Feds Pause Johnson & Johnson COVID Vaccine In MD, Across US

MARYLAND – The Food and Drug Administration and the Centers for Disease Control and Prevention recommended a pause in the use of the Johnson & Johnson COVID-19 vaccine on Tuesday because of blood-clot concerns.

"We are recommending a pause in the use of this vaccine out of an abundance of caution," Dr. Peter Marks of the FDA and Dr. Anne Schuchat of the CDC said in a joint statement.

As of Monday, more than 6.8 million doses of the single-dose vaccine have been administered in the United States, according to the FDA.

The Maryland Department of Health reports 173,534 people have received the J&J vaccine in Maryland as of Tuesday.

"Based on the federal government’s recommendation and out of an abundance of caution, the Maryland Department of Health directs all Maryland COVID-19 vaccine providers to pause the administration of Johnson & Johnson COVID-19 vaccines until further federal guidance is issued," the Maryland Department of Health said in a statement Tuesday morning. "Providers should continue to maintain their supplies of Johnson & Johnson vaccines in a manner that prevents wastage."

Health departments in Harford, Montgomery and Anne Arundel counties report they are following the state's guidance.

The Hagerstown mass vaccination site will pause administration of the Johnson & Johnson vaccine and switch to Pfizer vaccines, state health officials said, noting the site would honor all appointments Tuesday. Those who have questions may call Maryland's vaccination support center at 1-855-MD-GOVAX (1-855-634-6829).

At least three pharmacies announced that they will pause the distribution of the vaccine.

"We're pausing J&J vaccines immediately and we'll have more details soon," Walgreens reported.

Wegmans issued a statement saying: "Following the recommendations of the CDC & FDA, Wegmans has canceled all Johnson & Johnson vaccine appointments. We will pause use of the J&J vaccine while the CDC & FDA further investigate the issue."

CVS said it is "immediately implementing a pause in the use of the Johnson and Johnson's COVID-19 vaccine per the recommendation from federal health agencies."

The CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the vaccine.

"Right now, these adverse events appear to be extremely rare," Marks and Schuchat said in the joint statement from the FDA and CDC. "Treatment of this specific type of blood clot is different from the treatment that might typically be administered."

People who got the J&J vaccine already are likely "very concerned," Schuchat said at a joint news conference Tuesday morning about the pause in J&J vaccine administration.

For those who got the vaccine more than a month ago, Schuchat reported the risk was "very low."

Those who received the J&J shot in the last couple of weeks should "look for any symptoms" such as "severe headache, abdominal pain, leg pain or shortness of breath," Schuchat said, beyond the potential flu-like symptoms that many vaccine recipients may experience, and contact their health care providers.

Acting FDA Commissioner Janet Woodcock said the pause would not be a long one.

"We expect it to be a matter of days," Woodcock said.

The move to pause use of the vaccine comes weeks after the FDA halted production of the J&J vaccine at a Baltimore facility run by Emergent BioSolutions following a mix-up in ingredients. However, the company said none of the 15 million doses that had been tainted were ever shipped out from the plant.

Blood Clot Prompts Investigation

The CDC's Advisory Committee on Immunization Practices will meet Wednesday to further review the blood clot cases and assess their potential significance. The FDA will review that analysis as it also investigates.

"Until that process is complete, we are recommending this pause," officials said. "This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot."

Officials said a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia).

The vaccine triggered a rare immune system response that led platelets to activate and "extremely rare blood clots," Marks said, explaining the current hypothesis on the cause.

All six cases of the rare blood clot occurred among women between the ages of 18 and 48, and symptoms came 6 to 13 days after vaccination, according to a joint statement about the decision to stop using the J&J vaccine from the CDC and FDA.

"My understanding is that there weren't predisposing conditions for these events in some of those individuals," Schuchat said at the news conference Tuesday, stating it was difficult to make a generalization based on six cases. Some may have had predisposing conditions, but not all, she added.

"The issue here with these types of blood clots is that if one administers the standard treatments that we as doctors have learned to give for blood clots, one can actually cause tremendous harm, or the outcome can be fatal," Marks said. "One needs to make sure that providers are aware that if they see people who have low blood platelets, or if they see people who have blood clots, they need to inquire about a history of recent vaccination and then act accordingly."

Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System.

"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," according to the joint statement from the CDC and FDA. "People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider."

Marks said the headache providers should be concerned about is one that comes a week later.

"We know that for these vaccines, for the first several days after vaccination, there are flu-like symptoms which can include headaches," Marks said. "These [blood clots and severe headaches] have usually occurred at least about a week after vaccination and not longer than three weeks after vaccination, with a median of about nine days after vaccination."

How The Johnson & Johnson Vaccine Works

There are three vaccines currently available in the United States — Pfizer, Moderna, and Johnson & Johnson.

Both Pfizer and Moderna deliver mRNA — a genetic recipe that teaches your body how to build the spike protein found on the surface of the coronavirus. If the real virus enters the body, your immune system will recognize it and know how to fight it.

Johnson & Johnson, however, uses a different technology to prime the body to fight against COVID-19. Instead of mRNA, it utilizes an adenovirus — a common cold virus that cannot replicate and make a person sick once it enters the cells.

Ultimately, the cold virus will deliver the coronavirus-fighting genetic blueprint into the cells and teach the immune system how to recognize the spike protein found on the surface of the coronavirus.

Adenovirus vaccines can be refrigerated for up to three months at 36 to 46 degrees Fahrenheit, according to Johns Hopkins University.

Clinical trials showed the J&J vaccine as being less effective against the virus compared with the vaccines developed by Moderna and Pfizer. The company said the vaccine has a 72 percent efficacy rate among trial participants in the U.S., but is about 85 percent effective against the most severe forms of the virus.

Moderna and Pfizer tout efficacy rates at or near 95 percent.Johnson & Johnson's vaccine is for people 18 years old and up.

Below is the full news conference from the FDA and CDC on the J&J vaccine pause:

— By Tom Davis, Elizabeth Janney and Alessia Grunberger