CDC Hosts COCA Webinar on Post-Vaccine Events and Considerations
Regulation | December 15, 2020 | by Jodi Eyigor
CDC hosted a COCA webinar on December 14 reviewing adverse event reporting and post-vaccine infection control considerations for Pfizer's COVID-19 vaccine.
CDC hosted a Clinician Outreach and Communication Activity (COCA) webinar on December 14 to review adverse event reporting and post-vaccine considerations related to the Pfizer COVID-19 vaccine, which received emergency use authorization (EUA) from the Food and Drug Administration (FDA) on December 13. A recording of this webinar and accompanying slides are available here.
Vaccine Safety and Efficacy
The Pfizer COVID-19 vaccine was granted an EUA on December 13 following FDA review of data, including 3 phases of clinical trials during which the safety and efficacy of the vaccine is rigorously tested. More information on this process is available here. Safety monitoring continues even after a vaccine is authorized.
Vaccine Adverse Event Reporting System (VAERS)
One of the ways in which CDC and FDA continue to monitor vaccine safety after a vaccine has been authorized or licensed is through the Vaccine Adverse Event Reporting System (VAERS). VAERS is co-managed by CDC and FDA and covers all United States residents. Anyone can make a report into VAERS and the FDA will issue requirements for reporting under the EUA. Healthcare providers should report any adverse events noted in patients or residents. Reports can be submitted online at vaers.hhs.gov. Video instructions are also available to assist with reporting.
V-Safe After Vaccination Health Checker
Another way that CDC is monitoring post-vaccination experience is through a new smart-phone based monitoring system called V-Safe. This system uses text messages and web surveys to check in with vaccine recipients after vaccination, and includes active telephone follow-up by CDC on reports of significant health impact.
V-Safe participants will receive health check-ins by text from CDC daily for the first week following vaccination. After the first week, check-ins go to weekly through the 6th week following vaccination, then at 3 months, 6 months, and 12 months post-vaccination. Check-ins ask about clinically important health impacts such as missing work, inability to perform normal daily activities, and any resulting medical care received. Any clinically important health impacts reported will be followed up by phone by CDC. CDC requests healthcare provider support in encouraging participation in the V-Safe system.
Post-Vaccine Infection Control Considerations
CDC has posted 2 guidance documents on post-vaccine infection control considerations. Post-vaccine infection control considerations for long-term care residents is available here. Post-vaccine considerations for healthcare personnel is available here. CDC urges that residents and staff continue to follow all current infection prevention and control guidance to protect themselves from infection, regardless of vaccination status. Though extensively evaluated, the vaccine has only been evaluated for protection against illness, not transmission. For this reason, healthcare workers must continue to adhere to all CDC recommendations including the use of personal protective equipment (PPE) and everyone must continue to practice source control measures including masking, social distancing, and hand hygiene in order to prevent transmission of this virus regardless of vaccination status.
CDC also notes that the Pfizer vaccine will not affect COVID-19 viral testing (PCR and antigen tests). This means that a positive result on a viral test should be evaluated according to current guidance regardless of vaccination status.
Management of Residents and Staff with Symptoms Post-Vaccine
There is some overlap in presentation of vaccine side effects and COVID-19 symptoms. CDC has offered guidance to assist public health officials in guiding healthcare providers through decision-making around management of individuals experiencing symptoms post-vaccination.
The following symptoms have been found to occur post-vaccination: fever, chills, headache, fatigue, muscle aches, and joint pain. These symptoms appear within 3 days of vaccination (with the day of vaccination being Day 1) and resolve quickly. Symptoms occur most commonly on the day after vaccination, and are more common in individuals under the age of 55 than those older than 55 years.
The following symptoms are not found to occur post-vaccination and may indicate the presence of COVID-19 or other infection: couch, shortness of breath, runny nose, sore throat, and loss of taste or smell. Individuals experiencing these symptoms should be evaluated for COVID-19 or other infection.
Any individuals who have been exposed to COVID-19 in the past 14 days and show symptoms post-vaccination should be evaluated according to current guidance for exposure. Symptomatic residents who have had prolonged contact with someone with COVID-19 in the past 14 days should be isolated on transmission-based precautions and tested. Symptomatic staff who have had unprotected exposure in the past 14 days, either in the clinical setting or outside of work, should be restricted from work and tested.
Symptomatic individuals who have not been exposed in the past 14 days may be managed as follows:
Residents showing only symptoms found to occur post-vaccination (fever, chills, etc.) should be restricted to their rooms, placed on transmission-based precautions, and monitored closely. If symptoms do not improve or do not resolve within 2 days, proceed with testing. Residents showing any symptoms not found to occur post-vaccination (cough, sore throat, etc.) should be isolated on transmission-based precautions and tested.
Staff showing only symptoms found to occur post-vaccination (fever, chills, etc.) may be permitted to continue working provided they are afebrile and feeling well enough to work. If symptoms do not improve or do not resolve within 2 days, proceed with restriction from work and testing. Staff showing any symptoms not found to occur post-vaccination (cough, sore throat, etc.) should be restricted from work and tested.
It is important to remember that these recommendations are issued by CDC for use by public health officials. Healthcare providers should consult with state/local health departments related to management of residents or staff showing symptoms within 3 days of vaccination.