Vaccine delivery poses a challenge
The obstacles include funding, distribution and a nervous public
It’s an audacious, unprecedented task straight out of “Mission: Impossible” — inoculate some 40 million people in a matter of months with a coronavirus vaccine.
California is on the cusp of a mass campaign that faces colossal complexities, and it only starts with the now-well- publicized challenge of having enough cold storage for the Pfizer and Moderna vaccines once they finally arrive.
Will local health departments — expected to shoulder the lion’s share of the work — have enough cash to pull off such a daunting task? Will the panel of scientists charged with double-checking the Food and Drug Administration’s work on vaccine safety build the public’s confidence or just gum up the gears of a rollout? And where’s the massive public education campaign designed to dispel fear and persuade wary residents to roll up their sleeves?
Some wonder if states’ data systems are up to the task of tracking multiple injections for so many people — a capability needed to notify them when it’s time to return for the second shot and to ensure they don’t get Moderna’s booster if their first shot was from Pfizer.
And everyone, it seems, worries about equity. Who, among priority populations, will get the first vaccines? How will the state identify communities with the highest need and ensure they have access?
Though the task ahead is enormous, America managed to put a man on the moon, experts say: We can do this.
Getting back to normalcy won’t come cheap.
“A critical challenge facing vaccine distribution efforts will be funding,” said the nonprofit Kaiser Family Foundation, which examined 47 state vaccine rollout plans. “To date, only $200 million has been distributed to state, territorial and local jurisdictions for vaccine preparedness, though it is estimated that at least $6-8 billion is needed.”
And President- elect Joe Biden, who wants to guarantee the vaccine “gets to every American, cost-free,” has said his administration would seek to invest another $25 billion in manufacturing and distribution. That will require congressional authorization.
California’s cut of the federal money distributed so far was $28.7 million, or about 71 cents per resident. That won’t go very far.
“The one thing that all states struggle with is funding,” said Josh Michaud, associate director for global health policy with the Kaiser Family Foundation. “They’re having to hire people, train them, buy equipment like freezers, and, in general, the federal government has supplied very little.”
The state Department of Public Health says it stands ready to assist California’s local county and city health departments “should any gaps in funding occur or should there be a need for unforeseen large acquisitions.” But it’s not clear where that money would come from, either.
Safety check
The mission of Operation Warp Speed was to bring a vaccine to a plague-weary
world with dizzying velocity — within mere months of the deadly virus crashing onto the scene.
But the effort became politicized, and some feared safety might be sacrificed on the altar of speed. To ease such concerns, Gov. Gavin Newsom in October appointed a panel of experts to a COVID-19 Scientific Safety Review Workgroup.
They’re charged with independently examining the safety and efficacy of any vaccine that receives Food and Drug Administration approval and must give their blessing before California will distribute those vaccines to its citizenry.
Some experts argue that this extra step is now unnecessary and that California and other states with review panels should stand down. FDA Commissioner Stephen Hahn staved off the pressure to approve a vaccine before Election Day, insisting that companies provide at least two months of safety data before approval. That, some experts say, should resolve any worries that there’s a political finger on the scale.
“I have never been more confident in the FDA’S ability … that we will see a
very aggressive, comprehensive and fair review of this vaccine,” said Michael Osterholm, infectious disease expert at the University of Minnesota Center of Infectious Disease Research and Policy, who has been named to the Biden-harris Transition COVID-19 Advisory Board, in a recent webinar. “All the states that said they’ll have their own review groups — that can only complicate and hold up the efforts.”
Arthur L. Reingold, chair of California’s safety review panel and head of epidemiology and biostatistics at UC Berkeley, understands those concerns but believes wary Californians deserve the peace of mind that extra scrutiny will bring. “We clearly have a pretty substantial fraction of the population that, at the moment, doesn’t fully trust the current administration,” he said.
Reingold’s panel will get data soon after it’s presented to the FDA, review it quickly and make its recommendation in short order — “in a matter of a few days, not weeks,” Reingold said. “We’re quite confident that we will not impose additional delays on who gets the vaccine in California.”
Public education
It’s one thing to have a vaccine, and it’s another thing completely to have people vaccinated, said Vickie Mays, professor of health policy and management at UCLA, who also directs the National Institutes of Health- funded UCLA BRITE Center for Science, Research and Policy.
“Let’s say, ‘Hip, hip hooray!’ about the fact that we have potential vaccines, but we need to start educating people about them today, right now. We shouldn’t wait,” she said. “Start right now indicating what the vaccines can do: ‘ This one was tested to determine whether or not it could reduce the consequences of COVID-19 so people don’t get deathly sick. It doesn’t mean you won’t still get infected. It doesn’t mean that we can throw all the public health advisories out the window.’ If you don’t start telling people now they’ll still need to wear masks for a while even with a vaccine, they’re going to feel duped.”
A Gallup poll released earlier this month found that 58% of adults are willing to be vaccinated. That’s down from 66% in July, but up from 50% in September. It remains to be seen if that’s enough acceptance to halt the virus’ march — and skepticism runs deep.
State and local health departments say they’ve already started enlisting the help of trusted community leaders who can help get out the facts about vaccines — once they are approved. Public communication campaigns are in the works, they said.
Equity plans
Health care workers and first responders will get the first vaccines. But what if there’s not enough for all of them at the beginning? There will have to be a ranking, likely based on underlying health conditions and similar variables, experts say. The Centers for Disease Control is expected to issue guidance soon.
As the vaccination campaign unfolds to broader swaths of the public — following the model set by local flu vaccination clinics all over the state — California has vowed to make sure that the Black and Latinx communities most heavily hit by the virus will get priority access. But who, and how?
UCLA’S Mays and her colleagues in public health and urban planning have developed a predictive model that shows which neighborhoods are most at risk. The researchers weighed the usual things known to increase medical vulnerability to COVID-19 — pre- existing medical conditions, health care access, socioeconomic factors — but they also looked at “the built environment.”
“We’re really trying to think about space, about density,” Mays said. Using data from the U. S. Census Bureau, the California Department of Parks and Recreation and many other sources, the model points to neighborhoods and living situations likely to produce the highest risk.
Technology
Experts are confident that California’s data systems are up to the task at hand. The state is working on “a robust data system to track local inventories and doses administered,” and it already has a “confidential and secure” Immunization Information System.
The data will ultimately reside in California’s Immunization Registry, which supports “real-time immunization record query messages” and can return immunization histories, according to the Department of Public Health.
Health providers and the state will be able to keep track of who has received which shots when, and inform people when it’s time for a second shot, which is required for both the Pfizer and Moderna vaccines. People can expect reminders by text message and email when it’s time for their second shots.
But it’s important to understand that nothing goes perfectly.
“One reason why clinical trials sometimes show better results than what we see in the subsequent, real world, is that everything is done perfectly in a clinical trial,” said Andrew Noymer, an epidemiologist and population health scientist at UC Irvine. “You can bet your bottom dollar that Pfizer moved heaven and earth to make sure those vaccines were stored at the right temperature. But in the real world, the electricity goes out and some freezer turns off for an hour. People won’t get the second shot at the optimal time — and some won’t return for the second shot at all.
“There are little unavoidable mishaps which don’t result from people’s lack of competence, but because the real world is the real world and the universe has jagged edges. If that means a reduction in efficacy to, say, 80%, that’s still great. That’s what we were hoping for. This vaccine stuff is some of the best news we’ve had since, well, ever.”