COVID

‘This was a mistake’: Ashish Jha challenges continued pause of Johnson & Johnson vaccine

Federal officials have said more time is needed for the investigation into reports of severe, rare blood clots.

Vials of the Johnson & Johnson Janssen Covid-19 vaccine at San Rafael Commons in San Rafael, California, U.S., on Thursday, March 25, 2021. Health departments across the U.S. have deployed mobile units to eliminate challenges like waking up early to schedule appointments, navigating online portals and standing in line, all of which can deter the elderly, disabled or immune-compromised. Photographer: David Paul Morris/Bloomberg David Paul Morris / Bloomberg

By Dialynn Dwyer

April 15, 2021

Dr. Ashish Jha is expressing disappointment after a panel at the Centers For Disease Control and Prevention determined administration of the Johnson & Johnson COVID-19 vaccine should remain “paused” while more time is taken to investigate reports of rare, severe blood clots.

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The Food and Drug Administration and CDC advised states to halt use of the single-shot COVID-19 vaccine on Tuesday as officials investigate the unusual, and potentially dangerous, clots that occurred in six women aged 18 to 48, between six and 13 days after they were vaccinated. More than 7 million doses of the one-shot vaccine have been administered in the United States.

On Wednesday, the CDC panel said more time was needed to gather more evidence in determining whether the clots were linked to the J&J shot, and if so, how big the risk is.

Jha, dean of the Brown University School of Public Health, said earlier in the week that federal officials were taking the right step with the initial pause. But after the continuation of the timeout, the doctor expressed concern that the agencies are taking the wrong approach.

“After thoughtfully discussing what we know & don’t know about rare clotting events, they punted,” he wrote of the panel’s meeting. “The advisory committee decided not to advise. This was a mistake. J&J should be un-paused soon.”

The “risk-benefit” by the officials is all wrong, Jha said, arguing that the panel should have recommended continuing the pause of the vaccine for women between the ages of 18 and 49, since that is the group which appears to be at high risk for the clots, but allowed everyone else to resume getting the single-dose vaccine.

The doctor argued that for many people, the single-dose vaccine is a “life-saver” during the pandemic.

“Imagine a 54 [year-old] male migrant farm worker with diabetes who can’t return for a 2nd shot,” Jha wrote. “Based on what we know today, would you give him J&J? His risk of getting COVID may be as high as 1 in 1000 per day. His chances of dying of COVID may be 1 in 100. So each unvaccinated day, his risk of death is 1 in 100,000.”

Meanwhile, that worker’s lifetime risk of blood clots linked to the vaccine is “way less than one in a million,” according to the doctor.

“[The panel’s] decision to wait would be fine if there was no pandemic going on,” Jha wrote. “But there is. And waiting 7-10 days won’t do much. Not sure what data they will get in that time. But we’ll have done real harm to a terrific vaccine particularly well-suited for vulnerable populations.”

Nearly all the adverse events are in women 18-49 years old

Cerebral Venous Sinus Thrombosis (CVST), the clot seen with J&J, is known to be more common in young women

Suggests that young women probably the group at high risk

This actually gave ACIP a smart way forward

2/7

— Ashish K. Jha, MD, MPH (@ashishkjha) April 15, 2021

But what about the fact that we have Moderna/Pfizer?

They are great. But not easy for everyone.

For many, J&J is a life-saver

Imagine 54 yo male migrant farm worker with diabetes who can’t return for a 2nd shot?

Based on what we know today,

Would you give him J&J?

4/7

— Ashish K. Jha, MD, MPH (@ashishkjha) April 15, 2021

ACIP’s decision to wait would be fine if there was no pandemic going on

But there is

And waiting 7-10 days won’t do much. Not sure what data they will get in that time

But we’ll have done real harm to a terrific vaccine particularly well-suited for vulnerable populations

6/7

— Ashish K. Jha, MD, MPH (@ashishkjha) April 15, 2021

We’re in a pandemic

Short pause to alert folks is reasonable

Waiting when its unlikely to change what we know is not

J&J highly-effective, safe vaccine with rare side-effects

I’d make it available soon, particularly for those for whom alternatives are not good choices

Fin

— Ashish K. Jha, MD, MPH (@ashishkjha) April 15, 2021