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Coronavirus vaccine timeline hinges on manufacturing investment, right science

Billionaire philanthropist Bill Gates has been pushing for the U.S. government to take the responsibility of building manufacturing facilities now to produce vaccines for the new coronavirus rather than waiting until those products have completed clinical testing.

The Microsoft Corp. co-founder had urged international leaders for years to make greater investments in newer vaccine manufacturing technologies and beef up capacity so that if an emerging disease struck, the world would be prepared.

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Bill Gates
Source: AP Photo

Failure to follow Gates' advice came home to roost when the new coronavirus began spreading around the world, ultimately becoming a pandemic — an outbreak that has claimed the lives of nearly 100,000 people.

Efforts to create a vaccine against COVID-19 — the disease caused by the novel coronavirus — are already underway, but to roll out those products will depend on investing significantly in building the proper manufacturing facilities and the time to test their safety and effectiveness.

Gates acknowledged in a March 31 op-ed in The Washington Post that many of the top vaccine candidates are using unique equipment, so new facilities may need to be built for each of them, "knowing that some won't get used."

But the Bill and Melinda Gates Foundation also plans to make billions of dollars available for that effort, he said during an April 2 appearance on "The Daily Show with Trevor Noah."

Gates said his foundation would fund factories for up to seven of the top vaccine candidates, "even though we'll end up picking at most two of them."

There is likely to be billions of dollars wasted, "but a few billion in the situation where we're in, where there's trillions of dollars … being lost economically, it is worth it," he told Noah.

Timeline

Experts, including National Institute of Allergy and Infectious Diseases Director Anthony Fauci, have estimated it will take a year to 18 months to develop a COVID-19 vaccine.

SNL ImageNIAID Director Anthony Fauci
Source: AP Photo

During an April 8 online interview with the Journal of the American Medical Association, Fauci said that timeline could be accelerated if a vaccine candidate shows early efficacy in a phase 2 trial and the U.S. Food and Drug Administration grants an emergency use authorization to start using the product before it has completed a phase 3 study.

Other experts, however, have warned against pushing out new types of vaccines too quickly to a broad population before thoroughly knowing the scope of the products' safety and efficacy.

"This is definitely a concern since we live in a society who already has indicated vaccine hesitancy," said Krutika Kuppalli, infectious diseases physician and vice chair of the Infectious Diseases Society of America's Global Health Committee — though she said she could not comment specifically on circumstances involving an FDA emergency authorization.

"How the vaccine is developed and rolled out will be important," Kuppalli told S&P Global Market Intelligence. "I also think it's important to start sensitizing and developing community engagement around the vaccine."

Vaccine development, in many ways, is designed to be "slow, reflective, peer-reviewed, evidence-based," said Gregory Poland, director of the Mayo Clinic Vaccine Research Group in Rochester, Minn.

"What takes so long is not so much the science part of building the vaccine, it's the safety testing in enough people across enough time," Poland said during a March 25 JAMA Live interview.

Poland was skeptical any COVID-19 vaccine could be ready within a year. He noted, however, that the FDA in an "almost unprecedented" move has been allowing COVID-19 vaccine-makers to conduct their nonhuman primate studies simultaneously with their phase 1 human safety studies.

Poland said he had "some reservations about some of the approaches being taken" for the COVID-19 candidates, saying they are all focused on the so-called spike protein.

Including other proteins could help ensure the virus does not mutate around the vaccine design, he said.

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Global effort

The global research and development landscape includes 115 COVID-19 vaccine candidates, 73 of which are at exploratory or preclinical stages and five in phase 1 human safety testing, scientists from the Coalition for Epidemic Preparedness Innovations wrote in an April 9 commentary in the science journal Nature.

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Nicole Lurie
Source: AP Photo

On April 8, the science and medical academies from the G-7 nations and seven additional academies called for international cooperation in addressing COVID-19.

World Health Organization Director-General Tedros Adhanom Ghebreyesus told reporters April 8 that 130 scientists, funders and manufacturers from around the world have signed a statement committing to work to speed the development of a vaccine against COVID-19.

Too often, vaccine-makers and the government have "turned the research spigot off" when an infectious disease has dampened down or disappeared, as in the case of severe acute respiratory syndrome, Mayo's Poland said.

"That's not a good way to do science. It's an ongoing endeavor," Poland told JAMA.

While it is unlikely, if the COVID-19 pandemic abruptly ends before vaccines are ready, "we should continue developing the most promising candidates to a point at which they can be stockpiled and ready for trials and emergency authorization should an outbreak recur," said Nicole Lurie, the former assistant secretary for preparedness and response at the U.S. Department of Health and Human Services.

In a March 30 commentary in the New England Journal of Medicine, Lurie called for a global financing system that supports end-to-end development and large-scale manufacturing and deployment, ensures fair allocation and protects private-sector partners from significant financial losses.

READ MORE: Sign up for our weekly coronavirus newsletter here, and read our latest coverage on the crisis here.