Some of the earliest novel coronavirus (COVID-19) vaccines to be
approved are more likely to target prevention against developing severe
symptoms from catching the virus, rather than the initial infection,
multiple health experts told Bloomberg.
Imperial College London professor Robin Shattock, who is working on developing the university’s COVID-19 vaccine, told Bloomberg that the earliest vaccines are likely to come with limitations.
“It’s quite possible a vaccine that only protects against severe disease would be very useful,” he said.
“Vaccines need to protect against disease, not necessarily
infection,” Scripps Research immunologist and vaccine researcher Dennis
Burton added, as reported by Bloomberg.
The Food and Drugs Administration spokesperson Michael Felberbaum
also noted that the federal regulatory agency is willing to approve a
vaccine, even if it works just against deadly symptoms.
“We would potentially consider an indication related to prevention of
severe disease, provided available data support the benefits of
vaccination,” Felberbaum told Bloomberg. “For licensure we would not
require that a vaccine protects against infection.”
Governments across the globe are looking to restart economic
activities as lockdowns imposed to curb the spread of the virus become
infeasible to continue, without significantly hurting the domestic
economies and employment.
A vaccine that works just against developing the severe disease will
reduce the risk of death for some of the most vulnerable populations,
including the elderly and those with underlying diseases.
“I would have liked to have had protection against infection,” the
National Institute of Allergy and Infectious Diseases Director Anthony
Fauci told Stat earlier this month.
“But then again, it depends on what you’re looking for with the
vaccine. That vaccine doesn’t look like it’s a knockout for protecting
against infection, but it might be really very good at protecting
against disease,” Fauci said, referring to a vaccine candidate developed
by AstraZeneca plc AZN 2.1% in partnership with Oxford University.
Several other vaccine candidates, including those of Moderna Inc. MRNA 5%, Inovio Pharmaceuticals Ltd. INO 7.14%, and Pfizer Inc. PFE 1.4%, are seeing clinical trials. Johnson & Johnson JNJ 0.95% is expected to begin the clinical trial of its vaccine later this month.
https://www.benzinga.com/news/20/06/16250455/early-coronavirus-vaccines-likely-to-target-further-complications-not-infection-health-experts-say
Monday, June 15, 2020
NYC COVID-19 Contact Tracers Not Asking About George Floyd Protest Participation
Over the two last weeks, Mayor Bill de Blasio and others
have voiced concerns that packed police brutality protests across the
city could trigger a new wave of COVID-19 infections.
Whether or not that’s the case, however, remains unknown — and de Blasio’s team won’t be directly trying to find out.
The hundreds of contact tracing workers hired by the city
under de Blasio’s new “test and trace” campaign have been instructed
not to ask anyone who’s tested positive for COVID-19 whether they
recently attended a demonstration, City Hall confirmed to THE CITY.
“No person will be asked proactively if they attended a
protest,” Avery Cohen, a spokesperson for de Blasio, wrote in an emailed
response to questions by THE CITY.
Instead, test-and-trace workers ask COVID-positive
individuals general questions to help them “recall ‘contacts’ and
individuals they may have exposed,” Cohen said. Among the initial
questions: “Do you live with anyone in your home?”
Tracers then ask about “close contacts” — defined as being within six feet of another person for at least 10 minutes.
It’s up to tested individuals to volunteer whether any of
those close contacts occurred during protests. “If a person wants to
proactively offer that information, there is an opportunity for them to
do so,” Cohen wrote.
The mayor announced his “test and trace” program on May 8, promising that the city would hire 1,000 “contact tracers.”
City Hall has declined to spell out how many individuals have been
questioned so far, but de Blasio promised to release that information
Monday.
Since the effort began, officials say most — but not all —
people questioned by contact tracers have been cooperative. Some,
however, have refused to volunteer any information about their close
contacts.
“Naturally, we have not been able to obtain all
information from all positive cases, but engagement among those reached
is high,” Cohen wrote.
Mayor and Gov Want to Know
There’s no direct effort to resolve a question both de
Blasio and Gov. Andrew Cuomo have asked repeatedly since the
demonstrations against police brutality erupted following the death of
George Floyd at the hands of Minneapolis police: Are the protests
helping spread the virus?
“That’s the one variable in this equation that we’re not
sure of: We don’t know what the effect of those protests are,” Cuomo
said last week.
