CDC and FDA Lift Recommended Pause of Johnson & Johnson COVID-19 Vaccine Following Safety Review NC Vaccine Providers to Resume Use of Johnson & Johnson Vaccine

Raleigh

Following a thorough safety review, the Centers for Disease Control and Prevention and the Food and Drug Administration have confidence that the Johnson & Johnson vaccine is safe and effective in preventing COVID-19 and recommend its continued use to prevent serious illness, hospitalization and death from COVID-19. The North Carolina Department of Health and Human Services is recommending that providers in the state resume administration of the vaccine now that the CDC and FDA have reaffirmed its safety.

The pause was made out of an abundance of caution after reports of six cases of a rare type of blood clot in individuals after receiving the Johnson & Johnson COVID-19 vaccine. This potential reaction is very rare as millions of people have received the Johnson & Johnson vaccine. During the pause, medical and scientific teams at the FDA and CDC examined available data to assess the risk of this type of reaction. In a joint statement, the CDC and FDA shared the following:

  • The FDA and CDC have confidence that this vaccine is safe and effective in preventing COVID-19. 
  • The FDA has determined that the available data show that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older. 
  • At this time, the available data suggest that the chance of this type of rare blood clot occurring is very low, but the FDA and CDC will remain vigilant in continuing to investigate this risk. 
  • The Johnson & Johnson COVID-19 fact sheet for recipients has been updated to include information about the risk of this syndrome.

During the pause, 9 additional cases were identified, resulting in 15 total cases among more than 8 million doses given. All of these cases occurred in women between the ages of 18 and 59. More than 250,000 people have received the Johnson & Johnson vaccine in North Carolina as of April 13, 2021.    

Like all other COVID-19 vaccines, the Johnson & Johnson vaccine may produce temporary reactions like a sore arm and feeling tired or achy for a day or two. Mild headaches and flu-like symptoms in the first few days after vaccination can be expected. While it is extremely rare that you would have a serious adverse reaction, if you develop severe headache, backache, severe abdominal pain, new neurologic symptoms (like changes in vision, changed mental status or numbness), leg pain or swelling, shortness of breath, tiny red spots on your skin (called petechiae), or new or easy bruising within three weeks after vaccination, contact your health care provider or seek medical care.

Currently, there are approximately 132,000 doses of the Johnson & Johnson vaccine available in North Carolina. The state expects to be able to order new shipments of the Johnson & Johnson vaccine next week.

To read the full statement from the FDA and CDC, go to www.fda.gov.

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