Pausing use of J&J’s vaccine for another week was a deadly mistake

This week, the Advisory Committee on Immunization Practices (ACIP) of the Center for Disease Control and Prevention (CDC) made no recommendation on the Johnson & Johnson vaccine, meaning that the CDC’s initial decision to pause the vaccine will likely remain in effect until – at least – next Friday.

As a result, 10 million doses of the vaccine will remain unused in refrigerators since hundreds of thousands of Americans are infected with covid-19. As cases and hospitalizations continue to rise in many states, slowing down vaccinations has become a deadly mistake.

The Food and Drug Administration (FDA) and CDC justified the initial pause as necessary to help healthcare providers identify and properly treat a rare post-vaccination syndrome that involves not only blood clots but also low platelets.

They were right to share that information, but that emergency justification for taking the brief hiatus is no more.

There is no evidence that the risks of the vaccine, universally, or even typically, outweigh its benefits in preventing a pandemic disease with serious and unknown consequences. Agencies must end the hiatus, continue to share information, and let patients decide.

At the meeting, the ACIP discussed the side effects of vaccines with admirable transparency. But there was no rigorous analysis of the risks of not being vaccinated.

Rather, insisted that because “there are alternative vaccines available against covid-19 (mRNA vaccines)”, the compensations are inconsequential. This shows a profound disconnect from the reality many Americans face.

When the hiatus began, millions of Americans were still not eligible for vaccines. And universal eligibility on April 19 won’t mean immediate access; Obstacles to vaccination will continue to exist, especially for people who cannot travel long distances.

This undermines the cheerful claim that the unlimited supply of other vaccines makes the pause irrelevant. What’s more, J&J’s vaccine requires only one appointment instead of two and can be given in settings where others cannot.

The pause has hampered essential efforts, such as reaching out to homebound seniors with a much higher risk of COVID-19 than vaccination.

Looking at the ACIP list helps diagnose your error. Its voting members are nearly all physicians far more familiar with the rare side effects of vaccines than with the poor public health capacity to respond to an increase in infections.

The committee lacks comparative effectiveness experts or health economists familiar with weighing the inevitable trade-offs on a population scale.

Nirav Shah, a non-voting member representing the Association of State and Territorial Health Officials, argued that “Not making a decision is equivalent to making a decision. Any extension of the hiatus will invariably result in the fact that more vulnerable people in the United States than where the leading J&J vaccine candidates will remain vulnerable.” His pleas went unanswered.

What the ACIP should provide, but probably never will, is an estimate of How many of the hundreds of thousands of Americans infected with COVID-19 in the coming days could have been protected if J & J’s vaccines were available.

The hospitalizations and resulting deaths, likely concentrated in disadvantaged communities, will occur within weeks and will likely be ignored by the media.

The news will highlight the issue of blood clots after vaccination, but will not consider whether a single-dose vaccine could have protected a homeless person who came to the emergency room sick to death from COVID-19 or prevented an outbreak in their shelters.

The J&J hiatus reflects further dysfunction in our covid-19 response. Regulators design policies to optimally protect the better-off in society who can afford to take days off from work, travel for vaccinations, and face side effects twice.

A woman receiving a dose of the Johnson & Johnson vaccine in Chicago.

Like governors’ advice to “drive to the beach” to access vaccines, stopping access to single-dose vaccines in emergency rooms and homeless shelters ignores the most vulnerable Americans.

Britain took a better approach when the AstraZeneca vaccine caused similar adverse events. Its experts rigorously examined the benefits and burdens and recommended that people under the age of 30 receive different vaccines.

This policy facilitated the logistics of vaccine exchange, avoided leaving high-risk people unprotected and safeguarding confidence in vaccines.

In a pandemic, every day counts. The FDA has not deauthorized the vaccine, and CDC Director Rochelle Walensky is not bound by ACIP’s (non) advice. She could end the hiatus and restore access for people who reasonably prefer the protection of a single COVID-19 injection to the miniscule risks of vaccination.

If supported by a risk-benefit analysis, the CDC might recommend that certain subgroups (for example, healthy young adults) wait for an alternative vaccine.

The public can play a role, too: They should lobby senators and President Joe Biden to appoint a permanent FDA director who considers the benefits and risks, and recognizes the tradeoffs. And they should encourage state public health agencies to help end the pandemic by keeping access to the vaccine open to those who want it.