The three-day average percentage of New Yorkers whose
COVID-19 test turned out positive has dropped dramatically, from 69% on
March 31 to an all-time low of 2% as of June 8.
This has occurred, in part, because initially only people
diagnosed as very sick were tested. More recently, a much larger pool
of individuals has been tested — including those with no symptoms —
driving down the percentage of positives.
But there’s a growing concern the numbers could spike again, given Phase One of the city’s reopening and the protests.
So far, there have been no apparent signs of a dramatic
swing. De Blasio on Thursday announced the three-day average percentage
of positive tests had risen slightly from 2% to 3%.
Cuomo and de Blasio find themselves walking a tightrope,
warning protesters to be aware that COVID-19 remains a very real threat
to life and strongly advising all who attend demonstrations to get
tested. But they are also steering clear of dissuading anyone from
participating in demonstrations.
A Different Experience
A key source of tests for the virus now is the medical
chain CityMD with 100 clinics in the city, New Jersey and Long Island. A
New Yorker who called up CityMD last week to get an appointment for a
test after witnessing a daunting line at one of the clinics told THE
CITY that the CityMD staff asked the individual whether they’d attended a
protest.
CityMD officials did not respond to messages seeking comment.
In Nassau County, health officials take a slightly
different approach. While they do not ask individuals who test positive
whether they’ve attended protests, they do ask them where they’ve been
recently.
“We ask them questions about where they’ve been so that
we can gauge who may be at risk,” said Mary Ellen Laurain, a
spokesperson for the Nassau County Health Department. “It may come out
as part of the interview, but we ask more open-ended questions.”
Despite Cuomo’s concerns about the effect of the protests, the state Health Department has remained neutral on the issue.
Jonah Bruno, an agency spokesperson, stated, “We’re
working with New York City to balance the public health priority while
also protecting personal privacy, as we seek to ensure a thorough
contact tracing program that helps us contain the COVID-19 virus and
monitor any fluctuations in the infection rate as we continue reopening
New York.”
‘Treat People with Ease’
Dr. S. Patrick Kachur, a professor at Columbia University
Mailman School of Public Health and a former official at the Centers
for Disease Control and Prevention, said contact trackers face a
balancing act: trying to obtain useful information about an infected
person’s contacts without alienating them with overly intrusive
questions.
Asking someone if they’d been at a protest could wind up discouraging them from being candid in their answers, he noted.
“I think the logic has to do with the fact that contact
tracing requires a strong level of trust between the interviewer and the
person they’re talking to,” he said. “It’s really important to have a
good rapport and treat people with ease. It’s important to not ask
questions that will impede your ability to do the best job you can.”
For example, Kachur, who has been involved in contact
tracking during previous pandemics involving the flu and Zika, noted
that when investigators are trying to track the spread of HIV,
tuberculosis or most diseases, they make a point of not asking about a
person’s immigration status.
And while knowledge of how the protests might be sparking
a second wave would be helpful, it would be very difficult to track
close contacts at events attended by thousands of strangers, he said.
“There’s definitely a concern that state and city
officials have that the protests could be a place where transmission
occurs, but that risk is lower than household and other community
contacts,” Kachur said. “And it would be really challenging to trace
those contacts who you’ve been protesting with.”
Going forward, a key question will be whether Blasio’s
test-and-trace program can handle the workload as increased testing
yields more positive cases and more contacts to trace.
“How well are they able to keep up with the complete
investigations that they are able to trace?” Kachur asked. “If they have
more cases than they can deal with, that would be concerning. It would
be a confusing month or two here.”
https://www.thecity.nyc/coronavirus/2020/6/14/21290963/nyc-covid-19-trackers-skipping-floyd-protest-questions-even-amid-fears-of-new-wave
FDA OKs emergency use of third PerkinElmer COVID-19 test
The FDA has signed off on the emergency use of PerkinElmer’s (PKI -1.0%) EURORealTime SARS-CoV-2 molecular test for use during the COVID-19 pandemic. The nod is the third for the company.
https://seekingalpha.com/news/3583069-fda-oks-emergency-use-of-third-perkinelmer-covidminus-19-test
https://seekingalpha.com/news/3583069-fda-oks-emergency-use-of-third-perkinelmer-covidminus-19-test
RECOVERY Hydroxychloroquine Trials: ‘The Marx Brothers do science’
LAST Friday, hard on the heels of the retraction by The Lancet of its now-notorious paper purporting
to show that hydroxychloroquine not only did not help Covid-19
patients, but actually made them worse, came the termination of the
hydroxychloroquine ‘arm’ of the UK’s RECOVERY (Randomised Evaluation of COVid-19 thERapY) clinical
trials. A huge embarrassment was conveniently overlain by news from
Oxford University that sorry, hydroxychloroquine really isn’t any good.
