Around the time the WHO was making plans for its mega-trial, U.S. government officials were discussing how best to invest in – and speed up – vaccine trials. Some researchers, including Dr Fauci, have advocated a design similar to that of the WHO.
But Moncef Slaoui, chief adviser on Operation Warp Speed, the multi-agency effort to accelerate development of coronavirus vaccines and treatments, said in a statement that such a trial would not have been practical. . “If OWS had tested all vaccines under one master protocol, the operation would have had to wait months to start and recruit 200,000 volunteers at the same time.”
In the end, the government opted for what it described as a “harmonized approach”. This would allow vaccine makers to conduct their own trials, but only if they used protocols that followed certain guidelines and allowed the National Institutes of Health to test all of their volunteers in the same way. In return for following these rules, companies could tap into the NIH’s vast network of clinical trial sites and receive major financial support for their trials. Through this program, the government has so far pledged $ 10 billion to vaccine manufacturers.
So far, AstraZeneca, Johnson & Johnson and Moderna have started trials in the network. Novavax and Sanofi are expected to start their own phase 3 studies in the coming months. But Pfizer, one of the pioneers, never joined the network, opting for trials entirely on their own.
If Pfizer’s results are satisfactory, many experts expect the company to ask the Food and Drug Administration for emergency clearance of its vaccine, potentially for just one group of high-risk people. The company could then quickly apply for a license, making it widely available.
The approval of a vaccine will depend on the protection offered by the vaccine in the Phase 3 trial – what scientists call its effectiveness. In June, the FDA set 50% efficacy as a target for a coronavirus vaccine.