FDA Pauses Johnson & Johnson Vaccine Rollout After Rare Blood-Clot Issues

April 13, 2021

This morning, the FDA and the CDC recommended a temporary halt of distribution of the Johnson & Johnson COVID-19 vaccine after six women developed a rare blood-clotting disorder upon receiving the vaccine. One woman passed away from the disorder, while another remains in critical condition.

The FDA and CDC released a joint statement addressing the issue:

“Right now, these adverse events appear to be extremely rare. COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously.”

The FDA paused the rollout out of an “abundance of caution,” though six cases out of seven million remain in the margin of error. J&J stated that there is “no clear causal relationship” between the blood clots and the vaccine, adding that extensive research to assess the data is underway. 

Dr. Anne Schuchat, the principal deputy director of the CDC, reassured those who received the vaccine within the last couple of weeks. 

“For people who recently got the vaccine within the last couple weeks, they should be aware to look for any symptoms,” she said. “If you’ve received the vaccine and developed severe headaches, abdominal pain, leg pain or shortness of breath, you should contact your healthcare provider and seek medical treatment.” 

This comes weeks after manufacturing errors ruined about 15 million doses of the J&J vaccine, adding another fumble to their goal of 100 million doses to the U.S. by the end of May. Dr. Kavita Patel, a former federal health official, believes this error will be a “devastating blow” to the vaccine effort in the United States.

However, Jeffrey Zients, President Biden’s Covid czar, upheld the White House’s goal of administering 200 million shots within Biden’s first 100 days in office, adding that the J&J vaccine accounts for less than 5% of the shots administered to date.