Moderna: Letter of Authorization from
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Exhibit 8 Moderna: Letter of Authorization from Denise M. Hinton, Chief Scientist, FDA, to ModernaTX, Inc. (Feb. 25, 2021) FILED 2021 Sep-16 AM 11:09 U.S. DISTRICT COURT N.D. OF ALABAMA Case 2:21-cv-00702-CLM Document 24-8 Filed 09/16/21 Page 1 of 10 February 25, 2021 ModernaTX, Inc. Attention: Ms. Carlota Vinals 200 Technology Square Cambridge, MA 02139 Dear Ms. Vinals: On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Act, the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes Coronavirus Disease 2019 (COVID-19).1 On the basis of such determination, the Secretary of HHS on March 27, 2020, declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to Section 564 of the Act (the FD&C Act or the Act) (21 U.S.C. 360bbb-3), subject to terms of any authorization issued under that section.2 On December 18, 2020, FDA issued an Emergency Use Authorization (EUA) for emergency use of Moderna COVID‑19 Vaccine for the prevention of COVID-19 for individuals 18 years of age and older, as described in the Scope of Authorization (Section II) of this letter, pursuant to Section 564 of the Act. On February 25, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the December 18, 2020, letter in its entirety with revisions incorporated to allow flexibility on the date of submission of monthly periodic safety reports and to revise the requirements for reporting of vaccine administration errors by ModernaTX, Inc. Moderna COVID‑19 Vaccine is for use for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older. The vaccine contains a nucleoside-modified messenger RNA encoding the viral spike (S) glycoprotein of SARS-CoV-2 formulated in lipid particles. It is an investigational vaccine not licensed for any indication. 1 U.S. Department of Health and Human Services, Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3. February 4, 2020. 2 U.S. Department of Health and Human Services, Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3, 85 FR 18250 (April 1, 2020). Case 2:21-cv-00702-CLM Document 24-8 Filed 09/16/21 Page 2 of 10 Page 2 – ModernaTX, Inc. FDA reviewed safety and efficacy data from an ongoing phase 3 trial in approximately 30,000 participants randomized 1:1 to receive Moderna COVID‑19 Vaccine or saline control. The trial has enrolled participants 18 years of age and older. FDA’s review of the available safety data from 30,351 participants 18 years of age and older, who were followed for a median of 7 weeks after receiving the second dose, did not identify specific safety concerns that would preclude issuance of an EUA. Review of additional safety data from these participants with a median of 9 weeks of follow-up after receipt of the second dose did not change FDA’s assessment of safety of the vaccine. 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 1 confirms the vaccine was 94.1% effective (95% confidence interval (CI) 89.3, 96.8) in preventing COVID-19 occurring at least 14 days after the second dose (with 11 COVID-19 cases in the vaccine group compared to 185 COVID- 19 cases in the placebo group). In this final scheduled analysis participants had been followed for a median of 9 weeks following the second dose. This result is consistent with that obtained from an interim analysis of efficacy conducted after these participants had been followed for a median of 7 weeks after the second dose (vaccine efficacy 94.5%, 95% CI: 86.5, 97.8). Based on the safety and effectiveness data, and review of manufacturing information regarding product quality and consistency, it is reasonable to believe that Moderna COVID‑19 Vaccine may be effective. Additionally, it is reasonable to conclude, based on the totality of the scientific evidence available, that the known and potential benefits of Moderna COVID‑19 Vaccine outweigh the known and potential risks of the vaccine, for the prevention of COVID-19 in individuals 18 years of age and older. Finally, on December 17, 2020, the Vaccines and Related Biological Products Advisory Committee voted in agreement with this conclusion. Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of Moderna COVID-19 Vaccine for the prevention of COVID-19, as described in the Scope of Authorization section of this letter (Section II) and subject to the terms of this authorization. I. Criteria for Issuance of Authorization I have concluded that the emergency use of Moderna COVID‑19 Vaccine for the prevention of COVID-19 when administered as described in the Scope of Authorization (Section II) meets the criteria for issuance of an authorization under Section 564(c) of the Act, because: 1. SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus; 2. Based on the totality of scientific evidence available to FDA, it is reasonable to believe that Moderna COVID‑19 Vaccine may be effective in preventing COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of Moderna COVID‑19 Vaccine when used to prevent COVID-19 outweigh its known and potential risks; and Case 2:21-cv-00702-CLM Document 24-8 Filed 09/16/21 Page 3 of 10 Page 3 – ModernaTX, Inc. 3. There is no adequate, approved, and available alternative to the emergency use of Moderna COVID-19 Vaccine to prevent COVID-19.3 II. Scope of Authorization I have concluded, pursuant to Section 564(d)(1) of the Act, that the scope of this authorization is limited as follows: • ModernaTX, Inc. will supply Moderna COVID‑19 Vaccine either directly or through authorized distributor(s)4 to emergency response stakeholders5 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 Moderna COVID‑19 Vaccine covered by this authorization will be administered by vaccination providers6 and used only to prevent COVID-19 in individuals ages 18 and older; and • The Moderna COVID‑19 Vaccine may be administered by a vaccination provider without an individual prescription for each vaccine recipient. 