So even if The Lancet paper was fake, ‘a political hit job’ as one American doctor had it, Oxford’s clinical trial showed the same result.
Professor Martin Landray, MB ChB, PhD, FRCP, FHEA, FASN, FBPhS, FESC, Professor of Medicine and Epidemiology at Oxford, and deputy chief investigator of the RECOVERY trial, was interviewed by the increasingly astute France Soir. It began well: the trial termination was triggered by a request from the Medicines and Healthcare products Regulatory Agency who were bothered about safety (reasons not explained). In consequence the study was ‘unblinded’, that is, results were revealed. Finding no significant difference between treated and untreated patients, they called off the trial, with Oxford triumphantly announcing that hydroxychloroquine was no good for Covid-19, at least for hospitalised patients.
Since those following the issue already knew that no anti-viral was likely to help very sick late-stage Covid-19 patients, this wasn’t news. The trial design had already been savaged within days of launch; the results were no surprise. Internet sleuths also got to work on the very heavy doses of the drug that were given – 2400 mg in the first 24 hours, a ‘dose fit for a gorilla’ as one critic had it. Quizzed about this, Landray defended the dosage, twice, as being usual for other diseases such as amoebic dysentery. Say again? Hydroxychloroquine is used for lupus and arthritis as well as malaria, but dysentery? As a footnote in medical history, the older chloroquine was used half a century ago in attempts to control dysentery, but Professor Christian Perronne, head of infectious diseases at Garches, France, told France Soir that it had been abandoned before 1976. Was Landray confusing hydroxychloroquine with the hydroxyquinolines, which are used for dysentery? Perhaps all those post-nominals had induced some medical dyslexia.
Landray explained there was no approved dosing for Covid because it was a new disease. Well, yes, but the toxic dose won’t change depending on the illness. Asked whether the UK had a maximum dose for hydroxychloroquine, Landray wasn’t sure, but opined it would be much larger, say six to ten times the trial’s dose. That makes 24 whole grams. NICE says about 490 mg per day for a 75kg adult. In France 1800 mg in a day mandates hospitalisation as a poisoning. Twenty-four grams at one go would be almost certainly lethal, possibly even to a gorilla. So Landray has had notice of some hard questions on dose, which will no doubt be explained in the full report, not yet released.
Others were shocked by the overall mortality: about a quarter of patients had died after 28 days. These is very poor compared with hospitals and regions elsewhere. In New York and the Bouches-du-Rhône department of France, hospital mortality is around 13 per cent. At the University Hospital in Marseille it is 15.6 per cent for the sickest patients, those not just hospitalised, but in intensive care. Either the RECOVERY patients were very ill indeed, or something is badly wrong with the ‘standard of care’ in the 175 NHS hospitals involved.
RECOVERY was scattered over multiple hospitals, a network, and Prof Landray admitted that he did not treat any of the patients himself. Professor Didier Raoult, director of the University Hospital in Marseille, which has diagnosed more than 6,000 cases, described the mortality as ‘effroyable’ – appalling. Raoult published his hydroxychloroquine/azithromycin dual therapy in early March and has since used it in well over 3,000 patients with 18 deaths – about 0.5 per cent. He has, though, always been clear that ‘quand il est trop tard, il est trop tard’. Like other successful clinicians, he insists that early treatment is key. This is because, as Dr Harvey Risch of Yale explains: ‘Early outpatient illness is very different from later hospitalised florid disease, and the treatments differ.’ It is clear from world experience that the early infectious stage (‘just a mild illness’) is very different from the ‘inflammatory’ stage when patients start drowning in their own fluids. You can find a chart of the clinical course here.
What is killing patients is their own body’s immune response in overdrive. Treating this with anti-viral medications misses the target; the infection is no longer their really big problem.
