UNCLASSIFIED// ROUTINE R 161751Z DEC 20 MID600050095828U FM CNO WASHINGTON DC TO NAVADMIN INFO SECNAV WASHINGTON DC CNO WASHINGTON DC BT UNCLAS NAVADMIN 327/20 MSGID/GENADMIN/CNO WASHINGTON DC/CNO/DEC// SUBJ/SARS-COV-2 VACCINATION AND REPORTING POLICY// REF/A/DOC/DHA/DHA-IPM/13DEC2020// REF/B/DOC/DOD/23JUL2019// REF/C/DOC/32 CFR PART 199.21/1DEC2016// REF/D/DOC/FDA/EUA/11DEC2020 REF/E/DOC/CDC/DOC/13DEC2020 REF/F/DOC/OUSD/12DEC2020 REF/G/MSG/OPNAV/042056ZNOV20 NARR/REF A IS THE DEFENSE HEALTH AGENCY INTERIM PROCEDURES MEMORANDUM 20-004 DEPARTMENT OF DEFENSE (DOD) CORONAVIRUS DISEASE 2019 (COVID-19) VACCINATION PROGRAM IMPLEMENTATION PROGRAM. REF B IS THE DODI 6025.02 INDIVIDUAL MEDICAL READINESS ADDRESSING RESPONSIBILITIES AND PROCEDURES FOR MONITORING AND ON INDIVIDUAL MEDICAL READINESS. REF C IS 32 CFR PART 199.21, CIVILIAN HEALTH AND MEDICAL PROGRAM OF THE UNIFORMED SERVICES (CHAMPUS)/TRICARE: TRICARE PHARMACY BENEFITS PROGRAM. REF D IS THE FOOD AND DRUG ADMINISTRATION EMERGENCY USE AUTHORIZATION (EUA). REF E IS THE ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES INTERIM RECOMMENDATION FOR USE OF PFIZER-BIONTECH COVID-19 VACCINE UNITED STATES, DECEMBER 2020. REF F IS THE DEPARTMENT OF DEFENSE CORONAVIRUS-2019 VACCINATION PLAN (DOD COVID-19 VACCINE PLAN). REF G IS THE US NAVY COVID-19 STANDARDIZED OPERATIONAL GUIDANCE VERSION 3.1.// POC/ COVID-19 CRISIS ACTION TEAM /(703)681-1125/ EMAIL: USN.NCR.BUMEDFCHVA.MBX.BUMED-2019-NCOV-RESPONSE-CELL(at)MAIL.MIL. RMKS/1. The SARS-CoV-2 virus and the disease it causes, COVID-19, has disrupted Navy force mission execution and life in the United States. The shortest path to restoring normal operations, and protecting our Navy service members, civilians and dependents is to efficiently vaccinate a large portion of the force. Two SARS-CoV-2 vaccines are anticipated for near term use by the DoD. Additional vaccines may be approved for future use. The SARS-CoV-2 vaccine is a pandemic vaccine and the distribution and administration of it will follow similar protocols established by prior influenza vaccination seasons. DoD guidance was promulgated in reference (a) and Navy guidance follows and is broken into the following paragraphs. 2. Policy Guidance 2.a. Coordination. 2.b. Emergency Use Authorization (EUA). 2.c. Recipient Awareness. 2.d. COVID-19 Mitigations Measures. 2.e. Subsequent Symptoms. 3. Operational Guidance 3.a. Commanders Critical Information Reports (CCIRs). 3.b. Vaccine Planning considerations. 3.c. SARS-CoV-2 Vaccine Priority. 3.d. Adjudication. 3.e. Reserve Forces. 3.f. Navy Civilian Personnel. 3.g. Vaccination on the economy. 4. Medical Guidance 4.a. Partial Sequence Completion. 4.b. Side Effects. 4.c. Co-administration guidance. 4.d. Single Manufacture. 4.e. SARS-CoV-2 Vaccine Ordering and Shipping. 4.f. SARS-CoV-2 Vaccine Integrity. 4.g. SARS-CoV-2 Vaccine Administration. 4.h. Personnel Administering Vaccines. 4.i. Pre-vaccination briefing. 4.j. SARS-CoV-2 Vaccination Compliance. 4.k. Documenting SARS-CoV-2 Vaccination. 4.l. Navy Goals and Performance Standards. 4.m. Duty in a Flight Status. 4.n. Dive Status, Undersea, and Special Operations. 2. Policy Guidance 2.a. Coordination. Military Treatment Facilities (MTFs) will coordinate the execution and administration of the vaccine with their supported local units. MTFs will follow a detailed schema coordinated, updated and maintained by OPNAV. MTFs will contact each supported unit / command to validate crew complement for vaccine ordering, administration, and scheduling. Timing of vaccinations for individual units will be based on the vaccination schema and vaccine supplies. While the MTFs will schedule and execute vaccination, units should also closely track and coordinate vaccination with servicing MTFs, not just the first injection, but also the follow-up injection at 21 or 28 days (depending on the product) based on their schedule and in order to achieve maximum immunity. 2.b. Emergency Use Authorization (EUA). The current vaccines released under Federal Drug Administration (FDA) EUA or Expanded Availability (EA) are expected to receive full licensure in the future. While the SARs-CoV-2 vaccine is released under EUA/EA guidance, vaccination is voluntary for service members. For those members that have questions or concerns about the vaccine, they are encouraged to reach out to their medical providers for questions. 