The Johnson & Johnson Vaccine

Yesterday the Centers for Disease Control and Prevention (CDC) and the Food & Drug Administration (FDA) issued a joint statement regarding the Johnson & Johnson (J&J) COVID-19 vaccine.  

To date, more than 6.8 million doses of the Johnson & Johnson vaccine have been administered in the United States. Of those, there have been six reported cases of a rare type of blood clot, called a cerebral venous sinus thrombosis (CVST) occurring 6-13 days after vaccination. (The risk of this kind of clot is about one in a million. For people between 18-49 [close to the ages of those who experienced the CVST] the risk of dying from COVID is approximately 1,800 per one million cases. Dying from COVID is more likely than getting a blood clot from the J&J vaccine.)

The CDC is convening a meeting of the Advisory Committee on Immunization Practices (ACIP) today, Wednesday, April 14 to further review these cases and assess the significance. The FDA will review the analysis. Until these events occur, the CDC and FDA are recommending a pause in the use of the J&J vaccine. Although these adverse events appear to be extremely rare, safety is a top priority. 

The J&J vaccine was administered to 32 patients at TVC and FMH. Those individuals have been contacted and encouraged to monitor for symptoms associated with CVST. Again, the reactions appear to be very rare, but out of an abundance of caution we suggest that anyone that received the J&J vaccine monitor symptoms and seek medical care if they develop symptoms consistent with this kind of adverse reaction. Symptoms include; severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after the vaccination. 

The CDC and FDA held a media briefing yesterday, Tuesday, April 13. You can watch a replay of the briefing on the FDA’s YouTube page, here. For the most current information visit the CDC website here and click here to read the CDC’s J&J health alert.

Question & Answers

• Why is the FDA and CDC recommending a pause on distributing the Johnson & Johnson vaccine? Out of an abundance of caution, the FDA and CDC put a pause on the Johnson & Johnson vaccine based on six rare blood clotting events in recipients. While a review is underway to address next steps, the FDA and CDC are asking health care providers to watch for, evaluate and report cases. Visit the CDC website for the most current information.
• How long will this pause last? The Advisory Committee on Immunization Practices (ACIP) is meeting today, Wednesday, April 14, to evaluate and review the data from the rare adverse events. ACIP is an independent immunization advisory group for the government agencies. Based on that evaluation and recommendation the FDA and CDC will likely communicate the findings and define next steps. Visit the CDC website for the most current information.
• What should patients who have received Johnson & Johnson do at this time? This rare blood clotting reaction has occurred in 6 people out of nearly 7 million people who have received the Johnson & Johnson vaccine. The six cases involved women between ages 18 and 48 and occurred 6 to 13 days after vaccination. If you received the Johnson & Johnson COVID-19 vaccine in the last three weeks and are experiencing unexplained new severe symptoms after 72 hours and up to three weeks after vaccination, such as new severe headaches, leg pain, abdominal pain or shortness of breath, you should seek medical care. Visit the CDC website for the most current information.
• Does this affect the Pfizer and Moderna vaccines? Evidence of this rare clotting disorder has not been reported in either the Pfizer and Moderna vaccines. For the most current information on COVID-19 vaccines, visit the CDC website.
• How many Johnson & Johnsons vaccines have been administered in Alaska? As of April 12, there have been 11,178 Johnson & Johnson vaccine doses administered in Alaska out of 35,500 doses allocated in the state. This vaccine has been delivered to a number of sites in Alaska, including pharmacies, outpatient clinics, federally qualified health centers and local public health authorities. To learn more visit the Alaska DHSS website. Foundation Health Partners has administered 32.
• I had an appointment to receive the Johnson & Johnson vaccine, what should I do? All upcoming appointments for the J&J vaccine are being canceled in Alaska. This is because CDC’s Advisory Committee on Immunization Practices (ACIP) is reviewing six cases of a rare and severe type of blood clot in women aged 18-48 years after vaccination with the J&J vaccine. Anyone who was scheduled to receive the J&J vaccine in Alaska this week should reschedule their appointment to instead receive one of the mRNA vaccines (Pfizer or Moderna), call the Alaska Vaccine Helpline at 1-907-646-3322 or toll-free 1-833-4-VAXLINE (1-833-482-9546). For more information visit the Alaska DHSS website.
• I received the J&J vaccine and feel like I might have symptoms, what should I do? As with all health related situations, if you have concerns, you should reach out to your primary care provider or seek medical attention. 

Information in this communication was accurate at the time of posting. Due to the fluid nature of COVID-19 guidelines and recommendations may have changed since the original publication date. 

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