Coronavirus (COVID-19) | CBER-Regulated Biologics
CBER’s Document Control Center (DCC) will process paper and electronic media (CD/DVD, USB drive, etc.) submissions sent via U.S. mail or courier effective immediately. Submissions may be sent through the Electronic Submission Gateway or in some case by e-mail. Please see the Letter to CBER Sponsors, Applicants and Regulated Entities.
The mission of the FDA’s Center for Biologics Evaluation and Research (CBER) is to protect and promote the public health, in part by ensuring the safety and efficacy of the products we regulate. This includes biological products such as prophylactic and therapeutic vaccines, whole blood and blood products, cellular products and exosomal preparations, gene therapies, tissue products and live biotherapeutic agents. CBER also regulates selected drugs and devices used in the testing and/or manufacture of our biological products. In keeping with that mission CBER uses every tool available to help patients access promising biological products while facilitating research to evaluate their safety and efficacy as well as manufacturing efforts.
CBER is working on multiple fronts to address the COVID-19 pandemic such as:
- Expediting clinical trials for preventive vaccines and other therapeutic biological products that hold promise to prevent or treat COVID-19 by providing timely advice and interactions
- Supporting product development and scaling up of manufacturing capacity for high priority products for COVID-19
- Helping to ensure an adequate blood supply in light of reduced blood donations due to social distancing and the cancellation of blood drives
- Providing information to healthcare providers and researchers to help them submit emergency IND requests to use investigational products for patients with COVID-19
If you are developing or interested in developing a CBER-regulated product to treat or prevent COVID-19, including a vaccine, cellular product, or blood-derived product, this page and the associated links provide information on guidance and advice relevant to the development of therapies to treat or prevent COVID-19, and contact information for developers seeking additional information or assistance.
CBER is making every effort to review all regulatory submissions (e.g., requests for pre-investigational new drug application (IND) meetings, INDs, and emergency use authorizations (EUAs)) for COVID-19 related treatments as quickly as possible. In order to facilitate this rapid review, please ensure that regulatory submissions contain all of the information necessary to perform a complete review and are submitted in accordance with all regulatory requirements.
Agency review staff are prioritizing review of regulatory submissions based on a variety of factors including completeness of the submission, scientific merit, and stage of development. Although CBER is taking an all hands on deck approach to process and review regulatory submissions with the urgency warranted by this pandemic, due to the large volume of submissions and inquiries, once your product has been assigned to CBER, it may take up to one week for the appropriate review office to notify you that your submission has been received and, if applicable, rapid review has commenced.
This webpage provides additional resources to help you determine the next best steps for engaging with CBER, including what regulatory submission is appropriate, what to include in that submission, and how to submit it.
If you are not a product developer and are looking for general information on FDA and coronavirus response efforts, you can review materials provided on FDA’s COVID-19 website. FDA has also published resources for patients about COVID-19, including Questions and Answers for Patients About Clinical Trials.
Pfizer-BioNTech COVID-19 Vaccines
Pfizer-BioNTech COVID-19 Vaccine decision memos and regulatory documents
Moderna COVID-19 Vaccines
Moderna COVID-19 Vaccine decision memos and regulatory documents
Janssen COVID-19 Vaccines
Janssen COVID-19 Vaccine decision memos and regulatory documents
Novavax COVID-19 Vaccine, Adjuvanted
Novavax COVID-19 Vaccine, Adjuvanted decision memos and regulatory documents
April 18, 2023
On April 18, 2023, the Food and Drug Administration amended the emergency use authorizations (EUAs) for the Pfizer-BioNTech and Moderna COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. This action includes authorizing the current bivalent vaccines (Original and Omicron BA.4/BA.5 strains) to be used for all doses administered to individuals 6 months of age and older, including an additional dose or doses for certain populations.
The monovalent versions of the mRNA vaccines and associated Fact Sheets are no longer authorized for use in the United States with this action. The vaccines remain authorized for export under certain conditions. Please refer to the Letter of Authorization for each vaccine.
