In an Aug. 4 letter, the Centers for Disease Control and Prevention (CDC) provided interim guidance for state and tribal public health departments to draft a COVID-19 vaccine distribution plan by Oct. 1, but the administration also alerted providers and retail pharmacies to watch for federal agreements that will allow them to procure and administer the immunizations too. In the meantime, public health experts are hashing out the prioritization criteria for immunization. Healthcare workers are most likely to be first in line.
According to the CDC, the amount of vaccine allocated to each jurisdiction and “selected commercial and federal partners” will be based on a group of factors, including population size. Providers must enroll with their jurisdiction’s immunization program to receive the vaccine. Reimbursement for the shots and their administration are still “under consideration.”
As more vaccine supplies become available, the CDC recommends that states sign agreements with providers and said that a “federal provider agreement will be forthcoming,” as will memoranda of agreement (MOA) with multijurisdictional providers such as large drugstore chains and federal providers. However, those multijurisdictional providers will need to have “agreed-upon channels for communicating with each jurisdiction.”
The CDC also said it would prioritize groups that should receive the vaccine based on input from the National Academy of Medicine and the Advisory Committee on Immunization Practices (ACIP), a group of medical and public health experts who develop recommendations on the use of vaccines.
The National Academies of Sciences, Engineering and Medicine recommended that high-risk workers in healthcare facilities and first responders be in the first tier of those vaccinated, followed by people of all ages with comorbid conditions at “significantly higher risk” of complications from COVID-19 and older adults living in congregated or “overcrowded” facilities.
Essential workers in positions at high risk of exposure, such as teachers, people with comorbidities at moderately higher risk, all older adults, and people in homeless shelters or incarcerated individuals and staff in those settings would be in tier 2, according to the National Academies recommendations. The final group classified by the academies would be young adults, children and “critical risk” workers who are at moderate risk of infection because of their employment.
ACIP also appears to be coalescing around healthcare workers as the top priority group. A model presented at ACIP’s Aug. 26 meeting concluded that the vaccination of healthcare personnel and essential workers would lead to an estimated 3% reduction in COVID-19 infections and an equal rate of reduction in deaths with a vaccine that was 50% effective in those over 65 and 70% effective in all others.
Both rates were higher in those with underlying health conditions (3.8% reduction in infections, 4.3% reduction in deaths) while the effect on infections was lowest among persons aged 65 or older (0.7% reduction) although the reduction in deaths was much greater (6.1%).
Authorities have started to waive some requirements for vaccinators, while the safety and efficacy data for the most advanced vaccines could also guide the criteria, depending upon what the Phase III data show.
In response to the decline in pediatric vaccination rates because of the pandemic, HHS permitted pharmacists in all 50 states to give pediatric vaccinations to children ages 3 to 18, preempting restrictions in 22 states. In April, HHS authorized pharmacists to order and administer COVID-19 tests.
The FDA and the CDC have been encouraging vaccine manufacturers to enroll trials that are representative of the populations who are most at risk for COVID-19 infection and severe outcomes, including racial minorities, individuals with comorbidities and older adults.
An HRI analysis of early stage COVID-19 vaccine trials found that companies had not included these at-risk groups. However, several manufacturers have said they are trying to broaden their enrollment criteria. HRI found that the Phase III trials for several vaccine candidates do allow for patients who have comorbidities or are deemed to be at high risk by the investigator; it’s unclear if they will succeed in enrolling racial minorities. However, the safety and efficacy in certain subgroups such as the elderly or individuals with comorbidities could help determine in which populations the vaccines are used.
According to the August letter from the CDC, the federal government will procure and distribute the ancillary vaccine supplies at no cost to the providers. Additionally, the Department of Defense awarded a $104 million contract to obtain syringes and needles for vaccine distribution.