The USDA and CDC are currently recommending that the country puts a freeze on the COVID-19 vaccine from Johnson & Johnson after six reported cases of blood clots.
After more than 6.8 million doses of this particular vaccine have been administered, these six cases are said to be “rare and severe.”
All of these cases came about in women between the ages of 18 and 48. Blood clot symptoms appeared 6 to 13 days after the vaccine was administered.
This past Tuesday, a joint statement with Dr. Peter Marks, director of the Center for Biologics Evaluation and Research for the FDA, and Dr. Anne Schuchat, the principal deputy director for the CDC.
The statement read,
“CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) 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.”
Johnson & Johnson Releases a Statement
This past Tuesday, Johnson & Johnson also released a statement saying that the company has come to the decision to “proactively delay” its European vaccine rollout.
“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,” said the statement.
Those who have received the vaccine and have experienced certain symptoms within three weeks of administration, including severe abdominal pain, headaches, shortness of breath, or leg pains, should contact their healthcare provider.
The statement also notes that these negative effects “appear to be extremely rare.”
Executive associate dean of the Emory University School of Medicine at Grady Health System, Dr. Carlos Rio, said, “It’s a very rare event. You’re talking about 1 per million, and when you give millions of doses of vaccines, you will see events like this that you couldn’t see in the clinical trial just because you didn’t have millions of people enrolled.”
Del Rio also pointed out that blood clots may be connected to the fact that, similar to the AstraZeneca vaccine the Johnson & Johnson vaccine is what they call an adenovirus vector vaccine.
The AstraZeneca vaccine can be found in over 70 countries as of today, though is not available in the United States. Some cases of unusual blood clotting were concluded by the European Medicines Agency, though they put them down as a “very rare” side effect.
As of now, this latest announcement from the CDC and FDA means that all sites that were administering the Johnson & Johnson vaccine in the United States have now shut down. This pause is because this particular blood clot type was never listed as one of the potential negative effects of the vaccine.