The following Fact Sheets for Healthcare Providers Administering Vaccine (Vaccination Providers) and Vaccine Information Fact Sheets for Recipients and Caregivers for the monovalent mRNA vaccines have been archived but remain available for each vaccine for export in accordance with the applicable Letter of Authorization:
Moderna COVID-19 Vaccine
Archived Fact Sheets for Healthcare Providers, Recipients and Caregivers, including translations
Pfizer-BioNTech COVID-19 Vaccine
Archived Fact Sheets for Healthcare Providers, Recipients and Caregivers, including translations
If you are developing a CBER-regulated product and have questions, CBER’s Division of Manufacturers Assistance and Training in the Office of Communication, Outreach and Development (Industry.Biologics@fda.hhs.gov, 240-402-8010, or 800-835-4709) can provide additional information or answers to questions that can help you prepare your submission and ensure that it contains the necessary information to facilitate review.
If you are uncertain about CBER center or office assignment for your product, please contact: CBERProductJurisdiction@fda.hhs.gov
CBER-regulated therapeutic products fall within FDA’s Coronavirus Treatment Acceleration Program (CTAP). Please note that for products under CBER’s jurisdiction, submission to the CTAP mailbox helps to facilitate identification and assignment to the appropriate review office within our Center so that your inquiry gets to the right subject matter experts quickly. Although we are working diligently to expedite the development of multiple promising vaccine candidates to the greatest extent possible, preventive vaccines are not included within CTAP and submissions or inquiries regarding preventive vaccines should not be submitted to the CTAP mailbox.
As a general matter, if your product is already assigned to CBER for another intended use or you have been in contact with CBER staff regarding your CBER-regulated product, please do not submit any additional inquiries or materials to the CTAP mailbox. Such submissions are not necessary and may result in unnecessary delays in processing your information. Once a product has been assigned to a CBER office, all future communications regarding that product should be directed to the responsible review office point of contact, or, once your review team is established, to your assigned regulatory project manager.
Do not submit regulatory documents (e.g., pre-INDs, INDs, emergency IND, or EUAs) for CBER-regulated products to the CTAP Mailbox. Instructions for these submissions are provided below.
In particular, in the case of emergency single patient INDs (eINDs) for all CBER-regulated products other than convalescent plasma, please call 240-402-8010 or 800-835-4709 or email firstname.lastname@example.org. After working hours, call FDA's Office of Emergency Operations at 1-866-300-4374 or 301-796-8240. For information on the process for submitting eINDs for convalescent plasma, please see Recommendations for Investigational COVID-19 Convalescent Plasma. Failure to follow these processes may delay review of your eIND and possibly delay access for your patient.
For unapproved products, please note that your product may not be distributed for clinical use in humans until there is an IND in effect.
One investigational treatment being explored for COVID-19 is the use of convalescent plasma collected from individuals who have recovered from COVID-19. On August 23, 2020 FDA issued an Emergency Use Authorization (EUA) for COVID-19 Convalescent Plasma. In addition, the Recommendations for Investigational COVID-19 Convalescent Plasma page provides information on the pathways available outside of the EUA for administering or studying the use of COVID-19 convalescent plasma. It is critical to continue to enroll and complete randomized clinical trials to fully answer the questions about the effectiveness of convalescent plasma.
Please note that FDA does not collect COVID-19 convalescent plasma or provide COVID-19 convalescent plasma. Health care providers or acute care facilities should obtain COVID-19 convalescent plasma from an FDA-registered blood establishment.
Individuals who have fully recovered from COVID-19 may be able to help patients currently fighting the infection by donating your plasma.
Emergency Use Authorization
Under an Emergency Use Authorization, FDA may permit the use of unapproved medical products or unapproved uses of approved medical products in certain emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives. We encourage applicants to submit any questions to CBEREUA@fda.hhs.gov.
COVID-19 Convalescent Plasma
On August 23, 2020 FDA issued an Emergency Use Authorization (EUA) for COVID-19 Convalescent Plasma. A summary of updated evidence to support the emergency use of COVID-19 Convalescent Plasma is available here.
In October 2020, FDA issued guidance on Emergency Use Authorizations for Vaccines to Prevent COVID-19 with recommendations for vaccine sponsors regarding the scientific data and information that would support the issuance of an emergency use authorization (EUA) for an investigational vaccine intended to prevent COVID-19. In addition to outlining our expectations for vaccine sponsors, we also hope the agency’s guidance on COVID-19 vaccines helps the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy for any vaccine that is authorized or approved.
