Under normal circumstances, it could take years — if not decades — to bring a new vaccine to market. The COVID-19 pandemic has changed all that. In May, the Trump administration launched Operation Warp Speed with the goal of delivering initial doses of a safe and effective vaccine by January 2021 — shortening the development time from years to months.
Some worry that to meet that ambitious schedule, the administration might cut important scientific corners. They fear that President Trump could announce an “October surprise” — declaring that a vaccine works before it has passed scientific muster in order to enhance his reelection chances.
After all, the president ballyhooed supposed virtues of hydroxychloroquine when most scientists thought the drug was not helpful, and maybe downright dangerous in treating or preventing coronavirus infections. This week, the FDA granted authorization for using convalescent plasma as a treatment for COVID-19, a move some say was done under political pressure from the White House.
FDA officials have maintained that all their decisions are based on science, not politics.
In June, the agency released guidance for what it would require before granting any kind of approval for the COVID-19 vaccine.
The guidance states that at a minimum, the FDA wants to see any vaccine tested in thousands of people so that any relatively rare side effects can be caught, and to see if the vaccine is actually preventing disease. The agency also says the vaccine doesn’t have to prevent 100% of disease to get a green light; just 50% would be sufficient.
How long it would take to show that depends on several factors, including how fast volunteers can be enrolled in trials and how much virus is circulating where the trials are taking place. Certainly it’s a process that would take months.