WASHINGTON, D.C. – The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) have recommended a “pause” on the use of the Johnson & Johnson COVID-19 vaccine after six women developed blood clots days after having been administered the drug, according to reports.
In a joint statement issued by the CDC and FDA on Tuesday, the organizations will hold a meeting of the Advisory Committee on Immunization Practices on Wednesday to review the potential side effect – which is described as “a rare and severe type of blood clot” – that developed in the six cases.
After that, the FDA will investigate the issue to see if the problem could become widespread if use of the Johnson & Johnson vaccine continues, according to Deputy Director of the CDC Dr. Anne Schuchat, and Director of the FDA’s Center for Biologics Evaluation and Research Dr. Peter Marks.
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“Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” they said in Tuesday’s statement.Deputy Director of the CDC Dr. Anne Schuchat, and Director of the FDA’s Center for Biologics Evaluation and Research Dr. Peter Marks
The blood clots – known as cerebral venous sinus thrombosis – appeared 6 to 16 days after the women – who were between 18 and 48 years of age – were vaccinated, Schuchat and Marks noted.
“Treatment of this specific type of blood clot is different from the treatment that might typically be administered,” they said in the statement. “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.”Deputy Director of the CDC Dr. Anne Schuchat, and Director of the FDA’s Center for Biologics Evaluation and Research Dr. Peter Marks
To date, out of the over 190 million COVID-19 vaccine shots that have been administered nationwide, only approximately 6.8 million people have had the single-shot Johnson & Johnson vaccine; the majority of Americans have had the two-shot Pfizer or Moderna vaccines, neither of which have reported any major issues thus far.
On Tuesday the Biden Administration commented on the issue, saying that the “pause” on the Johnson & Johnson inoculation will not have much impact on President Joe Biden’s vaccine rollout plans for the country, given that only a small percentage of the public had actually been receiving that version of the drug, according to White House COVID-19 Response Coordinator Jeff Zients.
“This announcement will not have a significant impact on our vaccination plan: Johnson & Johnson vaccine makes up less than 5 percent of the recorded shots in arms in the United States to date,” he said. “Based on actions taken by the President earlier this year, the United States has secured enough Pfizer and Moderna doses for 300 million Americans.”White House COVID-19 Response Coordinator Jeff Zients.
“The safety and well-being of the people who use our products is our number one priority,” J&J wrote in a statement amid reports of the pause. “We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine. In addition, we have been reviewing these cases with European health authorities. We have made the decision to proactively delay the rollout of our vaccine in Europe. We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public.Johnson & Johnson