Description
This is one in a series of guidance documents intended to assist you, an applicant, in making postmarket regulatory submissions in electronic format to the Center for Biologics Evaluation and Research (CBER) at FDA. The guidance provides information and recommendations pertaining to the electronic submission of postmarketing safety reports involving vaccine products, including individual case safety reports (ICSRs) and attachments to ICSRs (ICSR attachments),1into the Vaccine Adverse Event Reporting System (VAERS). VAERS is a national vaccine safety surveillance program established in response to the National ChildhoodVaccine Injury Act2 of 1986, which requires health professionals and vaccine manufacturers to report specific adverse events that occur after the administration of routinely recommended vaccines. VAERS is co-sponsored by the Centers for Disease Control and Prevention (CDC) and FDA. The guidance is applicable to vaccine products marketed for human use with approved biologics license applications (BLAs) for which CBER has regulatory responsibility. The guidance does not apply to any other biologic product.
Scope & Applicability
Product Classes
2Preventative or therapeutic vaccines for infectious diseases.
Scope of the guidance for safety reporting
Stakeholders
4Entity submitting development data and knowledge; Entity performing the work process for change
Required to report specific adverse events
Persons or organizations seeking designation of a method of manufacturing; Entity that has developed a technology and submitted an AMT designation request.
FDA intends to contact the individual who submitted the waiver request unless an alternate contact person is provided
Regulatory Context
Attributes
1Required format for all submissions under section 505G(j)
Related CFR Sections (5)
- 21CFR600.80§ 600.80 Postmarketing reporting of adverse experiences.
(a) Definitions. The following definitions of terms apply to this section:Read full regulation →
- 21CFR310.305§ 310.305 Records and reports concerning adverse drug experiences on marketed prescription drugs for human use without approved new drug applications.
(a) Scope. FDA is requiring manufacturers, packers, and distributors of marketed prescription drug products that are not the subject of an approved new drug or abbreviated new drug application to establish and maintain records and make reports to FDA of all serious, unexpected adverse drug experiencRead full regulation →
- 21CFR314.80§ 314.80 Postmarketing reporting of adverse drug experiences.
(a) Definitions. The following definitions of terms apply to this section:Read full regulation →
- 21CFR329.100§ 329.100 Postmarketing reporting of adverse drug events under section 760 of the Federal Food, Drug, and Cosmetic Act.
(a) Reporting requirements. Reports of serious adverse events required by section 760 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) must include the information specified in this section, as applicable. Except as provided in paragraph (c)(2) of this section, these reports must be submitted Read full regulation →
- 21CFR600.90§ 600.90 Waivers.
(a) An applicant may ask the Food and Drug Administration to waive under this section any requirement that applies to the applicant under §§ 600.80 and 600.81 . A waiver request under this section is required to be submitted with supporting documentation. The waiver request is required to contain onRead full regulation →
Related Warning Letters (10)
- 2025-11-25
Compounding Pharmacy/Adulterated Drug Products
Wells Pharma of Houston, LLC
- 2025-05-13
Compounding Pharmacy/Adulterated Drug Products
Tailstorm Health Inc. dba Medivant Health
- 2025-03-25
Compounding Pharmacy/Adulterated Drug Products
Annovex Pharma, Inc.
- 2025-03-04
Compounding Pharmacy/Adulterated Drug Products
ProRx, LLC
- 2024-10-22
Compounding Pharmacy/Adulterated Drug Products
Stokes Healthcare Inc. dba Epicur Pharma
- 2023-08-08
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US Specialty Formulations, LLC
- 2022-01-18
Compounding Pharmacy/Adulterated Drug Products
Apothecary Health Solutions/Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop
- 2021-10-26
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Empower Clinic Services, LLC dba Empower Pharmacy
- 2021-08-31
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- 2021-08-03
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See Also (8)
- Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry (Status: Final)
- Postmarketing Adverse Experience Reporting for Human Drug and Licensed Biological Products: Clarification of What to Report (Status: Final)
- How to Complete the Vaccine Adverse Event Reporting System Form (VAERS-1): Guidance for Industry (Status: Final)
- Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines: Draft Guidance for Industry (Status: Draft)
- Evaluating the Risks of Drug Exposure in Human Pregnancies (Status: Final)
- Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other than Blood and Blood Components (Status: Final)
- Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application (Status: Final)
- Safety Reporting Requirements for INDs (Investigational New Drug Applications) and BA/BE (Bioavailability/Bioequivalence) Studies: Guidance for Industry and Investigators (Status: Final)