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Hiltzik: The FDA and vaccines

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It’s no doubt a coincidence, but two commentators that I find most thoughtful and trustworthy both weighed in on whether the Food and Drug Administration should just go ahead and grant a decision on Wednesday. full formal approval for COVID vaccines widely administered in the United States

They are Kevin Drum, recently of Mother Jones, and Paul Campos of the University of Colorado Law School and the Lawyers, Guns & Money Group Blog.

Unfortunately, they land on the other side of the question.

Any vaccine approval without the completion of the high-quality review and evaluation that Americans expect the agency to perform … would affect public confidence in the agency and do little to help combat vaccine hesitation.

FDA official Peter Marks

Drum Advocates allow the full approval process to unfold, which means approval might not be granted until January or later. Campos argues that, given what we already know about the safety and effectiveness of vaccines, the FDA should just go ahead and grant full clearance now.

I’m going to have to agree with Kevin on this one. It is true that with a combined total of over 300 million doses of Pfizer-BioNTech and Moderna vaccines administered in the United States alone, data on their safety and efficacy is abundant.

But it’s also true that the FDA has established a comprehensive drug authorization process that has served it well in the past. Tinkering with this procedure can only lead to a bad result.

Let’s look at the issues.

First of all, a little background. The FDA issued emergency use authorizations for the three COVID vaccines used in the United States starting December 11, 2020, when it granted the EUA for the two-dose Pfizer vaccine. The USA followed for the two-dose Moderna product on December 18 and for a single-dose vaccine manufactured by Johnson & Johnson on February 27 of this year.

The EUA process is not flippant or sloppy. It is used to grant approval for medical products needed to deal with public health emergencies, with the pandemic being a classic example.

The USA still requires manufacturers to submit detailed clinical data on the safety and efficacy of their products, and the FDA anticipates that applicants will continue clinical trials of products until they gather sufficient evidence to support them. full clearance – often involving up to tens of thousands of trial subjects followed over a period of months or even years.

This process is underway for all three vaccines. Pfizer on May 7 requested an expedited review of its vaccine, which would reduce the FDA process to about six months from the usual 10 months or more; Moderna made a similar request on June 1. Johnson & Johnson has not yet filed its claim.

The bottom line, then, is that, following the normal procedure for granting full authorization for a drug, the FDA continues to collect vaccine data. The agency is facing a lot of pressure to act as quickly as possible.

As late as Wednesday evening, in a town hall broadcast on CNN, President Biden said scientists around him expected the FDA to issue final clearances “maybe early in the year. school – end of August, beginning of September. , October. ”

Biden said the decision would be up to the FDA and hinted it would be based on science. But, whether deliberately or not, his words implicitly gave the FDA time to work.

This is an indication that the pressure on the agency to act quickly is not based on science, but on politics. The rise of the Delta variant of the virus, which is more transmissible than previous variants but which has not been conclusively shown to cause more serious disease, adds urgency to the vaccination campaign, as the three vaccines are effective against the variant. (Some recent studies have suggested that the Johnson & Johnson vaccine requires a second dose to be as effective as the two mRNA-based alternatives.)

The idea behind the push for a quick final clearance is that it will give policymakers, medical authorities and political leaders an additional tool to encourage people who are resistant to vaccines to get vaccinated, including a dossier. stronger legal framework to make vaccinations compulsory.

It is also believed that the final authorization could also allay concerns from resistance or refusal of vaccines that as long as vaccines are administered only in the context of EUA, they are “experimental” and, therefore, their safety and suitability. effectiveness have not been sufficiently verified.

But these arguments don’t really hold water.

To begin with, there is no doubt that the legal arguments in favor of compulsory vaccines under the EUA are strong. Federal Judge Lynn N. Hughes of Houston made short work of the claim that people cannot be forced to take the vaccines on June 12, when he launched a lawsuit brought by 117 Houston Methodist Medical Center employees who had been threatened with dismissal for refusal to immunize.

