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, even beyond the nuts-and-bolts logistics 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 data systems are up to the task of tracking multiple injections for so many people, and capable of notifying them when it’s time to return for the second shot, ensuring they don’t get Moderna’s second shot if their first was Pfizer, and vise versa.
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.
The struggle for funding
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.”
President-elect Joe Biden, who wants to guarantee the vaccine “gets to every American, cost-free,” has said his administration would seek to invest $25 billion in manufacturing and distribution, which would require congressional action, the Kaiser Family Foundation said.
California’s cut of the federal money was $28.7 million, or about 71 cents per resident.
“The one thing that all states struggle with is funding,” said Josh Michaud, associate director for global health policy with the Kaiser Foundation. “They’re having to hire people, train them, buy equipment like freezers and, in general, the federal government has supplied very little. Not having guaranteed funding is a real issue in their readiness.”
The state Department of Public Health said 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.” It’s using the federal money to recruit and enroll vaccine providers; buy software to register, order and allocate vaccines; fund positions for data analysis and tracking, public outreach and computer programming; support a statewide media campaign; and, eventually, fund contracts for registered nurses and/or licensed vocational nurses to help staff vaccination events throughout California.
The mission of Operation Warp Speed was to bring a vaccine to a plague-weary world with dizzying velocity — within months of the deadly virus crashing onto the scene — while previous vaccine efforts have taken years, or decades, and sometimes failed completely.
But the effort became politicized, and some feared safety might be sacrificed on the altar of speed. To ease such concerns, Gov. Gavin Newsom appointed a panel of experts to a COVID-19 Scientific Safety Review Workgroup in October. They’re charged with independently examining the safety and efficacy data of any vaccine that receives FDA approval, and must give their blessing before California will distribute those vaccines to its citizenry.
Some experts argue that this extra step is unnecessary, and that California and other states with review panels should stand down. FDA Commissioner Stephen Hahn pushed back on political pressure to approve a vaccine before Election Day, insisting that vaccine developers 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.”
It’s one thing to have a vaccine, 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.”
Richard Carpiano, a public health scientist and medical sociologist at UC Riverside, is disappointed there hasn’t been a massive public education campaign to explain the scientific breakthroughs that have brought so many vaccine candidates forward in record time. “There have been great opportunities to talk about how the science works, like when we were going to the moon. How do rockets work? What do the astronauts have to do up there?” he said. “Instead, we’ve been relying on talking heads sort of segments, giving off a message of ‘Just trust us.’ “
A Gallup poll released earlier this month found that 58 percent of adults are willing to be vaccinated. That’s down from 66 percent in July, but up from 50 percent in September. It remains to be seen if that’s enough acceptance to halt the virus’ march — and skepticism runs deep.
“The recent claims made by Pfizer and Moderna are simply early projections based on the first 95 people to catch COVID in each of their large phase 3 trials,” said Bob Sears, a pediatrician from Capistrano Beach.
“Their claims have not been peer-reviewed (that is, reviewed by a board of independent scientists who are NOT looking to cash in big time with their stock options),” he said by email.
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.
Who will get the first vaccines? Health care workers and first responders. But what if there’s not enough vaccine for all of them at the beginning? There will have to be a ranking, likely to be based on underlying health conditions and similar variables, experts say. The Centers for Disease Control is expected to issue guidance on that 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 Brown communities most heavily hit by the virus will get priority access. But how will experts drill down to the nitty-gritty of that?
UCLA’s May — and her colleagues in public health and urban planning — have developed a predictive model that shows which Los Angeles County neighborhoods are most at risk. The researchers weighed the usual things known to increase medical vulnerability to COVID-19 — preexisting medical conditions, health care access, socioeconomic factors — but they also looked outside the box, 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 sheds new light and can guide Los Angeles County to those most in need. It can also be adapted statewide to help officials plan out more fair and equitable vaccine distribution, she said.
“We could tell as we peeled back the layers that we had something that really could help,” Mays said.
In Los Angeles, the areas in and around South Los Angeles and the eastern portion of the San Fernando Valley were the most heavily impacted.
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.
Doses-administered data will ultimately reside in the 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 of informing people when it’s time for a second shot, which is required for both the Pfizer and Moderna vacines. They systems should also be adept at ensuring that people don’t get a Moderna injection if their first one was a Pfizer, and vise versa, officials and experts said. People can expect reminders by text message and email when it’s time for their second shots.
“We already have vaccines that are multiple dose — HPV, hepatitis B and the like,” said Andrew Noymer, an epidemiologist and population health scientist at UC Irvine. “Health care providers have experience with that, so I’m not really losing sleep over it.”
People have to understand, though, 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,” Noymer said. “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 percent, 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.”
Source: Orange County Register