The end of the COVID-19 pandemic will come with the development of a safe and effective vaccine, a process experts say will take at least 12 to 18 months. Last week, however, the U.S. Department of Health and Human Services (HHS) blew that timeline out of the water, announcing that it would pay British drugmaker AstraZeneca upwards of $1 billion for 300 million doses of an experimental vaccine, which will start to become available as early as this October. AstraZeneca CEO Pascal Soriot was even more bullish, telling CNN, “We will start getting substantial doses by September, October,” and that “lots and lots of people will be able to be vaccinated before the end of the year.” At that pace, Soriot confirmed, the entire U.S. and U.K. populations could be vaccinated by early 2021.
Soriot cautioned that the vaccine’s delivery depends on its successful completion of human trials—“It has to work,” he told CNN. But he said AstraZeneca was on target to prove that it will through an accelerated testing schedule. To date, the vaccine has been tested on monkeys and a small group of human volunteers, with recruitment for a 10,260-subject study currently underway.
To begin mass inoculations against COVID in the month before the election would be a massive achievement for the Trump administration, which has seen its prospects for a second term dwindle with the lockdown caused by the coronavirus and its resultant economic carnage. According to reporting by Vanity Fair’s Gabriel Sherman, Donald Trump has privately expressed the belief that a COVID-19 vaccine would be ready within months.
Many experts, however, say that it is impossible to reliably demonstrate the safety and efficacy of a drug in such a time frame. Moreover, absent those assurances, it would be unethical to give what is essentially an experimental vaccine to hundreds of millions of people. “You cannot do that,” says Maria Bottazzi, a microbiologist at the Baylor College of Medicine in Houston.
“We don’t want to put a vaccine in the population that hasn’t been tested for efficacy and toxicity,” says Ana Fernandez-Sesma, a professor of microbiology at the Icahn School of Medicine at Mount Sinai.
The AstraZeneca deal is part of “Operation Warp Speed,” a program announced by President Trump on May 15 that will pour billions into the parallel development of multiple candidate vaccines. AstraZeneca’s vaccine, dubbed AZD1222, is being developed in the U.K. by Oxford University’s Oxford Vaccine Group. Earlier this month the group announced promising preliminary results in tests on monkeys.
Despite the strong start, however, the odds are that the vaccine will ultimately fail. “A new investigational drug that’s going into human trials has a 90% chance of failing,” says Gail Van Norman, a professor of medical ethics at the University of Washington. If anything, that’s being optimistic; one study found that the average vaccine candidates has only a 6% chance of reaching the market.
Once a new vaccine is created, it’s first tested in animals, then a small number of humans to see if it causes any adverse reactions. The second phase of human trials enrolls a larger number of volunteers and is focused on whether the vaccine prompts the immune system to create defenses against the virus. Phase three then explores whether the vaccine actually protects people in the real world. To do this, researchers vaccinate a large number of subjects who are most at risk of being exposed to the virus.
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.
The problem is that by approving a drug before robust test results are in, the FDA will be taking a gamble of unknown dimension. “The amount of change of the risk is unknown,” says Van Norman. “Maybe it’s minuscule; maybe it’s big. We won’t know.”
The dangers of this kind of risk-taking were manifested during the swine flu scare of 1976. The Ford administration rushed to inoculate the public with a vaccine that had been too quickly deployed, and hundreds developed a neurological disorder as a result.
Speeding up the public use of unproven medications doesn’t just risk people’s lives; it risks undermining their trust in public health authorities. That’s particularly a problem when it comes to vaccines, which already face headwinds from a sizable constituency that believes that they cause autism or other health problems. If enough people are distrustful enough of vaccines to refuse to take them, then the population will fail to achieve herd immunity, making the collective benefit considerably weaker.
Ken Frazier, CEO of the pharmaceutical giant Merck, has said that due to the risks of accelerated vaccine development, he is skeptical of even the 12-to-18-month time frame.
“Our experience suggests those are very aggressive compared to other timelines for getting a safe and effective vaccine,” he told the Financial Times. “You want to make sure that when you put a vaccine into millions, if not billions, of people, it is safe.”
On the other hand, as the election draws close, President Trump will be looking for a boost. “Imagine what would happen if it all worked out,” says Van Norman. “You threw the dice in October, there’s an effective vaccine available, and every American was vaccinated by Election Day. Imagine what the likelihood is that a top politician who could make that happen would not be reelected.”
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