To win approval, a vaccine must be at least 50% more effective than a placebo in preventing or decreasing the severity of COVID-19.
There had been concern the FDA might face pressure from the White House to lower its standards and approve a COVID-19 vaccine before the Phase 3 trials are done. President Donald Trump has repeatedly promised an approved vaccine by late this year.
The FDA's actions around a drug called hydroxychloroquine – which it approved under emergency use, then rescinded approval – raised questions about the agency's independence from the Trump administration. The president strongly supported the drug based on weak early data that has been largely contradicted.
The strong COVID-19 vaccine guidance put some of those concerns to rest, said Peter Pitts, president of the Center for Medicine in the Public Interest. The agency set clear parameters for what "good science" looks like, with solid safety and large effectiveness trials.
“The FDA is saying that it’s not going to be rubber-stamping any vaccines for COVID-19,” he said.
The agency explained how the testing process can be safely streamlined, Nagarkatti said.
“The FDA’s guidance document and Emergency Use Authorization is not trying to cut short safety but to eliminate steps that are time-consuming while sticking to the principle that the benefits should outweigh the risks. This is always the goal of the vaccine,” he said.