The accelerated covid-19 vaccine research has led to the release of many recent notable manuscripts and another was published this week in the New England Journal of Medicine that analyzed an important high risk group: older adults. Conducted at three sites across the United States (Kaiser Permanente research center in Seattle, Emory University and the National Institute of Allergy and Infectious Diseases NIAID) this Phase 1 vaccine study was expanded to include forty older adults. The subjects were divided into two groups, 56-70 years old and those 71 and older. Interestingly, participants were not screened for past or current covid-19 infection before enrollment.
The vaccine being tested was developed by the National Institute of Allergy and Infectious Diseases and Moderna, a biotechnology company in Cambridge, MA. It utilizes the S protein by which the coronavirus enters host cells. Participants received either 25 micrograms or 100 micrograms of the injection. Each person received an injection on day 1 and 29 with the same dose given each time. Follow-up visits were performed on days 7, 14 and 57. Following vaccination, an assessment of antibody and T-cell response was studied. The 100 microgram dose (higher) dose exhibited higher binding- and neutralizing-antibody titers compared to the 25 microgram dose.
Of the 40 patients, one in the 56-70 year lower dose group did not receive the second dose after developing a fingernail infection which required antibiotic treatment. Common side effects such as headache, fever, body aches, chills and injection site pain were reported which were all classified as mild to moderate and were often associated with the second dose.
This small Phase 1 study of older adults shows promise in a vaccine for covid-19 and appears to be effective and well tolerated in older adults. It remains early. The question of long-standing immunity and the ability of these antibodies to prevent infection remains unanswered.
Yesterday several major healthcare insurers announced a change to their reimbursement rates for virtual healthcare visits, effectively limiting the impact of a policy that has proved vital to many Americans during the pandemic. Both UnitedHealthcare and Anthem have announced that they will no longer cover the full cost of virtual visits unrelated to covid-19, with Anthem applying cost-sharing measures based on a member's existing plan. When asked for specific estimates on cost to members, UnitedHealthcare cited $50, while Anthem would not commit to any figures, citing differences between types of plans and individuals.
The problem extends beyond just those patients covered by these insurers; as one company, or two in this case, begins restricting benefits, others tend to follow suit to cut down on expenses. This in turn forces healthcare providers to reconsider the services offered as well as the cost borne by the patient. While the Centers for Medicare and Medicaid Services has committed to expanded telehealth coverage in 2021 via the annual Physician Fee Schedule (which determines how much physicians are paid for their work in treating Medicare and Medicaid patients), individual companies have been known to make their own adjustments. That these two decided to do so in the middle of the pandemic seems particularly harsh. Various.