J&J Vaccine: Feds Lift Recommended Pause In Minnesota, Elsewhere

MINNESOTA —Federal health officials adopted a committee’s recommendation that the pause on the Johnson & Johnson single-dose coronavirus vaccine be lifted, effectively putting the vaccine in use again. Officials in Minnesota had put the vaccine on hold after rare cases of blood clots emerged in some people who had taken the vaccine.

"Right before the pause was announced last week, the State of Minnesota had distributed 9,600 doses of Johnson & Johnson vaccine to Minnesota providers," the Minnesota Department of Health said in a statement.

"Those doses have been stored by the providers who received them and we expect them to be available in the coming days along with any updated information to provide to those getting the vaccine. While Minnesota is not scheduled to receive any Johnson & Johnson vaccine this coming week, we anticipate the federal supply picking back up in the weeks ahead and we strongly encourage everyone who is eligible to get their vaccine so we can finally end this pandemic and enjoy a summer full of brighter days for all Minnesotans."

In a joint statement from the CDC and the FDA, officials said the available data show that the vaccine’s known and potential benefits outweigh the known and potential risks in adults. The vaccine is authorized for emergency use for anyone 18 and older. Both agencies said they have confidence that the vaccine is safe and effective in preventing COVID-19.

The joint statement said that based on the data the chance of developing the clots is very low “but the FDA and CDC will remain vigilant in continuing to investigate this risk.” Doctors and other health care providers have also been made aware of the potential for the clots so they can properly treat any patients that may develop them.

Symptoms occur anywhere between 6 to 15 days after receiving the vaccine.

At its meeting Friday, the Advisory Committee on Immunization Practices reported that there had been nine new confirmed cases of the rare blood clots, bringing the total to 15. The 15 cases were reported out of nearly 8 million vaccine doses given as of April 21, the committee reported. All the cases were in women and two of the cases were in women older than 50 while the rest were in women between the ages of 18-48.

At the time the pause was recommended, the FDA and CDC said in a joint statement that there were six reported cases of the rare and severe type of blood clot all in women between the ages of 18-48. At least 6.8 million people had received the single-dose vaccine when those numbers were reported.

The CDC is also investigating two deaths as part of its investigation into the vaccine, according to health officials in Virginia and Oregon.

"Above all else, health and safety are at the forefront of our decisions," CDC Director Dr. Rochelle Walensky said in a statement.

"Our vaccine safety systems are working. We identified exceptionally rare events – out of millions of doses of the Janssen COVID-19 administered – and we paused to examine them more carefully. As we always do, we will continue to watch all signals closely as more Americans are vaccinated. I continue to be encouraged by the growing body of real-world evidence that the authorized COVID-19 vaccines are safe and effective, and they protect people from disease, hospitalization, and death. I urge anyone with questions about the COVID-19 vaccines to speak with their healthcare provider or local public health department."

The committee voted 10-4, with one abstention to recommend lifting the pause and allow the vaccine to be used under its emergency use authorization in those 18 and older with an added warning label. The vote came 10 days after the initial pause.

Health officials in Minnesota stopped administering the vaccine April 13 after the recommendation from federal officials. Nearly 9,600 doses of the vaccine were set to arrive in Minnesota that week.

Health officials in Minnesota said none of the reported clotting cases occurred in the state.

As of Friday, more than 2,300,000 Minnesotans have received at least one shot of a COVID-19 vaccine.

The Johnson & Johnson vaccine was the third vaccine approved for emergency use in the U.S. against COVID-19. The vaccine uses an inactivated adenovirus to deliver instructions to cells and mount an immune response against COVID-19. In clinical trials, the vaccine was found to have an efficacy of 66.3 percent and people had the most protection from the shot two weeks after getting vaccinated. According to the CDC, the vaccine had a high efficacy in preventing people from being hospitalized and dying.

The vaccine has an advantage as it requires just a single dose and can be stored at normal temperatures unlike like the Moderna and Pfizer vaccines. Because of its advantages, the vaccine is a key part of state efforts to reach rural and other hard to reach populations.