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ASKED WHAT Keeps her awake at night while Texas prepares for the arrival of the first covid-19 vaccines, Imelda García, from the state health department, points out two opposite scenarios: a severe shortage of vaccines or many unused because no one wants to take them. These two concerns are on the minds of many other public health experts, as 6.4 million doses of vaccines are ready to ship across the United States, with a nod from the Food and Drug Administration (FDA).FDA), the federal drug regulator.
That assent is expected on or shortly after December 10, when the FDA will make a decision on the first covid-19 vaccine presented for approval in the United States, a jab developed by pharmaceutical firms Pfizer and BionorthTech. Moderna, the developer of another vaccine, will undergo FDA review on December 17th. Both vaccines are approximately 95% effective when given in a two-dose regimen. They are unlikely to stop America’s rampant epidemic until next spring, at best. But the United States is leading the way in vaccination against COVID-19, so the lessons of its initial experience will be closely followed in Europe and other parts of the world.
Organizing American supplies of covid-19 vaccines is the task of Operation Warp Speed, a program established by the current administration in May. This summer it pre-purchased 100 million doses of Pfizer and Moderna vaccines, and large quantities have already been manufactured. Each company expects to have about 20 million doses ready for distribution in the United States by the end of this year. This amount is roughly what it would take to vaccinate all of America’s healthcare workers, who are a priority group for early vaccine supplies.
Next will come groups particularly vulnerable to the disease, including essential workers at high risk of infection (such as police officers, teachers and bus drivers), nursing home residents, people with high-risk medical conditions, and people over 65. priority among these groups, which are suggested by the Centers for Disease Control and Prevention (Centers for Disease Control and Prevention) and other national health agencies, may vary somewhat from state to state. The current plan is that vaccine supplies, as they become available, will be spread across the states and six major metropolitan areas in proportion to their population. Each state will decide how to distribute them. At the current rate of vaccine production, widespread vaccination of the elderly is not planned until February.
The logistics of vaccinating more than 300 million Americans would be overwhelming with any vaccine. But Pfizer will be “extremely challenging,” says Claire Hannan of the Association of Immunization Managers. “It is nothing like what we’ve seen before,” he says. The vaccine should be stored at -70 ° C, which is the temperature in freezers that are rarely found outside of research laboratories and large medical centers. To address this, Pfizer will distribute the vaccine in “thermal carriers” – special containers filled with dry ice designed to hold between 1,000 and 5,000 doses. (You are now designing a smaller version for easier distribution.) But dry ice needs to be replenished regularly, the container can be opened only twice a day, and once it is removed, the vaccine lasts in a normal refrigerator for only five days. When ready to be given, it should be diluted with saline, which is also not a common step for vaccines.
People who handle the Pfizer vaccine will need extensive training, Ms. Hannan says. “This is not something that you can watch the video on and then be ready to go.” He is concerned that these new procedures will come at a time when hospitals and their staff are overwhelmed and exhausted by the flood of patients (see article). Due to all the complexities involved, a good amount of Pfizer’s early vaccine supplies can end up spoiling.
Moderna’s vaccine is more in line with what vaccinators are already used to. It should be stored at -20 ° C, the temperature of standard pharmacy freezers, it is stored in a normal refrigerator for 30 days, it is available in 100-dose containers and does not require dilution. This vaccine, if approved, would be delivered by McKesson, a medical distributor that already distributes vaccines nationwide.
Wherever vaccines go, supplies for injections must arrive at the same time. These will be distributed by McKesson in pre-assembled packages of syringes, alcohol wipes, gloves, and other items needed for each covid-19 puncture. Operation Warp Speed has been stockpiling them over the summer, to prevent a repeat of the fiasco with personal protective equipment for healthcare workers in the spring, when state and federal authorities competed with each other in a mad fight over the scarce world supplies.
Currently, states and the Department of Defense, which leads vaccine distribution logistics, are concentrating on preparing for the Pfizer vaccine. State authorities have been enrolling vaccination providers, creating lists of health workers and others who should be vaccinated first, and establishing systems to track vaccines. They’ve just started “dry testing,” placing orders for vaccines and syringes in the national system, and practicing what they’ll do with Pfizer thermal chargers (which, for now, come with empty vials).
The logistics of moving the vaccines will be complicated. However, the really difficult part will be convincing people to take them. America’s plan is to make vaccines freely available at all the usual places people get their flu shots, like pharmacies and doctor’s offices. The federal government is creating a fund to cover puncture provider fees for the uninsured; health plans will cover this fee for their members.
Many immunization experts worry that this “build it and they will come” approach is naive. At the moment, surveys suggest that between 20% and 60% of Americans may not accept a COVID-19 vaccine. In one survey, only a third of nurses said they would be vaccinated voluntarily. Some people worry that vaccines are not safe, and they suspect that corners may have been cut in the rush to develop them so quickly. Others have seen various types of alarming misinformation. Confusing messages from various political leaders have also done their share of damage.
Therefore, all vaccinators must be well trained to answer people’s questions about the risks and benefits of the vaccine, possible side effects, longevity of protection, etc. But such training has yet to begin, in part because this type of box information will be officially released as part of the FDAdecision about the vaccine. In some places, like Washington, DC, health departments have begun talking with community leaders to get an idea of the particular concerns of various groups. Campaigns in the media to encourage people to get vaccinated will be important.
All of this will create unknown challenges. Unlike many other countries, the United States has a more “passive” approach to vaccination and is not used to large immunization campaigns, says Tom Kenyon of Project HOPE, a non-profit health organization, which used to lead the Centers for Disease Control and Preventionworld health program. This works for childhood vaccination. But covid-19 is different. Lots of mini-vaccination campaigns to cover specific groups, like frontline workers, will be crucial, says Dr. Kenyon.
This type of groundwork, training, and campaigns is expensive. The Association of Immunization Managers estimates that, in total, state and local authorities will need $ 8.4 billion. the Centers for Disease Control and Prevention has put the total at around $ 6 billion. So far, however, states have received just $ 200 million for vaccination preparation and the promise of another $ 140 million this year. The approval of a large amount of federal money for this has been mired in political disputes in Washington. The Moderna vaccine, developed with the US National Institutes of Health, is a triumph of American science. Not vaccinating enough people to stop the virus would be a failure of American policy.■
This article appeared in the US section of the print edition under the title “Catching a cold one.”
