The Centers for Disease Control (CDC) and the Food and Drug Administration (FDA) announced findings surrounding review of the Johnson & Johnson (Janssen) vaccine Friday, confirming that the vaccine is safe to return to distribution. The Colorado Department of Public Health and Environment (CDPHE) and the Colorado Joint Vaccine Task Force have aligned with the findings and authorized the vaccine to return to clinics effective immediately, according to a San Miguel County news release.
Upon initial reports, the Advisory Committee on Immunization Practices (ACIP) launched an emergency investigation out of an abundance of caution to determine causation and appropriate response. The review panel determined that there have been seven cases per million doses among women between ages 18-49 who had rare and severe blood clots (now called thrombocytopenia syndrome or TSS) after receiving the Johnson & Johnson vaccine. With less than one in one million results of TSS, the ACIP concluded that the Johnson & Johnson vaccine is a safe and viable COVID-19 vaccine option.
According to a news release from the FDA and CDC, 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 have been provided updated information on the risks of this syndrome, which have occurred in a very small number of people who have received the Janssen COVID-19 Vaccine.
“The measures taken by the FDA, CDC and the state not only confirm that the proper precautions are in place, but also that the health and safety of all is of greatest importance,” county public health director Grace Franklin said. “This single dose vaccine is critical to the protection and recovery of rural communities like San Miguel County. We are excited to return to offering two options to our residents through our three vaccine distribution centers.”