What You Need to Know: Late on December 11, 2020, the Food and Drug Administration issued the first emergency use authorization (“EUA”) for a vaccine for the prevention of COVID-19 in individuals 16 years of age and older. Under the EUA, the Pfizer-BioNTech COVID-19 Vaccine can be distributed in the U.S. and shipment has begun this weekend.

The scope of the EUA is limited as follows:

• Pfizer Inc. will supply Pfizer-BioNTech COVID‑19 Vaccine either directly or through authorized distributor(s), who will distribute to emergency response stakeholders as directed by the U.S. government, including the Centers for Disease Control and Prevention (“CDC”) and/or other designee, for use consistent with the terms and conditions of this EUA;

• The Pfizer-BioNTech COVID‑19 Vaccine covered by this authorization will be administered by vaccination providers and used only to prevent COVID-19 in individuals ages 16 and older; and

• Pfizer-BioNTech COVID‑19 Vaccine may be administered by a vaccination provider without an individual prescription.

The manufacture of the authorized Pfizer-BioNTech COVID‑19 Vaccine is limited to those facilities identified and agreed upon in Pfizer’s request for authorization.

Labeling

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

The dosing regimen is two doses of 0.3 mL each, three weeks apart.

Product-specific information is required to be made available to vaccination providers and recipients, as follow:

• Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers): Emergency Use Authorization (EUA) of Pfizer-BioNTech COVID‑19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19)

• Fact Sheet for Recipients and Caregivers: Emergency Use Authorization (EUA) of Pfizer-BioNTech COVID‑19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19) in individuals 16 years of age and older

Conditions Regarding the Authorization

There are numerous conditions that must be met with respect to the EUA. These conditions are intended to ensure control over the vaccine, its administration and follow up for safety as follows:

1. The vaccine must be distributed, as directed by the U.S. government, including CDC and/or other designee, and the product-specific information identified above is required to be made available to vaccination providers, recipients, and caregivers. 

2. Pfizer Inc. and authorized distributor(s) are required to ensure that appropriate storage and cold chain is maintained until delivered to emergency response stakeholders’ receipt sites.

3. The terms of the EUA are required to be made available to all relevant stakeholders and a copy of the EUA authorization letter and subsequent amendments to the EUA and labeling changed are required to be provided to all stakeholders.

4. Pfizer Inc. may develop and disseminate instructional and educational materials (e.g., video regarding vaccine handling, storage/cold-chain management, preparation, disposal) that are consistent with the authorized emergency use of the vaccine without FDA’s review and concurrence, when necessary to meet public health needs during an emergency. 

5. Pfizer Inc. may request changes to this authorization, including to the product specific information for the vaccine, that do not alter the analysis of benefits and risks that underlies the EUA and FDA may determine that such changes may be permitted without amendment of this EUA. 

6. Pfizer Inc. will report to 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 in children and adults; and
   •  Cases of COVID-19 that result in hospitalization or death that are reported to Pfizer Inc. 

   These reports should be submitted to VAERS as soon as possible but no later than 15 calendar days from initial receipt of the information by Pfizer Inc.

7. Pfizer Inc. must submit to Investigational New Drug application (IND) number 19736 periodic safety reports at monthly intervals, within 15 days after the last day of a month.

   Each periodic safety report is required to contain descriptive information which includes: 

   • A narrative summary and analysis of adverse events submitted during the reporting interval, including interval and cumulative counts by age groups, special populations (e.g., pregnant women), and adverse events of special interest.

   • Newly identified safety concerns in the interval; and

   • Actions taken since the last report because of adverse experiences (for example, changes made to Healthcare Providers Administering Vaccine (Vaccination Providers) Fact Sheet, changes made to studies or studies initiated). 

8. No changes will be implemented to the description of the product, manufacturing process, facilities, or equipment without notification to and concurrence by the Agency.

9. All manufacturing facilities will comply with Current Good Manufacturing Practice requirements. 

10. Pfizer Inc. is required to submit to the EUA file Certificates of Analysis (CoA) for each drug product lot at least 48 hours prior to vaccine distribution. The CoA will include the established specifications and specific results for each quality control test performed on the final drug product lot.

11. Pfizer Inc. is required to submit to the EUA file quarterly manufacturing reports that include a listing of all Drug Substance and Drug Product lots produced after issuance of the EUA.

    This report must include lot number, manufacturing site, date of manufacture, and lot disposition, including those lots that were quarantined for investigation or those lots that were rejected. Information on the reasons for lot quarantine or rejection must be included in the report. The first report is due July 2021. 

12. Pfizer Inc. and authorized distributor(s) are required to maintain records regarding release of Pfizer-BioNTech COVID 19 Vaccine for distribution (i.e., lot numbers, quantity, release date).

13. Pfizer Inc. and authorized distributor(s) are required to make available to FDA upon request any records maintained in connection with the EUA. 

14. Pfizer Inc. is required to conduct post-authorization observational study(ies) to evaluate the association its vaccine and a pre-specified list of adverse events of special interest, along with deaths and hospitalizations, and severe COVID-19.

Conditions Related to Printed Matter, Advertising, and Promotion

All descriptive printed matter, advertising, and promotional material, relating to the use of the vaccine is required to be consistent with the product specific labeling.

All descriptive printed matter, advertising, and promotional material relating to the use of the vaccine is required to clearly and conspicuously shall state that:

• The product has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older; and

• The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product unless the declaration is terminated or authorization revoked sooner.

In summary, it is clearly evident that FDA conducted a thorough review and evaluation of the information and data submitted by Pfizer-BioNTech 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.