OHA clears health care providers to resume Johnson & Johnson vaccinations with informed decision-making in patient languages

Salem, Ore. — Oregon health care providers and pharmacies may resume administering the Johnson & Johnson COVID-19 vaccine if they can ensure patients or their caregivers are informed about the benefits and risks of the vaccine in their primary language.

The Oregon Health Authority issued guidance to health care providers earlier Saturday. Currently, there are approximately 124,000 doses of the Johnson & Johnson vaccine that have been stored at Oregon vaccination sites, while providers awaited resolution of the recent federal and Western States safety reviews.

On April 13, the federal Centers for Disease Control and Prevention (CDC) recommended a pause on use of the Johnson & Johnson vaccine following reports of rare and serious blood clots in a small number of people, out of the approximately 7.5 million people who’d been vaccinated at the time.

Friday, the Food and Drug Administration lifted the pause, with a warning about the potential for rare blood clots for women under age 50. The Western States Scientific Safety Review Workgroup also found that the Johnson & Johnson vaccine is “generally safe and effective and that the resumption of its use is warranted once culturally and linguistically appropriate patient and provider educational materials in plain language that support informed decision-making are available.”

Medical experts on the Western States Scientific Safety Review Workgroup also stated: “resumption of its use will support COVID-19 vaccine uptake and help reduce severe COVID-19 illnesses and control the pandemic in our states.”

According to OHA’s guidance to health care providers:

Vaccine providers in Oregon may now resume the use of the Johnson & Johnson COVID-19 vaccine so long as they ensure that recipients or their caregivers receive the new warning information regarding thrombosis and thrombopenia. This information must be provided in the individual’s primary language or in a manner that the individual can understand, considering English language proficiency and Americans with Disabilities Act accessibility needs. Updated fact sheets including this warning have been approved by the FDA, including the Fact Sheet for Healthcare Providers administering vaccine and the Fact Sheet for Recipients and Caregivers.

OHA’s guidance also states: “Recipients of the Johnson & Johnson vaccine should be made aware of this rare potential risk of blood clots within the first three weeks of vaccination. Clinical characteristics include clots in the cerebral, extremity, pulmonary or splanchnic vasculature. Symptoms may include severe or unusual headache, leg pain, shortness of breath, or abdominal pain; petechiae in the arms and shins indicating thrombocytopenia. Those who develop such symptoms should be advised to seek medical attention immediately … Vaccine providers should make information available about which vaccine is available at their site.”

More information about vaccinations in Oregon is available at covidvaccine.oregon.gov.