Federal officials lifted the temporary ban on use of the Johnson & Johnson COVID-19 vaccine Friday night, barely an hour after an advisory committee recommended resuming its use.
The advisory panel concluded the benefits of the single-shot vaccine far outweighed the risk of a rare but a life-threatening blood-clotting disorder. The Centers for Disease Control and Prevention agreed.
The product labeling will be revised to carry detailed information about the rare clotting disorder, including symptoms — notably headaches and blurred vision, shortness of breath, chest pain, abdominal pain.
“The J&J vaccine can and should be reinstituted,” said Arkansas Secretary of Health Jose Romero, chair of the Advisory Committee on Immunization Practices. “But it is our responsibility as clinicians to make women understand this risk and that they have the opportunity to access another vaccine.”
The J&J vaccine, authorized in the U.S. in February and rolled out in early March, was put on “pause” 11 days ago because six cases of the clotting syndrome were detected by the federal vaccine surveillance system, all but one case in women under 50. At Friday’s six-hour virtual advisory meeting, that number was updated to 15 cases, including three fatal, out of nearly 8 million doses administered.
CDC experts presented mathematical models showing the risk-benefit impact of resuming unrestricted use. For every million people vaccinated with J&J’s one-shot product, several thousand hospitalizations and deaths from COVID-19 would be averted, while less than a score of cases of the clotting syndrome would occur, mostly in premenopausal women.
Surveys show public confidence in the J&J shot has been shaken. Still, it has distinct advantages over the other authorized vaccines, made by Pfizer-BioNTech and Moderna, which require two shots and special refrigeration. J&J’s one-dose vaccine needs only ordinary refrigeration.
J&J’s inoculation has been heavily used in vaccinating the homeless, the homebound, prisoners, and other groups that have been disproportionately hard-hit by the pandemic, CDC officials told the panel. Also, a poll found that 6% of Americans exclusively prefer a single-dose vaccine.
While Pfizer and Moderna use RNA-based vaccine technology, J&J and AstraZeneca (which is not approved in the United States) use adenoviruses to carry genetic instructions that prime the immune system. Experts theorize that, in extremely rare cases, the adenovirus triggers an autoimmune response that disrupts normal clotting ability. Not only do dangerous clots form, particularly in veins that drain the brain, but platelets are somehow destroyed or used up. Platelets are the blood component that is vital to clotting.
In Europe, the AstraZeneca vaccine has been linked to the blood-clotting disorder, mostly but not exclusively among women under age 50. Britain has reported 79 cases, 19 of them fatal, among 20 million recipients of the shots. Other areas of Europe have had 86 cases, 18 fatal.
After suspending use of AstraZeneca’s vaccine, European regulators on Tuesday concluded the benefits of slowing the pandemic outweigh the remote risk of the rare clotting reaction. They added a warning to the product information. Member countries can opt to restrict or not use the vaccine; France has indicated that it will use the shot only on people over age 55, while Denmark opted to shelve the vaccine.
Of the 15 U.S. cases linked to the J&J vaccine, only one was a man, and seven were women ages 30 to 39. CDC experts calculated the risk at less than 1 in a million for women 50 and older, and 7 per million for women ages 18 to 49.
That clotting risk was far outweighed by the estimated benefits. If 1 million women ages18 to 49 got the J&J vaccine, 12 COVID-19 deaths would be prevented, 127 intensive care admissions would be averted, while 13 cases of the clotting disorder would occur. For older women and men, the calculation was even starker, with just a few cases of the disorder compared to thousands of severe COVID-19 illnesses and deaths averted.
On a population level, the panel was told, resuming the J&J vaccination should also speed the desperate race toward the goal of “herd immunity” — protecting enough people through vaccination and natural infection that the coronavirus stops spreading.
Although it’s not clear whether vaccination provides robust protection to immune-compromised people such as those with transplanted organs, vaccinating them as soon as possible is important because studies suggest the virus can rapidly evolve dangerous mutations in them. “I’m very concerned they’re at risk of producing novel variants” without vaccination, said panel member Helen Talbott, a professor of medicine at Vanderbilt University.
The CDC has found no evidence that the clotting disorder is triggered by the Pfizer or Moderna vaccines.