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Tag Archives: FDA

FDA grants full approval of Pfizer COVID-19 Vaccine

23 Monday Aug 2021

Posted by Michael Bersin in Uncategorized

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Tags

approval, Corona virus, COVID-19, FDA, Food and Drug Administration, pandemic, Pfizer, vaccine

No more excuses.

This morning, from the U.S. Food and Drug Administration:

FDA NEWS RELEASE

FDA Approves First COVID-19 Vaccine
Approval Signifies Key Achievement for Public Health

For Immediate Release:
August 23, 2021

Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing, or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose, or treat the disease, outweigh the known and potential risks of the product.

FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements. For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. The agency conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.

Comirnaty contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into – nor does it alter – an individual’s genetic material. Comirnaty has the same formulation as the EUA vaccine and is administered as a series of two doses, three weeks apart.

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”

[….]

If you haven’t already done so, get vaccinated.

Wear a damn mask while you’re at it.

Medical research or Big Pharma: Guess which Billy Long loves the most

30 Wednesday Nov 2016

Posted by willykay in Uncategorized

≈ 3 Comments

Tags

21st Century Cures Act, Big Pharma, Billy Long, Elizabeth Warren, FDA, Medical device makers

Rep. Billy Long (R-7) is excited about the possibility that Congress will pass the 21st Century Cures Act by the end of this session, and he wants his constituents to know that he cosponsored the bill. Unfortunately, even though Billy seems to think that his support for this bill is a big deal that will will help wipe disease off the map, I’m afraid that, along with some funding for medical research, it contains poison pills in the way of corporate giveaways that may be too big to swallow.

The bill does spend some money on limited types of medical research, and, no matter how inadequate, these days the situation is so dire that more is always good. But not when it comes at the cost of loosening important safety regulations, essentially giving the regulatory store away to pharmaceutical firms and medical device makers in order to solve problems that – guess what? – don’t really exist. Contributors to Health Affairs Blog, a Project Hope affiliated publication which “features posts from noted health policy experts and commentators from a wide variety of perspectives,” summarizes the problems with the bill:

Proponents of the proposed legislation—drug and device companies, and members of both parties in the House and Senate—argue that the FDA stifles innovation and advances in treatment by approving drugs and devices too slowly compared to other countries.

That premise is faulty. Nearly two-thirds of the novel drugs approved in 2015, for example—29 of 45, 64 percent — were approved in the United States before being approved in any other country. The proportion was even higher in 2012 and 2013. The majority of these drugs (60 percent) took advantage of existing FDA expedited review programs—fast track, breakthrough, priority review, and accelerated approval—and nearly half (47 percent) were approved to treat rare or orphan diseases.

As for devices, research shows that “it takes the same amount of time or less for patients to gain access to innovative, high-risk medical devices” in the U.S. as compared to Germany, France, Italy, and Britain.

The House and Senate bills ignore the above facts. They essentially seek to speed-up the approval process by relaxing FDA’s safety and effectiveness standards. And to make that more palatable, sponsors have attached the changes to increases in funding for the National Institutes of Health and the FDA.

Democratic Senator Elizabeth Warren (D-MA) leveled a powerful attack on the paltry and likely ephemeral increase in research funding that is on offer:

For more than two years, Congress has been working on legislation to help advance medical innovation in the United States. Medical innovation is powerfully important, and I have spent as much time working it as any other issue during my time in the Senate.

From the beginning, I have emphasized one obvious fact. Medical breakthroughs come from increasing investments in basic research. Right now, Congress is choking off investments in the NIH. Adjusted for inflation, federal spending on medical research over the past dozen years has been cut by 20%. Those cuts take the legs out from under future medical innovation in America. We can name a piece of legislation the “cures” bill, but if it doesn’t include meaningful funding for the National Institutes of Health and the Food and Drug Administration, it won’t cure anything.

That’s why months ago Senate Democrats said any so-called “cures” legislation must have a significant investment in medical research. And that’s why Senate Republicans publicly committed to doing exactly that. But now they have reneged on that promise and let Big Pharma hijack the Cures bill. This final deal has only a tiny fig leaf of funding, for NIH and for the opioid crisis.

And most of that fig leaf isn’t even real. Most of the money won’t really be there unless future Congresses passes future bills in future years to spend those dollars. …

Just in case, she hadn’t made her position clear, Warren added:

I support most of these proposals. I’ve worked on many of them for years. I even wrote several of them myself. If this bill becomes law, there is no question it will contain some real legislative accomplishments.

But I cannot vote for this bill. I will fight it because I know the difference between compromise and extortion.

Compromise is putting together common-sense health proposals supported by Democrats, by Republicans, and by most of the American people, and passing them into law. Extortion is holding those exact same proposals hostage unless everyone agrees to special favors for campaign donors and giveaways to the richest drug companies in the world.

Somehow, Billy Long neglected to tell us about the real focus of the bill; he wants us to believe that a poorly funded bill based on Big Pharma’s and medical device makers’ wish-list “could save millions of lives.”

When it comes down to it, if the choice is between Ozark Billy and Elizabeth Warren, I know who I believe.

 

Brett Penrose: You can see it in their eyes

29 Tuesday Apr 2008

Posted by Michael Bersin in Uncategorized

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Tags

Brett Penrose, eye surgery, FDA, snark

Brett Penrose on seeing the sight of insightful government oversight:

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