DHP Releases Statement on FDA and CDC's Decision to Lift the Pause of the Johnson & Johnson Vaccine
Friday, April 23, 2021, the CDC and FDA recommended lifting the pause on the use of the Johnson&Johnson Janssen vaccine, after the CDC’s Advisory Committee on Immunization Practices (ACIP) met and voted to recommend use of the vaccine continue. The Delaware Division of Public Health (DPH) will provide updated FDA materials to providers and is updating the FDA materials for providers and the public on its website. The CDC has indicated additional communication and materials will be available this week.
The FDA and CDC have confidence that this vaccine is safe and effective in preventing COVID-19, according to a CDC press release issued Friday evening. 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 blood clots and low platelets, also known as thrombosis-thrombocytopenia syndrome (TTS) occurring is very low, but the FDA and CDC will remain vigilant in continuing to investigate this risk.
We remain unaware of any issues of blood clots in Delaware that may be related to this vaccine. The effects that would indicate a blood clot are different than the usual flu-like symptoms experienced between 1 and 3 days after vaccination (minor headache, soreness or redness at the injection site, fatigue, nausea).
Patients experiencing the following symptoms within three weeks of getting the vaccine should seek immediate medical attention:
- Severe headache
- Backache
- Blurred vision
- Fainting
- Seizures
- Severe pain in your abdomen or stomach
- Severe pain in your chest
- Leg swelling
- Shortness of breath
- Tiny red spots on the skin
- New or easy bruising or bleeding.
As a reminder, CDC and FDA recommended this pause after the monitoring systems that make sure vaccines are safe received a small number of reports nationwide of people who received the J&J vaccine experiencing a rare and severe type of blood clot with low platelets. The pause was intended to gather more information about situation and give the agencies time to communicate with, and prepare the health care system to recognize and treat patients appropriately. There had been more than 7.5 million doses of the J&J/Janssen COVID-19 vaccine administered as of the time of the pause in the United States. This situation tells us that the safety systems in place work. This potential safety issue was caught early, and this pause reflects the federal government’s commitment to transparency as CDC and FDA reviewed the data.
Read the updated Emergency Use Authorization for the Janssen COVID-19 Vaccination.
