MONTGOMERY, Ala. – The Alabama Department of Public Health (ADPH) has received final guidance from the Centers for Disease Control and Prevention (CDC) concerning use of the Johnson & Johnson (J&J) COVID-19 vaccine.
After a temporary pause on its use since April 13, the U.S. Food and Drug Administration (FDA) and the CDC recommended resumption of J&J vaccine use among persons 18 years of age and older, as available data show that the vaccine’s known and potential benefits outweigh its known and potential risks. The Advisory Committee on Immunization Practices reaffirmed its interim recommendation under FDA’s Emergency Use Authorization which includes a new warning for women aged 18-49 years.
Reports of adverse events following the use of the J&J vaccine suggest a very low but increased risk of a rare adverse event called thromobosis with thrombocytopenia syndrome (TTS). Nearly all reports of this serious condition, which involves blood clots with low platelets, have been in adult women younger than 50 years old. Women younger than 50 years old should be aware of the rare but increased risk of this adverse event and that there are other COVID-19 vaccine options available for which this risk has not been seen.
People age 16 and 17 are only eligible to receive the Pfizer vaccine. At this time, the available data suggest that the chance of adverse reactions occurring is very low, but the FDA and CDC will remain vigilant in continuing to investigate this risk.
The surveillance systems that are in place to monitor the safety of COVID-19 vaccines authorized for emergency use are effective, as demonstrated by both agencies’ quick work to identify and investigate these rare, but serious adverse events. The FDA and CDC will continue with these efforts to closely monitor the safety of these vaccines.
Although the side effects of concern are extremely rare, the FDA and CDC recommend that people who develop severe headache or blurred vision, shortness of breath, chest pain, leg swelling, persistent abdominal pain, or easy bruising or tiny blood spots under the skin beyond the injection site within three weeks of receiving the J&J vaccine should immediately contact their health care provider and seek medical care right away. There have been no reported cases of these side effects in Alabamians.
Advantages of resuming use of the J&J COVID-19 vaccine include flexibility, choice, and improved access because this is a one-dose vaccine which has less strict storage and transport requirements.
As of April 23, TTS has not been linked to the Pfizer or Moderna COVID-19 vaccines. More than 1 million Alabama residents are now fully vaccinated. The full MMWR report may be viewed here.