2.c. Recipient Awareness. Administering MTF will make vaccine recipients aware the FDA has authorized emergency use of the vaccine and ensure recipients know potential benefits and risks and the extent such benefits and risks are unknown. Finally, the MTF will inform recipients of available alternatives to the vaccine and of the risks and benefits of the alternatives. Members receiving the vaccine will be required to sign a consent form. 2.d. COVID-19 Mitigation Measures. COVID-19 mitigation measures such as facemasks, physical distancing, frequent hand-washing, and ROM Sequester will remain in place until a sufficient percentage of the Navy/Unit population is immunized and the rate of infection reduced to no longer pose an operational risk to the force. Individuals vaccinated must still follow all the health protection measures implemented for the Navy at-large. 2.e. Subsequent Symptoms. Vaccinated individuals who experience COVID-19 symptoms outside the expected side effects should be tested for COVID-19 and follow return to work guidance per reference (g). 3. Operational Guidance 3.a. The following CCIRs are established specifically for vaccine reporting (other COVID CCIRs remain in effect). Make reports via OPREP-3 NAVY BLUE and address all reports TO CNO WASHINGTON DC, BUMED and operational and administrative chains of command. 3.a.1. Adverse reaction to a dose of the vaccine. Report if an individual has a significant adverse reaction or if a large number of a vaccinated population has minor symptoms and their duration and type are beyond what is anticipated as described in reference (a). Significant adverse events may include, but are not limited to, anaphylaxis or anaphylactic shock or events described in manufacturers package insert as contraindications to additional doses of vaccines. Information will be disseminated as any new medical data is collected and verified by the FDA. 3.a.2. Theft, loss or spoilage of vaccine, even a single vaccine dose. 3.a.3. Vaccinated individual, regardless of the number of doses, subsequently is diagnosed with COVID-19. 3.a.4. Negative media or public interest in the Navys vaccination process brought to the attention of commanders. Transparent communication and leadership is important to maintain confidence in and support for a robust voluntary vaccination program. 3.b. Vaccine Planning considerations 3.b.1. Side effects are expected to be mild, but may be similar to COVID-19 infection as per reference (e). Side effects for a specific vaccine will be explained by the medical provider immediately prior to administering the vaccine. Consider critical watch station manning and mitigation strategies when planning vaccination for operational units due to potential side effects. 3.b.2. Timing. Current SARS-CoV-2 vaccines are two-dose series with each vaccine separated by 21 to 28 days. Commanders must ensure second dose timing is planned and operational commitments support prior to initiating the sequence. 3.c. SARS-CoV-2 Vaccine Priority. The basic DOD schema is: Phase 1a: Healthcare and Emergency Service personnel. Phase 1b.1: Critical national capabilities, Strategic and National mission forces, National leadership. Phase 1b.2: Personnel deploying OCONUS. Phase 1b.3: Other critical and essential support personnel. Note: majority of service members will fall in this category. Phase 2: High-risk beneficiaries, as defined by the CDC. Phase 3: Healthy population beneficiaries. 3.c.1. Phase 1a is expected to be complete early January 2021. Phase 1b.1 is expected to take through February 2021, with phase 1b.2 overlapping with phase 1b.1 in February. These dates may change based on vaccine production. 3.c.2. Navy Component Commander (NCC) Fleet Surgeons and Naval Sea Systems Command (NAVSEA) / Naval Air Systems Command (NAVAIR) Surgeons will support planning by providing OPNAV with unit prioritization matched to the OSD Distribution Schema. OPNAV COVID Cell will maintain and disseminate the prioritized list for NAVMEDLOGCOM distribution and MTF planning purposes. 3.c.3. Navy Component Commanders (NCC) will provide OPNAV COVID Cell with prioritized vaccination plans and desired timing for deploying units (Phase 1b.2). The intent is to vaccinate units deploying within the next three to six months, but this timeline may not fit all pre-deployment operational schedules. 3.c.4. An update to reference (g) will be promulgated providing amplifying guidance for operational units. 