First Phase Priority Includes 21 Million Health Care Workers and 3 Million Residents of Long-Term Care Facilities, But Not Paramedics and Other First Responders
Health care personnel and residents of long-term care facilities will be the first groups to be offered the Covid-19 vaccine, according to a proposal issued Tuesday, December 1, 2020 from an independent advisory committee within the Centers for Disease Control and Prevention. The proposal passed 13 to 1. The “no” vote came from Vanderbilt University associate professor of medicine Dr. Helen Talbot, who said she supported giving the vaccine to health care workers, but had concerns about frail, older residents of long-term care facilities receiving the shot, and whether the vaccines would work as well for them. “I do not feel like our safety network for long-term care facilities is strong enough yet,” Talbot said. “I think there’s some work that needs to be done.”
The Advisory Committee on Immunization Practices (ACIP) — a panel of outside scientific experts — met virtually to discuss the selection of population groups that would receive the first doses of the vaccine and to vote on the proposed language for the recommendation for vaccine distribution that will amount to about 20 million pairs of doses by the end of 2020. Each vaccine requires two doses, and experts foresee that the vaccine will not become widely available in the U.S. until the spring, 2021. Vaccinations will be rationed in the early stages.
“We have spent eight months discussing and evaluating the data. We are using the principles of maximizing benefits and minimizing harms, promoting justice and mitigating health inequities.”
— Dr. José Romero, ACIP chair
The Advisory Committee on Immunization Practices will meet again in several weeks to decide the next priority of population groups. Initially under consideration are teachers, police officers, firefighters and workers in other essential fields such as food production and transportation; the elderly; and people with underlying medical conditions.
The first phase of the vaccine rollout (Allocation of Initial Supplies of COVID-19 Vaccine) will be known as Phase 1a and is set to begin as soon as a vaccine receives authorization from the Food and Drug Administration (FDA). Data for two vaccines, made by Pfizer/BioNTech and Moderna are currently under review. The FDA’s advisory committee will meet on Dec. 10, 2020 to consider an emergency use authorization for the Pfizer vaccine.
The two groups in Phase 1a together represent around 24 million Americans — 21 million health care workers and 3 million residents of long-term care facilities. Long-term care facilities staff are included among the health care workers.
During the discussion period, panel members asked about how the vaccine doses would be prioritized within the groups in Phase 1a. For example, health care workers with direct patient contact would be among the first to be offered the vaccine, as well as individuals working in long-term care facilities.
Other concerns involved vaccine safety and adverse events monitoring after people received the vaccine.
“We’re going to hold ourselves to an exceedingly high standard for safety monitoring after a vaccine is authorized and when it’s rolled out more broadly.”
— Dr. Nancy Messioner, Head of the National Center for Immunization and Respiratory Diseases at the CDC
Safety monitoring of vaccinations will include …
long-running Vaccine Adverse Event Reporting System, managed by both the CDC and FDA, and
V-SAFE, a new procedure which monitors early recipients of the COVID-19 vaccine with text messages and online surveys.
One or more COVID-19 vaccines may be authorized by FDA for use in December 2020.
Initial doses of any COVID-19 vaccine will be limited. We expect a constrained supply environment for some months and need to make the best use of available vaccine. By the end of December 2020, the number of doses available will be about 40 million, enough to vaccinate 20 million people. Experts anticipate 5-10 million doses per week post-authorization.
Health Care Personnel Sub-prioritization Considerations includes where sub-prioritization of health care personnel is needed, considered as follows:
– Individuals with direct patient contact (6 feet or less) and unable to telework:
• Personnel who provide services to patients or patients’ family members
• Personnel who handle infectious materials
• Can include inpatient or outpatient settings
– Personnel working in residential care or long-term care facilities
– Personnel without known infection in prior 90 days
• Reinfection appears uncommon during the initial 90 days after symptom onset of preceding infection
• Serologic testing not recommended prior to vaccination
Health are personnel Clinical Considerations include Pregnancy or Breastfeeding since 75% of health care workforce are women and approximately 330,000 health care personnel could be pregnant or recently
postpartum at the time of vaccine implementation
Data demonstrate potentially increased risks of severe maternal illness and
preterm birth due to COVID-19 disease
There is no data on use of mRNA vaccines in pregnant/breastfeeding women
There is a recommendation to await Phase III data, FDA assessment, EUA Conditions of Use before recommending vaccinations to the special population group connected to Pregnancy and Breastfeeding. Once reviewed, the upcoming data is reviewed, experts anticipate further guidance around the use of COVID-19 vaccines in pregnant/breastfeeding Phase 1a populations.
Regarding Reactogenicity (the recognition of production of common, “expected” adverse reactions, especially excessive immunological responses, inflammatory response, and associated signs and symptoms, including fever and sore arm at injection site). Initially recognized symptoms from trials are more common after the second vaccine does from both Moderna and Pfizer, and mostly involved mild to moderate fever, headache, and myalgia (muscle aches). Some older persons in trials reported severe symptoms.
According to the The Advisory Committee on Immunization Practices (ACIP), there are considerations for implementation of vaccination procedures for health care personnel operations includes consideration of staggering vaccination of personnel from similar units or positions, and planning for personnel to have time away from clinical care if health care personnel experience systemic symptoms post-vaccination.
Additional CDC guidance on health care personnel operations is forthcoming regarding the approach to systemic symptoms in HCP after COVID-19 vaccination.
According to the The Advisory Committee on Immunization Practices (ACIP), health care systems and public health officials should work together to ensure that vaccine access is available to health care personnel who are not affiliated with hospitals.
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