The U.S. Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) have lifted a temporary pause on the distribution and use of the Johnson & Johnson (J&J) COVID-19 vaccine.
The federal agencies announced on Friday, April 23 that the J&J vaccine distribution should resume. In a report, both agencies found that the vaccine was “safe and effective in preventing COVID-19” and that the benefits of the vaccine outweigh its known risks.
In mid-April, the CDC and FDA announced that it recommended pausing the J&J vaccine distribution “out of an abundance of caution” after six individuals experienced blood clots after taking the vaccine. These individuals, all females ranging in age from 18 to 48, experienced the symptoms in the first two weeks after the vaccine’s administration.
The CDC’s Advisory Committee on Immunization Practices met twice to discuss the matter and will be continuing vaccine safety monitoring for the J&J vaccine.
“Safety is our top priority. This pause was an example of our extensive safety monitoring working as they were designed to work—identifying even these small number of cases. We’ve lifted the pause based on the FDA and CDC’s review of all available data and in consultation with medical experts and based on recommendations from the CDC’s Advisory Committee on Immunization Practices. We have concluded that the known and potential benefits of the Janssen COVID-19 Vaccine outweigh its known and potential risks in individuals 18 years of age and older. We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality. We recommend people with questions about which vaccine is right for them have those discussions with their health care provider,” acting FDA Commissioner Janet Woodcock, M.D. said in a statement.
After the announcement of the vaccine pause, state officials agreed to pause the distribution of the J&J vaccine in Arkansas. On Monday, April 26, Gov. Asa Hutchinson announced that the state will resume the distribution of the vaccine.
“Vaccinations are the most important tool we have to neutralize COVID-19,” Hutchinson said in a statement. “The resumption of the J&J distribution allows us to say with confidence that the vaccine is as safe as the first two. This will reenergize our campaign to persuade everyone to be immunized. Vaccinations are the only way we can bring this global pandemic to an end. Now that the pause is lifted, the J&J vaccine will be available through many pharmacies and Arkansas’s local public health units. Don’t wait any longer to get your shot.”