Here is a link to the joint Food and Drug Administration / Centers for Disease Control statement on the recommended pause in administration of the Johnson and Johnson single dose COVID-19 vaccine that the agencies issued this morning. Becker’s Hospital Review reports that pharmacies and State governments administering the vaccine have implemented this recommendation.
Next steps —
CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these [six] cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.
STAT News adds
Experts applauded the decision as the right thing to do.
“The pause is a prudent step to take, because when very serious adverse events occur that are also very rare, what matters most is ‘very serious,’” said John Moore, an immunologist at Weill Cornell Medicine. “Not only are individual members of the public at some risk, but so is the wider confidence in the Covid-19 vaccines.”
“It’s a reasonable but unproven assumption that the J&J and AstraZeneca vaccine safety concerns are linked by being related to an immune response against an adenovirus component,” he said. “So, FDA and scientists need time to better understand what is going on, which means a pause is the right course of action.”
And now for the tidbits
- Modern Healthcare reports that the House today joined the Senate in delaying otherwise required 2% cuts in Medicare payments for the remainder of 2021. The means that CMS will be giving the Medicare Administrative Contracts its approval to resume paying Medicare claims once the President signs the bill into law.
- Healthcare Dive reports that “Salt Lake City-based Intermountain [which sponsors an FEHB HMO] is acquiring air ambulance company Classic Air Medical in a bid to better coordinate virtual and physical care for rural patients. Snapping up Classic, which operates aircraft in eight western states and has a significant overlap with Intermountain’s telehealth footprint, is meant to make it easier to transport high-need patients to the closest medical facility equipped for their needs, the nonprofit system said in a Monday statement.”
- The Department of Health and Human Services “have published several new resources to help states, vaccination providers, and others leading COVID-19 response activities improve access to vaccines for people with disabilities and older adults. These resources clarify legal requirements, illustrate some of the barriers to vaccine access faced by people with disabilities and older people, and provide strategies – and examples of how the aging and disability network can help employ them – to ensure accessibility.”
- FedSmith explains “the Difference Between Postponed and Deferred FERS Retirement While postponed and deferred retirement sound similar, there are big differences for FERS federal employees who retire early with these options.” You only receive lifetime FEHB coverage in retirement with a postponed FERS retirement.
- The trade association of prescription drug manufacturers Phrma has launched a new public relations campaign about its patient centered agenda while the Campaign for Sustainable Rx Prices “launched [its own] campaign Tuesday encouraging policymakers to act on campaign promises to hold Big Pharma accountable and lower prescription drug prices.” And so it goes.