Employees said the vaccines are “experimental and dangerous.” Hughes found the claim to be “false and also irrelevant.” The main complainant said she was forced to become a “human guinea pig”; the judge mocked, noting that “the hospital workers are not participating in a human trial” but willfully refused to accept the inoculation which the woman’s employer said “will make it safer for their workers and the patients in the care of the Methodists “.

Finally, the judge considered the plaintiffs’ request comparing the threat of dismissal to forced medical experimentation during the Holocaust. “To equate the injection requirement with medical experimentation in concentration camps,” he said, “is reprehensible”. Principal Complainant Jennifer Bridges, he said, “can freely choose to accept or reject a COVID-19 vaccine; however, if she refuses, she will simply have to work elsewhere.

Hughes also noted that the Federal Equal Employment Opportunity Commission ruled in May that employers can require employees to be vaccinated, provided they make accommodations for workers with disabilities, a real medical apology. or sincere religious beliefs against vaccination.

The distinction between treatments under EUA and those with final authorization has not been taken into account in many government actions targeting COVID vaccines.

The silly move by Tennessee state health officials and GOP Governor Bill Lee to end immunization of school-aged children, for example, not only covers COVID vaccines, which were the primary targets of policy, but according to the Nashville Tennesseean also influenza, measles, mumps, rubella, human papillomavirus or HPV, and others, all of which have been fully cleared by the FDA for years. This decision is entirely political.

Whether the final clearance alone will advance the needle of vaccine resistance is debatable. In fact, it is doubtful. Holders cite many reasons for resisting vaccination.

In a survey in March, healthcare consulting firm Surgo Ventures found that of the 38% of respondents who were vaccine refractory, nearly half – 16% of the total – were “COVID skeptics” who do not believe in vaccines in general or have deeply held beliefs around COVID-19. “[E]anyone in this group believes in at least one conspiracy theory, ”Surgo found.

The likelihood that these individuals will be influenced by upgrading EUA vaccines to final authorization is clearly low.

Among other categories of resistance, Surgo found, 6% of those surveyed were watching to see how friends or family were doing with the vaccine, 9% were worried about the cost (even though it is free) and 7% were “suspicious of the system,” mostly people of color who think the medical establishment has not served them well. They are more likely than “skeptics” to eventually take the photos.

Put it all together and it is obvious that there is more risk for the vaccine deployment to truncate the process and quickly issue a full authorization.

This includes the risk to the FDA’s own reputation. In a recent editorial, Eric J. Topol of the Scripps Research Institute in La Jolla – generally a wise and sober commentator on FDA policy – pointed out the “paradox” that the FDA has just approved a drug for the disease. Alzheimer’s disease despite limited evidence that it works at all, while “coronavirus vaccines are not yet fully licensed despite overwhelming evidence of their benefits.”

Yet this is not so much a paradox as the validation of the need to wait for more data to arrive. The hasty and scientifically unsustainable approval of the Alzheimer’s drug Aduheim shocked the agency, causing three members of the scientific panel that oversaw the drug’s review to step down and cause the agency’s acting commissioner to ask. an independent investigation into the approval. It’s a clue of what could happen if he approves COVID vaccines prematurely.

FDA official Peter Marks rebuffed Topol with a response stating that “any vaccine approval without the completion of the high-quality review and evaluation Americans expect from the agency would undermine statutory responsibilities. of the FDA, would affect public confidence in the agency and do little to help combat vaccine reluctance.

As Drum points out, an approval of a vaccine that involves truncating a formal procedure would lead skeptics to correctly assume that this means the approval is political and not science-based. That would pretty much destroy the credibility of the FDA.

He is right. After four years of relentless manipulation by Donald Trump and his minions, the FDA has little credibility to waste.

The best thing the agency can do to make sure the public sees vaccines as safe and effective is to go through the same approval process that has made the US drug market one of the safest in the world. . You don’t gain much by changing the rules, and you lose way too much.



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