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ASKED WHAT Keeps her awake at night as Texas prepares for the arrival of the first covid-19 vaccines, Imelda Garcia of the state health department identifies two opposite scenarios: either a severe shortage of vaccines, or many of these unused because no one wants to take it . These two concerns are on the minds of many other public health experts as 6.4 million doses of the vaccine are ready to be shipped across America, on a nod from the Food and Drug Administration (FDA), the federal drug regulator.
That nod is scheduled for December 10 or shortly thereafter, when the FDA will make a decision on the first covid-19 vaccine submitted for approval in America, a jab developed by pharmaceutical companies Pfizer and BioNo.Tech. Moderna, the developer of another vaccine, is expected to undergo FDA reviewed on December 17th. Both vaccines are approximately 95% effective when given in a two-dose regimen. They are unlikely to stem America’s runaway epidemic until next spring, at best. But America is leading the way in covid-19 vaccination, so the lessons from its first experience will be followed closely in Europe and other parts of the world.
Organizing America’s supplies of covid-19 vaccines is the task of Operation Warp Speed, a program set up 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 made. Each company expects to have approximately 20 million doses ready to be distributed in America by the end of this year. This amount is roughly what would be needed to inoculate all American health workers, who are a priority group for early vaccine supplies.
Groups particularly vulnerable to the disease will come next, 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 the age of 65 years old. priority among these groups, suggested by the Centers for Disease Control and Prevention (Center for Disease Prevention and Control) and other national health agencies, may vary slightly from state to state. The current plan is that vaccine stocks, as they become available, will be split between states and six major metropolitan areas in proportion to their population. Each state will decide how to distribute them. At the current pace of vaccine production, widespread vaccination of the elderly is not expected until February.
The logistics of vaccinating over 300 million Americans would be daunting with any vaccine. But Pfizer will be “extremely challenging,” says Claire Hannan of the Association of Immunization Managers. “It’s nothing like we’ve seen before,” he says. The vaccine should be stored at -70 ° C, which is the temperature in ultra-freezers that are rarely found outside research laboratories and large medical centers. To address this, Pfizer will distribute the vaccine in “thermal dispatchers,” special dry ice-packed containers designed to hold between 1,000 and 5,000 doses. (He is now planning a smaller version to facilitate distribution.) But the dry ice needs to be replenished regularly, the container can only be opened twice a day, and once extracted, the vaccine only lasts in a regular refrigerator for five days. When ready for administration, it must be diluted with saline, which is not a common step for vaccines.
People handling the Pfizer vaccine will need extensive training, Ms. Hannan says. “This isn’t something you can watch the video in and then you’re ready to go.” He fears that these new procedures will come at a time when hospitals and their staff will be overwhelmed and exhausted by the flow of patients (see article). Due to all the complexities involved, a fair amount of Pfizer’s early vaccine stocks could end up being ruined.
Moderna’s vaccine is more in line with what vaccinators are already used to. It should be stored at -20 ° C, the temperature of normal pharmacy freezers, can be stored in a normal refrigerator for 30 days, is available in packs of 100 doses and does not require dilution. This vaccine, if approved, would be delivered by McKesson, a medical distributor that already supplies vaccines nationwide.
Wherever the vaccines go, the supplies to take the shots 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 jab. Operation Warp Speed amassed these supplies over the summer, to prevent a repeat fiasco with personal protective equipment for health care workers in the spring, when state and federal authorities were competing with each other in a mad dash for scarce global supplies.
At present, the states and the Department of Defense, which leads the logistics of vaccine distribution, are focused on preparing the Pfizer vaccine. State authorities have enlisted vaccination providers, drawing up lists of health professionals and others who must be vaccinated first, and creating systems to track vaccines. They have just started “dry runs”, placing orders for vaccines and syringes into the national system and putting into practice what they will do with Pfizer thermal shippers (who, for now, come with empty vials).
The logistics of moving vaccines will be complicated. The really hard part, though, will likely be getting people to get them. The American plan is to make vaccination available for free in all the usual places where people receive flu shots, such as pharmacies and doctors’ offices. The federal government is creating a fund to cover supplier rates for the coup for the uninsured; health plans will cover this fee for their members.
Many immunization experts fear that this “build and come” approach is naive. At the moment, polls suggest that anywhere between 20% and 60% of Americans may not accept a covid-19 vaccine. In one survey, only a third of nurses said they would voluntarily vaccinate. Some people are concerned that vaccines may be unsafe, they suspect corners may have been cut in the rush to develop them so quickly. Others have witnessed various kinds of alarming misinformation. Confusing messages from various political leaders have also done their share of damage.
All vaccinators, therefore, need to be well trained to answer people’s questions about the risks and benefits of the vaccine, potential side effects, longevity of protection, and so on. But that training hasn’t started yet, in part because this type of box-insert information will be officially released as part of FDADecision on the vaccine. In some places, like Washington, A.D, health departments began talking to community leaders to get an idea of the particular concerns of various groups. Media campaigns to encourage people to get vaccinated will be important.
All of this will raise unknown challenges. Unlike many other countries, America has a more “passive” approach to vaccination and is not used to doing large immunization campaigns, says Tom Kenyon of Project. HOPE, a non-profit health association, which he headed Center for Disease Prevention and Controlglobal health program. This works for childhood vaccination. But covid-19 is different. Plenty of mini vaccinations to cover specific groups, such as frontline workers, will be crucial, says Dr. Kenyon.
This type of groundwork, training and campaigning is expensive. The Association of Immunization Managers estimates that all in all, state and local authorities will need $ 8.4 billion. The Center for Disease Prevention and Control put the total at around $ 6 billion. So far, however, states have only received $ 200 million for vaccination preparation and the promise of another $ 140 million this year. The approval of a large sum of federal money for this has been embroiled in political wrangling in Washington. The Moderna vaccine, developed with the American National Institutes of Health, is a triumph of American science. Not vaccinating enough people to stop the virus would be a failure of US policy.■
This article appeared in the US section of the print edition under the title “Grab a Cold One”
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