3.d. Reserve Forces. Reserve forces being mobilized and in the process of activation are prioritized for vaccination with their unit per current mobilization policy COMNAVRESFORINST 3060.7D. All other reserve forces are Phase 3 priority and will be vaccinated according to the approved Reserve Component (RC) COVID Vaccination Plan. Navy Operational Support Centers (NOSCs)/Navy Reserve Activities (NRAs) will coordinate with the nearest MTF to coordinate vaccinations during a Navy Reserve Unit (NRU) drill weekend where possible. For vaccines that require two doses, second dose planning with the MTF needs to be completed prior to administering the first dose. NOSCs shall inform supported NRU leadership teams of all vaccination plans to ensure Reserve personnel can plan appropriately for vaccination during a drill weekend. Where an MTF is not available, members should receive their vaccination from a civilian or local vaccination program. RC members will provide vaccination documentation received from civilian or local vaccination programs to NOSC medical staff for documentation in Medical Readiness Reporting System. 3.e. Navy Civilian Personnel. SARS-CoV-2 vaccination will be available for all civilian healthcare personnel and Navy civilian employees per reference (a). 3.f. Vaccination on the economy. Reference (c) authorizes retail network pharmacies to administer vaccines. TRICARE beneficiaries may receive SARS- CoV-2 vaccinations with no co-pay at DoD MTFs and authorized retail network pharmacies as per reference (a). Beneficiaries are encouraged to contact the pharmacy regarding vaccine availability. 4. Medical Guidance 4.a. Partial or Full Sequence Completion. Personnel who have received partial or full dosing of a COVID-19 vaccine course and develop symptoms consistent with COVID-19 outside of expected side effects time period should be tested for COVID-19. If they test positive, follow ALNAV 096/20. 4.b. Side Effects. Side effects are expected to be mild, but may be similar to COVID-19 infection. Side effects for a specific vaccine will be explained by the medical provider immediately prior to administering the vaccine. 4.c. Co-administration guidance. Administration of COVID vaccines with other vaccines must be done in accordance with the current Advisory Council on Immunization Practices (ACIP) guidelines: https://www.cdc.gov/vaccines/ hcp/acip-recs/vacc-specific/covid-19.html. 4.d. Single Manufacture. Service members should not be given SARS-CoV-2 vaccines from different manufacturers. If after one dose has been administered and the series cannot be completed with the same manufacturer, service members will consult with their medical provider before restarting the series with a different vaccine. 4.e. SARS-CoV-2 Vaccine Ordering and Shipping. The SARS-CoV-2 vaccine is centrally funded. MTFs will order vaccine for their supported commands. The Vaccine Information and Logistics System (VIALS) will be used to track requisitioned vaccines via Military Standard Requisitioning and Issuing Procedures orders from requisition to receipt. MTFs may track and verify their COVID-19 vaccine status in VIALS at: https://gov_only.nmlc.med.navy.mil/int_code03/vials/. 4.e.1. Commanders will ensure their unit census is reported to their supporting MTF vaccine coordinator. MTF vaccine coordinators will record the unit name, UIC, count of personnel, and MTF that is responsible for providing the vaccine. Commanders with their own embedded medical personnel, who routinely order annual vaccines, will coordinate with the MTF vaccine coordinator and, as indicated, submit the previously described data. Counts will be summarized in VIALs and consolidated in a report through the MTFs to NAVMEDLOGCOM vaccine coordinator as directed by BUMED. Vaccine points of contact can be found at the VIALS helpdesk noted in 4.e. 4.e.2. The Naval Medical Logistics Command (NAVMEDLOGCOM), consistent with reference (a) and upon direction from OPNAV N3N5 and BUMED, will submit MTF orders and oversee distribution of SARS-CoV-2 vaccine for all Navy and Marine Corps activities. Additional quantities required and/or changes in submitted orders will be coordinated with the NAVMEDLOGCOM SARS-CoV-2 Vaccine Manager, DSN: (312) 343-8054 or the Vaccine Information and Logistics System (VIALS) helpdesk at: usn.detrick.navmedlogcomftdmd.list.vialhelp(at)mail.mil. 4.e.3. SARS-CoV-2 Vaccine Shipping. All MTFs will verify their correct shipping address and point of contact information in VIALS to ensure prompt delivery. Shipment locations and the method of shipment is dependent upon the vaccine being shipped. Shipments will arrive to MTFs for administration and, in some cases, distribution to other sites. Future vaccines may be distributed directly to afloat medical units. 4.e.4. Vaccines are expected to be delivered incrementally over a period of several months. 4.e.5. The Pfizer vaccine has significant storage, maintenance, and administration requirements. Only select MTFs are authorized to receive the vaccine. Identified sites will receive the Pfizer vaccine and function as hubs to distribute the vaccine to smaller MTFs. 4.e.6. The other vaccine candidates are expected to be distributed and administered similarly to the annual influenza vaccine. 