StemCell Therapy

On Monday, Donald Trump held a meeting in the White House to discuss his Administrations response to COVID-19, the novel coronavirus that has spread to every continent except Antarctica. At the time there had been more than a hundred and five thousand cases reported in at least eighty-three countries, leading to more than thirty-five hundred deaths. Seated around an oval table in the Cabinet Room were health experts from the Centers for Disease Control and Prevention, the Food and Drug Administration, and the National Institutes of Health, as well as pharmaceutical executives from Pfizer, Johnson & Johnson, Sanofi, and others. With more than a hundred cases already discovered in the U.S., which had resulted in six deaths (the virus has since infected nearly four hundred people in the U.S., and killed at least nineteen of them), Trump was concerned. But he was also confused, despite having had several previous briefings with the Administrations top health officials. Grasping for some good news, he pressed the executives to deliver a vaccine within a few months, at which point Anthony Fauci, the longtime director of the National Institute of Allergy and Infectious Diseases (N.I.A.I.D.), spoke up. A vaccine that you make and start testing in a year is not a vaccine thats deployable, he said. The earliest it would be deployable, Fauci added, is in a year to a year and a half, no matter how fast you go.

The virus seems to have been circulating in the United States, particularly in Washington State, for the past month, and more cases are expected. A person can be infected but asymptomatic, and therefore unknowingly infect other people. This limits the ability of public-health tools to contain its spread. Even still, a COVID-19 vaccine developed, licensed, and manufactured at a global scale in twelve months would be an unprecedented, remarkable, even revolutionary achievement. No other vaccine has come close to being developed that quickly. The fastest effort to date was during the Zika outbreak, in 2015, when one was ready for testing in about seven months, but the epidemic fizzled out before an approved vaccine could be sent through clinical trials. At the meeting on Monday, Trump said, I like the sound of a couple months better, if I must be honest.

John Shiver, the global head of vaccine research and development at the multinational pharmaceutical company Sanofi, which is developing a COVID-19 vaccine, was at the meeting with Trump. There was some confusion there, Shiver said, that certain officials did not understand that being in people, as in human trials, is not the same as having a product. Clinical trials are conducted on healthy people, which is inherently challenging. You certainly dont want a vaccine that can make it worse, Shiver said. There have been some vaccine candidates historically that could actually enhance the disease. Sanofi is working with the United States Biomedical Advanced Research and Development Authority, a sort of biomedical DARPA, to advance a COVID-19 vaccine based largely on the vaccine candidate it had developed for SARS. Shiver told me that the authority doesnt expect to have anything ready for human trials until much later this year. Its difficult, Shiver said, to see how, even in the case of an emergency, a vaccine could be fully ready for licensure in a year and a half.

The Coalition for Epidemic Preparedness Innovations (CEPI), an Oslo-based nonprofit organization, was established at Davos, in 2017, to help the world prepare for a disease X pandemic. One of its aims is to dramatically hasten the process of vaccine development. To create a viable, scalable vaccine takes vast amounts of funding and R. & D., Rachel Grant, the advocacy and communications director at CEPI, told me. It is a long and complex business. Its all doable, science can meet the challenges, but there is lots of attrition before any vaccine gets to the point of licensure. The problem is twofold. First, there may never be a market for a vaccine at the end of the development process, because the epidemic is contained, or never comes to pass. Then, traditionally, if there is an epidemic, it may take hold in a developing country where the costs of research and development cannot be recouped. The resources and expertise sit in biotech and pharma, and theyve got their business model, Grant said. Theyre not charities. They cant do this stuff for free.

CEPI, with funding from the government of Norway, the Gates Foundation, the Wellcome Trust, and several other countries (the United States is not among them), is trying to bridge the gap. The challenge of vaccine development is what CEPI was set up to solve, Grant told me, played out writ large in an episode like this. Since the novel coronavirus emerged, CEPI has ramped up its grant-making expenditures to more than nineteen million dollars. Two grant recipientsa Massachusetts-based biotech startup named Moderna and a lab at the University of Queensland, in Brisbane, Australiahave, remarkably, already developed a vaccine candidate that they will start testing in human trials in the next few months, and another biotech startup supported by CEPI is not far behind. But, ultimately, to get three different vaccines through the final phase of clinical testing, Nick Jackson, CEPIs head of programs and innovative technology, told me, will require an estimated two billion dollars.

Barney Graham is the deputy director of the Vaccine Research Center, at the N.I.A.I.D., in Bethesda, Maryland, which is collaborating with Moderna and other academic labs on a possible vaccine. Graham is one of the worlds experts on the structure of viruses and how they interact with human cells to make us sick. In the seven years before the COVID-19 virus appeared, one of Grahams projects had involved understanding the MERS coronavirus, in order to potentially develop a vaccine. (MERS, which can be transmitted from camels to humans, has been contained to the Middle East, and seems to spread mostly in confined spaces, like hospitals.) Theres several ways of delivering a protein to a human body that will make a vaccine-type response, he told me. Certain proteins, when injected into a human, are antigenic, provoking the bodys immune system to create antibodies. Traditionally, proteins are made in a microbrewery type of bioreactor, Graham saida common flu-virus vaccine, for instance, is grown in chicken eggsand it takes up to two years to get that protein ready. That is not fast enough if youre in a pandemic situation. Researchers have long been working on so-called vaccine-platform manufacturing technologies for future use. The idea is akin to creating a frozen-yogurt maker for vaccinessame machine, different flavors. With vaccine-platform technologies, the hope is that the way in which the vaccine is manufactured and delivered to the bodysuch as Modernas messenger-RNA (mRNA) technologywill transport any antigen and, therefore, theoretically protect against any infectious disease. You can make the RNA in the same way, purify it in the same way, release it in the same way, and yet make many different proteins, Graham said.

Read the original here:
How Long Will It Take to Develop a Coronavirus Vaccine? - The New Yorker

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