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

Updated: 11:55 a.m., Tuesday

FLORIDA — 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.

This suggested pause comes as the four FEMA vaccine distribution sites in Florida — Jacksonville, Miami, Orlando and Tampa — were scheduled to switch from distributing the Pfizer vaccine to Johnson & Johnson starting Tuesday, NBC6 reported. It was planned for each walk-up site to administer up to 3,000 Johnson & Johnson doses daily.

Gov. Ron DeSantis said Florida would follow the CDC’s recommendations and temporarily halt distribution of the J&J vaccine at federal sites.

“We’re respecting that decision, we’re going to follow that recommendation and monitor what they’re doing for the time being,” DeSantis said at a Tuesday news conference in Manatee County, the South Florida Sun Sentinel reported. “But I think what they’re doing is out of an abundance of caution. I don’t think people should be worried who have already had it who haven’t had any effects. I think it’s likely to be very effective for you.”

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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 Florida Department of Health reports 473,416 people have received the J&J vaccine in Florida as of Monday. Nearly 7.3 million people have been vaccinated in the Sunshine State with at least one dose, including those who received the Pfizer and Moderna vaccine.

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."

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

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."

Walgreen's said, "We're pausing J&J vaccines immediately and we'll have more details soon."

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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.

With production impacted, Florida only expected to receive 37,000 Johnson & Johnson doses this week, according to the CDC's allocation data.

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."

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.

Blood Clot Prompts Investigation

The CDC and FDA issued a joint statement about the decision to stop using the J&J vaccine with more detail on the cases that prompted the investigation.

"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 statement said. "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."

All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination, according to the statement.

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

Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System. Leaders from the CDC and FDA will provide additional information and answer questions at a media briefing at 10 a.m. that will be broadcast on YouTube.

This is a developing story and will be updated.

— By Tom Davis and Elizabeth Janney

For more information on coronavirus vaccines in Florida, see the Florida Patch COVID-19 vaccination page.