A handful of coronavirus vaccines are now being rolled out around the world. Insider talked with leading vaccine developers and industry analysts to see how the vaccine landscape will change in 2021.As the first coronavirus vaccines are rolling out, the 200-plus additional candidates in development face immense challenges in ever reaching the public.
As it stands, US regulators have OK'd two vaccines from Pfizer and Moderna. Other vaccine candidates, developed by British, Russian, Indian, and Chinese companies and researchers, are also being rolled out in other countries around the globe. The sluggish start to vaccinating the world's population — with some projections showing widespread availability for all countries— means the door is open for many more vaccine developers to play a role.
These giants have disappointed, with the notable exception of Pfizer's work with the German biotech BioNTech to develop the first COVID-19 shot to win US authorization, Porges said. Warp Speed's support took financial risk off the table, allowing the selected companies like Moderna, Johnson & Johnson, and Novavax to run multiple studies in parallel and start ramping up production before knowing whether or not the shots work.
The San Diego-based biotech is aiming to start a placebo-controlled Phase 3 study in the second quarter of 2021, one that could produce pivotal results before the end of the year. Payne said he expects this will be a placebo-controlled study, but that will mean recruiting volunteers outside the US. The ex-US focus could make it easier to enroll volunteers in areas with high rates of infections who accept a chance of receiving a placebo, he said.
These so-called correlates of protection would be a game-changer in simplifying future studies, experts said. Trials would likely be able to proceed without a placebo group, meaning all volunteers would get the experimental shot. If the typical immune response is strong enough, that may be sufficient for authorization.