4.f. SARS-CoV-2 Vaccine Integrity 4.f.1. Temperature Monitors. All SARS-CoV-2 vaccine shipments include temperature monitors. Return temperature monitors to either the Defense Logistics Agency Troop Support Medical (DLA-TSM) cold chain office or the Manufacturers specific vaccine management program after receipt, per the included instructions. 4.f.1.a. If the temperature monitor has not alarmed, the vaccine is ready for immediate use. 4.f.1.b. If the temperature monitor has alarmed in shipment, do not administer those vaccine doses. Segregate in an appropriate vaccine storage refrigerator, label DO NOT USE, immediately return temperature monitor to DLA-TSM or the manufacturer, and await DLAs disposition of the vaccine. 4.f.2. Vaccine Cold Storage 4.f.2.a. The Pfizer vaccine will be primarily stored within ultra-cold freezers (-80C) at designated sites. Vaccine POCs will oversee receipt, storage, access, distribution, and administration of the vaccine. The vaccine may be shipped to external sites per reference (a). 4.f.2.b. Other vaccine candidates which require storage at -20C or 2 to 8C will be shipped and stored in accordance with specific vaccine policy and similarly to the annual influenza vaccine. 4.f.2.c. Vaccine transported from receiving MTF to another MTF storage and administration is called redistribution. Redistribution requires notification of and coordination with U.S. Army Medical Materiel Agency Distribution Operations Center (USAMMA-DOC) per reference (f). Specific cold storage and transportation conditions will be provided by USAMMA DOC if not already included in reference (f). 4.g. SARS-CoV-2 Vaccine Administration 4.g.1. MTFs will use the plans and exercises practiced during previous influenza seasons to administer COVID-19 vaccines. Review the Navy and Marine Corps Public Health Center general standard operating procedures and best practices to safely conduct a mass vaccination event. These documents can be found at: https://esportal.med.navy.mil/sites/ nmcphc/pps/wppc19/COVID-19-Toolbox.aspx. The Seasonal Influenza Resource Center available via Health.mil contains resources that can be used to assist in planning. 4.g.2. Maintain all COVID-19 mitigation measures during administration including but not limited to, wearing masks, social distancing, frequent hand washing, and limiting group size. 4.h. Personnel Administering Vaccines. Only trained and qualified medical personnel, working within their scope of practice, will administer the SARS- CoV-2 vaccine per reference (a). SARS-CoV-2 vaccination staff will complete the CDC and manufacturer educations modules: CDC COVID-19 Vaccine Training: General Overview of Immunization Best Practices for Healthcare Professionals (https://www2.cdc.gov/vaccines/ed/ covid19/SHVA/index.asp) and the online training module provided by each manufacturer for the products that will be administered. 4.i. Pre-vaccination briefing. In addition to informational material provided to Service members on the vaccine, if desired, commands will coordinate with their supporting MTF vaccine coordinator to provide an informational brief (virtual or in-person) by a competent medical authority on the benefits and risks of receiving the vaccine when notified they are eligible to receive the vaccine. Ideally, this briefing would offer the opportunity for Service members to ask questions. 4.j. SARS-CoV-2 Vaccination Compliance. Pending full licensure or Presidential action, the SARS-CoV-2 vaccine will be encouraged. Service members will be offered the vaccine in accordance with the priority scheme by vaccination personnel. Navys goal will be 100 percent contact of personnel, but under the EUA they are not required, and may not be compelled to receive the vaccination. 4.k. Documenting SARS-CoV-2 Vaccination. All SARS-CoV-2 vaccinations, exemptions, or declinations shall be documented in the Medical Readiness Reporting System (MRRS). While under EUA, MRRS will record individuals who received a vaccine, are exempt, or who were offered the vaccine but declined to receive it as having met the vaccination requirement. If the SARS-CoV-2 vaccine is made a readiness requirement, MRRS readiness reporting will be updated. Active and Reserve Component Navy SARS-CoV-2 vaccination administration will be monitored via MRRS. Designated command personnel will access MRRS to track their personnel. Civilian vaccination administration compliance will be monitored and tracked via AHLTA or other electronic tracking. 