In addition, on October 22, 2020, FDA’s Vaccine and Related Biological Products Advisory Committee met in open session, to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19. No specific application was discussed at this meeting. FDA intends to convene an open session of the VRBPAC upon submission of an EUA for a COVID-19 vaccine in order to publicly discuss the safety and efficacy of the particular vaccine.
We believe that transparency about CBER’s review of the scientific information supporting our recommendations to issue EUAs for COVID-19 therapeutics and vaccines promotes public confidence in FDA’s scientific review process and ultimately in using the authorized products appropriately.
Therefore, our goal is to be as transparent as possible about the scientific basis for recommending that a biological product be authorized for emergency use under section 564 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 360bbb-3) or be revised or revoked. In addition to convening FDA’s VRBPAC regarding COVID-19 vaccines:
- When a CBER-regulated product is authorized for emergency use, we intend to the extent appropriate and permitted by law to make public the Center’s review of the scientific data and information supporting our recommendation to issue the EUA
- When an EUA is revised, we also intend to make public the Center’s review of the scientific data and information supporting our recommendations to revise the EUA
Our goal is to disclose information from our EUA review documents as appropriate and consistent with our longstanding practice of posting scientific reviews after product approvals. We may redact certain information that is exempt from disclosure under the Freedom of Information Act (FOIA), 5 U.S.C. sec. 552, such as trade secrets or other information identified by the EUA requestors that is exempt under FOIA. The redacted information may vary depending on the type of data contained in the reviews and whether the requestor consents to release of information that is exempt under FOIA.
There have been tremendous efforts made in the development of vaccines for COVID-19 since the beginning of the public health emergency. As with all vaccines and other medical products, although the vaccine development process and FDA’s evaluation are rigorous and comprehensive, after a vaccine for COVID-19 is authorized under EUA by FDA, or following licensure (approval) of a BLA, additional pharmacovigilance will be conducted to monitor COVID-19 vaccine safety and effectiveness. Planning for this begins prior to authorization or licensure.
FDA and CDC recognize the need for significant effort in the pharmacovigilance area. Plans for pharmacovigilance include coordination with other Federal Partners. Many other state, or local government and other entities have a part to play in this effort domestically, as do other international groups.
CBER has posted an overview of the systems in use to monitor the safety of COVID-19 vaccines.
CBER is coordinating the response to COVID-19 vaccine pharmacovigilance inquiries from these stakeholders, across stakeholders, which will help to facilitate consistent and coordinated approaches. If you are an entity engaged in the evaluation of safety or effectiveness related to COVID-19 vaccines and have questions about pharmacovigilance, please contact us at: Covid19VaccinePV@fda.hhs.gov.
CBER’s webpage has information about the regulatory framework for products regulated by CBER, including the Center’s policies, procedures, and review resources that may be helpful in answering questions you have about developing a CBER-regulated product.
CBER has provided information for sponsors, applicants and regulated entities on steps the Center has taken to prioritize work that advances the nation’s response to the COVID-19 pandemic. These steps seek to address the impact of the public health emergency on day-to-day operations in CBER and industry, while ensuring that government and private sector response efforts receive the highest priority.
Important information provided to sponsors includes:
- Processing of Incoming Documents
- Conduct of Clinical Trials involving Medical Products
- Postmarket and Compliance Activities
Details about each of these topics and more can be found in the letter posted on CBER’s website.
COVID-19 Related Guidance Documents
FDA has issued several guidance documents related to COVID-19, including several that are immediately in effect. For the latest information, please see the FDA’s COVID-19 Related Guidance Documents web page.
Additional FDA Resources
All FDA Centers are working together to help bring new products for COVID-19 to the American people. Sponsors who want to develop drugs, medical devices or diagnostics related to COVID-19 can visit the following web pages:
- COVID-19 Resources for Healthcare Professionals
- Center for Drug Evaluation and Research: Coronavirus (COVID-19) | Drugs
- Center for Devices and Radiological Health: Coronavirus (COVID-19) and Medical Devices
- FDA’s Coronavirus Disease 2019 (COVID-19) web page
- DSCSA Exemptions from Certain Requirements Under Section 582 of the FD&C Act for Covered COVID-19 Products