The Centers for Disease Control and Prevention and Food and Drug Administration have lifted the pause on the Johnson & Johnson COVID-19 vaccine.
- The label for the vaccine will be updated to include a warning for blood clot risks.
- The FDA said vaccinations with the J&J vaccine can pick up beginning Saturday.
The rollout of the Johnson & Johnson COVID-19 vaccine was paused by the FDA and the CDC after there were reports of blood clots in people who received the vaccine, as I explained for the Deseret News.
Experts explain end of J&J pause:
- “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 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.”
Dr. Rochelle Walensky, the CDC director, said in a statement that the pause was an example of the COVID-19 vaccine process working.
- “As we always do, we will continue to watch all signals closely as more Americans are vaccinated. I continue to be encouraged by the growing body of real-world evidence that the authorized COVID-19 vaccines are safe and effective, and they protect people from disease, hospitalization, and death. I urge anyone with questions about the COVID-19 vaccines to speak with their healthcare provider or local public health department.”
The decision to approve the vaccine again came hours after the CDC’s Advisory Committee for Immunization Practices recommended lifting the pause on the J&J vaccine, according to CNN.
- “Everything is on the table,” Fauci said, according to USA Today. “My estimate is that we will continue to use it in some form. I doubt very seriously if they just cancel it. I don’t think that’s going to happen. I do think that there will likely be some sort of warning or restriction or risk assessment.”