CDC, FDA call for rollout pause amid blood clot reports
The CDC and FDA recommended suspending the use of the J&J vaccine amid reports of blood clots in six recipients of the jab. All six were women between the ages of 18 and 48, all of whom developed the illness within one to three weeks of vaccination. One woman in Virginia died while another in Nebraska was in critical condition. "We are recommending a pause in the use of this vaccine out of an abundance of caution," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, and Dr. Anne Schuchat, the CDC's principal deputy director, said in a joint statement. "Right now, these adverse events appear to be extremely rare." The rollout of the vaccine was now frozen in virtually the entire U.S., with all states, the District of Columbia and Puerto Rico halting or recommending pausing injections by Tuesday evening. (Related: Mass vaccination site in Colorado shut down after people experience adverse reactions from Johnson & Johnson vaccine.) J&J also said that it would delay rolling out the vaccine in Europe. This came a week after the European Medicines Agency, which approved the jab over a month back, announced that it was investigating four cases of blood clots in Americans vaccinated with the shot. Marks noted that it was "plainly obvious" that the J&J cases were similar to the ones involving the AstraZeneca-Oxford COVID-19 vaccine. Over the past month, multiple cases of blood clots in people who received the vaccine emerged in various countries, including Norway and Denmark. After a preliminary review, the EMA determined that the jab was safe and that its benefits outweighed its risks. But in its announcement on April 4, the regulator concluded that blood clots and low levels of blood platelets should be listed as "rare side effects" of the shot. It also warned that these conditions could occur within two weeks of vaccination.Batch of J&J vaccine was contaminated
This came weeks after a batch of the J&J vaccine was found to be contaminated. Last month, the pharmaceutical giant said that a batch of a key vaccine ingredient made at a Baltimore facility failed to meet quality standards. The firm said that the batch had been discarded, scrapping what could have been 15 million doses.
"This batch was never advanced to the filling and finishing stages of our manufacturing process," J&J said in a statement.
A senior federal official disclosed that the batch was contaminated with ingredients of the AstraZeneca-Oxford vaccine, which the Baltimore plant also manufactured until early this month. The facility, which wasn't approved yet to distribute the J&J doses it produced, was ordered to stop making AstraZeneca's jab due to the contamination incident.
A report from the New York Times revealed that the facility, which is owned by Emergent BioSolutions, often flouted basic industry standards, ignored missteps and repeatedly fell short of disinfecting areas. The report also indicated that Emergent dumped five batches of the AstraZeneca-Oxford jab between last October and January because of contamination or suspected contamination.
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