Gates Package — page 12

PANDEMIC I - THE FIRST MODERN PANDEMIC One step that was taken after the foundation and others called for investments in pandemic preparedness in 2015 was the creation of the Coalition for Epidemic Preparedness Innovations (CEPI). Although the resources were quite modest, they have helped advance new approaches to making vaccines that could be used for this pandemic. CEPI added resources to work on an approach called RNA vaccines, which our foundation had been supporting for some time. Three companies are pursuing this approach. The first vaccine to start human trials is an RNA vaccine from Moderna, which started a phase 1 clinical safety evaluation in March. An RNA vaccine is significantly different from a conventional vaccine. A flu shot, for example, contains bits of the flu virus that your body's immune system learns to attack. This is what gives you immunity. With an RNA vaccine, rather than injecting fragments of the virus, you give the body the genetic code needed to produce lots of copies of these fragments. When the immune system sees the viral fragments, it learns how to attack them. An RNA vaccine essentially turns your body into its own vaccine manufacturing unit. There are also at least five leading efforts that look promising and that use other approaches to teach the immune system to recognize and attack a viral infection. CEPI and our foundation will be tracking efforts from all over the world to make sure the most promising ones get resources. Once a vaccine is ready, our partner GAVI will make sure it is available even in low-income countries. A big challenge for vaccine trials is that the time required for the trials depends on finding trial locations where the rate of infection is fairly high. While you are setting up the trial site and getting regulatory approval, the infection rate in that location could go down. And trials have to involve a surprisingly large number of people. For example, suppose the expected rate of infection is 1 percent per year and you want to run a trial where you would expect 50 people to be infected without the vaccine. To get a result in six months, the trial would need 10,000 people in it. The goal is to pick the one or two best vaccine constructs and vaccinate the entire world--that's 7 billion doses if it is a single-dose vaccine, and 14 billion if it is a two-dose vaccine. The world will be in a rush to get them, so the scale of the manufacturing will be unprecedented and will probably have to involve multiple companies. I am often asked when large-scale vaccination will start. Like America's top public health officials, I say that it is likely to be 18 months, even though it could be as short as nine months or closer to two years. A key piece will be the length of the phase 3 trial, which is where the full safety and efficacy are determined. When the vaccine is first being manufactured, there will be a question of who should be vaccinated first. Ideally, there would be global agreement about who should get the vaccine first, but given how many competing interests there are, this is unlikely to happen. The governments that provide the funding, the countries where the trials are run, and the places where the pandemic is the worst will all make a case that they should get priority. TESTING All of the tests to date for the novel coronavirus involve taking a nasal swab and processing it in a Polymerase Chain Reaction (PCR) machine. Our foundation invested in research showing that having patients do the swab themselves, at the tip of the nose, is as accurate as having a doctor push the swab further down to the back of your