3 No other criteria of issuance have been prescribed by regulation under Section 564(c)(4) of the Act. 4 “Authorized Distributor(s)” are identified by ModernaTX, Inc. or, if applicable, by a U.S. government entity, such as the Centers for Disease Control and Prevention (CDC) and/or other designee, as an entity or entities allowed to distribute authorized Moderna COVID‑19 Vaccine. 5 For purposes of this letter, “emergency response stakeholder” refers to a public health agency and its delegates that have legal responsibility and authority for responding to an incident, based on political or geographical boundary lines (e.g., city, county, tribal, territorial, State, or Federal), or functional (e.g., law enforcement or public health range) or sphere of authority to administer, deliver, or distribute vaccine in an emergency situation. In some cases (e.g., depending on a state or local jurisdiction’s COVID-19 vaccination response organization and plans), there might be overlapping roles and responsibilities among “emergency response stakeholders” and “vaccination providers” (e.g., if a local health department is administering COVID-19 vaccines; if a pharmacy is acting in an official capacity under the authority of the state health department to administer COVID-19 vaccines). In such cases, it is expected that the conditions of authorization that apply to emergency response stakeholders and vaccination providers will all be met. 6 For purposes of this letter, “vaccination provider” refers to the facility, organization, or healthcare provider licensed or otherwise authorized by the emergency response stakeholder (e.g., non-physician healthcare professionals, such as nurses and pharmacists pursuant to state law under a standing order issued by the state health officer) to administer or provide vaccination services in accordance with the applicable emergency response stakeholder’s official COVID-19 vaccination and emergency response plan(s) and who is enrolled in the CDC COVID-19 Vaccination Program. For purposes of this letter, “healthcare provider” also refers to a person authorized by the U.S. Department of Health and Human Services (e.g., under the PREP Act Declaration for Medical Countermeasures against COVID-19) to administer FDA-authorized COVID-19 vaccine (e.g., qualified pharmacy technicians and State-authorized pharmacy interns acting under the supervision of a qualified pharmacist). See, e.g., HHS. Fourth Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 and Republication of the Declaration. 85 FR 79190 (December 9, 2020). Case 2:21-cv-00702-CLM Document 24-8 Filed 09/16/21 Page 4 of 10 Page 4 – ModernaTX, Inc. Product Description The Moderna COVID-19 Vaccine is supplied as a frozen suspension in multiple dose vials.. The Moderna COVID-19 Vaccine does not contain a preservative. Each 0.5 mL dose of the Moderna COVID-19 Vaccine contains 100 mcg of a nucleoside- modified messenger RNA encoding the viral spike (S) glycoprotein of SARS-CoV-2. Each dose of the Moderna COVID-19 Vaccine also includes the following ingredients: lipids (SM-102; 1,2- dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000 [PEG2000-DMG]; cholesterol; and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate, and sucrose. The dosing regimen is two doses of 0.5 mL each, one month apart. 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. The Moderna COVID-19 Vaccine vial label and carton labels are clearly marked for “Emergency Use Authorization.” The Moderna COVID‑19 Vaccine is authorized to be distributed, stored, further redistributed, and administered by emergency response stakeholders when packaged in the authorized manufacturer packaging (i.e., vials and cartons), despite the fact that the vial and carton labels may not contain information that otherwise would be required under the FD&C Act. The Moderna COVID‑19 Vaccine is authorized for emergency use with the following product- specific information required to be made available to vaccination providers and recipients, respectively (referred to as “authorized labeling”): • 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 I have concluded, pursuant to Section 564(d)(2) of the Act, that it is reasonable to believe that the known and potential benefits of Moderna COVID‑19 Vaccine, when used to prevent COVID-19 and used in accordance with this Scope of Authorization (Section II), outweigh its known and potential risks. I have concluded, pursuant to Section 564(d)(3) of the Act, based on the totality of scientific evidence available to FDA, that it is reasonable to believe that Moderna COVID‑19 Vaccine may be effective in preventing COVID-19 when used in accordance with this Scope of Authorization (Section II), pursuant to Section 564(c)(2)(A) of the Act. Case 2:21-cv-00702-CLM Document 24-8 Filed 09/16/21 Page 5 of 10 Page 5 – ModernaTX, Inc. Having reviewed the scientific information available to FDA, including the information supporting the conclusions described in Section I above, I have concluded that Moderna COVID‑19 Vaccine (as described in