Beginning to end, vaccine development usually takes 10 to 15 years. There are various ways to shorten the time table. Phase three will go quicker, for example, if you vaccinate a lot of people. That’s why AstraZeneca plans to enroll about 30,000 U.S. volunteers in its phase three trials of AZD1222 starting this summer. Even in the best-case scenario, however, it will take several months for researchers to get the most preliminary sense of whether the vaccine is working or not.
“Typically, you wait at least two weeks or a month later to characterize the immune response,” says Mark Feinberg, president and CEO of Iavi, a nonprofit research organization developing its own vaccine. “It just inherently takes time for the immune system to mount to maximal immune response, and then you have to follow those people with time to make sure that the immune response is maintained. It’s not going to help anybody if you have a vaccine that might protect you for a month or two and then protection wanes.”
Come October, AstraZeneca will likely have started supplying the United States with hundreds of millions of doses of a vaccine for which it will have only the most preliminary phase three data. If its efficacy is still unclear, but no evidence has emerged that it is immediately harmful, will the Trump administration greenlight its use?
In the past the answer would almost certainly have been no. “The FDA always focus their decision on robust scientific evidence,” says Bottazzi, who believes that the earliest robust data can be available is the end of 2021.
This administration is different. President Trump has consistently ignored scientific advice about the coronavirus, undermined his advisers’ health-policy recommendations, and urged the use of untested medications. After a Google Doc touting chloroquine went viral on the internet, Trump deemed it a potential miracle cure. His administration sidelined critics while spending tens of millions of dollars to buy and study the drug. Last week The Lancet published a study that found it provided no therapeutic benefits and increased the risk of death. That same week Trump declared, “I’m taking it, hydroxychloroquine. Right now, yeah. Couple of weeks ago, I started taking it. ’Cause I think it’s good, I’ve heard a lot of good stories.”
Just as the FAA has been criticized for being too lax in overseeing Boeing’s manufacturing of the 737 Max, the FDA has taken fire for loosening the reins on drug development. Janet Woodcock, the head of the agency’s drug-approval department, has led efforts to make it more friendly to industry, and drew fire for pushing the agency to approve a $300,000-per-year treatment for muscular dystrophy that lacked any proven medical benefit. Last week she temporarily left her role to be part of Warp Speed’s vaccine-development efforts.
With the coronavirus pandemic raging, the FDA is easing the rules further still. According to Soriot, AstraZeneca has worked with the agency to rewrite its vaccine-approval playbook. “We are actually trailblazing here because we are not following the standard process,” he told CNN. “We are working hand in hand with the FDA. We are sharing data on a day-to-day basis, on a real-life basis, and basically they have committed themselves to help look at our data as they come, so that by the time we finish with our phase three program in August, they can rapidly approve the vaccine for emergency use.”
On Wednesday, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN that he was optimistic about the administration’s timeline. “I still think that we have a good chance, if all the things fall in the right place, that we might have a vaccine that would be deployable by the end of the year, by December, November,” he said.