4.k.1. Shore-based commands or representatives may request access to MRRS based on their unit identification code by submitting a system access authorization request available at: //mrrs.dc3n.navy.mil/mrrs (note: MRRS Web address is case sensitive). Point of contact: MRRS program office and e-mail: mill_mrrs(at)navy.mil (800) 537-4617 / (504) 697-7070/ DSN: (312) 647-7070. Ship-based commands may use Navy Medicine Online (NMO) or Shipboard Non-Tactical Automated Data Processing Automated Medical System (SAMS) to populate MRRS. 4.k.2. MTFs must ensure that documentation of SARS-CoV-2 vaccine administration is coded to accurately reflect the manufacturer of vaccine given. 4.k.3. All personnel who receive the vaccination from a retail network pharmacy must provide documentation of vaccination no later than the next work day (or next drill day for Reserve personnel) to ensure vaccination is recorded in MRRS and the EHR. 4.k.4. MRRS will be the record of unit vaccination status. Senior leader reports of vaccination will be developed using MRRS similar to influenza vaccination reporting. Vaccination status will also be available in ADVANA. 4.k.5. Commands will not report deferral or declination of the vaccine in MRRS until they are given the opportunity to receive the vaccine and the individual has been fully briefed on the benefits and risk of the vaccine. 4.l. Navy Goals and Performance Standards 4.l.1. Vaccines should be given with minimal delay. MTFs should be prepared to begin administration of vaccine within 24 hours of receipt as per reference (f). Active duty operational units have 72 hours (three business days) following receipt of the vaccine to begin to administer and document vaccination. The 72-hour requirement begins immediately only if the temperature monitor has not alarmed upon receipt. If the temperature monitor has alarmed, time requirement begins when the vaccine is cleared for use by DLA-TSM. If the 72-hour requirement cannot be met, unit situation reports (OPREP-3 NAVY UNIT SITREP) will be submitted to OPNAV, copy to BUMED and respective Type and Fleet Commanders and Immediate Superior in Command. Situation reports are not required if the temperature monitor is in alarmed status and the unit is awaiting disposition from DLA-TSM. 4.l.2. Fleet and Echelon Two direct reports to the CNO will coordinate vaccination plans for subordinate units ensuring vaccination is managed to meet operational demands. 4.l.3. While under EUA, commands will ensure that 100 percent of personnel are offered a vaccine when the vaccine is available. Vaccination remains voluntary under an EUA. Commands will be considered complete after all personnel have been recorded in MRRS as either vaccinated or declining the vaccine. 4.l.4. When the vaccine is licensed, the vaccine may be required. If the vaccine becomes required, commands will be considered complete after 90 percent of personnel have been recorded in MRRS as either being vaccinated or having received an exemption for the vaccine. 4.l.5. SARS-CoV-2 Vaccination Performance Standards. The following goals will be monitored: 4.l.5.a. Navy VIALS reports of shipment arrival date. 4.l.5.b. MRRS reports 100 percent of personnel vaccinated or declined vaccination. Commands will coordinate with the servicing MTF to align command-wide vaccinations with Navy vaccination goals. Medical personnel at servicing MTFs will promptly report vaccinations in MRRS. 4.m. Duty in a Flight Status. The NATOPS Manual (CNAF M-3710.7) requires a 12-hour grounding period following immunizations unless otherwise specified in the current Aeromedical Reference and Waiver Guide (https://www.med.navy.mil/sites/nmotc/nami/arwg/Pages/ AeromedicalReferenceandWaiverGuide.aspx). The ARWG now includes nucleic acid vaccines with a 72-hour grounding period after any dose. When established SARS-CoV-2 vaccine platforms with known delivery systems become available, previously established grounding periods in the ARWG will apply. Navy and Marine Corps personnel in a special duty flight status may volunteer for administration of any SARS-CoV-2 vaccine. 4.n. Dive Status, Undersea, and Special Operations. Immediately following SARS-CoV-2 vaccination, do not conduct high-risk activities for 72-hours. To the best extent possible, the vaccination series should be completed a minimum of 2 weeks prior to deployment. Commands may conduct vaccinations in cohorts to avoid reductions in readiness due to potential side-effect impacts on an individuals ability to conduct their duties. 5. Released by VADM P. G. Sawyer, Deputy Chief of Naval Operations for Operations, Plans and Strategy, OPNAV N3/N5.// BT #0001 NNNN UNCLASSIFIED//