ACIP Votes to Lift Pause on J&J COVID-19 Vaccine

This story has been updated.

In its second meeting on the matter, members of the CDC’s Advisory Committee on Immunization Practices (ACIP) voted to reinstate the original emergency use authorization of Johnson and Johnson’s (J&J) COVID-19 vaccine in the United States following a pause in administration implemented on April 13.

Members weighed the implications a continued pause would have in the United States and the world against the benefits of having a single-dose, easy to store vaccine readily available. Ten members voted to lift the pause, while 4 were opposed and 1 abstained. Deliberations focused on whether to include warnings of the potential for rare blood clots within the updated recommendation.

New fact sheets about the risk of blood clots associated with the vaccine will be distributed to patients when they make an appointment to get vaccinated; the sheets will list symptoms including headache, shortness of breath, chest pain, leg swelling, and persistent abdominal pain, among others.

During a press conference later Friday, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said it is possible that J&J vaccinations could restart as early as Saturday.

One of the factors that went into the pause, said Acting FDA Commissioner Janet Woodcock, was that health officials did not know how many of the people who had just recently received the vaccination would develop the rare clots. In addition, it was unknown how many providers would know how to recognize the symptoms and treat appropriately, without heparin.

Health officials also stressed that the fact sheets for patients would be written in lay language, and CDC Director Rochelle Walensky, MD, said they are conducting outreach with the American College of Obstetricians and Gynecologists.

Outreach to those most at risk was on the minds of the panel earlier.

Although she voted yes, “I am concerned that the consumers and women in this age group in particular, will not be adequately informed just by the FDA,” said Beth Bell, MD, MPH, a clinical professor at the University of Washington and member of ACIP. In her comments, Bell stressed that public health agencies and partner organizations should make sure that people are informed and receive a balanced perspective.

The decision comes after the European Medicines Association (EMA) recommended resuming use of the J&J vaccine earlier this week, while also noting it should carry a label warning of an association with rare blood clots.

Out of around 8 million doses of the J&J vaccine administered to Americans thus far, 12 cases of cerebral venous sinus thrombosis (CVST) in combination with thrombocytopenia have been confirmed, mostly among younger women, within about 2 weeks of receiving the shot.

“I have no problem with the continued availability of this vaccine,” said Pablo J Sánchez, MD, a professor of pediatrics at Ohio State University and ACIP member who voted against the motion. “But I think that if we just make a blanket recommendation knowing the risks that seem to have biologic possibility and severity, I think we have to have stronger language and make sure people are informed appropriately.”

Officials are investigating another woman’s death in Oregon, who died after developing a rare blood clot and low platelets within 2 weeks of receiving the J&J vaccine. This individual received the dose before the pause went into effect. In addition, one woman in Texas was also recently hospitalized with possible blood clots associated with the vaccine.

Original safety signals were reported through HHS’ Vaccine Adverse Events Reporting System.

Data presented at the ACIP meeting show a total of 15 cases of thrombosis with thrombocytopenia syndrome (TTS) have been confirmed as of April 21, with additional potential cases under review, including some among males. Median patient age is 37 years old, and all patients with a confirmed care are female. Some patients with CVST reported thromboses in other locations. Of these confirmed cases, 3 women passed away, 7 remain hospitalized with 4 in the intensive care unit, and 5 patients have been discharged home.

CVST typically occurs in 10 to 15 individuals per 1 million, and affects those with a mean age of 35 years, according to research presented at the meeting. The J&J vaccine pause was initiated so providers could have time to become familiar with associated symptoms and better determine treatment regimens and so regulators could gather more data on the condition. Although blood clots are usually treated with the anticoagulant heparin, use of this therapy in patients with CVST may be dangerous.

CVST usually is not associated with thrombocytopenia and can result in substantial morbidity and mortality. In addition, CVST and thrombocytopenia in patients who contract COVID-19 is extremely rare. No instances of the 2 conditions occurring simultaneously have been reported among recipients of the Pfizer/BioNTech or Moderna vaccines approved in the United States, which use different technology (mRNA) than the J&J vaccine.

However, the clinical features of CVST with thrombocytopenia in J&J cases are similar to those observed among some recipients of the AstraZeneca vaccine approved in Europe. AstraZeneca and J&J vaccines share underlying technology as both contain replication-incompetent adenoviral vectors

Of patients with confirmed reports of TTS following the J&J vaccine, 2 used oral contraceptives, 7 had obesity, 2 had hypothyroidism and 2 had hypertension. No patients reported diabetes or coagulation disorders.

Initial symptoms included headache after 6 or more days following vaccination, chills, fever, nausea/vomiting, lethargy and abdominal pain, while later symptoms included severe neck pain, unilateral weakness, speech difficulty, and seizure, among others.

Production of the J&J vaccine in the United States has been plagued with glitches as 15 million doses were previously contaminated at a Baltimore plant, rendering them unusable. More recently, federal officials found more flaws at the facility saying additional doses may have been contaminated due to faults in disinfectant practices, handling of raw materials and training of workers. No doses produced at this plant have been distributed to the public, and all J&J doses administered in the United States were manufactured in Europe.

What was initially hailed as a more feasible option for a wider vaccine rollout, the single-dose vaccine can be stored at normal refrigerator temperatures and was eagerly ordered in bulk by the Biden administration.

But according to Politico, senior administration officials have largely written off the shot due to its series of setbacks and the company is unlikely to deliver its goal of 100 million doses by the end of May.

“In terms of Johnson & Johnson and the Baltimore facility…this is a process between the FDA and the companies, and we expect J&J to work through this with the FDA,” said White House COVID-19 Response Coordinator Jeff Zients prior to the ACIP announcement.

“Our vaccination program was never built on one vaccine. We have plenty of vaccine supply of Pfizer and Moderna. There are tens of millions of doses already out in the country—of Moderna and Pfizer—ready to be administered.”