement, and the claims remain allegations.
Moderna as claimant at the Unified Patent Court. The UPC's case page for UPC-CFI-0003215/2026 lists ModernaTX, Inc. as claimant against BioNTech and Pfizer entities, proceeding type "Infringement", case patent EP3981437 ("NUCLEIC ACID VACCINES"), Hamburg Local Division, date of formal receipt 7 September 2026 and case phase "Written Phase"; the documents it lists are marked "Not Public". This is a patent dispute between companies, and the infringement claim is Moderna's allegation.
Outcomes favorable to Moderna. In the Alnylam patent cases the court entered final judgments of non-infringement, the Federal Circuit decided the first appeal in Moderna's favor in June 2025, and the parties settled in September 2025 with a stipulated dismissal with prejudice; the Form 10-K says "The settlement did not include payments of any kind by us."
Is Moderna Legitimate?
Moderna, Inc. is an SEC registrant (CIK 1682852) whose common stock trades on Nasdaq as MRNA. It files annual and quarterly reports, most recently a Form 10-K for 2025 (filed 2026-02-20) and a Form 10-Q for the quarter ended June 30, 2026 (filed 2026-07-31). Its headquarters address on its own Contact page, in the SEC record and in FDA letters is 325 Binney Street, Cambridge, MA 02142. FDA lists ModernaTX, Inc. as the manufacturer on its pages for the Spikevax, mNEXSPIKE, mRESVIA and mFLUSIVA products, with approval letters dated through August 27, 2026 (the mFLUSIVA approval letter is dated August 5, 2026).
The company's own channels for questions and side-effect reports are Moderna WeCare (1-866-663-3762, [email protected]) and its Adverse Event Intake Portal; the government routes are VAERS (side-effect reports) and the HRSA compensation programs described above. BBB's file for Moderna Inc is not accredited and shows a rating of A+ with 0 complaints and 0 reviews as displayed on 2026-10-03; Trustpilot has an unclaimed page with 0 reviews. This page is a collection of verified records and does not rate or score the company, and it gives no medical advice.
Court & Public Records
| Case | Authority | Dates | Type | Outcome | Source |
|---|---|---|---|---|---|
| Wentz v. Moderna, Inc. (securities class action) Docket No. 1:24-cv-12058-IT | U.S. District Court, D. Massachusetts | Filed | Filed — no final outcome recorded Putative class action by shareholders against Moderna, Stephane Bancel, James M. Mock and Stephen Hoge over statements about the efficacy data for the RSV vaccine mRESVIA. These are allegations; the case concerns investors, not vaccine recipients. Moderna's Form 10-K says the amended complaint narrowed the class period to February 15, 2024 to May 31, 2024 and that Moderna filed a motion to dismiss on October 24, 2025, which was pending when the Form 10-Q for the quarter ended June 30, 2026 was filed. Docket entries read on 2026-10-03: the case was referred to Magistrate Judge Paul G. Levenson on May 7, 2026, and a motion hearing is recorded for June 18, 2026 (transcript filed July 1, 2026). On August 31, 2026 the magistrate judge entered an order (ECF 93) whose conclusion reads "Plaintiff's Motion to Strike (Docket No. 76) is ALLOWED" (the motion concerned exhibits the defendants offered with their motion to dismiss), and a Report and Recommendations (ECF 94). The docket text of ECF 101 (September 28, 2026) refers to the "Report and Recommendation on Motion to Dismiss the Amended Class Action Complaint" and to "Defendants' partial objection" to it. Objections were filed on September 14, 2026 (ECF 96-99) and responses and replies on September 28 and 29, 2026 (ECF 100-102). I could not read the Report and Recommendations itself (it is not in CourtListener's RECAP archive, and GovInfo lists only ECF 56 and ECF 93 for this case), so this page does not state what it recommends. In the entries read, through ECF 102 (September 29, 2026), no ruling by the district judge on the motion to dismiss or on the Report and Recommendations appeared. | Source |
Company Relationships
- Affiliated with: ModernaTX, Inc.
- Affiliated with: Moderna US, Inc.
- Formerly known as: Moderna Therapeutics, Inc.
Frequently Asked Questions
What is Moderna, Inc.?
Moderna, Inc. is listed by SEC EDGAR (CIK 1682852) as a Delaware corporation with its business address at 325 Binney Street, Cambridge, Massachusetts 02142 and the ticker MRNA on Nasdaq. Its Form 10-K for 2025 calls it "a biotechnology company advancing a new class of medicines made of messenger RNA (mRNA)" and says it changed its name from Moderna Therapeutics, Inc. in August 2018. FDA's pages list Spikevax, mNEXSPIKE, mRESVIA and, since an August 5, 2026 approval letter, mFLUSIVA as ModernaTX products. This page is not about unrelated businesses with "Moderna" in the name, such as Moderna Tea or Moderna Contractors LLC.
How do I contact Moderna about a vaccine product?
Moderna's Contact page says "For inquiries regarding customer support, medical information or product inquiries connect with us via Moderna WeCare" and lists telephone 1 866 MODERNA (1-866-663-3762) and email [email protected]. The page also links an Adverse Event Intake Portal under "Report a side effect". Moderna's media, investor and careers inboxes are listed separately on the same page, along with a "Speak Up Line" described as a way to "Report an ethical or compliance concern regarding Moderna's business activities".
