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Moderna, Inc. 8-K Report, Regulation FD Disclosure (Apr 13, 2021)

Reports
Regulation FD
Filing Date
Filed April 13, 2021
Period End
April 13, 2021
Security
MRNA
In the record · 2018–202610-K910-Q238-K117

MRNA filed 9 annual reports (10-K), 23 quarterly reports (10-Q) and 117 current reports (8-K) between 2018 and 2026.

  1. Material agreement8-K · Aug ’20Aug ’20
  2. Leadership change8-K · Sep ’22Sep ’22
  3. Leadership change8-K · Sep ’26Sep ’26

Summary

Summary of the 8-K filed April 13, 2021. Cited figures are marked; the original filing is the authoritative source.

Moderna, Inc. (MRNA) issued a statement on April 13, 2021, to address concerns regarding its COVID-19 vaccine, mRNA-1273.

The company's comprehensive review of safety data, encompassing over 64.5 million doses administered globally, concluded that there is no suggested association between the vaccine and cerebral venous sinus thrombosis or other thrombotic events. This disclosure, made under Regulation FD, aims to provide transparency and reassure investors and the public about the vaccine's safety profile. The company's proactive communication on safety data is crucial for maintaining confidence in its vaccine and its ongoing role in the global vaccination effort.

Key Highlights

  1. Moderna has reviewed safety data for over 64.5 million doses of its COVID-19 vaccine (mRNA-1273) administered globally.
  2. The company's assessment found no association between mRNA-1273 and cerebral venous sinus thrombosis.
  3. Moderna also reported no association between the vaccine and thrombotic events.
  4. This statement was issued under Regulation FD to ensure broad public disclosure.
  5. The company is proactively addressing potential safety concerns to maintain public trust.

Frequently Asked Questions

  1. What is the main purpose of this 8-K filing?

    The primary purpose of this 8-K filing is to disclose Moderna's statement regarding the safety of its COVID-19 vaccine, mRNA-1273, specifically addressing concerns about cerebral venous sinus thrombosis and other thrombotic events.

  2. What did Moderna conclude about the safety of mRNA-1273 regarding blood clots?

    Moderna's comprehensive assessment of safety data from over 64.5 million doses administered globally indicates no suggested association between mRNA-1273 and cerebral venous sinus thrombosis or other thrombotic events.

  3. How many doses of the vaccine have been administered globally according to the filing?

    According to the filing, over 64.5 million doses of the mRNA-1273 vaccine have been administered globally.

  4. Is this information considered 'filed' under SEC regulations?

    No, the information in this Current Report on Form 8-K is intended to be furnished and shall not be deemed 'filed' for purposes of Section 18 of the Securities Exchange Act of 1934, nor is it incorporated by reference into other filings unless expressly stated.