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Risk of side effects from Johnson & Johnson COVID-19 vaccine extremely low
Contact: Nicole Valentine, Summit County Director of Communications
SUMMIT COUNTY – The Colorado Department of Public Health and Environment (CDPHE) announced Tuesday that out of an abundance of caution, providers are being required to temporarily pause the use of the Johnson & Johnson (Janssen) COVID-19 vaccine. CDPHE issued this direction following the joint FDA and CDC announcement that six individuals in the U.S. experienced rare and severe blood clots after receiving the vaccine.
The federal government is allowing states to determine whether to pause use, and CDPHE is requiring providers to stop administration of the Johnson & Johnson (Janssen) vaccine until additional information becomes available. One of the reasons the FDA and CDC are recommending this pause is to ensure health care providers are aware of these potential but rare adverse events and can respond accordingly. The treatment for these types of blood clots is not the common treatment and thus time is needed to make sure healthcare providers know how to recognize and treat these rare occurrences.
“It is important to note that the risk of blood clots, particularly cerebral venous thrombosis (CVT), a blood clot of a cerebral vein in the brain, from this vaccine is very, very rare,” said Summit County Public Health Director Amy Wineland. “It is important that the CDC and FDA are taking this seriously and putting a temporary halt to the use. This will allow time to make providers aware of the possible but very rare reaction, and to see if there are any common denominators among the women who were involved. However, there have only been 6 reported incidences in 6.8 million doses administered. This is an occurrence rate of 0.88 per million and the vaccine remains to be safe and effective.”
“The risk of CVT in the general population, has ranged from five to over fifteen per million according to studies. Thus the risk of CVT from the vaccine is five to seventeen times less than the occurrence of this in the general population, prior to the introduction of Covid-19 illness or vaccinations,” added Wineland.
It is important to note that the risk of CVT in women, due a number of factors, is higher than men in general with about 60-65% of cases in females, potentially due to hormonal factors. Summit County Public Health officials emphasize that the risk from the vaccine at this point is less than the risk to the general population prior to having the vaccine.
The timeline to see blood clots is typically within nine days following vaccination. For individuals that received the J&J vaccine over a month ago, it is highly unlikely that they would develop a reaction at this point. Public health officials are asking that individuals who received the J&J vaccine within the last three weeks, including those that attended the State sponsored restaurant worker clinic on March 23, as well as the J&J vaccine clinic held in Copper on April 12, and who develop severe headache, abdominal pain, leg pain, or shortness of breath, contact their health care provider. These symptoms are different from the flu-like symptoms people may experience after receiving a COVID-19 vaccine.
Summit County Public Health has vaccinated over 15,470 individuals to date through community vaccination clinics. Moderna and Pfizer vaccines have been the primarily vaccines provided, as the J&J has only been available in limited quantities. Public Health officials report only minor reactions from community members including headache, nausea, tiredness, muscle pain, chills and fever. Some individual reported experiencing pain, redness, or swelling at the injection site. Summit County Public Health is not aware of any hospitalizations as a result of a vaccine administered in Summit County.
Summit County Public Health will not be cancelling any vaccination clinics this week as a result of the announcements. The clinics were planned with Moderna and Pfizer vaccine. Other providers in Summit County may need to cancel appointments if their weekly allocation of vaccine included J&J, and will reach out to impacted individuals directly to reschedule.
“Given our rising case numbers across the country, and the increasing presence of the new variant strains locally, we continue to encourage our residents to get vaccinated and this should not be a deterrent,” said Commissioner Tamara Pogue. “The path forward to reopening is through vaccination. If we can make a communitywide effort to reach a 70% vaccination rate in the next several weeks, we could be in Level Green by Memorial Day weekend. That is something that we all want, and something that our economy needs.”
Summit County’s seven-day cumulative incidence rate is currently in the Level Yellow threshold of concern with 274.3 new cases per 100,000 residents. The seven-day positivity rate for testing is currently in Level Orange, at 8.7.
For information on vaccination appointments with Summit County Public Health, visit: https://www.summitcountyco.gov/1423/Scheduling-Vaccinations.
To view Summit County Vaccination data, visit: https://www.summitcountyco.gov/1433/Vaccines.