Ramona Whittington From: Roxana Cruz Sent: Tuesday, April 13, 2021 7:18 PM To: Medical Directors; Dental Directors; [email protected]; [email protected]; Myrta Garcia; Lindsay Lanagan; catherine.threatt; Abby Villafane; Lynn Roberts; [email protected]; [email protected]; Dr Flower; Vicky Jefferson, Lone Star Circle of Care Cc: Jana Eubank; Daniel Diaz; Nancy Gilliam; Shelby Tracy; Ramona Whittington; ClinicalTeam Subject: COVID-19 Vaccine Weekly Update Week 18 (04-12-2021) Attachments: nejmp2103104_AddressingVaccineHesitanceBIPOC pops.pdf; COVIDVaccineAllocation-Week18 HealthCentrs.pdf; draft-fact-sheet-providers-pi_Moderna04.2021.pdf; Moderna Provides Storage Update & Announces the U.S. FDA Authorizes Up To 15-Doses Per Vial of its COVID-19 Vaccine.pdf Dear Fellow Directors and Vaccine Coordinators, COVID Vaccine Allocation: Week 18 (04‐12‐2021) 33 Health center sites with 6,900 doses allocated. That brings the total DSHS Allocations to 182,665 total doses to date, since roll‐out began, including Week 18 to 268 unduplicated FQHC sites https://www.dshs.texas.gov/news/updates/COVIDVaccineAllocation‐Week18.pdf (see Attachment with Health Centers highlighted) DSHS COVID Vaccines Total Distributed across Texas: 16,318,875. Total Reported as Administered: 11,950,969 across the state. HRSA Health Center Vaccine Program We will continue to update the list of participating health centers (invited and participating health centers as of 4/12/2021: 34 Currently participating plus 39 invited to date.) Updates are provided for list of participating health centers on the website each week. Site‐level information is posted in the Health Center COVID‐19 Vaccine Program Online Community (VPC). For more information, visit the CDC COVID‐19 Vaccination Program Provider Requirements and Support site URGENT Vaccine Update: Johnson & Johnson COVID 19 Vaccines We wanted to make sure you are aware of this information regarding ONLY Johnson & Johnson vaccines you may be receiving from DSHS and/or HRSA allocations. This update and this week’s allocations affect 3 of our health centers (total of 400 J&J Vaccine doses going to 4 different sites). Today, effective immediately, the US Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA) are recommending a pause for the U.S. for the use of Johnson & Johnson's Covid‐19 vaccine over six reported U.S. cases of a "rare and severe" type of blood clot. Health centers administering the Johnson & Johnson vaccine should immediately STOP for the time being. If you have this vaccine in stock, please keep it in storage. Do not discard or destroy it. Press release sent out from DSHS this morning: https://www.dshs.texas.gov/news/releases/2021/20210413.aspx The six (6) reported cases were among more than 6.8 million doses of the Johnson & Johnson vaccine administered in the United States. None of the cases of blood clots reported at this time have occurred in Texas, where more than 500,000 doses of the Johnson & Johnson vaccine have been administered. The pause happened because this type of blood clot (cerebral venous thrombosis) is not listed on the list of potential adverse side effects that were part of the emergency use authorization (EUA) for J&J. 1 All six cases occurred among women between 18 ‐ 48 years of age, and symptoms occurred 6 ‐ 13 days after vaccination, according to a joint statement on today (4‐13‐2021) from Dr. Anne Schuchat, principal deputy director of the CDC and Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. "CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) tomorrow, Wednesday (04‐14‐2021) to further review these cases and assess their potential significance.” https://www.cdc.gov/media/releases/2021/s0413‐JJ‐vaccine.html For people who have received the Johnson & Johnson shot, those who have developed severe headache, abdominal pain, leg pain or shortness of breath within three weeks after vaccination should contact their health care provider. Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.html As it happens, according to Imelda Garcia with the Department of State Health Services (DSHS) Expert Vaccine Allocation Panel (EVAP), this week Texas allocations decreased from about 500,000 doses of the Johnson & Johnson vaccine last week (Week 17) to about 130,000 this week (Week 18) That amounts to a decrease of about 74%. This decrease was due to manufacturing shortages that occurred earlier this month. Furthermore, today DSHS/EVAP had a call with the following additional information: No replacement or new vaccines to allocate from DSHS at this time, for Week 18. Allocations for Week 19 will be determined this week, attempting to take into account the current situation. Texas Military targeted calls: will be calling providers who have received any J&J vaccines to alert vaccine providers to stop vaccinating with J&J. CDC and FDA will provided additional information and answer