this Scope of Authorization (Section II)) meets the criteria set forth in Section 564(c) of the Act concerning safety and potential effectiveness. The emergency use of Moderna COVID‑19 Vaccine under this EUA must be consistent with, and may not exceed, the terms of the Authorization, including the Scope of Authorization (Section II) and the Conditions of Authorization (Section III). Subject to the terms of this EUA and under the circumstances set forth in the Secretary of HHS's determination under Section 564(b)(1)(C) described above and the Secretary of HHS’s corresponding declaration under Section 564(b)(1), Moderna COVID‑19 Vaccine is authorized to prevent COVID-19 in individuals 18 years of age and older as described in the Scope of Authorization (Section II) under this EUA, despite the fact that it does not meet certain requirements otherwise required by applicable federal law. III. Conditions of Authorization Pursuant to Section 564 of the Act, I am establishing the following conditions on this authorization: ModernaTX, Inc. and Authorized Distributor(s) A. ModernaTX, Inc. and authorized distributor(s) will ensure that the authorized Moderna COVID‑19 Vaccine is distributed, as directed by the U.S. government, including CDC and/or other designee, and the authorized labeling (i.e., Fact Sheets) will be made available to vaccination providers, recipients, and caregivers consistent with the terms of this letter. B. ModernaTX, Inc. and authorized distributor(s) will ensure that appropriate storage and cold chain is maintained until delivered to emergency response stakeholders’ receipt sites. C. ModernaTX, Inc. will ensure that the terms of this EUA are made available to all relevant stakeholders (e.g., emergency response stakeholders, authorized distributors, and vaccination providers) involved in distributing or receiving authorized Moderna COVID‑19 Vaccine. ModernaTX, Inc. will provide to all relevant stakeholders a copy of this letter of authorization and communicate any subsequent amendments that might be made to this letter of authorization and its authorized labeling. D. ModernaTX, 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 as described in the letter of authorization and authorized labeling, without FDA’s review and concurrence, when necessary to meet public health needs during an emergency. Any instructional and educational materials that are inconsistent with the authorized labeling are prohibited. Case 2:21-cv-00702-CLM Document 24-8 Filed 09/16/21 Page 6 of 10 Page 6 – ModernaTX, Inc. E. ModernaTX, Inc. may request changes to this authorization, including to the authorized Fact Sheets for Moderna COVID‑19 Vaccine. Any request for changes to this EUA must be submitted to Office of Vaccines Research and Review (OVRR)/Center for Biologics Evaluation and Research (CBER). Such changes require appropriate authorization prior to implementation7. F. ModernaTX, Inc. will report to Vaccine Adverse Event Reporting System (VAERS): • Serious adverse events (irrespective of attribution to vaccination); • Cases of Multisystem Inflammatory Syndrome in adults; and • Cases of COVID-19 that result in hospitalization or death, that are reported to ModernaTX, 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 ModernaTX, Inc. G. ModernaTX, Inc. must submit to Investigational New Drug application (IND) number 19745 periodic safety reports at monthly intervals, in accordance with a due date agreed upon with the Office of Biostatistics and Epidemiology (OBE), beginning after the first full calendar month after authorization. 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; • A narrative summary and analysis of vaccine administration errors, whether or not associated with an adverse event, that were identified since the last reporting interval; • 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). H. No changes will be implemented to the description of the product, manufacturing process, facilities, or equipment without notification to and concurrence by the Agency. I. All manufacturing facilities will comply with Current Good Manufacturing Practice requirements. 7 The following types of revisions may be authorized without reissuing this letter: (1) changes to the authorized labeling; (2) non-substantive editorial corrections to this letter; (3) new types of authorized labeling, including new fact sheets; (4) new carton/container labels; (5) expiration dating extensions; (6) changes to manufacturing processes, including tests or other authorized components of manufacturing; (7) new conditions of authorization to require data collection or study. For changes to the authorization, including the authorized labeling, of the type listed in (3), (6), or (7), review and concurrence is required from the Preparedness and Response Team (PREP)/Office of the Center Director (OD)/CBER and the Office of Counterterrorism and Emerging Threats (OCET)/Office of the Chief Scientist (OCS). Case 2:21-cv-00702-CLM Document 24-8 Filed 09/16/21 Page 7 of 10 Page 7 – ModernaTX, Inc. J. ModernaTX, Inc. will 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. K. ModernaTX, Inc. will submit to the EUA file quarterly manufacturing reports that include a listing of all Drug Substance and Drug Product lots produced after issuance of this authorization. 