Ivermectin Didnât Reduce Covid-19 Hospitalizations in Largest Trial to Date - WSJ
text
Researchers testing repurposed drugs against Covid-19 found that
ivermectin didnât reduce hospital admissions, in the largest trial
yet of the effect of the antiparasitic on the disease driving the
pandemic.
Ivermectin has received a lot of attention as a potential treatment
for Covid-19 including from celebrities such as podcast host Joe
Rogan. Most evidence has shown it to be ineffective against
Covid-19 or has relied on data of poor quality, infectious-disease
researchers said. Public-health authorities and researchers have
for months said the drug hasnât shown any benefit in treating the
disease. Taking large doses of the drug is dangerous, the Food and
Drug Administration has said.
The latest trial, of nearly 1,400 Covid-19 patients at risk of severe
disease, is the largest to show that those who received ivermectin
as a treatment didnât fare better than those who received a
placebo.
SHARE YOUR THOUGHTS
How should the most recent studies on the efficacy of ivermectin
against Covid-19 influence its use going forward? Join the
conversation below.
âThere was no indication that ivermectin is clinically useful,â said
Edward Mills, one of the studyâs lead researchers and a professor
of health sciences at Canadaâs McMaster University in Hamilton,
Ontario. Dr. Mills on Friday plans to present the findings, which
have been accepted for publication in a major peer-reviewed
medical journal, at a public forum sponsored by the National
Institutes of Health.
Dr. Mills and his colleagues looked at 1,358 adults who visited one
of 12 clinics in the Minas Gerais region of Brazil with Covid-19
symptoms. The patients all had a positive rapid test for
SARS-CoV-2, and were at risk of having a severe case for reasons
including a history of diabetes, hypertension, cardiovascular
disease or lung disease.
The researchers prescribed half of the patients a course of
ivermectin pills for three days. The other half received a placebo.
They tracked whether the patients were hospitalized within 28
days. The researchers also looked at whether patients on
ivermectin cleared the virus from their bodies faster than those
who received a placebo, whether their symptoms resolved sooner,
whether they were in the hospital or on ventilators for less time
and whether there was any difference in the death rates for the
two groups.
To make sure they were being thorough, the researchers analyzed
the data in three different ways. They looked at data from all
patients; then analyzed data from patients who received
ivermectin or a placebo 24 hours before they were hospitalized;
and in a third review, looked at data from patients who said they
had adhered strictly to their dosing schedule. In each scenario,
they found ivermectin didnât improve patient outcomes.
âThis is the first large, prospective study that should really help
put to rest ivermectin and not give any credibility to the use of it
for Covid-19,â said Peter Hotez, dean of the National School of
Tropical Medicine at Baylor College of Medicine, who reviewed the
findings.
Ivermectin is used primarily to treat patients with certain parasitic
diseases. Some doctors have been prescribing it to Covid-19
patients, and some people have been found ways to obtain
ivermectin without a prescription. The drug has antiviral
properties, but hasnât been approved by the FDA to treat any viral
infections.
Given its antiviral prospects, scientists early in the pandemic
thought it could be a candidate for treating Covid-19. In June
2020, a group of researchers in Australia published a paper
showing that large amounts of ivermectin could halt replication of
the coronavirus in cell cultures. But there was a problem: To
achieve that effect, a person would have to take up to 100 times as
much ivermectin as the dose approved for use in humans.
Some studies on ivermectin published in journals or on preprint
servers ahead of peer review have demonstrated no benefits, or
worsening of Covid-19 symptoms, after ivermectin use. Some have
shown some benefit, such as shorter time to symptom resolution,
reduction in inflammation, faster viral clearance and lower death
rates.
But most studies showing positive effects had significant
limitations such as small sample sizes or poorly defined outcomes,
according to the NIH. Several studies on ivermectin have been
withdrawn from publication, including a randomized controlled
trial looking at 100 patients in Lebanon that was retracted by the
journal Viruses due to issues with the statistical analysis,
according to the journal. Researchers at the NIH and Oxford
University also are conducting large trials on the effectiveness of
ivermectin, though results havenât been published.
Dr. Mills said ivermectin could improve outcomes in Covid-19
patients who are fighting off certain parasitic diseases at the same
time. But based on his teamâs findings, he said, the drug doesnât
seem to have any effect on Covid-19 itself.