In an interview on Tuesday, Raoult scathingly called RECOVERY ‘the Marx Brothers doing science’. He runs through the defects: lack of positive diagnosis, failure to discriminate different stages of the disease, the huge dosage, lack of virological follow-up, and the shocking mortality – which is when his simile ceases to be funny. The one upside is that no cardiac deaths occurred even with the thumping initial dose, showing that talk of the drug’s cardiac risk is massively overblown. But we did not need to experiment on more than 4,000 very ill people to find that. So more hard questions for RECOVERY’s report; we shall see.
Landray wrapped up his interview with France Soir: ‘We have demonstrated that this drug is no good for this disease whatever one wants to believe.’ Thousands of Professor Raoult’s patients, successfully treated with his hydroxychloroquine combination therapy, probably will go on wanting to believe something different. The cognitive dissonance needs resolving. A clue may lie in one of Landray’s papers published in February and entitled The Magic of Randomisation versus the Myth of Real-World Evidence which I first thought was irony. Only in today’s dreaming spires would it be possible for someone to call ‘real-world evidence’ a ‘myth’, revoking centuries of Oxford’s fabled reliance on primary sources. Rattling dice now determines the answer.
Professor Peter Horby, the chief investigator of the trial, doubled up: ‘The RECOVERY trial has shown that hydroxychloroquine is not an effective treatment in patients hospitalised with COVID-19. Although it is disappointing that this treatment has been shown to be ineffective, it does allow us to focus care and research on more promising drugs.’
His first statement is broadly true, and may well follow from the evidence (though we havn’t seen it all yet). Hydroxychloroquine, not in combination with adjuncts potentially important to its anti-viral effect, isn’t likely to work in very ill hospitalised patients with late stage disease. But plenty of doctors using the drug successfully knew that already. Their goal was keeping patients out of hospital.
Horby’s second statement isn’t so qualified and open to easy misrepresentation, so let’s be accurate now: RECOVERY has shown nothing whatever about the effectiveness of hydroxychloroquine-based combinations in the clinically very different early-stage infections, before the ‘inflammatory’ stage has set in. Horby does however declare his future recommendations, ‘to focus . . . on more promising drugs’. Good to have that made clear, but is this ‘following the science’, or what some major sponsors wish to hear?
It is well that the hydroxychloroquine ‘arm’ of RECOVERY has been cancelled. It was always looking in the wrong place. Will Oxford’s PRINCIPLE trials, based in GP surgeries, looking to treat early-stage disease, start to take note of successful empirical experience around the world, and arrange a trial of the Marseille combination, or the related protocol with zinc supplementation pioneered by Dr Zelenko in New York? Or will Oxford’s latter-day denial of ‘real-world evidence’ continue to blind them to what successful clinicians elsewhere – and sometimes whole countries – are reporting?
With a destructive lockdown ongoing, and the worst deaths per million in the world after Belgium, the UK needs far better than clinical trials run by the Marx Brothers. Wake up, Oxford, and rediscover your empirical inheritance. With a trail of deadly failure behind us, taking an objective look at what others have already done is a pretty small ask.
Dr Edmund Fordham is a physicist, and not a physician. He is an experienced patient: a 23-year survivor of Stage 4 lymphoma, cured by a clinical trial in stem-cell transplantation. He was an Independent parliamentary candidate in the General Election.
Professor Martin Landray, MB ChB, PhD, FRCP, FHEA, FASN, FBPhS, FESC, Professor of Medicine and Epidemiology at Oxford, and deputy chief investigator of the RECOVERY trial, was interviewed by the increasingly astute France Soir. It began well: the trial termination was triggered by a request from the Medicines and Healthcare products Regulatory Agency who were bothered about safety (reasons not explained). In consequence the study was ‘unblinded’, that is, results were revealed. Finding no significant difference between treated and untreated patients, they called off the trial, with Oxford triumphantly announcing that hydroxychloroquine was no good for Covid-19, at least for hospitalised patients.
Since those following the issue already knew that no anti-viral was likely to help very sick late-stage Covid-19 patients, this wasn’t news. The trial design had already been savaged within days of launch; the results were no surprise. Internet sleuths also got to work on the very heavy doses of the drug that were given – 2400 mg in the first 24 hours, a ‘dose fit for a gorilla’ as one critic had it. Quizzed about this, Landray defended the dosage, twice, as being usual for other diseases such as amoebic dysentery. Say again? Hydroxychloroquine is used for lupus and arthritis as well as malaria, but dysentery? As a footnote in medical history, the older chloroquine was used half a century ago in attempts to control dysentery, but Professor Christian Perronne, head of infectious diseases at Garches, France, told France Soir that it had been abandoned before 1976. Was Landray confusing hydroxychloroquine with the hydroxyquinolines, which are used for dysentery? Perhaps all those post-nominals had induced some medical dyslexia.
