COLORADO, USA — Colorado is temporarily halting the use of the Johnson & Johnson (Janssen) COVID-19 vaccine following a recommendation from the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) after blood clots were reported in six women who received the vaccine.
"We know that one thing is sure, COVID-19 is several orders of magnitude more dangerous than the limited reporting of any of these instances of side effects from vaccines," Gov. Jared Polis said during a Tuesday update.
"We're following the FDA and CDC guidelines to hold off a few days until we develop the protocols and measurements to make sure that we can restore full public confidence in all three life saving vaccines," Polis said.
Federal health officials recommended temporarily suspending the use of the vaccine after reviewing reports that six people in the U.S. got rare and severe blood clots after receiving the vaccine but allowed states to decide how to proceed on that recommendation.
"In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred six to 13 days after vaccination.
Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given,” the FDA and CDC stated in a joint statement.
The CDC's Advisory Committee on Immunization Practices will hold an emergency meeting Wednesday to further review the cases and assess their potential significance, and the FDA will continue to investigate.
"I do expect that over the next day or two, with this review occurring, other cases will be identified, hospitals across the nation may have cases today, that they'll report to the CDC, as well, and that will allow us to get a better sense of the number of these events that seem to occur in the weeks following this vaccine, and our ability to determine, 'Is this just coincidence, or is this something more associated with vaccination?'" said Dr. Eric France, the chief medical officer with the Colorado Department of Public Health and Environment (CDPHE).
One of the reasons the FDA and CDC recommended the 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 time is needed to make sure healthcare providers know how to recognize and treat these rare occurrences.
"I think this pause is a strong reflection of our national oversight of vaccine safety," France said. "Seeing events like this occur, something very rare, like these six blood clots really do require us to take a moment and look around."
The adverse effects appear to be "extremely rare", according to CDPHE, and people who received the J & J vaccine more than a month ago are at very low risk of serious side effects.
If you received J & J vaccine within the last three weeks and develop a severe headache, abdominal pain, leg pain or shortness of breath, contact your health care provider. The symptoms are different from the flu-like symptoms people may experience after receiving a COVID-19 vaccine.
Healthcare providers should report any adverse events to the Vaccine Adverse Event Reporting System (VAERS).
The J & J vaccine makes up only a small portion of Colorado’s weekly vaccine allocation, according to CDPHE. This week, for example, the state’s J & J allocation is 9,700, compared to the nearly 280,000 doses of Pfizer and Moderna the state expects to receive this week.
Most vaccine clinics will not be significantly affected and health leaders said they expect the pause to last a few days or possibly up to a week and expect to learn more after the meeting of the CDC committee on Wednesday.
"If the situation lasts more than a few days, it would likely have an impact and delay Colorado's achievement of herd immunity, but if it only lasts two, three, four even five days, I'm confident in saying we have the supply of Moderna and Pfizer and then be able to resume J & J that will not impact timelines," Gov. Jared Polis said Tuesday.
Anyone scheduled to receive the J & J vaccine will either receive the Pfizer or Moderna vaccine instead, or the vaccine provider will contact them to reschedule their appointment once FDA and CDC release additional information.
The state’s mobile vaccination buses, which have been administering only the J & J vaccine, will not operate Tuesday or Wednesday.
Providers who already have a J & J vaccine supply should keep it and continue to maintain proper storage.
Late last week, Centura Health, which was operating three clinics with the J & J vaccine, paused the use of it at those sites after adverse side effects were reported in 11 people who received the vaccine at Dick's Sporting Goods Park.
The individuals – two of whom required transport to the emergency department for care (treated and released that same day) – were experiencing dizziness, lightheadedness, feeling faint, rapid breathing, sweating, nausea, vomiting, and/or low blood pressure.
On Tuesday, Centura Health said it would expand the pausing of the vaccine at all of its sites.
To date, Centura has administered 13,500 doses of the J & J vaccine to the community. That includes 7,800 at the Broadmoor World Arena drive-up clinic in Colorado Springs and 6,600 at Dick’s Sporting Good’s Park in Commerce City. No Johnson & Johnson vaccine was administered to individuals at the drive-up clinic at the State Fairgrounds in Pueblo.
The City and County of Denver also said it will immediately pause all use of the J & J vaccine but and anyone scheduled to receive a J & J vaccine would instead receive Moderna or Pfizer. The city said they don't anticipate any impact on operations.
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