Dr. Mills and his colleagues also are studying other drugs that
could be repurposed to work against Covid-19. Such drugs could
be useful because their side effects are well known and they may
be cheaper to deploy in poor countries than drugs like Merck &
Co. and Ridgeback Biotherapeutics LPâs molnupiravir or Pfizer
Inc.âs Paxlovid.
Merck said it has taken steps to make molnupiravir available in
lowâ and middle-income countries, including allocating three
million courses for distribution through aid groups and granting
licenses to generic manufacturers. Pfizer said it was working to
expand its supply chain and licensing production of Paxlovid
through a United Nations program.
Dr. Mills and his collaborators have looked at 11 repurposed
treatments against Covid-19, of which at least one has shown
promiseâfluvoxamine, which is commonly used to treat obsessive
compulsive disorder and depression. They published the research
in the Lancet Global Health in October, showing that Covid-19
patients who received fluvoxamine were less likely to require
hospitalization than those who didnât.
The researchers are looking at the effect in Covid-19 patients of
combining fluvoxamine and an inhaled steroid, budesonide, as well
as a drug called peginterferon lambda, which is used to treat
chronic viral hepatitis.
Write to Sarah Toy at sarah.toy@wsj.com
tl;dr: donât take medical advice from podcasting nut jobs
text
Pfizerâs Covid-19 Booster Cleared for 5- to 11-Year-Olds
Under the FDAâs authorization, the children can get the third dose five months after they receive their second shot
Updated May 17, 2022 10:49 am ET
U.S. health regulators cleared for use a booster shot of the Covid-19 vaccine from Pfizer Inc. and BioNTech SE for children 5 to 11 years, expanding booster access to about 28 million youngsters.
The decision Tuesday by the U.S. Food and Drug Administration permits a third dose of the shot at least five months after the second dose.
It comes weeks after the drugmakers said a third shot safely generated a strong immune response in the children, including significantly increasing antibody levels against the Omicron variant.
âA booster dose can help provide continued protection against Covid-19 in this and older age groups,â said Peter Marks, who heads the FDAâs vaccine division.
Many children now eligible for the shots might not get them, however. Vaccinations among the youths have been relatively low compared with rates in older people. Opinion surveys have found limited support among parents for vaccinating their children, suggesting many of them donât plan to have their children get a booster.
Under the FDAâs authorization, the booster would be the same 10-microgram dose as the initial two shots the children received. The dosage is one-third the amount that people 12 years old and up receive.
Before the 5- to 11-year-olds can get the boosters, a panel of vaccine experts advising the Centers for Disease Control and Prevention are expected to meet and vote on whether to endorse the shots.
The meeting of the CDC panel, the Advisory Committee on Immunization Practices, is scheduled to take place Thursday, and the CDC usually endorses its recommendation soon afterward.
Once the CDC signs off, the additional doses are expected to be available at pediatrician offices, retail pharmacies and other places where children have already been going for shots.
Supplies should be sufficient to meet demand, according to the U.S. government and the drugmakers.
Five- to 11-year-olds have been eligible for the two-dose primary series of Pfizer-BioNTechâs vaccine since October.Photo: jeff kowalsky/Agence France-Presse/Getty Images
Booster doses of the Pfizer-BioNTech vaccine are already authorized for people as young as 12 in the U.S. The FDA recently greenlighted second boosters for people who are 50 years old and up or who have weakened immune systems.
Overall, children are less likely than adults to become infected with Covid-19 or develop severe disease, and many who develop cases experience mild or no symptoms, according to health experts and studies.
The hospitalization rate in children, however, increased during the Omicron wave, especially among those who werenât vaccinated.
Health authorities have encouraged vaccines and boosters to prevent severe disease and help protect people more vulnerable to serious cases. The boosters restore vaccinesâ efficacy, which has been found to wane after several months, according to many studies.
Research has also found that adults need at least three doses to have the same level of protection against the Omicron variant that vaccines had conferred for the earliest version of the virus.
Five- to 11-year-olds have been eligible for the two-dose primary series of the Pfizer-BioNTech vaccine since October, after researchers found it to be 90.7% effective at preventing symptomatic Covid-19.
The pace of vaccinations has been slow, with only about one in three children getting at least one dose, according to the American Academy of Pediatrics. Nearly 75% of people 12 years old and above are fully vaccinated, the CDC said.
