The transition team of President-elect Biden has taken its first step to reexamine the distribution of Covid-19 vaccines put in place by the Trump administration. Instead of keeping half the doses in reserve to make sure that every person who received their first dose can receive their second dose, the transition said Friday that it would release the vast majority of available doses of authorized vaccines at once.
It’s a great start. But it is also only a start.
The argument to hold back the second dose was not without merit at a time of limited supply of the vaccines, developed by Pfizer and its partner BioNTech, as well as Moderna. The fear has been that, without sufficient doses in reserve, there would be mayhem, with some sites keeping doses in reserve themselves and recipients becoming upset if their second dose was not available. But the policy has also meant that only half as many people get shots in their arm at a time when the U.S. breaks its record number of Covid-19 deaths daily and two new, apparently faster-spreading, variants of the SARS-CoV-2 virus have been let loose on the world.
Governors have called for Operation Warp Speed, the government’s effort to fast-track the development and distribution of vaccine, not to hold back doses.
On Friday, Scott Gottlieb, a former FDA commissioner, called the move “a prudent move that will help expand Covid vaccine access to more high-risk patients at a time when the epidemic is worsening.” Gottlieb, who is also a member of Pfizer’s board of directors, has been pushing the idea of distributing doses as they are manufactured since vaccine distribution began.
Over time, holding the doses in reserve made less and less sense. A recent analysis published by researchers in Ottawa argued that even holding half the doses in reserve would mean more people would get Covid. Holding them all in reserve only makes sense if a massive shortfall in manufacturing is expected.
Some researchers go a step further. Estimates based on a small amount of data in pivotal clinical trials indicate that the first dose of the vaccines may reduce transmission by as much as 85%. This contrasts with data from the early studies that showed the second dose was needed to ramp up the body’s immune response. But Britain has already decided to wait as long as three months, not one, between doses, and some researchers are arguing for gambling by skipping second doses entirely. The Food and Drug Administration has said it would not change its dosing schedule without further evidence that it made sense to do so.
While the transition’s announcement Friday makes sense, it also may be mostly symbolic, as it’s not clear that the practice of keeping doses in reserve was going to be permanent. Last week, Nancy Messonnier, an expert at the Centers for Disease Control and Prevention, indicated during a STAT virtual event that the policy was a moving target.
“In the short term, the holding back of the second dose is to ensure that individuals get the full benefit of the vaccination series by getting a second dose,” she said. “I hope that, in short time, the supply will be more dependable, we’ll have more confidence in it, and we will be able to, as you say, have less vaccine held back.”
The bigger problems with the vaccine rollout have less to do with supply or distribution and more to do with disorganization, which has prevented getting shots into arms. In the past week, for example, the mayor of New York City and New York’s governor have sparred in public over which first responders, including police officers, are up for vaccination right now. The American Hospital Association has complained to the health and human services secretary that it is not even clear who is responsible for answering hospitals’ questions about vaccine distribution.
The Biden administration is going to have to figure out how to reshape the effort without shaking public confidence in the vaccines. And, like so many tasks involved in the Covid-19 rollout, the devil will be in the details.