Six patients, none believed to be in Washington state, developed severe blood clots shortly after receiving the Johnson & Johnson vaccine
The Washington State Department of Health (DOH) paused the use of the Johnson & Johnson (J & J) vaccine statewide, effective immediately, following the guidance of the FDA/CDC.
Use of the vaccine will be put on hold until the DOH receives further recommendations from its federal partners about how best to move forward. A Tuesday news release from the DOH stated that “safety is the highest priority when it comes to all COVID-19 vaccines.
“This morning, the CDC and FDA recommended pausing the Johnson & Johnson vaccine across the country due to finding six of these kinds of rare and severe blood clots shortly after getting the Johnson & Johnson vaccine,’’ said Dr. Steven Krager, deputy health officer for six counties in Southwest Washington including Clark County.
Krager, who spoke to reporters on a Zoom call Tuesday morning, said that any potential adverse reaction to the Johnson & Johnson vaccine appears to be very rare, given the fact that 6.8 million doses have been administered across the country and there have been just six cases of blood clotting.
The DOH added that the “action is being taken out of an abundance of caution based on the appearance of a rare but serious side effect including serious brain blood clots (CVST) combined with low platelet counts in six patients, all women under 50. The CDC’s Advisory Committee on Immunization Practices (ACIP) will review these cases in the days ahead and will recommend guidance going forward.’’
The DOH reported that about 149,000 doses of J & J vaccine have been administered in Washington so far, out of more than four million doses total, including the Pfizer and Moderna vaccines, which Clark County Today examined in this recent story story. At this time, the DOH has no knowledge of the six patients who experienced these blood clots being Washington residents.
The DOH reported that for those who got the vaccine more than a month ago, the risk of this complication is very low at this time. People who have received the J & J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider.
“If you’re a month out from your Johnson & Johnson vaccine, you’re well outside of this window where those potential adverse reactions may happen,’’ Krager said. “If you’re within four weeks or so, just pay attention to your body. Watch for severe headaches, abdominal pain, pain in your legs, something that might indicate a blood clot. If the symptoms are severe enough, then go to the ER.’’
DOH officials also stated that Tuesday’s news demonstrates how well the vaccine safety monitoring systems work, since this potential safety concern was identified quickly and vaccines were paused to allow for further investigation.
No definitive cause has been identified yet, but the FDA said Tuesday that a probable cause is a rare immune response generated by an individual after receiving the vaccine.
DOH will continue to monitor the situation related to J & J vaccine and update on its use as the pause is reviewed and once it is lifted.
Krager said the immediate impact on area residents who currently have an appointment to have the J & J vaccine administered will be determined by the individual provider.
“I know some providers are going to switch to another vaccine if people are okay with that,’’ Krager said. “Some clinics are just going to have to cancel for now.’’
Krager stated that Clark County had about 2,200 doses of the J & J vaccine on hand. He said those doses will be stored as health officials monitor the situation. A total of 12,500 doses have been allocated to facilities in Clark County. It is not known how many of the doses have been administered.
Krager said there was a point of dispensing clinic scheduled for this weekend in Clark County at which the J & J vaccine was to be given. He said that the clinic will obviously be put on hold. Marissa Armstrong, senior communications specialist with Clark County, said that event was still in the early planning stages and no appointments had been scheduled, therefore no area residents were impacted.
The pause of the J & J vaccine comes at a time when Krager confirms there is still anxiety among area residents in the safety of the vaccines.
“This is obviously a challenge,’’ Krager said. “I think it just depends on your perspective. From my perspective, I think this provides a lot of confidence in our system. Out of 6.8 million doses, we were able to identify six adverse events, which is an incredibly small amount. But enough that it caused concern so that the FDA and CDC decided to pause it.
“It is absolutely a setback, it’s gonna cause people to have some confidence issues, especially in the Johnson & Johnson vaccine,’’ Krager said. “We may get to a point where the risks of a severe case of COVID-19 are much higher than this potential adverse event and we will still may recommend the Johnson & Johnson vaccine because the risk of COVID-19 is so much higher. We have a lot of COVID-19 right now, circulating in our community. People continue to die from it.’’
Krager said he didn’t believe that the pause on the J & J vaccine would impact the eligibility shift scheduled to take place on April 15, when all Washington residents 16 and older will become eligible to receive a vaccine (16 and 17 year olds will only be able to receive the Pfizer vaccine)..
Information from the Johns Hopkins Center for Biosafety reported that the six known cases occurred among women between the ages of 18 and 48, and the condition presented 6 to 13 days following vaccination. One woman died, and another was hospitalized in critical condition. In these cases, cerebral venous sinus thrombosis (CVST) was identified in combination with low levels of blood platelets (thrombocytopenia), according to the agencies. Typical treatment for blood clots often involves the administration of heparin (a blood thinner); however, the administration of heparin to treat CVST can be dangerous, so alternative treatments are recommended.
Johns Hopkins officials also expressed concern that the pause could set back U.S. vaccination efforts, due to not only fewer available doses, but also the impact on public confidence in SARS-CoV-2 vaccines.
Johns Hopkins also reported that on April 9, the European Medicines Agency announced it was investigating four cases of blood clotting among recently vaccinated individuals who received the J & J vaccine in the U.S., in addition to expanding its probe into a possible link between blood clot events and the AstraZeneca-Oxford vaccine.
Also on April 9, the New England Journal of Medicine published two studies describing 11 patients in Austria and Germany and five in Norway who developed rare blood clotting disorders after receiving their first dose of the AstraZeneca-Oxford vaccine. In the first study, nine of the 11 described cases occurred among women, with patients ranging in age from 22 to 49 years, and in the second study, four of the five cases involved women, with patients ranging in age from 32 to 54 years.