Important COVID-19 Vaccine Updates, Resources, EUA fact sheets

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Immunization Program

Important COVID-19 Vaccine Updates and Resources

As we transition this week from COVID-19 vaccine planning to implementation, we at DHS will send you information as we receive it from our federal partners. In this historic time, we ask for your patience, understanding, and partnership as we work through the details that have emerged about COVID-19 vaccination over the weekend. We are working to add this information to our DHS COVID-19 vaccine program website.

Timeline

On Friday December 11, 2020, The Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to the Pfizer vaccine product.

On Saturday December 12, 2020 the expert committee members of the Advisory Committee on Immunization Practices (ACIP) voted to recommend the use of the vaccine. The director of the Centers for Disease Control and Prevention (CDC) accepted those recommendations. The Pfizer-BioNTech COVID-19 vaccine may be administered in persons aged 16 years and older for the prevention of COVID-19.

On Monday December 14, 2020 vaccine shipments will begin to arrive in Wisconsin at designated regional hubs. DHS is prioritizing hospitals and clinics as initial vaccination sites so as to reach front-line healthcare workers, as recommended both by the Advisory Committee on Immunization Practices and the State Disaster Medical Advisory Committee.  

Clinical Resources

Ensure that your staff are familiar with the EUA fact sheet for clinicians and give each vaccine recipient the EUA Factsheet for patients. The patient factsheet is given in lieu of a vaccine information statement.

Ensure your clinicians are familiar with the Morbidity and Mortality Weekly Report (MMWR) outlining ACIP’s vaccine recommendations and the MMWR outlining ACIP’s initial allocation recommendations of COVID-19 vaccine.

Monitoring Vaccine Safety

Please join the next COCA call on Monday December 14, 2020 from noon to 1:00 p.m. What Every Clinician Should Know about COVID-19 Vaccine Safety

Ensure all of your patients are aware of and receive a QR code for the V-Safe program.

Remember to submit all vaccine administration errors and adverse events to VAERS. Be sure to familiarize yourself with the specific EUA reporting requirements including:

  • Vaccine administration errors whether or not associated with an adverse event
  • Serious adverse events (irrespective of attribution to vaccination)
  • Cases of Multisystem Inflammatory Syndrome (MIS) in adults and children
  • Cases of COVID-19 that result in hospitalization or death.

Contraindications

Please review the EUA information and ACIP recommendations and become familiar with all clinical guidelines including contraindications. Do not administer the vaccine to people with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine.

Ensure that appropriate medical treatment for managing immediate allergic reactions is immediately available in the event of an acute anaphylactic reaction occurring following COVID-19 vaccine administration.

Communications

We know that your staff may have many questions about the COVID-19 vaccine. Please take a moment to review CDC’s COVID-19 Vaccination Communication Toolkit for Medical Centers, Clinics, and Clinicians and find answers to many frequently asked questions on CHOP’s Vaccine Education Center website.

On December 13, 2020 CDC released new COVID-19 vaccine information for consumers, including:

Product-specific Resources

CDC's new Pfizer-BioNTech COVID-19 Vaccine webpage has information specific to Pfizer’s vaccine, including resources to assist providers in storing and handling the vaccine. The materials now available on the CDC webpage are attached to this email. Currently the page contains storage and handling information, and tomorrow the CDC will update it with administration information; CDC are working to align this information with ACIP’s clinical recommendations that will be released then.

You can also view CDC's Product Information Guide for COVID-19 Vaccines and Associated Products for key product information including product package dimensions and weight, minimum order quantities, product presentation, distribution method, storage information, and additional information. Additionally, McKesson updated their ancillary supply kit information to clarify the Contents and Quantities for Mega Kits to Support Pfizer Vaccine.

Pfizer also launched a new COVID-19 vaccine website for vaccinators.

Continuing COVID-19 Precautions

We are many months away from having enough COVID-19 vaccine supply and reaching high vaccination coverage. In the meantime, please continue to encourage your patients and stakeholders to continue wearing masks, physical distancing, washing their hands, and getting tested and isolating if they have signs and symptoms of COVID-19.

Even after the first people get vaccinated, it is important to continue using all these COVID-19 precautions so that we stand the best chance of getting our families, communities, schools, and workplaces “back to normal” sooner.

Thank you for your continued work as we move to implement an important tool in the fight against COVID-19.