Talk about a rebuke.
President Trump may want a Covid-19 vaccine to ship in time to boost his reelection chances, but the pharmaceutical industry doesn’t appear ready to cooperate — at least, not on his terms.
In a highly unusual turn of events, nine vaccine makers — including some of the world’s biggest companies — on Tuesday issued a public pledge not to seek government approval without extensive safety and effectiveness data. This follows a fairly similar open letter the BIO trade group released last week warning any vaccine or therapy should only become available with the same sort of “rigorously considered” data.
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These are only words, but right now, these are the words that Trump needs to hear.
After Trump has brazenly and transparently bullied members of his own team — most notably, Food and Drug Administration Commissioner Stephen Hahn — someone has to draw a line in the sand and push back against him.
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There’s good reason. As we move closer to Nov. 3, vaccine makers are still testing their shots. Yet at a Friday press conference, Trump said a vaccine might be ready “maybe even before Nov. 1” or “sometime in the month of October.”
Wouldn’t that be convenient?
The vaccine makers that signed this pledge — Pfizer, Merck, AstraZeneca, Sanofi, GlaxoSmithKline, BioNTech, Johnson & Johnson, Moderna, and Novavax — are rushing to complete clinical trials. But only Pfizer has indicated it may have late-stage results in October, and that’s not a given.
Yet any move by the FDA to greenlight a Covid-19 vaccine without late-stage results will be interpreted as an effort to boost Trump — and rightly so.
Consider Trump’s erratic and selfish remarks. He recently accused the FDA of slowing the vaccine approval process and being part of a “deep state.” No wonder there is concern he may lean on Hahn to authorize emergency use prematurely. For his part, Hahn has insisted he won’t buckle to political pressure, but he also said emergency use may be authorized based on preliminary data.
“It’s unprecedented in my experience that industry would do something like this,” said Ira Loss of Washington Analysis, who tracks pharmaceutical regulatory and legislative matters for investors. “But we’ve experienced unprecedented events since the beginning of Covid-19, starting with the FDA, where the commissioner has proven to be malleable, to be kind, at the foot of the president.”
Remember, we’ve seen this movie before.
Amid criticism of his handling of the pandemic, Trump touted hydroxychloroquine, a decades-old malaria tablet, as a salve and the FDA authorized emergency use. Two weeks ago, he touted convalescent blood plasma as a medical breakthrough, but evidence of its effectiveness against the coronavirus is inconclusive. And Hahn initially overstated study results.
Most Americans seem to be catching on. A STAT-Harris poll released last week found that 78% of the public believes the vaccine approval process is driven by politics, not science. This goes for a majority of Democrats and Republicans.
The pharmaceutical industry has to be vocal, though.
Why? The FDA has long been seen as the global gold standard among regulators. No government agency is perfect, but Trump is sadly undermining its credibility. If he keeps this up, it will only make it harder for companies to later point to the FDA as validation for the safety and effectiveness of their products.
This explains why the biotech executives used such pointed phrases as “FDA should maintain its historic independence” and “political considerations should be put aside.” The vaccine makers, however, avoided using any language that might appear confrontational and further provoke Trump. Instead, they underscored a need to “adhere to high scientific and ethical standards.”
Let’s be clear, though. These public pronunciations are not simply altruistic attempts to take the moral high ground. With each tweet and off-the-cuff remark about the vaccine timeline, Trump is eroding whatever confidence the public may have in vaccine makers, which is already questionable as far as some people are concerned.
“The companies are aware that, on a good day, they have trouble selling vaccines to 25% of the country that is suspicious about safety. So the last thing they need is to have Trump pull a stunt and push through a vaccine ahead of its time,” Loss said. “In many ways, the industry is doing a defensive move to ensure they’re not going to have to defend any approval because the president is doing a dance.”
The pharmaceutical industry is keenly aware that its reputation is also at stake as the pandemic becomes more and more politicized.
And simply put, that’s not good for business.
About the Author Reprints
Let’s hope the companies stay true to their platform and stand up to trump and his fantasies, let alone his spineless appointees and their meaningless agendas !!!!!
Trump should be the first to get that vaccine no one shouldn’t trust this. This trump is making America worse this trump is destroying the world THE FIRST ONE THAT SHOULD AND NEEDS TO GET THAT VACCINE IT SHOULD BE THAT TRUMP
The biopharmaceutical industry has always been skittish about vaccines, specifically in the context of vaccine safety. In the early 1980s, most established companies were unwilling to produce existing, childhood vaccines, or invest in new vaccines, because of liability issues related to safety. The issue was not that vaccines were unsafe, but the very large number of healthy children who were being vaccinated every year, so that even very rare adverse events associated with these (remarkably safe) products, created significant liability. The National Childhood Vaccine Injury Act of 1986 was crafted to address these concerns, and was strikingly effective in promoting a period of dramatic advances in childhood and adult vaccines.
The balance of risk and benefit is very different in a time of COVID. Nevertheless, the industry’s concern about adverse events is neither new nor surprising.
I am so sad to see the state of affairs in this country. It’s all politics and everyone is in it, there seems to be no state or country. Sometimes I wonder if an authoritarian system is better suited to the country whose people do not seem to be mature enough for democracy.
– A narcissistic president who wants to hog all the limelight and is only focused on re-election. Shoots off the hip for anything that he feels will give him credit.
– A vile opposition whose only function seems to be to oppose anything and everything that would give the current president any credit. Even if it is looks promising, they would rather have people die and starve rather than move things forward. God forbid – what if it makes the current president look good.
In the meantime, even a country like Russia has a viable vaccine about to go into mass production. China has four vaccine candidates already being produced in large quantities. Because they could not get enough folks in their country to test on, they made the effort to go international and signed up countries like Argentina to do the testing. Here. we have stalled the process of people getting into trials. Even the Indians (another chaotic democracy) is progressing towards it and hopes to have it by year end.
There does not seem to be any such urgency or concern in this country. I can’t tell if the folks are just incompetent or they just want to delay it enough so that a viable vaccine does not become available before the election.
People, please wake up before you end up cutting the nose to spite the face.
I agree with your excellent perception.
First off all, Trump does not like vaccines and most of us know it but he’s a true American and wants options for people due to the fact the left has shot down HCQ and other Options that have proven to work that we’re already FDA approved . I’m sure he felt that the “pro” Vaxers would appreciate the fact he was trying to come up with a solution because he knew the left would come up with excuses not to open their state or business . Personally I not take a vaccine for a virus with 99.99999999 recovery rate but an old person can and quests what that’s their choice because this is America folks . Damned if you do and don’t right !!
Reading the comments is baffling. Good column. I actually see very little bias, simply a history lesson in Trump’s blunders and proclamations on the risks and recovery from COVID19. I believe he wants a vaccine, I do not believe his approach to the presidency works. He surrounded himself with “yes” men and alienated any dissenting opinions.
If a vaccine is ready in October following rigorous verification, validation, and clinical studies, I think people will be fine with it. The issue is that the public does not have a trust to ensure safety of a drug.
Really too bad to see another article bashing the President of the US.
He is doing his best to facillitate this. Did you dare say this things when there was a rush to get the HIV cocktail drugs out ?
I agree .
This article = biased.
Hi GM,
Thanks for your note.
Look again, and you’ll see the column – yes, it’s a column – is labeled ‘The Pharmalot View.’ It’s not a news story. One of my roles here at STAT is to write columns – and columns have opinions.
Hope this helps,
ed at pharmalot