In a blow to the single dose Johnson & Johnson COVID-19 vaccine rollout, the FDA and CDC have just announced that they are “recommending a pause in the use of this vaccine out of an abundance of caution.” The Food and Drug Administration said Tuesday it is asking states to temporarily halt using Johnson & Johnson’s Covid-19 vaccine after six people in the U.S. developed a rare blood clotting disorder. However, this is just a recommendation and healthcare providers can consult with their patients and decide if administering the vaccine is appropriate on a case by case risk assessment basis. JJ vaccine pause Acting FDA administrator Janet Woodcock told reporters the recommendation was made out of an abundance of caution. She said the federal health agencies want more time to review the data. Six women developed blood clots a week or two after they were vaccinated. Woodcock called the cases extremely rare. One woman died and another is in critical condition. J&J is providing the only single-dose vaccine. Six American women between the ages of 18 and 48 developed a rare disorder involving blood clots within two weeks of being vaccinated. One died and a Nebraska woman is hospitalized in critical condition. Nearly seven-million people in this country have already received Johnson and Johnson shots and about nine-million more doses have been shipped out to states. As a result, the Village of Wellington has canceled their pop-up COVID-19 vaccination clinic due to concerns about the Johnson & Johnson vaccine. The clinic was set to distribute 400 doses of the Johnson & Johnson vaccine on Tuesday.
Shares of J&J were down more than 3% in premarket trading Tuesday. The FDA’s Dr. Peter Marks said there are no such concerns with the Moderna and Pfizer vaccines. Further details are expected at a 10 am Eastern time news conference.