Johnson & Johnson delay prompts criticism of CDC panel

A Centers for Disease Control and Prevention (CDC) advisory panel is coming under increased criticism for continuing a pause on the use of the Johnson & Johnson vaccine, which is keeping doses on the shelf while the pandemic rages.

Many experts backed the initial pause, announced on Tuesday, when it appeared that it would only last for a few days and would give time to alert health care providers to treatment guidelines around extremely rare cases of blood clots in people receiving the J&J vaccine.

But the CDC’s Advisory Committee on Immunization Practices (ACIP) decided to put off making a recommendation during a Wednesday meeting in order to gather more data, in practice keeping the pause in effect until the panel meets again in seven to 10 days and raising alarms among experts about a more substantial delay.

“I think the initial pause was the right step but I was really disappointed by ACIP yesterday,” said Leana Wen, a public health professor at George Washington University. “They essentially kicked the can down the road.”

As the delay lengthens, there are worries both that the stoppage will lower the willingness of some members of the public to get vaccinated, and that it is keeping millions of shots out of action while over 700 people are still dying from COVID-19 every day.

“There is a vacuum for anti-vaccine activists to put out disinformation in this time,” Wen said, while also noting “we are in the middle of a pandemic” and there are “hundreds of people dying every day.”

Asked if the White House was frustrated by the delay, White House press secretary Jen Psaki said Thursday: “Science moves at the speed of science and they want to review more data.”

“We believe they are the gold standard, the [Food and Drug Administration] FDA is the gold standard in the world,” she added. “Actually, their thorough and transparent approach should give the American public additional confidence in the role they play and the approach the United States takes to the approval of vaccines out on the market.”

But several experts said the risk-benefit analysis of keeping a life-saving vaccine on the shelf because of six reported issues with blood clots out of 7 million vaccinations was way off.

Those six cases were in women aged 18-48, so the CDC panel could have kept the vaccine paused for that demographic group while restarting it for others, said Ashish Jha, dean of the Brown University School of Public Health.

“Initial pause by FDA on Tuesday was a close call,” Jha tweeted. “But I supported it. A few days to alert people, begin process of collecting more data, advise physicians — all made sense. Now advisory panel wants to return in 7 – 10 days to discuss further. The risk-benefit here is all wrong.”

Johnson & Johnson is a small part of the U.S. vaccination effort, less than five percent of the shots given so far, and the White House has stressed that there are plenty of doses of the Pfizer and Moderna vaccines to keep up or even increase the country’s three million shots-per-day pace. There have been no serious safety concerns reported with the Pfizer or Moderna vaccines.

“We have multiple other alternatives in the US to help stop this pandemic,” Helen Keipp Talbot, a professor at Vanderbilt University and a member of the CDC panel, said during Wednesday’s meeting, adding that that allows the panel to be “much more cautious” around Johnson & Johnson.

However, the J&J vaccine is only one shot, not two, and is easier to store, meaning that its absence could make it more difficult to vaccinate hard-to-reach populations, such as migrant workers, homeless people, or people who are homebound. And while they are not binding, U.S. regulatory decisions affect perceptions of the vaccine in lower-income countries that do not have an abundance of other options.

The concern about hard-to-reach people was raised by Nirav Shah, president of the Association of State and Territorial Health Officials, and director of Maine’s CDC, during Wednesday’s meeting.

Because of the pause, he said, “the most vulnerable individuals in the United States, who are prime candidates for the Johnson & Johnson vaccine, will remain vulnerable.”

Amid concerns about vaccine hesitancy, a YouGov poll found that the percentage of U.S. adults saying the Johnson & Johnson vaccine is safe dropped from 52 to 37 percent after the pause and blood clot issue was announced.

Importantly, though, while some experts expressed concern that Johnson & Johnson fears would bleed into the other two vaccines, the YouGov poll found that confidence in the Pfizer and Moderna vaccines was essentially unchanged after the news.

Technically, the CDC panel only makes recommendations, and the CDC director and the FDA could decide not to follow them, but that does not appear to be on the table. States also technically could make their own decisions, but governors have been following the federal guidance.

“The Advisory Committee on Immunization Practices will reconvene as quickly as possible to review additional scientific evidence and deliberate further,” said Benjamin Haynes, a CDC spokesperson. “CDC and FDA will consider the committee’s recommendations when they are made.”

Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia, said there is already plenty of data, between the Johnson & Johnson vaccinations and a similar problem of blood clots in Europe with the AstraZeneca vaccine. That vaccine uses a similar mechanism to Johnson & Johnson, which is different than the mechanism used by Pfizer and Moderna.

“You have an abundance of evidence that this is a real but rare problem,” Offit said. “I just don’t know what they’re waiting for.”

He said a few more cases of people with blood clots could come forward, but it would not be enough to change any decision. Meanwhile, there are people potentially being discouraged from getting vaccinated at all.

“There will be people who won’t get a vaccine at all who would have gotten it otherwise, in which case you will have done more harm than good,” Offit said.