Johnson & Johnson Vaccine Pause: 6 Things To Know

WASHINGTON, DC — The one-dose coronavirus vaccine developed by pharmaceutical giant Johnson & Johnson is facing scrutiny Tuesday after the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration called for a temporary pause in administering the vaccine following "extremely rare" adverse reactions in several states.

The FDA announced on Twitter it was calling for the pause “out of an abundance of caution” due to blood clot concerns. The clots occurred in veins that drain blood from the brain.

During a news conference Tuesday morning, officials stressed the pause was a “recommendation” for vaccine providers, not a mandate.

“These events appear to be extremely rare, but COVID-19 vaccine safety is a top priority and we take all reports seriously,” Dr. Janet Woodcock, acting FDA commissioner, said during the news conference. “We are committed to vaccinations and feel they are a really important tool to getting this pandemic under control. But we’re also committed to patient safety and feel we’re taking the best route to ensure that.”

The call for a pause will likely leave Americans with questions. Here are answers to a few:

What’s happening to people who experience a reaction to the J&J vaccine?

The CDC and FDA are reviewing six reported cases of people developing a severe type of brain blood clot after receiving the J&J vaccine. All six cases were in women ages 18-48, and symptoms appeared anywhere from six to 13 days post-vaccination.

One person died following the reaction, and another is in critical condition, officials Tuesday. There’s also no evidence the clots were tied to contraceptive use, since all patients were of child-bearing age.

While officials have found no definitive cause of the blood clots, they likely occurred due to an immune response to the body’s blood platelets, which are what cause blood clots, officials said.

Officials said the reaction is similar to one reported following the administration of the AstraZeneca vaccine, which has not yet received authorization in the U.S.

Last week, European regulators said they found a possible link between the shots and a very rare type of blood clot that occurs together with low blood platelets. The reaction also appeared to occur more in younger people, AP reported.

Similar reactions have not been reported in those receiving the Pfizer or Moderna vaccines.

How many people have received the J&J vaccine?

More than 6.8 million doses of the New Jersey-based company's vaccine have been administered in the United States as of Tuesday, according to the FDA.

Overall, more than 121 million people have received at least one dose of the three vaccines approved for use in the United States. Other approved vaccines include Pfizer and Moderna.

Who has paused the use of the J&J vaccine?

Federally run mass vaccination sites will pause administration of the J&J shot, and states and other providers are expected to follow, according to an Associated Press report. CVS and Walgreens were among nationwide pharmacies that halted doses of the J&J vaccine.

States and cities are also moving to implement the pause.

New York state health commissioner Dr. Howard Zucker said people with Tuesday appointments for J&J vaccines at state-run mass vaccination clinics will instead get the Pfizer vaccine, AP reported.

The city of Dallas also had planned to begin an in-home vaccination program using the J&J vaccine for homebound or elderly people, according to AP; however, the city will pause the program until more guidance is released.

A CDC panel is to meet Wednesday to review current data about the reactions and determine next steps. Ideally, the pause will only last several days, officials said.

Meanwhile, Johnson & Johnson on Tuesday said it will delay the rollout of its vaccine in Europe, citing the pause in the United States.

“We have been reviewing these cases with European health authorities,” the company said, according to an AP report. “We have made the decision to proactively delay the rollout of our vaccine in Europe.”

I already received the J&J vaccine. What should I do?

If you received the J&J vaccine more than a month ago, the risk of an adverse reaction is very low, officials said.

Anyone who recently received the J&J vaccine should be aware of any symptoms associated with blood clots, including severe headache, abdominal or leg pain, or shortness of breath.

If people experience any of these symptoms, they should contact their local health care provider immediately.

I have an upcoming vaccine appointment. Should I cancel?

If you have an appointment to receive the J&J vaccine, keep your appointment, officials said. Federal partners will be working with local clinics to reschedule.

The CDC's Dr. Anne Schuchat said officials have not seen similar clots following doses of the Pfizer or Moderna vaccines, and that people should continue to receive those vaccines.

How will this affect President Joe Biden’s goal of 200 million shots by his 100th day in office?

Achieving the president’s goal is not dependent on the J&J vaccine, White House officials said Tuesday.

J&J vaccines comprise only 5 percent of the total vaccines administered in the United States, according to a CNN report citing White House coronavirus coordinator Jeff Zients.

Over the last few weeks, the Biden administration has distributed more than 25 million doses of the Pfizer and Moderna vaccines each week. Last week, more than 28 million doses were distributed.

“This is more than enough supply to continue the current pace of 3 million shots per day, and meet the president’s goal of 200 million shots by his 100th day in office,” the statement read.