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

ARIZONA — 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 Arizona had put the vaccine on hold after rare cases of blood clots emerged in some people who had taken the vaccine.

The Arizona Department of Health quickly followed suit, advising providers in the state to start administering the vaccine again.

"After recommending a pause out of an abundance of caution, we join our federal partners in encouraging everyone to get vaccinated against COVID-19 with the vaccine available to you," ADHS Director Dr. Cara Christ said. "Arizonans can be confident that all COVID-19 vaccines approved for emergency use, including the Johnson & Johnson vaccine, have undergone a thorough review for safety and efficacy. The federal review will continue on all of the vaccines as more people are vaccinated."

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 as of April 13.

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 member abstaining to recommend lifting the pause and recommended resuming the vaccinations with an added warning about the rare blood clots. The vote came 10 days after the initial pause.

Health officials in Arizona stopped administering the vaccine April 13 after the recommendation from federal officials. 12,000 doses of the vaccine were shipped to the state for the week of April 12.

To date, officials in Arizona have administered 2,811,591 first doses, or 39.1 percent of Arizona's population, of the vaccine while 2,061,845 people have been fully vaccinated.

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.