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. L. ModernaTX, Inc. and authorized distributor(s) will maintain records regarding release of Moderna COVID‑19 Vaccine for distribution (i.e., lot numbers, quantity, release date). M. ModernaTX, Inc. and authorized distributor(s) will make available to FDA upon request any records maintained in connection with this EUA. N. ModernaTX, Inc. will conduct post-authorization observational studies to evaluate the association between Moderna COVID-19 Vaccine and a pre-specified list of adverse events of special interest, along with deaths and hospitalizations, and severe COVID-19. The study population should include individuals administered the authorized Moderna COVID-19 Vaccine under this EUA in the general U.S. population (18 years of age and older), populations of interest such as healthcare workers, pregnant women, immunocompromised individuals, subpopulations with specific comorbidities. The studies should be conducted in large scale databases with an active comparator. ModernaTX, Inc. will provide protocols and status update reports to the IND 19745 with agreed-upon study designs and milestone dates. O. ModernaTX, Inc., working with its contract research organization, will continue to monitor the performance of its clinical investigators in ongoing clinical studies of its vaccine and will report to FDA promptly any significant deviations from the protocols. Emergency Response Stakeholders P. Emergency response stakeholders will identify vaccination sites to receive authorized Moderna COVID‑19 Vaccine and ensure its distribution and administration, consistent with the terms of this letter and CDC’s COVID-19 Vaccination Program. Q. Emergency response stakeholders will ensure that vaccination providers within their jurisdictions are aware of this letter of authorization, and the terms herein and any subsequent amendments that might be made to the letter of authorization, instruct them about the means through which they are to obtain and administer the vaccine Case 2:21-cv-00702-CLM Document 24-8 Filed 09/16/21 Page 8 of 10 Page 8 – ModernaTX, Inc. under the EUA, and ensure that the authorized labeling [i.e., Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Fact Sheet for Recipients and Caregivers] is made available to vaccination providers through appropriate means (e.g., e-mail, website). R. Emergency response stakeholders receiving authorized Moderna COVID‑19 Vaccine will ensure that appropriate storage and cold chain is maintained. Vaccination Providers S. Vaccination providers will administer the vaccine in accordance with the authorization and will participate and comply with the terms and training required by CDC’s COVID-19 Vaccination Program. T. Vaccination providers will provide the Fact Sheet for Recipients and Caregivers to each individual receiving vaccination and provide the necessary information for receiving their second dose. U. Vaccination providers administering Moderna COVID‑19 Vaccine must report the following information associated with the administration of Moderna COVID‑19 Vaccine of which they become aware to VAERS in accordance with the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers): • 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 adults • Cases of COVID-19 that result in hospitalization or death Complete and submit reports to VAERS online at https://vaers.hhs.gov/reportevent.html. The VAERS reports should include the words “ Moderna COVID‑19 Vaccine EUA” in the description section of the report. More information is available at vaers.hhs.gov or by calling 1-800-822- 7967. To the extent feasible, report to ModernaTX, Inc., by contacting 1-866-663- 3762, by providing a copy of the VAERS form to ModernaTX, Inc., Fax: 1-866- 599-1342 or by email; ModernaPV@modernatx.com. V. Vaccination providers will conduct any follow-up requested by the U.S government, including CDC, FDA, or other designee, regarding adverse events to the extent feasible given the emergency circumstances. W. Vaccination providers will monitor and comply with CDC and/or emergency response stakeholder vaccine management requirements (e.g., requirements concerning obtaining, tracking, and handling vaccine) and with requirements concerning reporting of vaccine administration data to CDC. X. Vaccination providers will ensure that any records associated with this EUA are Case 2:21-cv-00702-CLM Document 24-8 Filed 09/16/21 Page 9 of 10 Page 9 – ModernaTX, Inc. maintained until notified by FDA. Such records will be made available to CDC and FDA for inspection upon request. Conditions Related to Printed Matter, Advertising, and Promotion Y. All descriptive printed matter, advertising, and promotional material relating to the use of the Moderna COVID‑19 Vaccine shall be consistent with the authorized labeling, as well as the terms set forth in this EUA, and meet the requirements set forth in section 502(a) and (n) of the FD&C Act and FDA implementing regulations. Z. All descriptive printed matter, advertising, and promotional material relating to the use of the Moderna COVID‑19 Vaccine clearly and conspicuously shall state that: • This 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 18 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 under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. IV. Duration of Authorization This EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act. Sincerely, ____________________________ RADM Denise M. Hinton Chief Scientist Food and Drug Administration Enclosures Case 2:21-cv-00702-CLM Document 24-8 Filed 09/16/21 Page 10 of 10
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