Our lives won’t return to normal without a COVID-19 vaccine. Fred Hutch experts are at the forefront of an unprecedented, global effort to conceive of and test safe and effective vaccines against this virus, build factories to manufacture them and provide the logistics to deliver them to the arms of billions of people.
It’s about saving lives, protecting our way of life and making history. Here’s how it will happen.
Fred Hutch is working with the National Institutes of Health and others to design human clinical trials for five to seven of the most promising vaccine candidates developed by industry partners capable of making millions of doses. These candidates must pass three phases of human testing. Vaccine trials can take five years to design and complete. The goal: to get one or more COVID-19 vaccines ready to go by year-end.
Making enough vaccine to protect the world from COVID-19 will require an astonishing scale-up of global manufacturing. U.S. experts say 4.4 billion doses are needed to cover adults worldwide, a figure that would jump if shots are needed for kids. No one pharmaceutical company can meet that demand. Hence, current strategy supports development of many different vaccine types and building factories in advance, in hopes of approval. The U.S. has already bought vaccines “at risk” so that those doses — now in production — will be ready immediately if approved. Bill Gates has pledged to help fund factories for seven different vaccine candidates, knowing not all will succeed. Yet factories alone won’t work unless their supply lines for biological ingredients, immune-boosting adjuvants, and even the specialized glass vials and rubber stoppers to hold vaccines are stocked. The Trump administration initiative to have 300 million doses ready by January is called “Operation Warp Speed.”
– Bill Gates, Chairman, Bill & Melinda Gates Foundation
Shipping enough vaccines to cover 200 million adults in the United States, let alone to billions of others around the globe, is also massive undertaking and logistical challenge. Scale-up of distribution must consider that different vaccines may be more appropriate for one part of the world than others. For example, vaccines that require refrigeration may not work for developing countries in hot climates. Where health care clinics are hard for people to reach, single-dose vaccines will be better than those requiring two. With much of world trade constrained by COVID-19 border closings, transport of vaccines must clear regulatory hurdles and compete for cargo space. The sheer volume of shipments requiring careful handling will be a challenge for planes, trucks and even bicycles needed to get COVID-19 vaccines to the right places.
From the moment the idea for a COVID-19 vaccine formed in researchers' minds, the goal has been to deliver it into the arms of billions. It is a difficult journey that typically takes a decade or more, but given this crisis, those time scales are being compressed. It is possible that the first vaccine may be ready by year-end. Those doses are likely to be limited. So, the question will be, who gets the vaccine first? Policymakers are likely to urge that health care workers — doctors, nurses and first responders — should be given priority. Nursing home residents have borne the brunt of this pandemic, but will the vaccines protect them? Which essential workers should be first if supplies are limited? Are highly paid executives more essential than grocery store clerks? Are meat packers and farm workers more essential than waiters and cooks in restaurants? Will there be policies in place to assure that access to vaccines does not divide along racial, ethnic or international lines? With luck, we’ll have to answer these difficult questions soon.