T.Alk about a rebuke.
President Trump may wish to send a Covid-19 vaccine in a timely manner to increase his chances of selection, but the pharmaceutical industry will not appear willing to cooperate – at least not on their terms.
In an unusual turn of events, nine vaccine manufacturers, including some of the world’s largest companies, plan to issue their public pledges on Tuesday seeking government approval without comprehensive safety and efficacy data. This follows exactly the same open letter that the BIO trade group issued last week stating that any vaccine or treatment should only be available with the same type of “strictly considered” data.
Advertising
These are just words, but for now, these are the words that Trump needs to hear.
After Trump threatened his own team in a ruthless and transparent manner – most notably, Food and Drug Administration Commissioner Stephen Hahn – someone would have to line up in the sand and push against him.
Advertising
There is good reason. 3 Nov. Moving closer to, vaccine manufacturers are still testing their shots. However, in a news conference on Friday, Trump said, “Maybe nine. The vaccine can be prepared “even before 1” or “sometime in October”.
Wouldn’t that be convenient?
Vaccine manufacturers signing the pledge – Pfizer, Merck, AstraZeneca, Sanofi, GlaxoSmithKline, Bioentech, Johnson & Johnson, Moderna and Novavax – are rushing to complete clinical trials. But only Pfizer has suggested it may have late-phase results in October, and it hasn’t.
Yet any move by the FDA to greenlight the Covid-19 vaccine without end-stage results would be interpreted as an attempt to promote Trump – and rightly so.
Consider Trump’s erratic and selfish comments. He recently accused the FDA of slowing down the vaccine approval process and being part of a “deep state.” Surprisingly, there is concern that he may lean on Hen to prematurely authorize emergency use. For his part, Hahn has insisted he will not face political pressure, but he also said the use of the emergency could be authorized based on preliminary information.
“In my experience, the industry will do something like this,” said Ira Loss, a Washington Washington analyst who oversees pharmaceutical regulatory and legal matters for investors. “But we have experienced unprecedented developments since the beginning of Kovid-1, starting with the FDA, where the commissioner has proved hateful, kind, following in the footsteps of the president.”
Remember, we may have seen this movie before.
Amid his criticism of handling the epidemic, Trump cited the decades-old malaria pill, hydroxychloroquine salve and the FDA authorized for emergency use. Two weeks ago, he obscured convulsive blood plasma as a medical breakthrough, but evidence of its effectiveness against coronavirus is inconclusive. And Hehn initially overstated the results of the study.
Most Americans seem to be catching this. A State-Harris poll released last week found that of 78% of people believe the vaccine approval process is driven by politics, not science. The majority goes for Democrats And Republican.
However, the voice should be raised for the pharmaceutical industry.
Why The FDA has long been seen as a global gold standard among regulators. No government agency is perfect, but Trump is unfortunately undermining its credibility. If it continues this, it will later make it difficult for companies to turn to the FDA as a recognition for the safety and effectiveness of their products.
This explains why biotech officials “should the FDA maintain its historic historical independence” and “put political considerations aside.” However, vaccine makers avoided using any language that could appear confrontational and provoke Trump further. Instead, they emphasized the need to “adhere to high scientific and ethical standards.”
Let’s be clear though. These public utterances are not just philanthropic efforts to take on moral high ground. With every tweet and and f-the-cuff comment about the vaccine timeline, Trump is publicly shifting whatever confidence he has in vaccine manufacturers, which is already questionable as far as some people are concerned.
“Companies know that, on a good day, they find it difficult to sell vaccines to 25% of the people in the country who are skeptical about safety. So the last thing they need is for Trump to pull the stunt and push through the vaccine ahead of his time. Loss said. “In many ways, the industry is taking a defensive step to make sure they don’t have to defend any approval because the president is dancing.”
The pharmaceutical industry is keenly aware that its reputation has also been jeopardized by the increasing epidemic in politics.
And simply put, it’s not good for business.
