The next phase of the pandemic battle is upon us, so hike up your sleeves.
The U.S. Centers for Disease Control released a long-awaited playbook for rolling out COVID-19 vaccines this week, urging state and local governments to shift into high gear by forming critical “vaccination program planning and coordination teams” and “implementation committees” reflecting the community at large.
Vaccines should be free for all who wish to get them; and the CDC itself will take vaccine orders, and fill and ship them to local health departments and providers, the plan says.
The vaccination program will unfurl in three distinct phases, with supplies limited in the early weeks. First in line for shots should be health care personnel likely to be exposed to, or to treat people with, COVID-19; those with underlying medical conditions and people aged 65 and older, who are at increased risk for severe illness; and other essential workers. The specifics will differ from place to place depending on local needs, the CDC said.
That puts the onus on state and local health departments to fill in the many blanks of a massive, nationwide vaccination effort — including how to assure that vaccines would be kept at super-cold temperatures, as some would require. That work appears in its infancy in California and its four populous southern counties.
Of course, there is no vaccine yet. There are, however, 36 candidates in clinical evaluation worldwide as of Sept. 17, and another 146 in preclinical evaluation, according to the World Health Organization.
“The government is keen to remind us that a vaccine is imminent, and I think this document is part of the virtue-signaling around that,” said Andrew Noymer, an epidemiologist and population health scientist at UC Irvine. “But it’s a good prompt for state and local health departments. They may not have much of a plan yet — I mean, there’s no vaccine yet — but ask them again in four weeks. There’s a lot they can do in four weeks. “
Rollout prep?
In an emailed statement about the Golden State’s vaccination rollout plan, the California Department of Public Health said it “continues to work diligently to prepare for the eventual distribution and administration of COVID-19 vaccines in California.” Planning will involve local health departments, multiple state agencies and community-based stakeholders.
Officials are closely monitoring information about the candidate vaccines, their Phase 3 trials, the FDA review process and any independent evaluations. “CDPH will need evidence that the vaccine candidates are safe and effective before distributing them,” it said.
In San Bernardino County, officials are mulling how to use the infrastructure created for COVID-19 testing — sites, staffing, communications, organization and logistics — to administer both flu vaccines and an eventual COVID-19 vaccine, said spokesman David Wert.
That’s an infrastructure skeleton likely to be tapped in Los Angeles, Orange, Riverside and other counties as well, though the CDC also wants individual health providers to administer vaccines eventually as well.
In a best-case scenario mapped out by CDC, there could be some 40 million doses of vaccine available by the end of the year.
Some have doubt
The president has been hopeful for a vaccine before Election Day, though public health experts say the first doses likely won’t be available until much later in the year, and most Americans won’t likely get one until well into 2021.
As of now, two doses are required, about a month apart. To inoculate 300 million people — most of the U.S. population — 600 million doses would be needed.
Vaccines usually take years to produce — sometimes decades — and the compressed timetable here has prompted worries that speed may trump safety.
“I am concerned that COVID-19 vaccines have skipped much of the safety research that other vaccines go through, such as animal research to assess harm prior to human testing and three-year clinical trials to ensure both efficacy and to determine the side-effect profile,” said pediatrician Bob Sears of Capistrano Beach by email.
“Throw in the fact that hundreds of millions of doses are already bought and paid, our FDA director really has no choice but to approve them no matter what the safety trials show. No one wants to waste a few billion dollars — especially not now.”
Sears — who is “pro-informed consent and anti-mandate” on vaccines, and was slapped by the Medical Board of California for being too free with medical exemptions for children — said people certainly can opt in to gain whatever level of protection a vaccine can offer, but he hopes it remains a free choice.
“Because if this vaccine is like the flu shot and the whooping cough vaccine, it WON’T prevent the spread of disease,” Sears said. “It will only offer some reduction in personal symptoms. But you’ll still get sick and be contagious to others. … The vaccine isn’t going to help eliminate the disease — public health measures and the natural progression of this virus will see to that.”
Children and vaccines
The CDC’s playbook says precious little about children and whether they’ll be vaccinated, said Noymer of UCI. The leading vaccine candidates are being tested on adults, not children.
“Technically, findings from the trials are applicable to those 18 and up. I’m not comfortable giving kids a vaccine that hasn’t been tested on them,” Noyer said. “There’s an epidemiological rationale in this case that we don’t need to vaccinate kids because, by and large, they don’t get very sick, so we could just vaccinate everyone else. But there’s no unanimity on that. In my mind, if we’re not testing the new vaccines on kids, we should be careful about giving them to kids.”
CDC spokeswoman Kristen Nordlund said recommendations for pediatric populations, and other information in the interim playbook, will be updated as new information becomes available.
Drug company front-runners
The two drug companies at the front of the COVID vaccine-development pack — Moderna and Pfizer — released heretofore confidential details of how they’re evaluating their vaccines and what evidence they’ll use to determine whether they work on Thursday, in an effort to tamp down concerns. It’s a rare move, but worries persist.
“They run trials, stop as soon as there’s a scintilla of positive evidence and before other evidence comes in to make them look bad, and reap windfall profits,” Noymer said. “I hope it comes in like a home run, then we can all breathe a sigh of relief and say, ‘It works.’ “
But if the data reveals that it’s only 50 percent better than nothing — the low bar the Food and Drug Administration has set for COVID vaccines — it’s unclear how much good it would really do.
“I’m more worried that the trials are just going to show, ‘This doesn’t work, sorry,’ than I am that there’s going to be some incredible problem getting the vaccines delivered,” Noymer said.
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