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Omar E. Zapata | THE RIDER
A UTRGV School of Medicine official says the university has neither received nor administered the Johnson & Johnson vaccine, whose distribution the Centers for Disease Control and Prevention and the Food and Drug Administration on Tuesday recommended be paused due to an abundance of caution after six reports of a rare and severe type of blood clot.
“As a scientist and physician, I fully support the review of the reported adverse events with the Johnson & Johnson vaccine,” said Dr. Michael Dobbs, vice dean of Clinical Affairs for the UTRGV School of Medicine and chief medical Officer for UT Health RGV. “They are very rare and I’m hopeful that after they pause for review, that they’ll determine that the vaccine is safe and go back to approving administration of the vaccine. We don’t know that, but I hope that’s what will happen.”
The Rider asked Dobbs if UTRGV will or was expecting to receive the Johnson & Johnson vaccine.
“We depend on the state government and the Department of State Health Services to allocate vaccines to us,” he said. “So, we can’t say for sure what they would allocate in the future. But indicators are that hub sites like us would continue to get the two-dose vaccines.”
In a joint news conference of the FDA and CDC Tuesday via Zoom, FDA Commissioner Janet Woodcock explained the reason for recommending the pause in the Johnson & Johnson vaccine.
“We’re recommending this pause while we work together to fully understand these events, and also so we can get information out to health-care providers and vaccine recipients,” Woodcock said.
Dr. Peter Marks, director of the FDA Center for Biologics Evaluation and Research, said that both agencies are reviewing the data from the six reports of a rare type of blood clot called cerebral venous sinus thrombosis or CVST.
Marks said a combination of CVST and low levels of platelets in the blood called thrombocytopenia, found that women aged 18 to 48 presented symptoms between 6 to 13 days after receiving the Johnson & Johnson COVID-19 vaccine.
“Treatment of this specific type of blood clot is different from typical treatments for other types of blood clots, which usually involve an anticoagulant called heparin,” he said. “With cerebral venous sinus thrombosis, heparin may be dangerous and alternative treatments need to be given, preferably under the guidance of physicians experienced in the treatment of blood clots.”
Marks said these events appear to be extremely rare, with six reports of more than six million doses of the Johnson & Johnson vaccine administered so far.
“The FDA will revise the fact sheet for the health-care providers administering vaccines, and the fact sheet for recipient and caregivers for the Janssen COVID-19 vaccine to include this adverse event information to ensure that health-care providers are able to make appropriate benefit risk determinations for their patients,” he said.
Asked how long the pause is expected to be, Woodcock replied, “The time frame will depend, obviously, on what we learn in the next few days. However, we expect it to be a matter of days for this pause.”
Anne Schuchat, principal deputy director of the CDC, said, “So, I think that our intent is, in the days ahead, to provide an update regularly and that the pause provides us time for deliberation and assuring appropriate diagnosis entries.”
Dobbs said that as of Monday, UTRGV had administered 61,352 total doses of vaccines. Of these, 58,962 were Pfizer vaccines and 2,390 were Moderna.
Of the vaccines administered, 35,147 were first doses and 26,205 were second.
“Everyone who doesn’t have a medical reason to not get vaccinated, should get vaccinated,” Dobbs said. “We’re all in this together.”
