The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) handed down a recommendation to pause the use of Johnson & Johnson's JNJ COVID-19 vaccine.
In a joint audio press conference hosted by Acting FDA Commissioner Janet Woodcock, FDA Center for Biologics Evaluation and Research Director Peter Marks and CDC Principal Deputy Director Anne Schuchat, the agencies explained the motive behind the action and potential timeline for resolution, among other things.
Rare Blood Clot That Claimed a Life: The CDC and FDA are together reviewing data involving a rare kind of blood clot called cerebral venous sinus thrombosis, or CVST, in combination with a lower level of platelets, called thrombocytopenia, in women, ages 18-48 years, who presented symptoms within six and 13 days after vaccination, Marks said.
Unlike normal clots, which are treated with an anticoagulant called Heparin, CVST requires alternative medication to be administered by a physician specializing in the treatment of blood clots, he added.
Marks disclosed that out of the six cases, one case was fatal and another is under critical condition.
The FDA will now revise the fact sheet to include this adverse event to ensure healthcare providers can make an appropriate benefit-risk determination.
The regulatory agency reiterated that these events are now extremely rare but it takes all reports following vaccination seriously.
Delving on the mechanism of the blood clot, the agencies said it's probably an immune response that has occurred with other adenovirus vaccines. The extensive work between FDA and CDC helped uncover the issue.
The combination of CVST and thrombocytopenia makes a pattern that was very similar to what was seen with another vaccine in Europe, Marks said. This was in an apparent reference to AstraZeneca plc's AZN vaccine, which has also been plagued with reports of blood clots.
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Why The Pause? More than six million doses were administered so far, and there have been reports of only six cases so far. The pause, according to Schuchat, is to prepare the healthcare system to recognize and treat people appropriately and to record severe events that may be seen in vaccinated individuals. The pause will also allow the Advisory Committee on Immunization Practices, CDC's independent vaccine advisory committee, to review the situation.
The meeting is scheduled for Wednesday to review the data on the initial cases. The committee will deliberate on what is known so far and deliberate on the next steps to be taken in the context of the COVID cases in the U.S. and the broader immunization practices.
For people who got the vaccine more than a month ago, the risk of these events is very low, Schuchat said.
Those who received the vaccine over the last couple of weeks should look for symptoms such as severe headache, abdominal pain, leg pain and shortness of breath. They should contact their healthcare provider and seek medical treatment. These symptoms, Schuchat, said are different from the mild flu-like symptoms or fever seen a couple of days after receipt of the vaccine.
Schuchat clarified that these symptoms are not seen with respect to the use of the other two vaccines that are available under emergency use. With the 180 million Pfizer Inc. PFE and Moderna Inc MRNA vaccine doses administered so far, there haven't been reports of CVST or thrombocytopenia, Marks said.
Schuchat also said the agencies' partners will help reschedule the appointment of those who were to receive Johnson & Johnson's vaccine.
Likely Duration of Pause: The timeframe will depend on what is known in the next few days, Woodcock said. The agencies said they are committed to an expeditious review of available information. The AICP will review data on the cases, in the context of the subset of the population.
Pause Vs. Stoppage: FDA's Marks clarified that the agency is recommending the pause and it is not a mandate. The recommendation is made out of abundant caution. However, if an individual healthcare provider determines that the benefit-risk profile for an individual patient is appropriate, the agency will not stop the provider from administering the vaccine.
(Photo: Johnson & Johnson)
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