About 72% of Republicans and 82% of Democrats worry the vaccine approval process is being driven more by politics than science, according to an August survey done by the Harris Poll and STAT News.
There’s some evidence to back up those fears. Food and Drug Administration Commissioner Stephen Hahn told the Financial Times that he would consider an emergency use authorization before the end of Phase 3 trials. And the Centers for Disease Control and Prevention has asked state officials to get their vaccine distribution plans ready by Nov. 1 — conveniently two days before the election.
To be honest, the federal government has made coronavirus moves before that have seemed political rather than scientific. I like plasma therapy as an option for coronavirus patients, but Hahn and Health Secretary Alex Azar can’t be making false statements to boast about its efficacy. The CDC removal of hospitalization data has been sketchy. Of course, there’s the news that President Donald Trump intentionally downplayed the virus early. "I wanted to always play it down,” he told journalist Bob Woodward.
Because of all of the above, I would have counted myself in that skeptical group that believed politics would win out in this battle, to the harm of many. But two things have happened this week that have made me feel a lot better about the vaccine process.
The first: The nine major companies involved in vaccine development signed an important pledge defending the standard approval process Tuesday.
As you’d expect, there’s a lot of “safety is our first priority” mumbo-jumbo in there. Companies making plush dog sweaters and folding lawn chairs use the same kind of language. Skepticism is warranted.
But I’m more impressed with the specific points listed in the pledge and, in particular, that the companies agreed to “only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.”
That’s a clear repudiation of the FDA commissioner’s early approval idea. These nine companies got together and basically said, “Oh, it would be convenient for you to get this before we’ve finished, but that ain’t gonna happen.”
The second point of optimism: One of those companies actually halted its trial due to a safety concern. AstraZeneca, the Big Pharma company that partnered with University of Oxford researchers who have been in the lead in the vaccine race since February, put its study on hold while investigating a “potentially unexplained illness” in one person in one Phase 3 trial.
In particular, The New York Times later reported that the patient had transverse myelitis, which is a rare syndrome that is sometimes caused by viruses. AstraZeneca wanted to get 30,000 people involved in just the U.S. version of this trial, and the company has a few others like it around the globe, so there are a bunch of people involved in this. Whether this individual’s syndrome was due to the vaccine, or COVID-19, or any number of other viruses is to be determined.
Clinical holds happen all the time in trials. The trials for the HPV vaccine also reportedly had a clinical hold due to this same syndrome. Those researchers did some digging, found out that the vaccine wasn’t responsible for the disease, and the vaccine was eventually approved. And New York microbiologist Florian Krammer wrote about how one of his department’s trials was stopped due to a car accident with one of the participants. Clinical holds can take anywhere from a few days to months, though the smart money is on the former with the coronavirus.
Remember, this is coming from the company that was in the lead. AstraZeneca/Oxford was poised to hugely benefit from being the winners in the vaccine race, and it still could win. The stock price fell 6% in after-hours trading after this news was announced. But it stuck to its ethical code and put the study on pause for now. Scientific standards are still being followed.
The truth is that Phase 3 trials take a long time anyway. All of the vaccine candidates but one are either requiring or investigating the effectiveness of a booster shot, usually four weeks after the initial shot. You have to take a couple of weeks for the vaccine to become fully effective. And then you have to give people time to go out in their communities and be exposed to the disease by random chance, and for that disease to be incubated in their bodies until a test would come back positive.
Government officials have said that each Phase 3 test would likely need 150 people to test positive, with at least 100 of those in the placebo group to show effectiveness. At average U.S. rates, that’s going to take a month or two. Then, you need to compile all of that data, compare the vaccine group and the placebo group, then send it to the regulatory bodies for review.
The absolute fastest all of the above can happen is probably about 90 days. AstraZeneca/Oxford started its Phase 3 trials in June, while Pfizer/BioNTech and Moderna started theirs in July, which would put the 90-day window in October. But given the hold AstraZeneca/Oxford just announced, October looks unlikely for them.
Moderna has had all sorts of troubles in the lead-up to its Phase 3 trial. CNN reported that Moderna had under 5,000 participants enrolled by mid-August and was only completing enrollment by the end of September. That means the company is not going to have final results by October, either.
That leaves Pfizer/BioNTech. It had vaccinated over 2,000 people by early August and sought to complete 30,000 sign-ups by early September. In an interview with NBC’s “Today” show, Pfizer CEO Dr. Albert Bourla said “our best case predicts that we will have an answer by the end of October.”
Dr. Anthony Fauci has called that timeline “conceivable” but “unlikely.” Even Operation Warp Speed director Dr. Moncef Slaoui called the prospect of any vaccine having enough data to award an emergency use authorization in October “extremely unlikely but not impossible." Those in the know are holding the door open just a tad but sending clear signals that the vaccine Trump wants by Election Day probably isn’t in the cards.
So what is a reasonable timeline? Truth be told, November and December look like relatively good guesses to see an Emergency Use Authorization, which would mean vaccines starting to go out to the very highest-risk populations — likely health care workers in both hospitals and nursing homes. Then, the next tier of high-risk populations probably follows: elderly, schoolteachers, and those with preexisting conditions. Finally, it’s probably reasonable to guess a couple of months would pass before everyday folks could get the vaccine, likely in the spring or summer.
There are signs to watch out for to make sure the process doesn’t get overly politicized. An emergency authorization issued before study numbers are public would be a huge red flag. So, too, would be the resignation of medical professionals associated with the vaccine effort — Slaoui, in particular, has vowed to resign if the vaccine acceptance process becomes at all political. Sensical distribution will be key. We can’t have this work like the rationing early in the pandemic, where the president’s favorite governors got better access. We should keep our eyes peeled.
But, for now, it looks like the scientists in the room are very much still in charge of the process. And for that reason, I still believe in the efficacy and safety of this vaccine. As of now, I’d be first in line, whenever I’m allowed to be.
Andy Larsen is a data columnist who is focusing on the coronavirus. He is also one of The Salt Lake Tribune’s Utah Jazz beat writers. You can reach him at alarsen@sltrib.com.
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