The Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) this week made no recommendation on the Johnson & Johnson vaccine, meaning the CDC’s initial decision to pause administration of the vaccine will likely remain in place until at least next Friday.
The Food and Drug Administration and the CDC justified the initial pause as necessary to help health-care providers identify and properly treat a rare post-vaccination syndrome involving not only blood clots but also low platelets. They were right to share that information, but that emergency justification for a short pause is now gone. There is no evidence the vaccine’s risks universally, or even typically, outweigh its benefits in preventing a pandemic disease with serious and unknown consequences. The agencies should end the pause, keep sharing information and let patients decide.
At its meeting, ACIP analyzed vaccine side effects with admirable transparency. But there was no rigorous analysis of the risks of not being vaccinated. Rather, ACIP insisted that because “alternative covid-19 vaccines (mRNA vaccines) are available,” the tradeoffs are inconsequential. This shows a profound disconnect with the reality many Americans face.
When the pause began, millions of Americans were still ineligible for vaccines. And universal eligibility on April 19 will not mean immediate access; obstacles to vaccination will remain, especially for people who can’t travel long distances. This undermines the blithe assertion that unbounded supply of other vaccines makes pausing one irrelevant. Plus, the J&J vaccine requires only one appointment instead of two and can be delivered in settings where others can’t. The pause has stymied essential efforts, such as outreach to homebound D.C. seniors at far higher risk from covid-19 than from vaccination.
Looking at ACIP’s roster helps diagnose its mistake. Its voting members are almost all doctors far more familiar with rare vaccine side effects than with marshaling scarce public health capacity to respond to a surge of infections. The committee lacks comparative effectiveness experts or health economists familiar with weighing inevitable tradeoffs at a population-wide scale. Nirav Shah, a nonvoting member representing the Association of State and Territorial Health Officials, argued that “not making a decision is tantamount to making a decision. Any extension of the pause will invariably result in the fact that the most vulnerable individuals in United States who were prime candidates of J&J vaccine will remain vulnerable.” His pleas went unanswered.
What ACIP must provide, but likely 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 vaccines were available. The resulting hospitalizations and deaths, likely concentrated in disadvantaged communities, will happen weeks from now and will probably be ignored by the media. News stories will highlight blood clots following vaccination but not consider whether a one-dose vaccine could have protected a homeless person who arrived at the emergency room deathly ill from covid-19 or prevented an outbreak at her encampment. Without a comparison of the pause’s harms to the vaccine’s side effects, we have every reason to fear that ACIP loudly fiddled while Rome quietly burned.
The J&J pause reflects greater dysfunction in our covid-19 response. Regulators design policies to optimally protect the best-off in society who can afford to take days off work, travel for vaccinations and face side effects twice. Like governors’ tone-deaf 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 examined benefits and burdens rigorously and recommended people under 30 receive different vaccines. This targeted policy eased the logistics of swapping vaccines, avoided leaving high-risk people unprotected and safeguarded vaccine confidence.
In a pandemic, each day counts. The FDA has not removed the vaccine’s authorization, and CDC Director Rochelle Walensky is not bound by ACIP’s (non-)advice. She could end the pause and restore access for people who reasonably prefer single-shot protection from covid-19 to the minuscule risks of vaccination. If backed up by risk-benefit analysis, the CDC could recommend that certain subgroups (e.g., younger healthy adults) wait for an alternative vaccine. The public can play a part, too: They should press senators and President Biden to appoint a permanent FDA director who considers benefits as well as risks and acknowledges tradeoffs. And they should encourage state public health agencies to help end the pandemic by keeping access to the vaccine open for those who want it.