Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a press release:
“As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for this population.
Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”
According to the press release, the FDA’s decision to approve the therapy, marketed under the name Veklury, is supported by a clinical study conducted on infants 4 weeks and older weighing a minimum of 6.6 pounds.
The study is underway and will not be completed until February 2023. There are no published results.
However, Gilead Sciences, maker of remdesivir and sponsor of the study, provided the following details in a company press release:
- A total of 53 hospitalized pediatric patients were enrolled in the clinical study.
- 72% suffered adverse events.
- 21% suffered serious adverse events determined to be unrelated to the drug.
- Three children died from either underlying conditions or COVID-19.
Nevertheless, Gilead Science assured that “no new safety signals were apparent for patients treated with Veklury.”
The study was of single-arm, open-label design.
Open-label means participants and investigators were aware they were receiving the drug, making it impossible to separate placebo from drug effect.
Studies show little or no benefit
Beyond the absence of any publicly available data on the efficacy and safety of this drug in humans of this age, available studies on older subjects indicate remdesivir offers no more than a meager benefit to those who survive its use.
In fact, this is why the World Health Organization (WHO) in November 2020 recommended against the use of remdesivir to treat COVID-19. The WHO only recently (April 22, 2022) updated its recommendation to support the drug’s use in patients who are at high risk for hospitalization.
Nevertheless, the FDA explains its long-standing support of remdesivir use in adults here, citing six studies that had the greatest impact on the agency’s position.
Here is a summary of the findings of each study from the FDA’s webpage:
- ACTT-1 Trial: Time to clinical recovery was shortened from 15 days to 10 through the use of remdesivir. There was no difference in mortality. The drug was no better than placebo when administered to patients who required high-flow oxygen, non-invasive respiratory support, mechanical ventilation or extracorporeal membrane oxygenation at baseline. A benefit was seen only in patients who required low levels of supplemental oxygen.
- Discovery Trial: There was no clinical benefit of remdesivir in hospitalized patients who were symptomatic for >7 days and who required supplemental oxygen. There was no difference in mortality between remdesivir and standard of care. Investigators judged three of 429 participants who received remdesivir died from the drug.
- WHO Solidarity Trial: Remdesivir did not decrease in-hospital mortality or the need for mechanical ventilation compared to standard of care. Four hundred and forty patients in this study were also enrolled in the Discovery trial above.
- Journal of the American Medical Association (moderate disease): After 10 days of treatment with remdesivir, clinical status was not significantly different from standard of care.
- New England Journal of Medicine (severe disease): No difference between five and 10 days of remdesivir treatment. No placebo group, thus “the magnitude of benefit cannot be determined.”
- PINETREE study: Three consecutive days of IV remdesivir resulted in an 87% relative reduction in the risk of hospitalization or death when compared to placebo.
As demonstrated, the first five studies used to justify the FDA’s approval of remdesivir showed little, if any, benefit to hospitalized patients with moderate or severe disease.
This is in contrast to the sufficiently proven benefit of off-label use of the previously licensed medications hydroxychloroquine and ivermectin.
Only the PINETREE study investigated the benefit of remdesivir for outpatient use. In that study, the drug provided a substantial benefit in preventing hospitalization when given in three separate doses over three days.
However, only eight individuals under the age of 18 were enrolled in the study, and none were younger than 12.
The primary endpoint, a composite of COVID-19-related hospitalization or death from any cause, did not occur in the under-18 group.
In other words, the study — funded by Gilead Sciences — showed the drug offered no benefit in this cohort.
Nevertheless, in reporting on the FDA’s approval of remdesivir for infants and young children, CNN found someone to support the FDA’s decision.
“The FDA’s approval of remdesivir for young children is ‘great,’ said Dr. Daniel Griffin, an instructor in clinical medicine and associate research scientist in the Department of Biochemistry and Molecular Biophysics at Columbia University.”
The entire country has seen what happens when men enter women's sports.
Lia Thomas is a biological male, but he was nonetheless allowed swim against elite female competitors to win an NCAA Freestyle competition, much to the disappointment of those women who had trained so hard to compete.