About a third of parents of 5- to 11-year-olds surveyed in April by the Kaiser Family Foundation said they definitely wouldnât get their children vaccinated, and another 12% said they wouldnât unless their schools required it.
In Pfizer and BioNTechâs study evaluating the extra shot, 140 children between 5 and 11 years old got the third dose, and researchers analyzed blood samples from 30 of the young subjects.
The researchers found a 36-fold increase in neutralizing antibodies against Omicron one month after the third dose, compared with levels measured one month after the second dose, the companies said.
Data from study subjects not previously infected with Covid-19 showed a sixfold increase in neutralizing antibodies against the original strain one month after the extra shot compared with one month after the second dose, Pfizer said.
Researchers havenât determined to date how well the extra shot protects against Covid-19 because too few children have become sick. Researchers could still learn more as the trial continues, a Pfizer spokesman.
The studyâs findings havenât been published yet in a peer-reviewed medical journal.
Paxlovid has shown to be quite effective, reducing Covid-19-related hospitalization and death by 89% in a group of unvaccinated out-patient adults
https://www.nejm.org/doi/full/10.1056/NEJMoa2118542
However, a new wrinkle is emerging: often patients treated with Paxlovid are experiencing COVID rebound after finishing their course of the medicine. Some are completely symptom free, then develop symptoms again days later. Some have even tested negative, then tested positive days later. At this point the FDA is not recommending a longer course of treatment with Paxlovid.
https://www.fda.gov/drugs/news-events-human-drugs/fda-updates-paxlovid-health-care-providers
Hereâs a nice discussion about the future of covid vaccines in the US
Yeah I donât see the public getting behind a new, 2 dose series. That would only make the vaccine hesitant dig in even harder. The most effective vaccine is the one people would actually take, and I think thatâs the one shot Omicron specific booster.
I really donât understand the logic of insisting on a new series. We donât do that for flu, which mutates substantially enough that there are often all-new versions in the annual vaccine.
I often get frustrated with the FDAâs regulation (ask me about the drug my mom used to take) and this looks like another example. Like, why has it taken THIS LONG for them to even agree to consider Novavax. They said, âwe donât need another vaccineâ
The Novavax vaccine can be stored and transported at +2oC to +8oC for up to 9 months. Just that feature makes it worth approving, assuming itâs safe and effective (which several other countries think it is). How much easier is that for a pediatricianâs or PCPâs office than these things that need to be stored in ultra-cold conditions, and carefully thawed by the vial before use? Not to mention that itâs familiar technology that some of the vaccine-hesitant might be more comfortable with.
Iâm hoping that the FDA can eventually agree on a process to get new variant-based vaccines to market quickly, ideally before a new variant becomes dominant.
I worry that the ship has sailed on that front. If Noravax had been available alongside the others, I think thereâd have been more uptake, because the mRNA seemed scary. My guess is the unvaccinated have dug in, but maybe will yield if a scarier variant appears.
Yeah, that is probably true. It still wins on storage costs/convenience.
Just n=1, but my BIL is not vaccinated, but will take one that is older tech (not mRNA).
I had 2 different mRNA shots (Pfizer primary, Moderna boost). Lucky for me, the gene re-sequencing tech canceled each other out.
well, thatâs a shame.another failure we can attribute to western medicine (per a quote in the article)
Ivermectin is used on humans in the US to treat scabies. I suspect the veterinary version is exactly the same thing, and would work fine for scabies and other parasitic diseases so long as your took an appropriate dose. I used to give my cat drugs formulated for humans because they were cheaper. (I had to cut the pills into quarters. A person would have taken a few of those pills each day.)
I wish they focused more on people taking high doses for months, which is the actually problem, rather than âitâs a veterinary medication.â
The fact that âivermectin influencerâ is a thing⌠Iâd like off this timeline, please.
âNow his followers are worriedâŚâ
Yeah. Now. There was other, real, science out there.
To be fair stopping the antibiotics for his Lyme disease is probably what killed him, not the ivermectin per se
The Med Cram Youtube channel had an interesting video on near IR light helping greatly with long covid. You donât need a special light, as sunlight will do just fine - as little as 10 min/day. And you donât have to worry about sunburn and cancer, as UV protective clothes allow near IR though just fine. Sitting by a window wonât help, though, as fairly recent energy-efficient windows will block IR. He talks a little on why IR makes some biological sense and talks about a couple studies, but thereâs been no rigorous study yet. Good excuse to get outside, anyway.