On April 25, the FDA extended its approval of Gilead’s drug Remdesivir (aka Veklury) to include children as young as 28 days old.
Gilead’s controversial drug has a history that even mainstream science and news sources have questioned. According to the journal Science regarding the initial approval in October 2020 :
. . . both FDA’s decision and the EU deal came about under unusual circumstances that gave the company important advantages. FDA never consulted a group of outside experts that it has at the ready to weigh in on complicated antiviral drug issues. That group, the Antimicrobial Drugs Advisory Committee (AMDAC), mixes infectious disease clinicians with biostatisticians, pharmacists, and a consumer representative to review all available data on experimental treatments and make recommendations to FDA about drug approvals—yet it has not convened once during the pandemic.
AMDAC’s website now shows it has met twice since the Science article was published. Once to review a drug for the treatment of adults with post-transplant cytomegalovirus infection, and once regarding Merck’s mutagenic/teratogenic molnupiravir oral capsules for treatment of mild to moderate COVID-19 in high-risk adults.
[See C19Early for all studies on all early treatment protocols, and then further explore the studies, looking at design, sponsor, and other emergent information. For example, on C19Early’s graph, Pfizer’s Paxlovid shows 83% effectiveness, but that is based on just 2 studies sponsored by Pfizer, and they have refused independent trials. The drug is only authorized under Emergency Use and has significant contraindications, known serious side effects, and reports are increasing about rebound effects.)
There are no meetings posted with Remdesivir as the topic.
The FDA decision is based on ADULT studies, and just one pediatric study that isn’t yet completed. From Gilead’s Press Release (Note: bolded statements in [ ] are our comments, not part of quote.)
This approval was supported by results from the CARAVAN Phase 2/3 single arm, open-label study [ongoing, won’t be complete until 2023]
Of the 53 pediatric patients enrolled in the CARAVAN study, no new safety signals were apparent for patients treated with Veklury [There is no control group. “No new safety signals” means the same safety signals already seen in all other age groups were seen with the babies and kids up to age 12.]
Overall, 75% and 85% showed clinical improvement (≥2 point increase on the ordinal scale) at Day 10 and last assessment [that means 25% and 15 percent did NOT show improvement], respectively, while 60% and 83% were discharged by Day 10 and Day 30, respectively [which leaves 40% and 17% still hospitalized]
In the study 38 patients (72%) experienced adverse events (AEs), with 11 patients (21%) experiencing serious adverse events (SAEs) that were determined not to be study-drug related, including three participant deaths, which were consistent with the patients’ underlying medical conditions prior to study entry or with COVID-19 disease during hospitalization [Shockingly high rates of adverse events and death. Gilead made all determinations.]
The most common adverse reaction (≥5% all grades) was nausea
The most common lab abnormalities (≥5% all grades) were increases in ALT and AST [Abnormal liver function tests]
The study criteria for subjects included a positive PCR test and being hospitalized for Covid. When the data was pulled, there were just 53 children enrolled, and they experienced 11 serious adverse events and 3 deaths. That’s a 21% serious adverse event rate and a 5.66% fatality rate.
Putting that in context, in the U.S., according to the AAP, the hospitalization case rate in children is 0.1%-1.5%, and the case fatality rate in children is 0.00%-0.02%. Infection fatality rates (which include all the estimated infections that are never reported) are even lower. A study looking at the mortality rates of those hospitalized with a positive PCR test found that in 2020, the rate in those under 18 was 0.2%. (This post will be updated with more recent rates.)
Why was Gilead jubilant over a study that had a 5.66% mortality rate in hospitalized children?
Association of Remdesivir Treatment With Survival and Length of Hospital Stay Among US Veterans Hospitalized With COVID-19“The findings suggest that routine use of remdesivir may be associated with increased use of hospital beds but not with improvements in survival.”
“This is a very, very bad look for the FDA, and the dealings between Gilead and EU make it another layer of badness,” says Eric Topol, a cardiologist at the Scripps Research Translational Institute who objected to remdesivir’s FDA approval.”
“The most reported ADRs [adverse drug reaction] for remdesivir represented liver dysfunction, kidney injury, death and bradycardia.”