Revamp of the nation's vaccination effort may not be enough

As Joe Biden takes over as president, inheriting a failing vaccination effort, public health experts are cautiously optimistic that the new administration will provide some much-needed direction to the process. But some are already questioning whether his strategy will be aggressive enough to stem the pandemic’s spread.

Under President Donald Trump, of the more than 30 million vaccine doses that have been distributed, just 11 million people had received an initial dose as of Jan. 14, according to the Centers for Disease Control and Prevention. That amounts to roughly 3% of the U.S. population and comes well under initial projections by federal health officials. In early December, HHS Secretary Alex Azar estimated as many as 20 million Americans would receive an initial dose by the end of 2020, with a goal of administering 100 million by the end of March.

Last week, Biden unveiled details of his $1.9 trillion COVID relief plan that calls for allocating $20 billion toward a national vaccination program.

Biden and his pandemic task force set a target of administering 100 million doses of vaccine in the first 100 days of his administration in an effort to get the country on pace to achieve herd immunity by later this year.

Some argue that more vaccinations are needed. “One million should not be the ultimate target, that’s not nearly ambitious enough,” said Dr. Leana Wen, an emergency physician and public health professor at George Washington University who previously was Baltimore’s health commissioner.

Wen said a goal of 1 million vaccinations a day serves as a good baseline but is still too slow to achieve herd immunity by fall. Experts have estimated around 75% of Americans would need to get vaccinated to reach a threshold to effectively stop widespread transmission of the virus. “We need to be doing 3 million vaccinations a day,” Wen said.

Wen said the problems with the vaccine rollout thus far under the Trump administration will likely require an entire reset of the program to scale up vaccinations. “A big part of the problem was that the infrastructure was never established in the first place that’s really required,” she said.

Issues that have contributed to the slow start have included some hospitals receiving too much of the vaccine while others have gotten amounts too small to meet their demand. Some doses have come without prior notice, or arrived too late for providers to schedule patients to receive their second dose. Some vaccine supplies have arrived missing items like syringes and needles needed to extract all of the doses from vials, leading to waste. And in some instances, shipments have been delivered already thawed because no arrangement had been made to store them in the ultra-cold chain storage required.

“We expect these issues to be worked out, and the pace of vaccinations will increase dramatically over the coming weeks,” said Rick Pollack, CEO of the American Hospital Association, in an emailed statement.

The organization sent a letter to Azar Jan. 7 detailing some of the barriers hospitals have faced in their vaccination efforts and called for HHS to better coordinate the states.

“I don’t believe that the current administration has a national strategy for the vaccine rollout,” said Dr. Georges Benjamin, executive director of the American Public Health Association. Most of the planning for administering the shots was left to individual states.

Benjamin and other public health experts believe the Biden administration will seek to take more of a hands-on approach in its vaccination strategy. Requests to the Biden transition team for comment were not answered.

Biden’s vaccination strategy will call for the Federal Emergency Management Authority to create thousands of community mass vaccination centers, with a goal of opening 100 such sites within the first month to ease some of the burden off of hospitals. Mobile vaccination units and distribution of supplies to federally qualified health centers will be carried out to medically-underserved communities to reach remote areas.

The plan also aims to expand the public health workforce with the hiring of an additional 100,000 personnel to initially help with vaccine outreach and contact tracing but will transition into longer-term community health roles. Biden has promised to ensure free access to vaccines with no cost sharing for all people regardless of their immigration status. Other suggestions include streamlining paperwork.

A key element many experts are seeking from the new administration’s approach is whether they can establish a system that provides better coordination and communication among states. Benjamin said the absence of a more centralized plan has attributed to a host of problems across a number of states, leading to longer than expected delays in getting people vaccinated as well as coordination errors resulting in some vaccine getting wasted.

That’s left crucial strategic gaps Benjamin said the Biden administration will need to address logistical demands.