questions today at a media briefing at 10 AM ET here. A recording of that media call will be available on the FDA’s YouTube channel. Guidance for providers for recently administered J&J Vaccines to identify and determine patients who need support and/or referral to hospital for evaluation Dr. Shuford provided an overview of the cause for the FDA and CDC guidance to ‘pause’ on administration of the J&J Vaccines: 6 cases with rare and severe blood clot (cerebral venous sinus thrombosis,CSVT), have occurred in women b/w 18 – 48 years old, occurring approximately 2 – 3 weeks post vaccination Cerebral venous thromboses are rare and severe, with potential for mortality. Similar to heparin induced thrombocytopenia. Similar syndrome seen w/Astra Zeneca (in both men and women) in Europe. Recommendations for treatment & management, CDC Health Alert published [April 13, 2021, 1:00 PM ET]: https://emergency.cdc.gov/han/2021/han00442.asp Primary Care providers should: o Monitor with awareness of symptoms, abdominal pain, severe headache, shortness of breath, leg pain within 3 weeks post vaccination with J&J vaccine. o Check platelet counts and evaluate symptoms for potential of coagulopathy as an adverse event linked to immunological response. o Refer to Hematology to assess for treatment. RECOMMENDATIONS For Clinicians 1. Pause the use of the J&J COVID‐19 vaccine until the ACIP is able to further review these CVST cases in the context of thrombocytopenia and assess their potential significance. 2. Maintain a high index of suspicion for symptoms that might represent serious thrombotic events or thrombocytopenia in patients who have recently received the J&J COVID‐19 vaccine, including severe headache, backache, new neurologic symptoms, severe abdominal pain, shortness of breath, leg swelling, petechiae (tiny red spots on the skin), or new or easy bruising. Obtain platelet counts and screen for evidence of immune thrombotic thrombocytopenia. 3. In patients with a thrombotic event and thrombocytopenia after the J&J COVID‐19 vaccine, evaluate initially with a screening PF4 enzyme‐linked immunosorbent (ELISA) assay as would be performed for autoimmune HIT. Consultation with a hematologist is strongly recommended. 2 4. Do not treat patients with thrombotic events and thrombocytopenia following receipt of J&J COVID‐19 vaccine with heparin, unless HIT testing is negative. 5. If HIT testing is positive or unable to be performed in patient with thrombotic events and thrombocytopenia following receipt of J&J COVID‐19 vaccine, non‐heparin anticoagulants and high‐dose intravenous immune globulin should be strongly considered. 6. Report adverse events to VAERS, including serious and life‐threatening adverse events and deaths in patients following receipt of COVID‐19 vaccines as required under the Emergency Use Authorizations for COVID‐19 vaccines. Additional Vaccine Updates Pfizer and BioNTech say vaccine is 91% effective at 6 months, protects against variants ‐ Pfizer and BioNTech said their COVID‐19 vaccine remains 91.3% effective up to 6 months after administration of the second dose, according to an updated analysis of a phase 3 study. https://www.healio.com/news/infectious‐ disease/20201109/covid19‐vaccine‐more‐than‐90‐effective‐pfizer‐says Pfizer and BioNTech announced this week that the vaccine, which has been authorized since December in the U.S. for use in people aged 16 years or older, is also protective in adolescents aged 12 to 15 years. This is not yet approved by the FDA, and the companies plan to submit that data to the FDA, and experts said it means a vaccine could be available for this age group by next school year. https://www.healio.com/news/primary‐ care/20210331/pfizer‐and‐biontech‐say‐covid19‐vaccine‐protects‐adolescents‐plan‐to‐submit‐data‐to‐fda Pfizer and Moderna Messenger RNA vaccines lower risk for asymptomatic infection ‐ Participants who received two doses of a messenger RNA COVID‐19 vaccine were 80% less likely to test positive for asymptomatic SARS‐ CoV‐2, according to real‐world study results published in Clinical Infectious Diseases. https://www.cdc.gov/media/releases/2021/p0329‐COVID‐19‐Vaccines.html Moderna Vaccine‐ Moderna Provides Storage Update & Announces the U.S. FDA Authorizes Up To 15‐Doses Per Vial of its COVID‐19 Vaccine (attachment) o The FDA has authorized the Moderna COVID‐19 Vaccine to be kept at room temperature conditions once removed from the refrigerator for administration for 24 hours, an increase from the previous 12 hours. o Additionally, a punctured vial is now useable for up to 12 hours, an increase from the previous 6 hours. o The FDA also authorized inclusion of a new vial presentation with a maximum of 15 doses of its COVID‐19 vaccine. In parallel, the FDA also authorized a maximum of 11 doses of its COVID‐19 vaccine in the current format, from the previously authorized 10 doses per vial.