By Judy Recker, MHA, RPh, CPHQ, CPHRM
On February 27, 2021 the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for Johnson & Johnson’s COVID-19 vaccine, Ad26.COV2.S. This is welcome news, as many states across the country are reporting shortages of the Pfizer and Moderna COVID-19 vaccines. The Johnson & Johnson vaccine was shown to be 85% effective in preventing severe COVID-19, 28 days after vaccination.
There are three key differences between the Johnson & Johnson vaccine and the Pfizer and Moderna vaccines. The Johnson & Johnson vaccine was developed using a viral vector platform, while the Pfizer and Moderna vaccines were developed by a genetic technology called synthetic messenger RNA (mRNA). COVID-19 viral vector vaccines use a modified virus to deliver the coronavirus genes into cells to provoke an immune response. The modified virus, the vector, is a different, non-toxic virus and not the virus that causes COVID-19. Viral vectors cannot cause infection with COVID-19 or with the virus used as the vaccine vector. Viral vector vaccine technology has been around since the 1970s and was recently used for a vaccine against Ebola outbreaks. The second key difference is that the Johnson & Johnson vaccine requires a single dose to develop immunity towards COVID-19, while the Pfizer and Moderna vaccines require two doses. The third key difference is that Johnson & Johnson’s vaccine can be stored at refrigeration temperatures and does not need to be frozen. The dosing and storage differences provide a significant positive public health impact, especially for low-income countries.
EUA is a pathway to make unapproved medical products available during public health emergencies, provided that there are no adequate, approved, and available alternatives. For the FDA to issue an EUA for a vaccine, there must be adequate manufacturing information to ensure quality and consistency, and the FDA must determine whether the vaccine’s known and potential benefits outweigh its known and potential risks. Even though an EUA has been issued, vaccine manufacturers are continuing their clinical trials to obtain additional safety and effectiveness information and will eventually apply for FDA approval. Therefore, Ad26.COV2.S is still considered investigational.
Consider the following recommendations to mitigate risks associated with the COVID-19 Ad26.COV2.S vaccine:
- Ensure readiness. Assemble a vaccine workgroup composed of representatives from multiple disciplines: physicians, advanced practice providers, pharmacists, infection prevention nurses, risk managers, attorneys, materials managers, human resource managers, information technology managers, facility managers, security managers, and employee health professionals.
- Develop a policy and procedure. Develop a written policy and procedure for the COVID-19 Ad26.COV2.S vaccine. Consider using the organization’s influenza vaccine policy and procedure as a guide.
- Follow your state and local health department guidelines. The Centers for Disease Control and Prevention (CDC) has posted links to individual state COVID-19 vaccination plans in its COVID-19 Vaccination Program Operational Guidance.
- Store the vaccine properly. Be familiar with vaccine storage requirements. Ensure that appropriate refrigerators are working properly and that temperature monitoring is in place. According to the CDC’s Vaccine Storage and Handling Tool Kit, a healthcare organization should follow the proper storage and handling crucial to an effective vaccine cold chain.
- Provide patient education. Prior to administering the vaccine, give patients the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and answer any questions they may have. Document that the patient received the Fact Sheet for Recipients and Caregivers. This may be included on the informed consent form.
- Obtain informed consent. Prior to administering the vaccine, obtain written informed consent from the patient and incorporate the consent document into the medical record. The informed consent discussion should include the fact that the vaccine is investigational, the vaccine’s risks and benefits, and alternatives to receiving the vaccine.
- Know the vaccine. Familiarize staff and providers with the vaccine prior to administering it at your facility. In particular, train staff and providers on its method/route of administration, dosing schedule, patient selection criteria, side effects, warnings and contraindications, and storage considerations. For information regarding the vaccine, see the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers).
- Consider alternate care sites for vaccine administration to accommodate large groups. When the vaccine is administered in a non-traditional or alternative setting, organizations should anticipate and prepare for vaccine-related adverse reactions and emergencies by securing additional supplies, designating waiting/observation areas, and hiring additional staff if necessary. In some cases, organizations may need to employ security officers to ensure patient and healthcare worker safety. For additional guidance on alternative vaccination sites, see Guidance for Planning Vaccination Clinics Held at Satellite, Temporary, or Off-Site Locations and/or Considerations for Planning Curbside/Drive-Through Vaccination Clinics.
- Report adverse events. Report all vaccination errors and serious adverse effects related to the vaccine to the Vaccine Adverse Event Reporting System (VAERS) and to the extent feasible, the manufacturer. For more information about reporting adverse events, refer to the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers).
No legal or medical advice intended. This content includes general guidelines. Such materials are for informational purposes only and may not reflect the most current legal or medical developments. These informational materials are not intended, and must not be taken, as legal or medical advice on any particular set of facts or circumstances.