Coronavirus vaccine rollout set to begin next week
If all goes as planned, the Navajo Area Indian Health Service expects to receive its first delivery of the Pfizer Inc./BioNTech COVID-19 vaccine next week, NAIHS Chief Medical Officer Loretta Christensen told Navajo Nation leaders Saturday.
The shipment will be sent out within 24 hours of the anticipated U.S. Food and Drug Administration approval and would include approximately 4,900 doses of the vaccine, said Christensen.
On Tuesday, an FDA vaccine advisory committee reported that the Pfizer vaccine is approximately 95% effective and data analyses indicate similar efficacy across age groups (above 16 years), genders, and racial and ethnic groups. The most common side effects reported were injection site reactions, fatigue, headache, muscle pain, chills, joint pain and fever.
The committee stated that there are “no specific safety concerns identified that would preclude issuance of an emergency use authorization.” Christensen said she also expects that the Moderna Inc. vaccine will also be approved and anticipates that about 7,000 or more doses will be shipped to Navajo within seven days of the Pfizer vaccine.
Both the Pfizer and Moderna vaccines use a new technology called messenger RNA to build immunity against COVID-19. Christensen said her NAIHS team is prepared with a vaccine distribution plan in place that encompasses all service units and tribal Public Law 93-638 organizations in three phases.
The limited vaccine distribution in December will be followed by a large-scale distribution by March/April, and a third phase later in the spring, when it is expected millions of doses of the vaccines will become widely available.
The vaccines arriving this month will be administered first to the “Tier 1” prioritization group, which includes health care providers and first responders who have direct contact with COVID-19 patients; people with more than one medical condition, including cancer, kidney disease, COPD, pulmonary disease, organ transplant, obesity, diabetes and heart conditions; elders in group and nursing homes; and essential personnel such as health care and tribal administrators.
Members of the Tier 1 priority group, who have already been identified, will be contacted notifying them of vaccination, which will be administered in “safe environments” within their respective health care facilities. “The distribution will be equitable across the Navajo Nation according to user population,” Christensen reported to the Health, Education and Human Services Committee on Nov 25.
The vaccine will require consent and is not mandatory. Christensen anticipates that most of the vaccine will be given out within the first five days of arrival and the second dose must be given at 21 to 28 days thereafter. NAIHS is coordinating with suppliers to ensure the second doses are held in cold storage and shipped at the appropriate time and has a system in place to remind participants of their second dose.
Christensen said she thinks that they should be able to get through the majority of the Tier 1 priority group with the first Pfizer and Moderna shipments combined.
The vaccine rollout will continue through the spring until all Tier 1, 2, 3 and 4 groups are vaccinated as approved vaccines become more widely available. Tier 2 includes: health care personnel with non-COVID-19 contact; teachers, school staff, child care workers; critical infrastructure workers; people with one comorbid condition; those living and working in congregate settings such as homeless shelters and correctional institutions; substance abuse or mental illness patients; and adults over 65 years of age without comorbidities.
Tier 3 includes young adults, children, and workers in non-essential businesses and Tier 4 consists of all others. As of yet, the vaccines have not been tested in children 16 years old and under.
Christensen said IHS will use the Vaccine Adverse Event Reporting System to closely track the safety of vaccines and the Vaccine Tracking System through the Center for Disease Control and Prevention for coordinated vaccine ordering. As the CDC, IHS, states and tribes have been planning and coordinating the distribution of a vaccine for federal sites and tribal health programs, they have developed standard data requirements that all health care facilities must meet for COVID-19 vaccine administration, inventory, and monitoring, according to a Dec. 1 IHS headquarters press release.
“The success of a COVID-19 vaccine program for tribes and urban Indian communities depends on the strong partnership between the federal government, tribes, and urban leaders,” said IHS Director Rear Adm. Michael D. Weahkee. “There are system wide planning efforts in place to make sure we’re ready to implement vaccination activities as soon as (they are) Food and Drug Administration authorized or approved vaccine is available,” he said.
As more FDA approved vaccines become available, NAIHS will also have more choice as to which vaccine to order, said Christensen.
The ongoing Pfizer vaccine trial study being conducted by Johns Hopkins at the Chinle Comprehensive Health Care Center, Gallup Indian Medical Center and Northern Navajo Medical Center, will also provide researchers additional data specific to the Navajo and Native American populations which could help inform those decisions, said Christensen.