Colorado health officials clear resumption of the single-dose vaccine.
The Johnson & Johnson COVID-19 vaccine has been cleared for use in Colorado by state health officials, following the lead of federal regulators in lifting an 11-day pause on the vaccination as scientific advisers decided its benefits outweigh risks.
“We are happy to have this highly effective, one-dose vaccine back as an option for Coloradans,” said Dr. Eric France, CDPHE chief medical officer, in a news release. “We appreciate the caution the CDC and FDA took to evaluate the Johnson & Johnson vaccine and are ready to ramp back up distribution as quickly as possible.”
On April 13, the CDPHE directed vaccine providers across Colorado to suspend the single-dose shot temporarily after federal regulators reported rare blood clots in six women nationwide after they had been inoculated. The blood clots, after receiving the vaccine, are now referred to as thrombosis with thrombocytopenia syndrome (TTS).
The J&J vaccinations will resume in Colorado with and updated warning from the Food and Drug Administration about the increased risk of TTS. It is very rare but potentially severe, particularly among women under age 50. About seven cases of TTS per 1,000,000 vaccine doses have been identified in the at risk group to date, according to the CDPHE. State health officials are informing local health care providers how to identify and treat TTS.
So far, the government has uncovered 15 vaccine recipients nationwide with TTS out of nearly 8 million people given the J&J shot, according to The Associated Press. All have been women, most under 50. Three have died, and seven remain hospitalized.
The FDA and the Centers for Disease Control and Prevention, according to the CDPHE news release, have determined:
- 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 vaccine’s known and potential benefits, based on available data, outweighs its known and potential risks in people above the age of 17.
- At this time, based on data, the risk of TTS is very low.
- Vaccine providers and recipients should review available fact sheets about the vaccine.
“Vaccine safety and the health and safety of all Coloradans is a top priority,” France said. “The CDC and FDA conducted this investigation and review out of an abundance of caution…a result of their long-standing and ongoing safety monitoring processes of all vaccines.”
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