Updated 4/23/21 at 7:55 pm ET.
The FDA and CDC announced they are lifting the pause on use of the Johnson & Johnson Covid-19 vaccine after a review of safety data on the rare risk for blood clots and thrombocytopenia reported among recipients of the shot.
The announcement followed mere hours after the CDC’s Advisory Committee on Immunization Practices voted ten to four, with one abstention, to recommend resuming use of the Johnson & Johnson Covid-19 vaccine under the FDA’s Emergency Use Authorization (EUA), with additional language added to warn vaccine recipients of the clotting risk.
This decision brings a close to the emergency investigation launched into the single-shot adenovirus vaccine after reports surfaced of rare cases of blood clots accompanied by low platelet counts—referred to by the CDC as thrombosis with thrombocytopenia syndrome, or TTS—following immunization, prompting the FDA and CDC to recommend discontinuing use of the vaccine while these cases were investigated. Six cases, including one death, had been announced as of the pause in vaccinations 11 days ago; as of this decision, the case count has risen to 15, including three fatalities. To date, all reported cases of TTS have occurred in women, and 13 out of 15 occurred in women under 50 years of age. The majority of cases manifested as cerebral venous sinus thrombosis.
Further details on ACIP’s decision will be outlined in a future report in Morbidity and Mortality Weekly Report, the Committee noted, and the FDA is expected to issue a revised version of the vaccine EUA in the coming days. In light of this vote, the EUA fact sheet would be revised to warn individuals receiving the vaccine of the risk of TTS and advise them to seek immediate medical attention if they develop any of the following symptoms within one-two weeks after vaccination:
- Shortness of breath.
- Chest pain.
- Leg swelling.
- Persistent abdominal pain.
- Severe or persistent headaches or blurred vision.
- Easy bruising or tiny blood spots under the skin beyond the site of injection.
The American Medical Association (AMA) issued a statement in support of ACIP’s decision.
“The AMA commends the Advisory Committee on Immunization Practices (ACIP) for today reaffirming its recommendation on the use of the [Johnson & Johnson] Covid-19 vaccine for persons 18 years of age and older in the U.S. population under the Food and Drug Association’s (FDA) Emergency Use Authorization,” AMA president Susan R. Bailey, MD, wrote. “The population-level data presented during ACIP’s meeting today clearly demonstrates that the benefits of this approach outweigh the risks.”
While many voting ACIP members voted to recommend use of the vaccine without additional language, several members argued that the committee’s recommendation should contain language explicitly warning of the risk of TTS.
“I have no problem with the continued availability of this vaccine,” Pablo Sanchez, MD, of the Center for Perinatal Research at the Research Institute at Nationwide Children’s Hospital in Columbus, Ohio, said in explaining his “no” vote. “I think if someone offered informed consent, after knowing the risks involved, let them get it. But I think that we just made a blanket recommendation… I think we have to have this proper language and make sure that people are informed appropriately.”
Grace M. Lee, MD, MPH, associate chief medical officer for practice innovation at Lucile Packard Children’s Hospital and professor of pediatrics at Stanford University School of Medicine in Stanford, California, countered this and similar points, arguing that “the only choices we really had were to recommend or not recommend… and I think that the emphasis, and the vote itself, reflects the challenge that was before us today, that we need to be able to reflect the importance of this particular adverse event and elevate it. But I also think that we have to come out with a clear recommendation. I think that the recommendation [with additional language] would have been confusing and is actually inconsistent with all of the other priorities of other recommendations we’ve given.”
The committee was quick to dismiss the option of recommending against use of the vaccine for all individuals or limiting its use to adults ≥50 years of age, with all members agreeing across the board that the vaccine’s benefits are too strong to ignore given the dire risks associated with the ongoing Covid-19 pandemic.
The cases of TTS that prompted this investigation are strikingly similar to blood clotting cases reported in Europe following vaccination with AstraZeneca’s adenovirus-vectored vaccine—and those cases, researchers found, bore a resemblance to autoimmune heparin-induced thrombocytopenia, as previously reported by BreakingMED.
Are People Still Willing to Get a Covid-19 Vaccine?
In their deliberations, several ACIP members raised concerns that the 11-day pause to investigate cases of TTS following vaccination with the Johnson & Johnson shot might lead to increased vaccine hesitancy in the U.S.—which Beth Bell, MD, MPH, of the department of global health at the University of Washington School of Public Health in Seattle, called a paradox, arguing that, if anything, the prompt and transparent investigation should increase the public’s confidence in Covid-19 vaccines.
Indeed, according to a poll of daily willingness to receive a Covid-19 vaccine that was discussed during the meeting, confidence in the Johnson & Johnson dropped dramatically in the days following the April 13 recommendation to pause shots, landing at 19% as of the start of this week. However, the announcement seems to have had the opposite effect on the two mRNA vaccines currently authorized in the U.S.—confidence in the Pfizer vaccine rose from around 60% to 68% during the same period, and confidence in the Moderna vaccine shot up from around 50% to over 60% before settling back down to 56%.
A recent poll from the de Beaumont Foundation came to a similar conclusion, with 40% of respondents indicating that they were overall more willing to receive a Covid vaccine than they were a month ago, despite the Johnson & Johnson blood clotting concerns. And, according to that same poll, 76% of respondents said the pause did not decrease their likelihood of receiving a vaccine.
John McKenna, Associate Editor, BreakingMED™
Cat ID: 31
Topic ID: 79,31,730,933,31,926,561,927,151,418,928,925,934
