FDA Lifts Pause on J&J Vaccine Inoculations, Adds Blood Clot Risk Warning
The FDA on Friday amended its Emergency Use Authorization (EUA) for the Johnson & Johnson COVID-19 vaccine to reflect the risk of rare blood clots and said vaccinations could resume immediately, based on recommendations by a Centers for Disease Control and Prevention (CDC) advisory committee.
“After an extensive review of the available data … the FDA and CDC have concluded that the possibility of [rare blood clots] occurring [are] very low, but the investigation into the level of potential vaccination-related risk will continue to be ongoing,” said FDA Acting Commissioner Janet Woodcock. “Safety is our top priority. This pause was an example of our extensive safety monitoring working as they were designed to work — identifying even these small number of cases.”
Inoculations with the J&J vaccine were halted in the U.S. and abroad on April 13 to allow for investigation into six cases of rare blood clots seen in Americans given the vaccine. The European Medicines Agency (EMA) concluded a week later that rollout of the vaccine could resume in Europe, but the EMA did find a potential link to very rare cases of blood clots and called for a warning to be added (DID, April 21).
In its Friday meeting, the CDC’s Advisory Committee on Immunization Practices (ACIP) voted 10-4 with one abstention, recommending that the J&J vaccine start being used again in all adults with a new warning of blood clot risks. In a previous meeting held April 14, the expert panel had failed to vote or make any recommendations, pending the evaluation of more data (DID, April 15) — leading to an unfortunate delay given the urgent need for inoculations.
Some ACIP members expressed support for allowing women younger than age 50 to choose which vaccine they receive, keeping in mind that the rare blood clots have so far been seen exclusively in women. Several experts said that it would be possible to increase the number of vaccination sites that stock multiple vaccines, while others questioned the feasibility of such action.
ACIP Executive Secretary Amanda Cohn noted that patients who sign up for vaccination using certain websites, including vaccinefinder.org, can specify the vaccine they wish to receive.
As of April 21, there were 15 confirmed cases of rare blood clots in the U.S. out of nearly 8 million administered doses of the vaccine, according to a presentation by Tom Shimabukuro, deputy director of the CDC’s Immunization Safety Office. All of the cases were seen in women, though additional patients, including potential male cases, are under review, he said.
The rates of rare blood clots were found to be extremely low but not insignificant. According to April 22 data that was presented during the meeting, there were seven cases per 1 million doses in females younger than 50 years old, with the highest rate seen in women between ages 30 and 39. By contrast, the risk of rare blood clots was less than one per 1 million doses in females age 50 and older and males of any age. In total, there were three deaths, seven hospitalizations (four in intensive care), and five patients discharged to their homes.
J&J issued a statement expressing its intent to “continue to collaborate with the CDC, FDA and health authorities around the world … to ensure this very rare event can be identified early and treated effectively.”
The extent to which the Biden administration will utilize J&J’s one-dose shot in the U.S. vaccination effort is uncertain, given that mass rollout is held up until Emergent BioSolutions’ troubled Bayview, Md., facility, which was sidelined during an FDA inspection that revealed a number of concerning issues, gets agency authorization (DID, April 22). Further, J&J reportedly could take up to four months to remake any doses found to be contaminated beyond the 15 million J&J doses the facility had to discard after a serious mix-up of AstraZeneca (AZ) and J&J vaccine materials at the Bayview facility. J&J had previously pledged to contribute 100 million doses by the end of May, but that timeframe now seems unlikely.
Merck is pitching in to assist J&J with vaccine manufacturing, a collaboration brokered by the U.S. government, but it will take time to adapt the two Merck facilities that have been selected for J&J production (DID, March 3).
Even without J&J’s shot, however, White House COVID-19 Response Coordinator Jeff Zients said this month that the U.S. has secured enough Pfizer/BioNTech and Moderna vaccine doses for 300 million Americans, enough to vaccinate all adults. The mRNA vaccines have proven to be the most reliable in the country’s vaccination program despite requiring two doses and having more logistical considerations, with no safety concerns or significant supply delays. — James Miessler