To help make important unapproved medical products, including vaccines, available quickly during the COVID-19 pandemic, the US Food and Drug Administration (FDA) can use what is known as an Emergency Use Authorization (EUA)external icon. Before any vaccine can be authorized for use under an EUA, FDA must determine that the vaccine’s benefits outweigh possible risks.
CDC and FDA are monitoring vaccine safety closely. The United States is using existing robust systems and data sources to conduct ongoing safety monitoring. An additional layer of safety monitoring has also been added that allows CDC and FDA to evaluate COVID-19 vaccine safety almost immediately. Learn more about COVID-19 vaccine safety monitoring.
For LTCFs in particular, CDC will work with pharmacies and other partners to report possible side effects (called adverse events) to the Vaccine Adverse Event Reporting System (VAERS)external icon. Facility staff and residents’ families are encouraged to also report any adverse events immediately.
CDC is working with pharmacies and other partners to provide communication materials to help LTCFs educate residents and their families about the vaccine, answer their questions about vaccine safety and other issues, and prepare them for vaccination clinics.
Each recipient or caregiver will receive a vaccination record card. For some COVID-19 vaccines, two shots are needed to provide the best protection, and the shots are given several weeks apart. The vaccination record card can ensure they receive the correct vaccine for the second dose (if a second dose is needed).
Risks and benefits will be explained to everyone offered a COVID-19 vaccination
Explaining the risks and benefits of any treatments to a patient – in a way that they understand – is the standard of care. Written consent is not required by federal law for COVID-19 vaccination in the United States; however, COVID-19 vaccine providers should consult with their own legal counsel for state requirements related to consent. In LTCFs, consent or assent for vaccination should be obtained from residents (or the person appointed to make medical decisions on their behalf) and documented in the resident’s chart per standard practice.
Pharmacy partners that are administering COVID-19 vaccine at LTCFs as part of the Federal Pharmacy Partnership for Long-term Care Program may require verbal, email, or written consent from recipients before vaccination. This is at the discretion of the pharmacy. LTCF administrators can request pharmacy partners obtain consent from residents’ families in advance when they are serving as medical proxies.
Pharmacy partners will also work directly with LTCFs to ensure staff and residents who receive the vaccine also receive an EUA fact sheet before vaccination. The EUA fact sheet explains the risks and benefits of the COVID-19 vaccine they are receiving and what to expect. Each LTCF resident’s medical chart must note that this information was provided to the resident. If a resident is unable to make medical decisions due to decreased mental capacity or illness, the EUA fact sheet will be provided to the person appointed to make medical decisions on their behalf (the medical proxy or power of attorney).