Governor pauses use of Johnson & Johnson vaccine after CDC news; WVU Medicine, Mon Health comment

Apr. 14—MORGANTOWN — Following Tuesday's joint CDC /FDA announcement about the Johnson and Johnson COVID-19 vaccine, Gov. Jim Justice put an immediate statewide pause on all use of the vaccine.

Clinics that are scheduled to use the Johnson & Johnson vaccine will substitute with another COVID-19 vaccine manufacturer as supplies allow, he said in his announcement.

While the Johnson & Johnson vaccine requires a single dose, the Pfizer and Moderna vaccines in more prevalent use require two doses.

WVU Medicine issued its own statement on the pause following Justice's announcement and separately answered some questions submitted by The Dominion Post. Mon Health System said it has not been using the vaccine in question but will abide by the guidance going forward.

Justice said, "The safety of West Virginians is always our first and foremost priority. This pause will not impact our ability to continue vaccinating West Virginians, and is exactly the reason why we stood up our Joint Interagency Task Force led by our West Virginia National Guard. They were absolutely ready for this scenario."

The state Department of Health and Human Resources, through the federal Vaccine Adverse Event Reporting System, has not received any reports of the extremely rare blood-clotting events in West Virginia residents who have received the Johnson & Johnson vaccine, Justice said. The DHHR will continue to monitor for instances.

The CDC and FDA said early Tuesday that as of Monday, more than 6.8 million doses of the Johnson & Johnson vaccine have been administered in the U.S. The agencies are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J &J vaccine.

In these cases, they said, 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 6 to 13 days after vaccination.

A New York Times report added that one woman died and a second woman in Nebraska has been hospitalized in critical condition.

The CDC and FDA said 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.

CDC planned to convene a meeting of the Advisory Committee on Immunization Practices on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases.

"Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot."

WVU Medicine said it will pause administration of the J &J vaccine. Dr. Clay Marsh, vice president and executive dean of WVU Health Sciences and West Virginia's coronavirus Czar, said, "The fact that CDC and FDA are acting out of caution for six clotting episodes in 6.8 million doses given should reassure West Virginia residents that we are watching any and all associated findings in those vaccinated to make sure safety is our priority."

Until the federal review process is complete, WVU will pause in the use of the J &J vaccine on all campuses and will work with those who have appointments to receive the J &J doses, including a clinic scheduled for Wednesday, to reschedule for Pfizer and Moderna doses based on availability.

WVU administered 846 doses of the J &J vaccine during a clinic held on April 8 at the Student Recreation Center on the Morgantown Campus. All other clinics held at WVU have administered doses of the Pfizer and Moderna vaccine.

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, WVUM said.

Marsh said, "We have sufficient Pfizer and Moderna vaccines to continue our goal of vaccinating all West Virginia residents, and the key to our success or failure to save lives and protect West Virginia citizens is the number of people choosing to get vaccinated."

Answering some questions from The Dominion Post, WVUM said the vast majority of the vaccines provided at the Greater Monongalia County COVID-19 Vaccine Clinic (at the former Sears building in the Morgantown Mall) have been Pfizer vaccines. They have had some Moderna vaccines, which were second-dose vaccines for WVU employees.

"It's also important to note that pauses like this are not uncommon in the development of new vaccines and medications. Because this is not a full recall of the Johnson & Johnson vaccine, any organization that has doses on hand can keep them in the storage freezer until further guidance from the CDC and government is provided.

"While this pause of Johnson and Johnson vaccine administration does not impact our vaccine clinic at all, we are facing another challenge: a lack of people signing up to be vaccinated. We have vaccine appointments available, but they are not being filled. We encourage all West Virginians over the age of 16 to visit WVUMedicine.org /Vaccine to schedule an appointment at the Greater Monongalia County COVID-19 Vaccine Clinic."

Mon Health System is a partner in that clinic. Mon Health President and CEO David Goldberg said following CDC guidance is forthright in their sight and they will follow the governor's guidance issued in response to the CDC.

"We currently, for the most part, are a Pfizer shop. So it's not really impacting our operations, " he said.

They are vaccinating employees and family members of employees. "Anything else about broader vaccinations we coordinate with Dr. [Lee 3/8 Smith and the Health Department, related to the opportunity to go to the next level, " Goldberg said.

So they will honor the delay and continue to work in the current process.

"While there's discussion about potential side effects with Johnson & Johnson — and they have to be validated by the scientists — we still encourage people to get their vaccines, " Goldberg said.

"Register at the hub [along with the Mon County clinic, the state hub is at https://dhhr.wv.gov /COVID-19 /Pages /Vaccine.aspx 3/8, continue to get your vaccines, " Goldberg said. "Because we need the COVID-19 to be mitigated while we wear our masks, wash our hands, socially distance and get vaccinated with either Moderna or Pfizer."

Both have proven safe and effective, he said. They also provide protections against the variants. "People need to do their part and those proven vaccines are showing great positives."

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