How do I report a suspected side effect after a Moderna vaccine?
The Spikevax package insert says "To report SUSPECTED ADVERSE REACTIONS, contact ModernaTX, Inc. at 1-866-663-3762 or VAERS at 1-800-822-7967 or https://vaers.hhs.gov." The mFLUSIVA package insert (Revised 8/2026) gives the same two numbers and www.vaers.hhs.gov, and Moderna's mFLUSIVA page says "You may report side effects to Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or http://vaers.hhs.gov." The VAERS site says "Anyone can report an adverse event to VAERS" and "If you are experiencing a medical emergency, seek immediate assistance from a healthcare provider or call 9-1-1." VAERS adds that its reports "alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness." This answer is not medical advice.
How do I file a claim for a COVID-19 vaccine injury?
HRSA's FAQ says "COVID-19 vaccines are covered countermeasures under the Countermeasures Injury Compensation Program (CICP), not the National Vaccine Injury Compensation Program (VICP)." HRSA says "You must file a Request for Benefits Package within one year of receiving or using the countermeasure that you believe caused the injury," either through the HRSA Injury Compensation Programs website or by mail to the CICP at 5600 Fishers Lane, Room 14W-18, Rockville, MD 20857; the CICP "does not accept" packages by email or fax. HRSA also lets a requester submit a Letter of Intent (full name and a statement of intent, by mail, courier or the CICP portal), which "is only accepted for the purposes of meeting the filing deadline"; the Request for Benefits Form must still be filed as soon as possible. Questions: 1-855-266-2427 or [email protected]. HRSA also says the CICP "is not authorized to provide reimbursement for attorneys' fees."
What is the difference between the CICP and the VICP?
HRSA describes the VICP as "a no-fault alternative to the traditional legal system" in which a petition is filed with the U.S. Court of Federal Claims, and says it "covers most vaccines routinely given in the U.S." (the list includes MMR, HPV and seasonal influenza). The CICP is an administrative program: it "reviews and resolves claims through an administrative process" for countermeasures named in PREP Act declarations, which include COVID-19. For COVID-19 vaccines HRSA directs claims to the CICP. The covered-vaccines list I read does not include an RSV vaccine, and I did not find an HRSA page stating which program covers mRESVIA; HRSA says the VICP "covers all seasonal influenza vaccines" but I found no HRSA page naming mFLUSIVA.
How many COVID-19 vaccine injury claims has the CICP paid?
HRSA's aggregate CICP data as of September 1, 2026 show 14,206 COVID-19 countermeasure claims filed (11,145 alleging injuries or deaths from COVID-19 vaccines and 3,061 alleging them from other COVID-19 countermeasures), 8,122 decisions, 120 claims found eligible for compensation and 63 compensated. HRSA states that it "does not maintain its aggregated data concerning alleged countermeasures, including vaccines, by specific manufacturer or trade name," so the figures are not specific to Moderna.
What does the PREP Act say about lawsuits over COVID-19 vaccines?
HHS's ASPR page says a PREP Act declaration "provides immunity from liability (except for willful misconduct)" for claims of loss caused by the administration or use of covered countermeasures. The twelfth amendment to the COVID-19 declaration extends PREP Act coverage "through December 31, 2029"; the ASPR page lists no later amendment. Moderna's Form 10-K states that PREP Act protection applies if the declaration's requirements are met and that "this cannot be assured" for every product it sells to the U.S. Government. Whether the immunity applies to a particular claim is a legal question for a court or a lawyer.
What has FDA said about Moderna's vaccines and labels?
FDA's pages say Spikevax is approved for people 65 and older or 6 months through 64 with at least one underlying condition that puts them at high risk for severe COVID-19 outcomes, mNEXSPIKE for 65 and older or 12 through 64 with such a condition, mRESVIA for RSV lower respiratory tract disease in adults 60 and older and in adults 18 through 59 at increased risk, and mFLUSIVA (approved August 5, 2026) for active immunization against influenza in people 50 and older, with the 65-and-older indication approved under accelerated approval. FDA revoked the Moderna COVID-19 Vaccine emergency use authorization on August 27, 2025. In a June 25, 2025 Safety Communication FDA announced an updated myocarditis and pericarditis warning for Spikevax and Comirnaty labeling. The package inserts are the authoritative source; this is not medical advice.
What lawsuits is Moderna involved in?
Moderna's Form 10-Q for the quarter ended June 30, 2026 describes patent suits it filed against Pfizer and BioNTech and patent suits against it by GSK, Northwestern University, Bayer and Monsanto, mNG Bio, BioNTech, CureVac and Sanofi subsidiaries, plus a shareholder class action and derivative litigation in the U.S. District Court for the District of Massachusetts over statements about its RSV vaccine. A March 2026 settlement with Arbutus and Genevant provides for a $950 million payment and a possible additional $1.3 billion depending on a Federal Circuit appeal. On September 28, 2026 the court in the Bayer patent case (D. Del., No. 1:26-cv-00012) denied Moderna's motion to dismiss, according to the docket entry; that is a ruling on the pleadings, not a finding of infringement. These are allegations and business disputes; the filings I checked did not describe a consumer injury class action.