Landray explained there was no approved dosing for Covid because it was a new disease. Well, yes, but the toxic dose won’t change depending on the illness. Asked whether the UK had a maximum dose for hydroxychloroquine, Landray wasn’t sure, but opined it would be much larger, say six to ten times the trial’s dose. That makes 24 whole grams. NICE says about 490 mg per day for a 75kg adult. In France 1800 mg in a day mandates hospitalisation as a poisoning. Twenty-four grams at one go would be almost certainly lethal, possibly even to a gorilla. So Landray has had notice of some hard questions on dose, which will no doubt be explained in the full report, not yet released.
Others were shocked by the overall mortality: about a quarter of patients had died after 28 days. These is very poor compared with hospitals and regions elsewhere. In New York and the Bouches-du-Rhône department of France, hospital mortality is around 13 per cent. At the University Hospital in Marseille it is 15.6 per cent for the sickest patients, those not just hospitalised, but in intensive care. Either the RECOVERY patients were very ill indeed, or something is badly wrong with the ‘standard of care’ in the 175 NHS hospitals involved.
RECOVERY was scattered over multiple hospitals, a network, and Prof Landray admitted that he did not treat any of the patients himself. Professor Didier Raoult, director of the University Hospital in Marseille, which has diagnosed more than 6,000 cases, described the mortality as ‘effroyable’ – appalling. Raoult published his hydroxychloroquine/azithromycin dual therapy in early March and has since used it in well over 3,000 patients with 18 deaths – about 0.5 per cent. He has, though, always been clear that ‘quand il est trop tard, il est trop tard’. Like other successful clinicians, he insists that early treatment is key. This is because, as Dr Harvey Risch of Yale explains: ‘Early outpatient illness is very different from later hospitalised florid disease, and the treatments differ.’ It is clear from world experience that the early infectious stage (‘just a mild illness’) is very different from the ‘inflammatory’ stage when patients start drowning in their own fluids. You can find a chart of the clinical course here.
What is killing patients is their own body’s immune response in overdrive. Treating this with anti-viral medications misses the target; the infection is no longer their really big problem.
In an interview on Tuesday, Raoult scathingly called RECOVERY ‘the Marx Brothers doing science’. He runs through the defects: lack of positive diagnosis, failure to discriminate different stages of the disease, the huge dosage, lack of virological follow-up, and the shocking mortality – which is when his simile ceases to be funny. The one upside is that no cardiac deaths occurred even with the thumping initial dose, showing that talk of the drug’s cardiac risk is massively overblown. But we did not need to experiment on more than 4,000 very ill people to find that. So more hard questions for RECOVERY’s report; we shall see.
Landray wrapped up his interview with France Soir: ‘We have demonstrated that this drug is no good for this disease whatever one wants to believe.’ Thousands of Professor Raoult’s patients, successfully treated with his hydroxychloroquine combination therapy, probably will go on wanting to believe something different. The cognitive dissonance needs resolving. A clue may lie in one of Landray’s papers published in February and entitled The Magic of Randomisation versus the Myth of Real-World Evidence which I first thought was irony. Only in today’s dreaming spires would it be possible for someone to call ‘real-world evidence’ a ‘myth’, revoking centuries of Oxford’s fabled reliance on primary sources. Rattling dice now determines the answer.
Professor Peter Horby, the chief investigator of the trial, doubled up: ‘The RECOVERY trial has shown that hydroxychloroquine is not an effective treatment in patients hospitalised with COVID-19. Although it is disappointing that this treatment has been shown to be ineffective, it does allow us to focus care and research on more promising drugs.’
His first statement is broadly true, and may well follow from the evidence (though we havn’t seen it all yet). Hydroxychloroquine, not in combination with adjuncts potentially important to its anti-viral effect, isn’t likely to work in very ill hospitalised patients with late stage disease. But plenty of doctors using the drug successfully knew that already. Their goal was keeping patients out of hospital.
