Johnson & Johnson delay rollout of vaccine in Europe after US pause
Johnson & Johnson said Tuesday it would proactively delay its vaccine rollout in the European Union following reports of rare but severe cases of blood clots in people who received the shot.
“The safety and well-being of the people who use our products is our number one priority,” the company said in a statement on Tuesday.
The move came after the U.S. Centers for Disease Control and the Food and Drug Administration recommended a pause in distribution of the Johnson & Johnson vaccine while regulators investigated six cases of unusual blood clots in recipients.
Nearly 7 million doses of the single-shot Johnson & Johnson vaccine have been administered in the U.S. so far, according to the CDC.
“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,” Johnson & Johnson said in the statement.
“The United States Centers for Disease Control (CDC) and Food and Drug Administration (FDA) are reviewing data involving six reported U.S. cases out of more than 6.8 million doses administered.
“Out of an abundance of caution, the CDC and FDA have recommended a pause in the use of our 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.
“The CDC and FDA have made information available about proper recognition and management due to the unique treatment required with this type of blood clot.
“The health authorities advise that people who have received our COVID-19 vaccine and develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider,” the statement stated.