Last Updated: Apr 15, 2021
The Pennsylvania Department of Health notified all COVID-19 vaccine providers to pause administering doses of the Johnson & Johnson (Janssen) vaccine until April 24 (extended from April 20) or until updated guidance is provided from the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA).
This comes after the FDA and CDC recommended a pause in the use of the Johnson and Johnson COVID-19 vaccine out of an abundance of caution, following six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving this vaccine.
A joint FDA/CDC media briefing was held on April 13, and you can access the recording on the FDA’s YouTube channel.
The CDC convened a meeting of the Advisory Committee on Immunization Practices (ACIP) on April 14 to review these cases and assess their potential significance. The ACIP decided to continue the pause while they further assess a potential link. The ACIP is expected to meet again within a week to 10 days.
The six reported cases involve a type of blood clot called cerebral venous sinus thrombosis (CVST), which was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48,
and symptoms occurred 6 to 13 days after vaccination.
CDC's HAN alert can be found here.
DOH's HAN alert can be found here.
What physicians and other health care providers should know?
- Providers who were planning to administer Johnson & Johnson vaccine to individuals are
asked to cancel those appointments immediately, or, if possible reschedule those
appointments using the Pfizer or Moderna vaccine.
- If a patient presents with blood clots, a low platelet count, severe headache, abdominal pain, leg pain, or shortness of breath, inquire about their recent vaccination history.
- The FDA and CDC noted that while an anticoagulant drug called heparin is typically used to treat blood clots, in this setting, administration of heparin may be dangerous. In these cases, alternative treatments need to be given, preferably under the
guidance of a physician who has experience with treating blood clots.
- Report any adverse events to the Vaccine Adverse Event Reporting System.
What patients should know?
- Right now, both the FDA and the CDC say that these adverse events appear to be extremely rare. As of April 12, 2021, more than 6.8 million doses of the Johnson & Johnson vaccine have been administered in the U.S., and there have only been six
reported cases of this type of blood clot.
- If you’ve received the Johnson and Johnson vaccine and develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination, contact your health care provider immediately.
- Both the FDA and CDC reiterated that vaccine safety is a top priority of the federal government.