Suspending use of Johnson & Johnson’s vaccine for an additional week was a fatal mistake

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

Therefore, 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 fatal mistake.

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

They were right to share this information, but that urgent rationale for taking the brief interruption is gone. 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 need to end the hiatus, continue to share information, and let patients decide.

During the meeting, ACIP discussed the side effects of vaccines with admirable transparency. But there has not been a rigorous analysis of the risks of not being vaccinated. Very good, insisted that “there are alternative covid-19 vaccines (mRNA vaccines)”, the compensations are irrelevant. It shows a deep disconnect from the reality that 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; Barriers to vaccination will continue to exist, especially for people who cannot travel long distances.

This undermines the light claim that the unlimited supply of other vaccines makes the break unnecessary. In addition, J & J’s vaccine requires only one appointment instead of two and can be given in settings where others cannot. The hiatus has hampered essential efforts, such as reaching homebound seniors with a much higher risk of COVID-19 than vaccination.

Examining the ACIP list will help diagnose your error. Its voting members are almost all physicians much 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 efficacy experts or health economists familiar with assessing the inevitable trade-offs at the population level.

Nirav Shah, a non-voting member representing the Association of State and Territory Health Officials, argued that “Not making a decision is like making a decision. Any extension of the break will invariably result in more vulnerable people in the United States than where major J&J vaccine candidates will remain vulnerable. “. His requests went unanswered.

What 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 resulting hospitalizations and deaths, likely concentrated in underprivileged communities, will occur in a matter of weeks and will likely be ignored by the media. The news will highlight the problem of blood clots after vaccination, but will not examine whether a single dose vaccine could have protected a homeless person who arrived at the emergency room sick to death from COVID-19 or prevented an outbreak in their homes. shelters.

The J&J pause reflects an additional dysfunction in our response to covid-19. Regulators are designing policies to optimally protect the better-off in society who can afford time off work, travel for vaccinations, and face side effects twice.

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

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

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

In a pandemic, every day counts. The FDA has not revoked the vaccine’s authorization and CDC director Rochelle Walensky is not bound by ACIP’s advice (no). It could end the hiatus and restore access for people who reasonably prefer the protection of a single injection of COVID-19 to the minuscule 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 also play a role: They must pressure senators and President Joe Biden to appoint a permanent director of the FDA who considers the benefits and risks and recognizes the trade-offs. And they should encourage national public health agencies to help end the pandemic by keeping access to the vaccine open to those who want it.

* By Govind Persad (Associate Professor, University of Denver Sturm School of Law and Greenwall Foundation Fellow in Bioethics) and William F. Parker (Parker is Associate Professor of Pulmonary and Critical Care Medicine at the University of Chicago and Deputy Director of the MacLean Center for Clinical Medical Ethics)

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