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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.

  • Fortunately Mr. Silverman wasn’t an editor for a Philadelphia newspaper back in 1777 when George Washington made the bold decision to inoculate the Continental Army against smallpox. I could just imagine him demanding the head of a new FDA to
    dot all the i’s and cross all the t’s with his quill pen before granting approval. Desperate times require desperate measures. Today, those making such bold decisions are now called erratic and selfish. Luckily, we now sing God Bless America and not God Save the Queen.

    • @Mark Santoro Smallpox had a very high fatality rate. COVID-19 has a mortality rate of 0.5% to 1%, according to the most accurate data coming from S Korea, Germany and Singapore, where they actually tested and contact traced. Even China’s early data showed a 0.7% mortality rate for those under age 80. About 50-60% of people will have no symptoms, and 80% mild symptoms, and 5% end up in ICU. So no, this isn’t the time to be making “bold” moves, you want to make moves that are safe and effective. You don’t want a vaccine that causes more harm than the virus, or one that is ineffective or wears off in a few weeks. That’s why studies are done.

      And yes, this conflicts with the perception that covid is invariably fatal and we will all die unless there is an immediate vaccine, but that is not the case. In the meantime, just as a contrast, about 1-2 million people die of malaria every year and 300-500 million are infected. So where is the outrage for a vaccine?

  • Ed, you have no shame do you? This virus is the worst thing since the Spanish Flu is what the media spouts everyday for the last 6 months. The fact that Trump wants a vaccine faster and is pushing on people to get it done faster is somehow a bad thing? No shame.. If this virus is so bad (which most Americans don’t believe) that we had to lock down and shut down the economy than how is it a bad thing that Trump is pushing for a vaccine? Orange man bad, even if he is pushing to save lives. The silent majority and possibly even now the majority sees right through the media bias. Trump 2020.

    • Pushing a vaccine through too soon is dangerous because it hasn’t been tested thoroughly enough. It may have harmful side effects that wouldn’t present themselves until later, which would ideally be caught in trials before administering it to the entire country. A concern I have is that if this first draft of a vaccine gets distributed and doesn’t work, then people will be less likely to accept another vaccine later that has actually been properly tested and could effectively quell the pandemic.

      It’s best to do things right the first time and not rush when it comes to public health. Given this knowledge, unfortunately that means Trump is not prioritizing the health of our country. I encourage you to think about this objectively.

  • It truly is sad. The Democrats would rather that the American people suffer than to cooperate in anything that would be perceived as an accomplishment by President Trump. They have spent the last 3.5+ years trying to destroy Trump rather than improve our country. How much time and money have they wasted that could have been put to better use?

    STAT News, CNN, MSNBC and other media outlets are so biased – everything is reported in a political or distorted manner rather than reporting the facts and letting the readers/viewers make their own conclusions. So may instances of twisting the President’s remarks while completely ignoring the Democrats’ contradictions. Trump does something and gets criticized for it, then he gets criticized for not doing it sooner! All they want is for him to fail without any concern for the collateral damage to our country.

  • STAT is a news that likes crashing a stock to make money. I would not believe a word that comes out of this news agency. They are a bunch of criminals. That steal from investors.

  • I find this hilarious. Rawr we don’t like Trump. All you people are doing is making more people afraid to vaccinate if one is approved in October. Can we then blame everyone in this article for the subsequent deaths? I mean you all blame Trump for a VIRUS…he can’t control that nor can he control stupid people spreading. If he did that then you would call him a fascist. Also if you look up a good verified study that is peer reviewed HCQ is effective in early stage not late stage much like the steroid is effective in late stage not early stage. Look up 33 drugs with known covid19 inhibition in a lung extract. Chloroquine is on that list and is quantified as a % of inhibition. So are 32 other drugs we aren’t using……Trust no media outlet study the science.

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