Experts have lauded Biden for expressing a willingness to invoke the Defense Production Act if needed to boost vaccine production. The law would allow the president to require companies to manufacture items deemed crucial to national security such as masks, personal protective equipment, and materials to produce more vaccine. “That’s the big thing that the Trump administration was not willing to do,” said Dr. Marcus Plescia, chief medical officer for the Association of State and Territorial Health Officials.

Plescia sees maintaining an adequate, sustainable vaccine supply as the biggest factor that will determine whether the Biden team ultimately meets its vaccination target.

But production issues are only one of the challenges facing the new administration’s effort to expand vaccinations.

“It appears that the Biden administration is inheriting from the Trump administration a system that has not thought out this last mile between vaccine distribution to the states and actual vaccine doses given into arms,” Wen said. “We are months behind where we really should be at this point.”

Recently the president-elect proposed releasing all available vaccine supplies now as opposed to holding onto a portion to ensure enough doses are available to give a second dose to those who received their first.

It’s an idea that was initially rejected by the Trump administration but has since adopted. Last week, HHS Secretary Alex Azar announced plans to make available the rest of the vaccine supply that was being held and recommended states provide shots to everyone age 65 and older and to those with preexisting medical conditions.

“We now believe that our manufacturing is predictable enough that we can ensure second doses are available for people from ongoing production,” Azar said last week about the policy change. “Everything is now available to our states and our healthcare providers.”

The change in distribution carries a potential risk of making the vaccinations of those who received an initial dose less effective or even ineffective if production issues lead to supply shortages that delay people from receiving their second dose in time. The coronavirus vaccines have an efficacy rate of more than 90% when two shots are given 21 days apart for the Pfizer-BioNTech vaccine, and 28 days apart for the vaccine produced by Moderna. While a Food and Drug Administration analysis showed a single dose of the Pfizer-BioNTech vaccine had a protection rate of 82%, it cautioned not enough information was known about whether a single dose provided protection past 21 days.

Despite the urgent need to increase vaccinations, Wen does not favor releasing all available supplies unless there are guarantees enough would be available to vaccinate patients in the way the vaccine was intended to be used. “People who receive the first vaccine dose have a reasonable expectation that they should receive the second in a timely manner,” she said.

In defending the Trump administration’s vaccination strategy, Azar said last week in a meeting with reporters an average of more than 700,000 vaccinations had been conducted over the past several days and projected an average of 1 million vaccinations a day would be reached over the following week to 10 days.

Azar blamed the slow vaccine rollout on states adhering too strictly to federal guidance that recommended front-line healthcare workers and staff and resident of long-term-care facilities receive the vaccine first.

“This is just moving to the next phase of the vaccine program,” Azar said. “We’ve had so much success with quality and predictable manufacturing and almost flawless distribution of the vaccine, but we have seen now that the administration in the states has been too narrowly focused.”

Azar also announced the administration was moving forward on plans to open more channels to administer the vaccine that included local pharmacies and community health centers. HHS plans to deploy teams to provide technical assistance to states in their efforts. “It has been overly hospitalized so far in too many states,” Azar said.

But Dr. Carmen Rexach, an infectious disease expert and a spokeswoman for the Infectious Disease Society of America, said a key component that has yet to be addressed involves effectively communicating with the public the benefits of taking the vaccine. Biden's plan includes launching a mass public education campaign to bolster confidence in the vaccine’s safety and efficacy.

The lack of a robust public education campaign about the vaccine thus far has led to a sizable portion of the public remaining hesitant to get vaccinated. A survey conducted last month by the Kaiser Family Foundation found more than a quarter of the public said they would not get the COVID-19 vaccine. The share of those who said they would not get vaccinated was higher among Black adults and essential workers, despite the fact that both groups have been disproportionately impacted by the pandemic.

Rexach said raising adherence, particularly among the highest-risk populations, is crucial to stem COVID-19’s spread.

“I think people are so afraid of COVID that they’re more likely to be willing to get a vaccine than they are to get an MMR (measles, mumps and rubella vaccine),” Rexach said. “What (the Biden administration) might do that would help even more is actually show people how this vaccine works and how it is different from other types of vaccines.”