CDC Panel Recommends Resumption Of J&J Vaccine As “Benefits Outweigh Risks”

What little faith a sizable skeptical portion of Americans may have had in covid vaccines or the so-called “scientific process” may have just been crushed on Friday afternoon when shortly before 5am a CDC Panel recommended in a 10-4 vote (with 1 abstaining) to resume use of the J&J Covid vaccine, saying that it would add a warning about rare clots but not restrict its use as “benefits outweigh the risks. The decision sets the stage for regulators to allow use of the shot to resume.

The committee, an outside panel of experts that advises the CDC, decided to postpone a decision on the vaccine last week while officials continued to investigate cases of six women, ages 18 to 48, who developed cerebral venous sinus thrombosis, or CVST, in combination with low blood platelets within about two weeks of receiving the shot.

The recommendation, which was adopted by the CDC’s Advisory Committee on Immunization Practices, will pave the way for U.S. regulators to lift their recommended pause on using the J&J shot as early as this weekend.

J&J executives told the committee the benefits of its vaccine still outweighed its risks, adding that the shots would prevent deaths and hospitalizations. They suggested a new warning label for the vaccine that explains the risk of blood clots.

“We could expect that if 1 million people in the United States were vaccinated with the J&J single-dose vaccine, there would be over 2,000 fewer deaths and 6,000 fewer Covid-related hospitalizations,” said Dr. Joanne Waldstreicher, J&J’s chief medical officer.

The decision to resume J&J vaccinations comes ten days after the Food and Drug Administration and CDC asked states on April 13 to temporarily halt using J&J’s vaccine “out of an abundance of caution” following reports of the rare blood clots. Within hours of the warning, more than a dozen states as well as some national pharmacies halted inoculations with J&J’s vaccine, some replacing scheduled appointments with either the Pfizer or Moderna vaccine.

The CDC panel reviewed evidence from 15 people who suffered blood clots after receiving the JNJ jab, out of a total of 8 million Americans injected. Of these, three died, while seven remain hospitalized and five were discharged. All 15 cases of clotting were observed in women, with 13 under the age of 50, according to the presentation. Meanwhile, 12 of the 15 cases involved rare brain blood clots. As of April 21, about 4 million women in the U.S. had received the J&J vaccine.

A CDC model presented at the meeting showed not resuming the use of J&J’s vaccine would delay immunizing all adults intending to get the shots by 14 days.

The JNJ single shot vaccine has been a critical tool in getting lifesaving vaccines to hard-to-reach places that may not have reliable refrigeration, such as tribal lands, poorer neighborhoods and rural communities, as well as to people who may not be able to come back for a second dose, U.S. health officials say.

Prior to Friday’s vote, the committee debated whether to recommend against the use of J&J’s vaccine or endorse it with U.S. regulators enforcing a warning label. The committee also considered limiting the vaccine’s use based on age or other risk factors.

Rare blood clots with low platelets are occurring at a rate of 7 per 1 million vaccinations in women ages 18 to 49 for the J&J shot and 0.9 per 1 million in women age 50 and older, according to a slide presented at the CDC panel meeting. CDC has confirmed 15 cases total of rare blood clot conditions, which includes 12 women who developed blood clots in the brain. Three women have died and 7 remained hospitalized, according to the slides.

The rare blood clot, or CVST, occurs when a blood clot forms in the brain’s venous sinuses. It can prevent blood from draining out of the brain and can eventually cause a hemorrhage and other brain damage. The blood clots are similar to those reported in some individuals who received AstraZeneca’s Covid-19 vaccine.

During Friday’s meeting, Dr. Tom Shimabukuro, a CDC official, said there have been no reports of the condition in those who received the Pfizer-BioNTech mRNA vaccine. There were three reports of CVST in patients who received the Moderna vaccine, he said, though the patients didn’t have the low level of blood platelets seen in the J&J recipients.

Earlier this week, J&J said it would resume the rollout of its vaccine in Europe after regulators there backed the single-shot vaccine with the recommendation that a warning be added to the label. The European Medicines Agency researched all available evidence, it said, including the reports from the United States. Meanwhile in the US, health officials said last week they expected the pause on the use of the vaccine to last only a matter of days, depending on what they learn in their investigation of the cases.

Before the CDC meeting, Dr. Wilbur Chen, a member of the committee, told CNBC that he saw “a huge amount of evidence” that the benefits of the J&J vaccine still outweighed its risks.

“I think that there is a willingness for us to use this vaccine. We did need to make an important pause to be able to look at this safety information to be able to consider the risks. But certainly, I think there’s a huge amount of evidence that the benefit greatly outweighs this risk,” Chen, a professor at the University of Maryland School of Medicine, told “Worldwide Exchange.”