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Now is not a good time to release new information about a revolutionary vaccine against a global pandemic amid a hotly contested election. “That’s the Comey problem, isn’t it?” said Susan Ellenberg, professor of biostatistics and epidemiology at the University of Pennsylvania Hospital, with a sad laugh. Whether the news breaks before or after the vote, it is doomed to politicization.
On Monday, Pfizer announced that the vaccine it was working on with German biotech company BioNTech could prevent more than 90% of infections. It should not be a new policy in itself. But it has certainly become that, with the floating conspiracy theories of the president’s son and President Trump and Pfizer publicly disagreeing on the importance of the administration’s role in this development.
And bad timing isn’t the only trust issue here. After all, we’re talking about hugely promising news from a major pharmaceutical company, in the form of a press release – no data to review, no details to verify. If you look at this ad with a raised eyebrow, well… you’re not alone.
But the good news is that Pfizer’s announcement is actually good news, experts told me. The study is still ongoing, but at this point, 94 volunteers in the trial have contracted COVID-19 at least seven days after receiving the second of two doses of the vaccine. We do not know how many of the 43,538 study participants had reached this stage when this assessment was performed. We also don’t know how many of those 94 people received the vaccine as opposed to the placebo, although experts say we can deduce that it is less than 10 if the vaccine’s effectiveness is really over 90%. This level of efficacy may not stay the same, but it is a very good sign for a vaccine that would have been accepted by the Food and Drug Administration with an efficacy rate of only 50%.
“There is efficiency. There was no guarantee for this. We now know that a vaccine will work, ”said Dr Eric Topol, executive vice president of Scripps Research, a not-for-profit biomedical research institute. He has kept a critical eye on the research and development of COVID-19 vaccines, pressuring pharmaceutical companies for more transparency in their process and criticizing the president’s past attempts to claim that a vaccine would be made public ahead of the elections. . But he is cautiously hoping now – with the caveat that there are still a lot of important details that we don’t yet know.
Topol is particularly interested in knowing more about the seriousness of these 94 cases. There aren’t any details on that yet, and that’s important, Topol said, because what we really want is a vaccine that prevents the worst cases of this disease. A vaccine that is statistically effective, but which mainly prevents only mild cases, would be less useful.
Ellenberg, meanwhile, is keen to learn more about the vaccine’s safety data, because while this trial will likely be long enough to detect the most common side effects, most vaccines are tested over years, not months. – a duration which allows it. researchers to spot rare but serious complications that would not necessarily present in a shorter study.
And Dr Paul Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, wants to know more about the demographics of people who have contracted the virus, especially their age. It is not out of the question that you may end up with a vaccine that is very effective for healthy young people, but not so much for high-risk older people who really need protection.
We don’t know any of this because what has been published is not scientific data. This is a preliminary effectiveness check performed by an independent review committee outside of Pfizer itself. Even Pfizer scientists don’t know the answers to the questions the experts have asked me – at least not yet – because the trial is ongoing and is still blind to them, so knowing who is taking the placebo isn’t ‘will not affect the final results.
And this independent review is a good thing. This outward outlook is something pharmaceutical industry critics like Topol like to see, as it’s another layer of transparency that ensures we’re not just taking Pfizer’s word. They’re also an integral part of any serious illness drug trial, Ellenberg told me. You don’t want to give it a try for years if it’s already clear that the drug is extremely effective and could already save lives. But at the same time, you don’t want to just randomly lift the lid of the jar and stop the test when it feels right – that would tend to make you quit whenever things look statistically good, even if that success is. a mirage that would have disappeared in a few weeks.
“So you have these very well-constructed statistical blueprints that say when you get to that particular point and have that many positive results, you can conclude that the data is very unlikely to change,” Ellenberg said.
Sadly, she and other experts told me, in this case, that a planned external review was on a collision course with the surge in coronavirus cases that hit the country over the past month. Between those two things, there was almost no way to prevent the timing from being very awkward.
Pfizer was originally supposed to gain insight into the effectiveness after 32 volunteers contracted the disease. But somewhere along the line, the company and the FDA together decided to wait longer, fearing that positive results in 32 cases could lead the company to seek approval too soon. The first look was then supposed to occur after the trial touched 62 cases. But this is where the pandemic itself appears to have collided with research.
We don’t know exactly what happened between the 62nd case and the 94th – something Topol, for his part, really wants more information about. In an email, representatives from Pfizer told FiveThirtyEight that there was “absolutely no political consideration involved in this process.” What appears to have happened is that the sudden increase in the spread of the coronavirus across the United States led to an equally sudden increase in cases within the study, Offit said. “I think by the time they submitted all the data, the number had probably changed,” he told me.
A reasonable choice and pandemic surge later, Pfizer said it received preliminary efficiency ratings from independent critics on Sunday after media networks screened Joe Biden as president-elect. If they had decided to release 32 cases, we probably would have seen this announcement in October. If the pandemic had been less… pandemic… we might not have hit 62 cases (let alone 94) before the end of November or December. “I don’t think there was a political angle,” Offit said.
And while Pfizer certainly could have stayed on the news and left a bigger gap between election and announcement, that would have been, in its own way, a pretty questionable decision. “They could be accused of withholding data, or that close investors know something the public doesn’t know,” Ellenberg said.
The timing was therefore not perfect. And the information we know is irregular. But it is, even so, a reason to hope. The current increase in transmission will likely mean the study reaches its pre-planned endpoint of 164 cases within the next month, experts predicted. Full data could be available very soon.
And that’s something the Trump administration should be proud of, Offit said. Although Pfizer’s research and development was not funded by the U.S. government, the administration’s Operation Warp Speed program likely provided competition that accelerated the work of Pfizer, which the first vaccine to come out of. the gate was created directly or not. “Operation Warp Speed was a phenomenal scientific endeavor that they should be proud of,” he told me. “What they shouldn’t be proud of is dispelling hygiene measures, but it was a good job.”
Good job, even if bad timing.
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