FDA & CDC Resumes Use of J&J Covid Vaccine
Recently, the FDA paused the use of the J&J Covid-19 vaccine while it investigated a very small cluster of extremely rare events in 6 women in the United States that received the single dose vaccine within two weeks of symptoms. There have been no reported cases in Massachusetts. It is a rare occurrence that involved both a blood clot and low platelets. This small cluster of events occurred as the United States has given more than 7 million J & J vaccines since its rollout. The FDA paused the J&J vaccine “out of an abundance of caution”.
However, following a thorough safety review, including two meetings of the CDC’s Advisory Committee on Immunization Practices, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention have determined that the recommended pause regarding the use of the Johnson & Johnson (Janssen) COVID-19 Vaccine in the U.S. should be lifted and use of the vaccine should resume.
The two agencies have determined the following:
- Use of the Janssen COVID-19 Vaccine should be resumed in the United States.
- 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 TTS occurring is very low, but the FDA and CDC will remain vigilant in continuing to investigate this risk.
- Health care providers administering the vaccine and vaccine recipients or caregivers should review the Janssen COVID-19 Vaccine Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Fact Sheet for Recipients and Caregivers, which have been revised to include information about the risk of this syndrome, which has occurred in a very small number of people who have received the Janssen COVID-19 Vaccine.
IT IS REALLY IMPORTANT TO GET VACCINATED AGAINST COVID-19! Vaccines are safe and one of the best ways to protect yourself and those around you from getting sick from COVID-19.
For trusted and up to date information about the Covid vaccine, visit https://www.mass.gov/info-details/trust-the-facts-get-the-vax