November 26, 2022

Volume XII, Number 330


Round Two - FDA Issues Emergency Use Authorization for Moderna’s COVID-19 Vaccine

What You Need to Know: On December 18, 2020, the Food and Drug Administration issued the second emergency use authorization (“EUA”) for a vaccine for the prevention of COVID-19 in individuals 18 years of age and older.  Under the EUA, the Moderna COVID-19 Vaccine can be distributed in the U.S. and shipment has begun and immunizations will begin this week.

FDA’s analysis of the efficacy data from 28,207 participants 18 years of age and older without evidence of SARS-CoV-2 infection prior to dose one confirms the vaccine was 94.1% effective in preventing COVID-19 occurring at least 14 days after the second dose. The most common adverse reactions reported were pain at the injection site, erythema (like reddening of the skin), swelling, enlarged lymph nodes and a higher rate of severe reactions after the second dose.

Moderna has said it plans to continue to monitor all clinical trial participants for two years. The manufacture of the authorized Moderna COVID 19 Vaccine is limited to those facilities identified and agreed upon in the ModernaTX, Inc. request for authorization. 

In order to mitigate the risks of using this unapproved product under EUA and to optimize the potential benefit of the Moderna COVID-19 Vaccine, the following items are required.

The Moderna COVID 19 Vaccine must be accompanied with product specific information to be made available to vaccination providers and recipients:

  • Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers): Emergency Use Authorization (EUA) of the Moderna COVID 19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19)
  • Fact Sheet for Recipients and Caregivers: Emergency Use Authorization (EUA) of the Moderna COVID 19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) in Individuals 18 Years of Age and Older.

Requirements for Use

Use of unapproved Moderna COVID-19 Vaccine for active immunization to prevent COVID-19 under the EUA is limited to the following (all requirements must be met):

  1. The Moderna COVID-19 Vaccine is authorized for use in individuals 18 years of age and older. 
  2. The vaccination provider must communicate to the individual receiving the Moderna COVID-19 Vaccine or their caregiver, information consistent with the “Fact Sheet for Recipients and Caregivers” prior to the individual receiving the Moderna COVID-19 Vaccine.  
  3. The vaccination provider must include vaccination information in the state/local jurisdiction’s Immunization Information System (IIS) or other designated system. 
  4. The vaccination provider is responsible for mandatory reporting of the following to the Vaccine Adverse Event Reporting System (VAERS):
  • vaccine administration errors whether or not associated with an adverse event, 
  • serious adverse events (irrespective of attribution to vaccination),
  • cases of Multisystem Inflammatory Syndrome (MIS) in adults, and 
  • cases of COVID-19 that result in hospitalization or death.

The vaccination provider is responsible for responding to FDA requests for information about vaccine administration errors, adverse events, cases of MIS in adults and cases of COVID-19 that result in hospitalization or death following administration of the Moderna COVID-19 Vaccine to recipients.

Labeling and Storage

The Moderna COVID-19 Vaccine vial label and carton labels are required to be clearly marked for “Emergency Use Authorization.”

The Moderna COVID-19 Vaccine multiple-dose vials must be stored frozen between -25º to -15ºC (-13º to 5ºF) and should be stored in the original carton to protect from light.  Unlike the Pfizer vaccine, the Moderna COVID-19 Vaccine should not be stored on dry ice or below -40ºC (-40ºF). 

Vials can be stored refrigerated between 2° to 8°C (36° to 46°F) for up to 30 days prior to first use. Unpunctured vials may be stored between 8° to 25°C (46° to 77°F) for up to 12 hours. Do not refreeze once thawed.

The Moderna COVID-19 Vaccine is administered intramuscularly as a series of two (0.5 mL each) one month apart. 

There is no data available on the interchangeability of the Moderna COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of the Moderna COVID-19 Vaccine should receive a second dose of the Moderna COVID19 Vaccine to complete the vaccination series.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Moderna COVID-19 Vaccine during pregnancy. Women who are vaccinated with Moderna COVID-19 Vaccine during pregnancy are encouraged to enroll in the registry by calling 1-866- MODERNA (1-866-663-3762).

In summary, once again, it is clearly evident that FDA conducted a thorough review and evaluation of the information and data submitted by Moderna regarding the COVID 19 Vaccine.  It is also clear that there are a number of requirements that must be met to ensure that the vaccine is properly controlled, distributed, stored and administered to the public.  Most importantly, there are extensive post marketing pharmacovigilance requirements necessary to monitor the safety profile of the product.  We will be reporting on other vaccines as they may be available in the future under EUA.

© 2022 Foley & Lardner LLPNational Law Review, Volume X, Number 356

About this Author

David L. Rosen, Foley Lardner, FDA Regulatory Lawyer, Life Science Industry Attorney,

David Rosen is a partner and public policy lawyer with Foley & Lardner LLP. Mr. Rosen has extensive experience in health law, life sciences, and food and drug regulation, including a range of Food and Drug Administration (FDA) regulatory issues affecting prescription and over-the-counter pharmaceuticals, medical devices and biologics. He is co-chair of the firm’s Life Sciences Industry Team and is also a member of the firm’s Government & Public Policy Practice and the Health Care and Food & Beverage Industry Teams.

Mr. Rosen was...

Nathan A. Beaver, Foley Lardner, FDA Enforcement Lawyer, Regulatory Attorney,

Nathan A. Beaver is a partner and food and drug lawyer with Foley & Lardner LLP, where his practice focuses on the representation of manufacturers whose products and activities are regulated by the Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and the Federal Trade Commission (FTC). He advises clients on regulatory issues affecting prescription and over-the-counter drug products (including animal drugs), medical devices, dietary supplements, cosmetics, and foods with special emphasis on the strategic considerations involving the approval...

Paul Joseph Government Solutions Lawyer Foley Lardner Law Firm
Of Counsel

Paul Joseph is of counsel in Foley & Lardner LLP’s Washington, D.C. office and a member of firm’s Government Solutions Practice. Joseph previously was an associate chief counsel for enforcement at the U.S. Food and Drug Administration (FDA). During his time at the FDA, Paul worked closely with the Office of Criminal Investigations at the U.S. Department of Justice (DOJ), and other government agencies to investigate and prosecute violations of the Federal Food, Drug, and Cosmetic Act. He was also involved in numerous health care fraud matters and False Claims Act investigations...

Kyle Faget, Foley Lardner, Government policy lawyer

Kyle Faget is a Partner and business lawyer with Foley & Lardner LLP. She is a member of the firm’s Government & Public Policy Practice and the Health Care and Life Sciences Industry Teams. Her practice focuses on advising clients on regulatory and compliance matters involving the Food, Drug & Cosmetic Act, the False Claims Act, the Anti-Kickback Statute, the AdvaMed Code, and the PhRMA Code. She also regularly drafts and negotiates agreements required for the development and commercialization of pharmaceutical and medical device products. Prior to joining...