With multiple COVID-19 vaccines in development, the CDC is confident that any vaccines the FDA authorizes or approves will be safe because they are based on the FDA’s usual stringent protocols. The greater question, after a vaccine is approved, is how it will be distributed.
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With multiple COVID-19 vaccines in development, the Centers for Disease Control and Prevention (CDC) is confident that any vaccines the FDA authorizes or approves will be safe because they are based on the FDA’s usual stringent protocols. The greater question, after a vaccine is approved, is how it will be distributed.
“There is a complicated vaccine landscape, and many types could be authorized by the FDA,” Nancy Messonnier, M.D., director, National Center for Immunization and Respiratory Diseases (NCISD) at the CDC, said in a recent COVID-19 vaccine development briefing for physicians, hosted by the American Medical Association.
Therefore, the key points healthcare professionals need to understand are that the CDC and FDA will deploy their routine procedures and systems to ensure the vaccines are safe and effective, and that recommendations on who will be vaccinated will change over time.
“Operation Warp Speed assures us some vaccines will be available in 2020, but we expect the initial quantities will be limited,” Messonnier said. “Because vaccines are being manufactured while clinical trials are ongoing, we expect supplies to increase, perhaps quite quickly.”
Operation WARP Speed contracted with manufacturers for 100 million doses each, she pointed out.
The CDC expects the COVID-19 vaccine rollout to follow the pattern used for the H1N1 vaccine.
“Initial doses likely will be administered at large hospitals for healthcare workers. As supplies increase, our thinking shifts to ensuring broad access, working with private sector partners like mobile clinics,” said Amanda Cohn, M.D., acting chief medical officer at NCIRD and executive secretary for the Advisory Committee on Immunization Practices (ACIP).
Later, with ample – possibly excess – vaccine supplies, open vaccination will be possible, and administered through commercial and private partners.
“The vaccines will be sent to centralized distributors with the needles, syringes, vials…everything needed to administer the vaccines,” Cohn said.
There’s no need for healthcare personnel or systems to stockpile needles or syringes.
It’s widely known that the national vaccination plan prioritize people associated with critical infrastructure (such as first responders, healthcare providers and teachers), those at risk of severe illness (the elderly or ill), people at increased risk from COVID-19 (institutionalized persons) and those with limited access to vaccinations (rural and disabled populations).
“We’re framing ways to ensure access for these people and will make that information available as soon as we can,” Cohn said.
“At the state and local levels there will be more people in each group than we have vaccines. Therefore, state and local groups will need to prioritize those they think are most critical to receive early vaccination,” Cohn said. This means developing a tiered system even within the prioritized groups. “We think this local prioritization will only be in place for a short time, before there are ample vaccines to ship to pharmacies.”
One of the challenges is vaccinating long-term care personnel. Cohn suggested onsite or mobile clinics, as well as ensuring that vaccination sites are open evening and weekend hours to enable shift workers access.
Currently, health departments are recruiting healthcare providers to administer vaccines, “to expand equitable access and eventually provide access to the general public. We anticipate having vaccine products available over the next year that can be easily administered in providers’ offices.” Currently, information suggests the vaccine will be free, but that providers can be reimbursed for administration fees.
Because so many different types of vaccines are being developed with different temperature requirements or administration protocols, the CDC also expects to develop training to smooth administration.
“The impact of vaccination depends on the rapid uptake of a complete vaccine series,” Cohn stressed. Therefore, the CDC’s plan includes a patient recall system for subsequent vaccinations and post-injection safety monitoring.
The CDC has added V-SAFE (Vaccine Safety Assessment for Essential Workers) and the National Healthcare Safety Network, and the FDA has added databases from large insurers and third-party payers to the previously existing reporting systems. Medicare data and electronic medical records also can be accessed, to monitor adverse events and to better understand the effects of COVID-19 on existing conditions.
“Having a vaccine is a critical step to a return to normalcy,” AMA President Susan R. Bailey, M.D. noted during the briefing. But to be useful, it must be safely administered. The CDC’s work now helps ensure the healthcare system will be ready, along with the vaccine.
