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Connection Newsletter - COVID-19 Vaccine Adverse Event Reporting

The CDC and FDA encourage anyone who experiences any problems after vaccination to report including patients and parents.

COVID-19 Vaccine - Vaccine Adverse Event Reporting System

The Vaccine Adverse Event Reporting System (VAERS) is a national program managed by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) that monitors the safety of vaccines after they are licensed. VAERS monitors any adverse events that happen after vaccination. Not all events reported to VAERS are caused by the vaccine therefore VAERS is unable to determine that a vaccine did or did not cause an adverse event. However, it gives the CDC and FDA important information that can signal a problem. If it looks as though a vaccine might be associated with an adverse event, the FDA and CDC will investigate further. 

The CDC and FDA encourage anyone who experiences any problems after vaccination to report including patients and parents. Healthcare providers are required by law to report certain problems

Individuals are able to report by going online and report an event or by downloading and filling out the PDF form and uploading it to the VAERS website.

For assistance in reporting to VAERS, email [email protected] or call 1-800-822-7967.

FDA confirms Pfizer’s efficacy and safety claims for COVID-19 vaccine candidate

The Food and Drug Administration (FDA) this week released a briefing document on Pfizer’s BNT162b2 COVID-19 vaccine candidate that confirms the drug maker’s claims of the vaccine’s efficacy and safety. The document is among a host of materials released in advance of today’s Vaccines and Related Biological Products Advisory Committee meeting in which Pfizer’s request for an emergency use authorization for BNT162b2 will be considered. FDA mirrored Pfizer’s application in its findings, stating that there are no specific safety concerns across key categories of race, age, ethnicity, medical co-morbidities or prior COVID-19 infection.

Yet, the agency notes more data is needed to understand the vaccine’s efficacy against asymptomatic infection, which FDA says is possibly lower than its effectiveness against symptomatic infection. FDA also would like to see additional testing on the vaccine’s effectiveness in preventing the virus’ transmission.

FDA approves COVID-19 plus flu in-home collection test

The Food and Drug Administration last week authorized the first prescription diagnostic test for both COVID-19 and influenza A and B which will allow patients to collect a sample at home and ship it to a laboratory for analysis. The Quest Diagnostics test received emergency use authorization for use by individuals with a suspected respiratory viral infection consistent with COVID-19 when their healthcare provider deems home collection is appropriate.

New ICD-10 codes for COVID-19-related conditions

The Centers for Disease Control and Prevention published addenda with instructions for implementing six new ICD-10 diagnosis codes for reporting COVID-19-related conditions on healthcare claims effective January 1. Codes for COVID-19 screening include suspected exposure to COVID-19, personal history of COVID-19, multisystem inflammatory syndrome, other systemic involvement of connective tissue and pneumonia due to COVID-19.

How we adopted and are using the POLST form in Arizona

Arizona, Maine and New Hampshire are the only states who have adopted the national POLST, a “portable medical order,” form within the U.S. As one of the early adopters, Arizona was present in this week’s national webinar How We Adopted and Are Using the National POLST Form, hosted by National POLST. At the table were AzHHA’s Senior Vice President of Care Improvement, Sandy Severson and Director of Care Improvement, Vicki Buchda. Severson and Buchda shared with attendees what it took, and lessons learned when adopting the POLST form in Arizona.

Interested in learning how to use the Arizona POLST form with your patients? The one-hour Introduction to POLST workshop equips healthcare professionals with knowledge and resources to begin using POLST in Arizona. The objectives are to describe what POLST is at the state and national level, explain why POLST is important, define the population for POLST, when to begin the conversation and who completes POLST, describe the process for completing, reviewing and updating POLST and learn the process of submitting healthcare planning documents to the Arizona Healthcare Directive Registry. Dates for the first quarter of 2021 have been announced. Click on the date to register for a workshop.

Upcoming Events

December 16 – Arizona telehealth virtual office hour

Join the Arizona Telemedicine Program in an informational Zoom call to discuss the current telehealth landscape in Arizona. Click here to register.

December 16 - Planning to emerge smarter and more resilient after the pandemic

In this webinar, leaders from IBM Watson Health will discuss how hospitals and health systems in the U.S. can think about technology’s use for securely engaging consumers while improving performance and population health in an increasingly digital healthcare ecosystem. Click here to register.

In Other News

Detailed data on AstraZeneca-Oxford Covid-19 vaccine show it has moderate efficacy

What the COVID-19 vaccine rollout will look like in Arizona
Phoenix New Times

St. Luke's Medical Center in Phoenix remains a 'last resort' for Arizona COVID-19 patients
Arizona Republic