Vaccines against COVID-19 could be widely available in the USA in 2021, and at least a couple vaccine manufacturers are on track to submit Biologics License Applications (BLA) to the FDA. In the COVID-19 Vaccine Timeline, inDemic experts track the clinical development, regulatory milestones, and manufacturing capacity associated with each of the most promising vaccines. The timeline shows not only when vaccines could be approved, but also when they could be rolled out for at-risk populations and the general public.
For answers to the most frequently asked questions regarding these vaccines, see indemic.org/covid19-vaccine-faqs, and for more direct research analysis and clinical trials updates, see inphronesis.indemic.org
In the United States and internationally, developing an effective COVID-19 vaccine is only the beginning, and the vaccine rollout will likely span most of 2021 in the United States. A number of factors (technical, logistical, scientific, and sociologic) will either hinder or support -vaccine rollout.
Here, we map barriers and catalysts to COVID-19 vaccination in the USA:
Generally, to support licensure or BLA of a vaccine, the FDA requires at least 6 months of safety follow-up. This includes any serious adverse events, such as immune-related adverse events. So, while some vaccine manufacturers have completed their primary efficacy analyses of phase 3 trials, we anticipate additional safety follow-up prior to BLA submission for their vaccines.
We believe that vaccines developed by the Gamaleya Institute and Sinopharm may be used widely. However, it is unlikely they will be approved in the USA or Europe, due to their public rollout prior to starting phase 3 trials. Hence, the “full regulatory approval by the FDA and/or EMA” milestone is absent in their timelines. We may amend their timelines if compelling peer-reviewed data from their phase 3 trials is published.