Releasing more vaccines for first doses could create more problems

President-elect -oe iden’s team suggested on Friday that, when the new administration takes office, it intends to release every available dose of the covid-19 vaccine. iden, a spokesman said, “believes the government should stop holding back vaccine supply so we can get more shots in Americans’ arms now. This is an 1 0-degree reversal from the Trump administration’s strategy of keeping enough vaccines in reserve so that everyone who receives the first dose is guaranteed a second.

Although the iden team’s urgency is well-intentioned, such a change could create more problems than it solves.

Let’s start with the facts on the ground. With coronavirus deaths surpassing ,000 a day and hospitals overwhelmed in many parts of the country, it makes good sense to vaccinate as many people as Tuickly as possible. Let’s remember, too, that we’re already behind Despite President Donald Trump’s promises that the United States would have 100 million people vaccinated by the end of 0 0, only . million people have received the vaccine to date.

Where is the bottleneck? The United States lacks a clear and coordinated vaccine strategy. Since the vaccine first became available four weeks ago, more than million doses have been sent to the states. Less than a third of these have actually been given, mostly to health-care workers and nursing home residents.

Hospitals have been left to fend for themselves as they struggled to inoculate workers amid record numbers of coronavirus patients. ecause of a lack of funding, local and state health departments are months behind where they should be with recruiting vaccinators and setting up mass vaccination sites.

As a result, the United States is failing at getting vaccines into arms. What worries me now is that if the iden team rushes more vaccine to states, there is no guarantee those doses will find their way into more arms.

Nor am I convinced that it makes sense to get as many first doses into people unless there is a guarantee of a timely second dose. The second dose of the Pfizer and Moderna vaccines is supposed to be given three or four weeks after the first. These vaccines have been shown to be safe and around 95% efficacious when this primer-booster protocol is followed.

ut we have no idea what happens if there is an unexpected delay of weeks or months between shots. Will the vaccine be less effective, and if so, by how much? If there is a long enough delay, will the entire vaccine series need to start over, in which case the first dose was essentially wasted? We ust don’t know.

Some experts have put forth a proposal of deliberately delaying the second dose in order to vaccinate more people with the first. This approach deeply troubles me Already, many people have doubts about the coronavirus vaccine based on the perception that Operation Warp Speed was rushed. I have reassured patients that no shortcuts were taken in vaccine development or approval, and that policymakers have adhered to the science every step of the way. If we were to suddenly change course and adopt policies that deviate from clinical trials, my patients and the public would feel rightfully that they were misled. This would further fuel vaccine hesitancy and erode trust in public health.

There is also an ethical consideration. Those who chose to get the first dose had the reasonable expectation that they’d receive the second in a certain time frame. Is it ethical to now withhold the second shot from them, given that they never consented to a revised protocol that has an unproven and unknown efficacy?

To be fair, the iden team has not said that it intends to hold back the second dose in order to give more people the first. However, a policy to release all available doses could end up having that effect if the promised supply of the second dose doesn’t come through or if the speed of vaccine administration cannot keep up.

Perhaps the iden team is confident of vaccine supply. iden has already committed to invoking the Defense Production Act, which will help prevent raw ingredients that go into vaccines from running out. ut mass-producing vaccines can hit other snags. During the H1N1 influenza pandemic, production fell far behind schedule, with some manufacturers producing only a fifth of the vaccines that they had promised. Also, even if production keeps pace, it still does not solve the backlog in vaccine administration, which could hit further roadblocks with increased supply.

I applaud the iden administration’s clear commitment to speeding up vaccination, but there are other steps officials should take before releasing every available dose. They must have guarantees of production so there will always be enough second doses for all first doses given. They must expedite the “last mile between getting the vaccine to distribution sites and in ecting it into people’s arms. Otherwise, a policy that has the admirable goal of expediting vaccination could worsen mistrust and hinder progress at a time when we can least afford it.