• Sign in
  • Communities
  • About Us
  • Shop
0
DailyClout
Unleash Liberty

Support DailyClout

Help fund independent journalism.

Support Us
  • News
  • Opinion
  • Communities
  • Pfizer Reports
  • Home
  • BillCam
  • Communities
  • Submissions
  • Events
  • Our Story
  • Shop
  • Donate
  • Become a Member!
  • Login/Sign Up
DailyClout

“The FDA Will Not Inspect Vaccine Production Plants”

November 5, 2020 • by Dr. William Haseltine

Approval of a vaccine by the Food and Drug Administration (FDA) typically requires inspection of the vaccine’s manufacturing plants. In a Covid-19 world, this will not be the case. Covid-19 vaccine candidates will get a pass on FDA plant inspections, according to Bloomberg. As candidates reach the final phases of testing, emergency use authorization will be granted without pre-approval inspection, said FDA Director of Viral Products Jerry Weir.

Beware of lower safety standards with fast-tracked Covid-19 treatments. Vaccines and therapies are being rushed through the testing and approval process without substantial evidence of success. Shorter test periods reduce the confidence that they will be safe and effective. I have described some of the uncertainties and potential hazards of rushed trails elsewhere.

Under normal circumstances, the FDA requires several batches of vaccines and drugs to be made, all meeting the same safety, consistency, and potency standards using the same facilities as will be used to sell the drug or vaccines. These requirements prevent quality control issues on the side of the pharmaceutical company.

Drug and vaccine manufacturing plant inspections are routine and any violation of protocols is cited. Just last year, an Eli Lilly pharmaceutical plant was cited by the Food and Drug Administration (FDA) for quality control issues, according to Reuters. Sources close to the situation told Reuters that Eli Lilly had falsified records pertaining to FDA manufacturing standards. That same Eli Lilly plant is set to manufacture a Covid-19 treatment used by the president during his infection.

All biological drugs including vaccines, antibodies, and other proteins are subject to additional scrutiny because the preparations are likely to vary from batch to batch. Several of the leading vaccine candidates deploy entirely new technologies, technologies that have not been previously approved for human use.  Verification that a new manufacturing process yields the desired product is especially important. The rushed time frame also obligates the FDA to forgo stability tests of the new vaccines, if they are to be used before the end of this year or early2021. There simply is not time to do what is routine.

Pushing Covid-19 vaccines and treatments through the approval process may have already contributed to health complications. Major vaccine trials like AstraZeneca and Johnson & Johnson paused testing due to severe illness in some participants. AstraZeneca has since restarted, but concerns about short and long-term health safety continue.

The recent history of other pharmaceuticals pushed through the emergency use authorization process is instructive. Hydroxychloroquine was granted authorization back in March. The FDA’s authorization letter cited only a 36-person French study. Three months later, post-authorization monitoring found an increased risk of heart problems in hydroxychloroquine users, in addition to little evidence of reduced Covid-19 symptoms. The authorization was promptly revoked. Remdesivir was recently approved by the FDA. A recent WHO controlled trial found no benefit of remedesivir for hospitalized patients in a multi-country study.

The dangers of unregulated Covid-19 drugs and vaccines are clear and present. Normal circumstances require years for a vaccine to be produced. I know pandemic fatigue is setting in for many. Many hope for a vaccine to stop the disease instantly. They will be sadly disappointed. Even if a vaccine is approved early next year, and even if it is safe and effective, the hoped-for relief will be months in coming. People may forgive the failure of a vaccine because of the intense difficulty of preventing Covid-19 infections. They will not forgive a vaccine that endangers their life because of manufacturing errors. People my age still remember the Cutter laboratory disaster with improperly inactivated polio vaccine preparations in the 1950s.

FDA regulations are ultimately in place designed to protect us. They should not abrogate the essential duty for speed under any circumstance.

 

This piece originally appeared on Forbes.com. Reprinted with permission.

Spread the love

William Haseltine, PhD, is chair and president of the global health think tank, ACCESS Health International. He is author of numerous books, including the recently released, “A Family Guide to COVID-19: Questions and Answers for Parents, Grandparents and Children”

Spread the love
Spread the love
Previous StoryNaomi Wolf Interviews Joe Sackman, Candidate for NYS Assembly District 15
Next Story“Controlling the COVID-19 Pandemic is the Main Challenge Facing the Biden Administration”

Leave your comment Cancel Reply

You must be logged in to post a comment.

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Recent Posts

  • Dr. Naomi Wolf's Outspoken
    Dr. Naomi Wolf’s Outspoken Thursday, 27, Oct
  • Addiction-1
    Addiction: A Disease or A Choice? Friday, 2, Sep
  • shutterstock_796969141-768×450-1
    How I Almost Did Not Graduate from Stanford University Thursday, 1, Sep
  • Capture-78
    A Letter to California Attorney General on Vaccine Adverse Events Thursday, 5, May
  • Capture-91
    Dr Naomi Wolf Shares SHOCKING New Pfizer Discoveries Thursday, 5, May

Blog Archive

Subscribe to Our Newsletter

  • I agree to receive emails and other content from DailyClout. I understand that I may repeal my consent at any time.

  • Home
  • BillCam
  • Communities
  • About Us
  • Submissions
  • Advertise with Us
  • Events
  • Shop

Do you really want to logout of DailyClout?
Yes

You are now leaving DailyClout...