The Food and Drug Administration (FDA) on May 5 limited authorized use of the Janssen Johnson & Johnson COVID-19 vaccine. Vaccine use now is restricted to individuals 18 and older for whom other authorized or approved COVID-19 vaccines are not accessible or clinically appropriate, as well as those who elect to receive the Janssen COVID-19 vaccine because they would otherwise not receive a COVID-19 vaccine.
The agency cites the risk of thrombosis with thrombocytopenia syndrome (TTS), a life-threatening condition characterized by blood clots combined with low levels of blood platelets, with symptoms developing one to two weeks following vaccination.
FDA authorized the vaccine in February 2021, and, along with the Centers for Disease Control and Prevention (CDC), paused administration in April 2021 to investigate six reported TTS cases. Distribution resumed later that month after a safety evaluation and two meetings of CDC’s Advisory Committee on Immunization Practices (ACIP). In December 2021, ACIP made a preferential recommendation for the use of mRNA COVID-19 vaccines over the Janssen COVID-19 Vaccine in all people 18 and older in the United States, citing updated vaccine effectiveness and safety data.
Examples of individuals still authorized to receive the Janssen vaccine include those who:
- experienced an anaphylactic reaction after receiving an mRNA COVID-19 vaccine;
- have personal concerns with receiving mRNA vaccines and would otherwise not receive a COVID-19 vaccine; and
- would remain unvaccinated for COVID-19 due to limited access to mRNA vaccines.
FDA has updated its fact sheets for health care providers and recipients and caregivers to reflect the vaccine’s limited authorization.
ASPE: COVID-19 Medicare Hospitalizations Declined during Early Vaccine Period
COVID-19 vaccinations were associated with a reduction in Medicare hospitalizations and an estimated $2.6 billion in savings in early 2021, according to a new report from the Office of the Assistant Secretary for Planning and Evaluation (ASPE).
Using Medicare fee-for-service claims data and county vaccination rates, ASPE estimated 107,000 fewer Medicare COVID-19 hospitalizations during the period from January through May 2021, compared with projected hospitalization rates if no COVID-19 vaccines were available. Hospitalization cost savings from this period were nearly large enough to offset the cost for approximately 67.7 million single-dose vaccines or 31.2 two-dose series, assuming an average cost of $40 per dose.
FDA Leader Highlights Agency Guidance for Paxlovid Prescription
John Farley, MD, MPH, director of the FDA Office of Infectious Diseases, shared guidance for health care providers about prescribing Paxlovid for non-hospitalized adults with COVID-19 who are at risk for progression to severe disease.
Notably, FDA recently updated the Paxlovid fact sheet for health care providers with information about Paxlovid’s interaction with other drugs. The agency also developed a Prescriber Patient Eligibility Screening Checklist to help health care providers determine patients’ eligibility for Paxlovid.
FDA Extends Bamlanivimab Shelf Life
FDA on May 4 extended from 18 to 24 months the shelf life of select lots of bamlanivimab, an Eli Lilly monoclonal antibody used for COVID-19 treatment and post-exposure prevention. Bamlanivimab and etesevimab, another monoclonal antibody prescribed in concurrence with bamlanivimab, currently are not authorized to treat COVID-19 due to the high frequency of the omicron SARS-CoV-2 variant in the United States, against which bamlanivimab and etesevimab are not effective. However, the U.S. government has recommended that product be retained should future SARS-CoV-2 variants that are susceptible to the antibody become prevalent.
FDA plans to share an update on etesevimab’s shelf life in November 2022; all etesevimab vials may be retained until the shelf-life extension evaluation is complete, regardless of the current labeled expiry date or previously provided extension dates. Contact COVID19Therapeutics@hhs.gov with questions about expiration dates.
Visit the America’s Essential Hospitals coronavirus resource page for more information about the pandemic.
Contact Senior Director of Policy Erin O’Malley at eomalley@essentialhospitals.org or 202.585.0127 with questions.