SIGN THE PETITION TO BAN MALES FROM WOMEN'S SPORTS TODAY
Males have a natural advantage over females in the vast majority of sports, so allowing them to enter women's sports can:
- crush the motivation of the biological girls who have worked hard to compete on a level playing field
- put females into harm's way in contact sports and locker rooms
- deprive women of their right to fairly compete for college scholarships and many other accolades
We all know the spectacle of Lia Thomas defeating those female swimmers was a charade, a mockery of women's sports, but now it's time to do something about it.
Please SIGN this urgent petition calling on members of Congress to pass a law banning the participation of biological males in women's sports.
This is not just about ensuring biological girls and women can compete fairly and win in their chosen sports, but it's also a major safety issue in contact sports and the dangerous use of women's locker rooms by gender-confused males.
Some of you will remember Fallon Fox, the male MMA fighter who claimed to be a woman and left his female opponent concussed and with a fractured skull.
Fox later announced on social media that he enjoys "smacking up" women who "talk transphobic nonsense."
Any reasonable person knows men shouldn't compete against women, but some people are too politically correct to take a stand and protect girls and women from this madness.
It's now time to join the growing pushback against the gender-confused lobby and their dangerous beliefs that have literally left some female competitors in the hospital.
Please SIGN this common sense petition calling on Congress to ban all males from competing in women's sport.
Future generations will look back with gratitude on those who stood on the right side of history, defending women from these very confused males.
Nothing less than a federal ban on biological males forcing their way into women's sport is enough, so this petition will be sent to all members of Congress demanding legislative action.
FOR MORE INFORMATION:
'Olympians, coaches, swimmers write open letter demanding NCAA protect women’s sports' - https://www.lifesitenews.com/news/olympians-coaches-swimmers-write-open-letter-demanding-ncaa-protect-womens-sports/
'Female swimmer torches NCAA after losing spot to William ‘Lia’ Thomas: ‘Make the right changes’' - https://www.lifesitenews.com/news/female-swimmer-nudged-out-of-competition-by-william-lia-thomas-torches-ncaa-in-open-letter/
'Rep. Boebert files resolution declaring female runner-up to ‘Lia’ Thomas the rightful winner' - https://www.lifesitenews.com/news/boebert-leads-resolution-to-declare-female-runner-up-to-lia-thomas-the-rightful-winner/
**Photo Credit: Fox News/YouTube screenshot
Safety ‘not established’ in pediatric patients
Not only is there scant evidence that remdesivir is an effective treatment for COVID-19, the drug’s safety is debatable.
With regard to its use in infants, even the FDA must acknowledge nobody knows how safe it is.
After all, the manufacturer’s label states:
“The safety and effectiveness of VEKLURY (remdesivir) have not been established in pediatric patients younger than 12 years of age or weighing less than 40 kg.”
With regard to pharmacokinetics (where the drug distributes in the body) the label states:
“The pharmacokinetics of VEKLURY in pediatric patients have not been evaluated.”
An indictment of the drug regulatory process
Let’s reflect on what the director of the FDA’s Center for Drug Evaluation and Research said regarding the approval of remdesivir for treating COVID-19 in infants 4 weeks and older:
“As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for this population. Today’s approval of the first COVID-19 therapeutic for this population demonstrates the agency’s commitment to that need.”
- Some children do not have a vaccination option.
- They need a safe and effective treatment.
- The FDA meets that need by approving a drug with no safety and efficacy record in children.
Safety and efficacy apparently can be conveniently established by fiat, not evidence.
In the end, the FDA’s approval of remdesivir is not an assurance of the drug’s safety and efficacy but an indication the agency is no longer interested in protecting the public from potentially harmful and ineffective therapies — or, in other words, in doing its job.
There will undoubtedly be doctors like Griffin who welcome this approval.
However, I don’t believe every pediatrician will accept the FDA’s guidance so readily.
It’s not easy to place an intravenous line to administer remdesivir in the tiny vein of an irritable baby coming from home with a positive rapid test. And then do it again the next day. And the day after that.
At some point, clinicians’ sensibilities will be challenged enough to compel them to actually examine how the FDA arrived at its conclusions.
Guidelines are meaningless if doctors choose not to abide by them.
The views and opinions expressed in this article are those of the authors and do not necessarily reflect the views of Children’s Health Defense.