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VRBPAC Recommends Pfizer Vaccine, AHCA/NCAL Holds Webinar. The Vaccines and Related Biological Products Advisory Committee (VRBPAC), which provides recommendations to the Food and Drug Administration (FDA), today voted overwhelmingly in favor of granting Emergency Use Authorization (EUA) to the BioNTech/Pfizer COVID-19 vaccine. The next step is for the FDA to act on the EUA, which is expected to happen very soon.

This afternoon, AHCA/NCAL held a webinar to inform members about COVID-19 vaccines and the vaccination program. A recording of the webinar is available here, and the slides can be found here. Here are a few key points from the program:

  • AHCA/NCAL plans to hold at least two office hours sessions next week that will be devoted entirely to questions and answers.
  • If you selected Walgreens in the Pharmacy Partnership for Long-Term Care, AHCA/NCAL indicated that they completed outreach to partner facilities yesterday. If you have not heard from them, contact immunizeltc@walgreens.com.
  • CVS is to complete their outreach by Monday, December 14. If you selected them and do not hear by Monday, check your spam, update your facility contact information at https://www.omnicare.com/covid-19-vaccine-resource, and then email covidvaccineclinicsltcf@cvshealth.com with "CONTACT" as the subject and your facility name, address, and contact information.
  • Both Walgreens and CVS today agreed to accept an email consent attached to their consent form instead of requiring a hand-written signature. They also are looking at a digital signature option. AHCA/NCAL's Dr. David Gifford urged members to work with their pharmacy partners to find ways to meet the written consent requirement.
  • Dr. Gifford and Mark Parkinson emphasized that most people suffer only mild to moderate symptoms after being vaccinated and should be able to work with use of acetominophen or ibuprofen. Because of this and the possibility of staff missing out on being vaccinated, AHCA/NCAL does not recommend staggering vaccination dates for staff.
  • The Centers for Disease Control and Prevention (CDC) is expected to issue guidance next week that will address, among other things, post-vaccine symptoms relative to COVID-19 screening required to work in facilities.
  • AHCA/NCAL updated their now 10-page frequently-asked questions document on vaccines today to add the latest details.
  • AHCA/NCAL produced a rich communications toolkit with a variety of materials to help members communicate effectively about the COVID-19 vaccine, including template letters to families for consent and a "#GetVaccinated" social media package. They will update this information after the EUA is finalized.
COVID-19 Vaccination Does Not Cause Female Infertility. Dr. Gifford provided the following strong rebuttal to a false internet article suggesting the vaccine causes infertility, which understandably would increase vaccine hesitancy among the mostly female long-term services and supports workforce:

First off this is a false statement and article

https://www.politifact.com/factchecks/2020/dec/10/blog-posting/no-pfizers-head-research-didnt-say-covid-19-vaccin/

Second, there is not plausible biological explanation for how the vaccine would cause infertility.

Third, no infertility has been shown among people who have contracted COVID during the pandemic

Fourth, in the vaccine trial with the Pfizer vaccine; 12 women became pregnant after receiving the vaccine

Health Director Clarifies Pre-Positioning Centers, Vaccine Priorities. In a public letter, Director of Health Stephanie McCloud addressed the widespread misconception that the 10 Ohio hospitals designated as COVID-19 vaccine pre-positioning centers will redistribute vaccines they receive to other locations (which likely was the original plan). She also restated Ohio's decision on the groups that are part of Phase 1A. The following are two key excerpts from the letter:

I am writing to you to clarify the role of these pre-positioning hospitals, as there appears to be a misunderstanding that they will redistribute COVID-19 vaccine to other healthcare providers in their regions, which is not accurate. Ohio’s pre-positioning hospitals will receive a very limited supply of the Pfizer/BioNTech vaccine (975 doses each) to begin vaccinating some of their critical healthcare workers after the U.S. Food & Drug Administration approves an emergency-use authorization and CDC’s Advisory Committee on Immunization Practices (ACIP) issues its recommendations on the vaccine’s use. These pre-positioning hospitals will not redistribute vaccine to other healthcare providers.

...

The vaccine supply will be limited initially. Pending final CDC ACIP recommendations, Ohio will first vaccinate individuals in Phase 1A who are in critical groups and choose to get vaccinated, including healthcare providers and personnel who are routinely involved with the care of COVID-19 patients, residents and staff at nursing facilities, residents and staff at assisted living facilities, patients and staff at psychiatric hospitals, people with intellectual disabilities and those with mental illness who live in group homes or centers and staff at those locations, residents and staff of Ohio’s veterans homes, and EMS responders. 

CMS Testing Guidance. At long last, the Centers for Medicare and Medicaid Services (CMS) issued their anticipated guidance on COVID-19 testing in SNFs. The guidance clarifies in writing a number of points, some of which previously were covered informally and none of which are particularly surprising. Here of some of the items covered in the guidance.
  • It is the county positivity color, not the percentage, that determines testing frequency.
  • SNFs still must wait two weeks to implement longer testing frequency if the county positivity rating drops.
  • A facility would not be required conduct outbreak testing following a positive test result if the person does not enter the facility during the infectious period. 
  • Facilities have flexibility, as described in the guidance, in scheduling testing for staff members who come in infrequently (test them on next arrival) and those who come in regularly (stagger testing schedules).
  • Non-emergency medical transportation personnel need to be tested at the center's established frequency.
  • 48-hour turn-around time is not a hard-and-fast requirement but a goal.
  • Admission of a COVID-19-positive patient does not trigger outbreak testing.
Latest OPHAS Warning, Travel Advisory. Today the state refreshed the Ohio Public Health Advisory System (OPHAS) map. The following counties are now purple: Richland, Medina, Summit, Portage, and Stark. Only Wyandot, Monroe, Hocking, Vinton, and Gallia Counties are orange. All the rest are red. The state also posted the latest travel advisory based on positivity over 15%.

Ohio SNFs Without SAMS-3 Access. Michael Leitson of AHCA/NCAL provided a list (Excel download) of Ohio SNFs that have not obtained Secure Access Management System (SAMS) Level 3 grid cards that enable them to report point-of-care (POC) antigen test results to the National Healthcare Safety Network (NHSN), as required by CMS. While CMS currently is not enforcing this requirement, that is based on the provider's good-faith efforts to comply. Mr. Leitson added:

Please note that SAMS Level-3 is granted to an individual and not an organization. AHCA is encouraging providers to have more than one staff member with SAMS Level 3 access should one of these individuals not be available to report. CDC estimates it takes four weeks to upgrade, but have heard it can take longer.

Instructions on upgrading to SAMS Level-3 access are available here. Facilities can email?nhsn@cdc.gov ?with the subject line “Enhancing Data Security” to begin upgrading their SAMS access to use this Pathway.??Please allow up to 7-9 business days for NHSN to reply to any email concerning SAMS.