In response to the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) announcement that providers should resume using the Johnson & Johnson vaccine, the Colorado Department of Public Health and Environment (CDPHE) and the Colorado Joint Vaccine Task Force are alerting providers they can proceed with using the Janssen (Johnson & Johnson) COVID-19 vaccine immediately.
“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. “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.”
The ACIP’s recommendation comes after federal health officials recommended temporarily suspending use of the vaccine after reviewing reports of six individuals in the U.S. who got rare and severe blood clots after receiving the vaccine (now called thrombosis with thrombocytopenia syndrome or TTS). In light of today’s news, CDPHE has decided to proceed by including FDA’s updated warning to patients about the increased risk of very rare but potentially severe TTS, particularly among women under the age of 50 (approximately 7 cases of TTS per 1,000,000 vaccine doses have been identified in this group to date). CDPHE has also sent information to health care providers to inform how to identify and treat TTS in the very rare case it were to occur.
According to a press 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 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.
“Vaccine safety and the health and safety of all Coloradans is a top priority,” Dr. France added. “The CDC and FDA conducted this investigation and review out of an abundance of caution and is a result of their long-standing and ongoing safety monitoring processes of all vaccines.”
Vaccine providers are required to report any adverse events following COVID-19 vaccination to the Vaccine Adverse Event Reporting System.
The CDC’s v-safe is a new smartphone-based, after-vaccination health checker for people who receive COVID-19 vaccines. When you receive your vaccine, you should also receive a v-safe information sheet telling you how to enroll in v-safe. If you enroll, you will receive regular text messages directing you to surveys where you can report any problems or adverse reactions you have after receiving a COVID-19 vaccine. V-safe is available in English, Korean, simplified Chinese, Spanish, and Vietnamese.
All Coloradans over the age of 16 who want a vaccine can get one. The vaccines will help us get back to work, back to spending time with friends and family, and back to a more normal life. None of the currently authorized vaccines is currently recommended over any other. All three vaccines are safe and work well to prevent moderate to severe COVID-19 disease. For more information about COVID-19 vaccines, please visit CDPHE’s vaccine webpage.
Additional Resources from the CDC and FDA:
- Fact Sheet for Healthcare Providers Administering Vaccine
- Fact Sheet for Recipients and Caregivers
- CDC Health Alert for Health Care Providers (April 13, 2021)
- Johnson & Johnson Granting EUA Amendment (April 23, 2021)
Continue to stay up to date by visiting covid19.colorado.gov.