Just days before an advisory committee of the Food and Drug Administration granted an emergency use authorization (EUA) to two manufacturers’ COVID-19 vaccine candidates, the Centers for Disease Control and Prevention prepared health care providers to handle the vaccine.
In parallel, the Defense Health Agency’s Immunization Healthcare Division (IHD) is working in collaboration with the CDC to offer the training to the Military Health System’s health care providers.
The training module provides health care providers information about the COVID-19 vaccine’s EUA, safety, storage, handling, administration, and reporting to assist them in administering COVID-19 vaccines safely and equitably. They’re also encouraged to follow their state, tribal, local, and territorial health officials’ guidance.
The module highlights that vaccine safety is a key element of every phase of development — from initial research, discovery, and pre-clinical trials; through the three phases of clinical trials, the FDA’s and Advisory Committee of Immunization Practices’ review, and the phase 4 post-approval safety monitoring and research process.
“The U.S. vaccine safety system ensures that all vaccines are as safe as possible,” says the CDC’s training module. “Safety is a top priority while federal partners work to make a COVID-19 vaccine available”.
Dr. Limone Collins, Jr., chief of IHD’s Vaccine Safety and Evaluation, which supported the Department of Defense-sponsored vaccine trials for the Astra-Zeneca candidate, highlighted that the FDA undertakes a very rigorous review of every product submitted to make sure that general precept is adhered to.
“They’re not going to let any product go through their review and analysis without giving that assurance to the U.S. population,” he said.
In addition to ensuring health care providers learn about the vaccines ahead of their approval for public distribution, the CDC scaled up an expanded network for safety surveillance in real time. Additional information sources and new technology for evaluation will give CDC and FDA the ability to monitor vaccine administration to ensure COVID-19 vaccines are safe.
For example, a new smartphone-based app, called V-SAFE, will use text messaging and web surveys from CDC to check in with vaccine recipients for any health problems following their vaccination. The app, together with CDC’s National Healthcare Safety Network — an acute care and long-term care facility monitoring system that reports to an existing vaccine event reporting system — and other FDA insurer/payer databases, comprise the broad network of monitoring systems in place for surveillance.
When FDA issues an EUA, it allows access to critical medical products that may help specifically during a public health emergency, according to the CDC’s training module. It is different from approval/licensure because it meets certain requirements that deem it for emergency use, such as that there is no adequate FDA-approved alternative available.
For health care providers, this means that a COVID-19 vaccine has been authorized for use according to the scope specified in a fact sheet like the package inserts for licensed vaccines. Additionally, health care providers must provide the fact sheet to vaccine recipients or their caregivers to communicate potential risks and benefits, vaccine administration data must be reported to CDC, and administration errors and specific and serious adverse events must be reported to the Vaccine Adverse Event Reporting Systems (VAERS) co-managed by the CDC and FDA. This includes cases of COVID-19 that result in hospitalization or death after the recipient has received a COVID-19 vaccine.
The training module also provides information such as a description of the COVID-19 disease; dosage and administration; storage and handling instructions; dose preparation and administration; requirements for use of the vaccine under EUA; risks and benefits, including any adverse events; any approved alternatives to prevent COVID-19; reporting requirements; and additional resources. This is done to ensure vaccine recipients are aware of all aspects of the experimental vaccine before its administration and to encourage them to monitor themselves post-vaccination, and report any significant events back to CDC for continuous research.
The training module also goes into detail about proper storage and handling of the vaccines, highlighting that failing to store and handle them properly could reduce their potency and result in “inadequate immune responses in patients and poor protection against the disease”. For example, their expiration and Beyond Use Date is an important step in the handling and storage process. Likewise, storing them at the recommended temperature is key, and any variation in that storage temperature, called a temperature excursion, should be noted and corrected immediately.
According to the information provided in the module, the nature of the COVID-19 pandemic underscores the importance of implementing standard infection prevention practices during vaccine administration by intramuscular injection. These include physical distancing, wearing the correct Personal Protective Equipment, respiratory and hand hygiene and surface decontamination, and source control.
Finally, the training module emphasized that COVID-19 vaccine products are not interchangeable, stating “the same product must be used for each dose in the vaccine series”. To manage this, healthcare providers will provide recipients personal vaccination cards so they’re aware of which vaccine product they received and when to schedule their next appointment to receive the second dose.
They will also provide each recipient or caregiver the EUA Fact Sheet for Recipients and V-SAFE information and encourage them to participate in the safety monitoring efforts as part of the phase 4 post-approval monitoring research. Health care providers will then record the date each dose was administered, the manufacturer and lot number, the vaccination site and route, and the name and title of the person administering the vaccine in their medical record systems as well as the patient’s medical record or immunization information system in order to report this data to each jurisdiction no later than 72 hours post-administration.
The Federal government has purchased COVID-19 vaccine and is making it available to the DOD for distribution and administration to DOD uniformed service members, both the active and Selected Reserve components, including members of the National Guard; dependents; retirees; civilian employees, and selected DoD contract personnel as authorized in accordance with DoD regulation.
The Department remains focused on protecting our Service members, DOD civilians, and families; safeguarding our national security capabilities; and supporting the whole-of-nation response to the COVID-19 pandemic.