Horby’s second statement isn’t so qualified and open to easy misrepresentation, so let’s be accurate now: RECOVERY has shown nothing whatever about the effectiveness of hydroxychloroquine-based combinations in the clinically very different early-stage infections, before the ‘inflammatory’ stage has set in. Horby does however declare his future recommendations, ‘to focus . . . on more promising drugs’. Good to have that made clear, but is this ‘following the science’, or what some major sponsors wish to hear?
It is well that the hydroxychloroquine ‘arm’ of RECOVERY has been cancelled. It was always looking in the wrong place. Will Oxford’s PRINCIPLE trials, based in GP surgeries, looking to treat early-stage disease, start to take note of successful empirical experience around the world, and arrange a trial of the Marseille combination, or the related protocol with zinc supplementation pioneered by Dr Zelenko in New York? Or will Oxford’s latter-day denial of ‘real-world evidence’ continue to blind them to what successful clinicians elsewhere – and sometimes whole countries – are reporting?
With a destructive lockdown ongoing, and the worst deaths per million in the world after Belgium, the UK needs far better than clinical trials run by the Marx Brothers. Wake up, Oxford, and rediscover your empirical inheritance. With a trail of deadly failure behind us, taking an objective look at what others have already done is a pretty small ask.
Dr Edmund Fordham is a physicist, and not a physician. He is an experienced patient: a 23-year survivor of Stage 4 lymphoma, cured by a clinical trial in stem-cell transplantation. He was an Independent parliamentary candidate in the General Election.
The Marx Brothers do science
FDA revokes emergency use ruling for hydroxychloroquine
The Food and Drug Administration on Monday said it had withdrawn an
emergency approval for use of the malaria drug hydroxychloroquine as a
Covid-19 treatment.
Almost since the beginning of the novel coronavirus pandemic, President Trump and other world leaders have touted hydroxychloroquine as an effective treatment based on scattered anecdotes, not reliable scientific studies. But the FDA said Monday that the drug, along with chloroquine, is “unlikely to be effective in treating Covid-19,” and highlighted “serious side effects.”
The FDA’s withdrawal of the emergency use order, which Politico first reported, appears to formally close the door on U.S. officials’ willingness to use the drug to prevent or treat Covid-19, the disease caused by the novel coronavirus.
In recent weeks, an increasingly conclusive body of research showed
the drug was not effective at treating Covid-19 or at preventing the
respiratory disease from developing in individuals who’d been exposed to
the virus.
The controversy has pitted Trump and his high-profile allies against the country’s scientific establishment. Rick Bright, a prominent government scientist, has alleged he was ousted from his vaccine-development role after he opposed the initial emergency approval for hydroxychloroquine. At a March press conference, Trump said his belief in the drug was “just a feeling,” contradicting Tony Fauci, the country’s top infectious disease researcher, who told reporters minutes before there was no reliable evidence supporting hydroxychloroquine’s use.
Despite the lack of evidence supporting the drug’s use, Trump
continued to tout it as a promising tool to treat and prevent Covid-19,
even announcing last month that he had taken a regimen of
hydroxychloroquine as a safeguard.
Asked for comment, an FDA spokesman directed STAT to an online list of current emergency use authorizations for Covid-19 medical products. The list no longer includes hydroxychloroquine.
In a letter to Gary Disbrow, the acting director of the Biomedical Advanced Research and Development Authority, a top FDA official said the withdrawal of the hydroxychloroquine approval was based on recent science that showed the drug to be ineffective.
“Today’s request to revoke is based on new information, including clinical trial data results, that have led BARDA to conclude that this drug may not be effective to treat [Covid-19] and that the drug’s potential benefits for such use do not outweigh its known and potential risks,” wrote Denise Hinton, the FDA’s chief scientist.”
Almost since the beginning of the novel coronavirus pandemic, President Trump and other world leaders have touted hydroxychloroquine as an effective treatment based on scattered anecdotes, not reliable scientific studies. But the FDA said Monday that the drug, along with chloroquine, is “unlikely to be effective in treating Covid-19,” and highlighted “serious side effects.”
The FDA’s withdrawal of the emergency use order, which Politico first reported, appears to formally close the door on U.S. officials’ willingness to use the drug to prevent or treat Covid-19, the disease caused by the novel coronavirus.
The controversy has pitted Trump and his high-profile allies against the country’s scientific establishment. Rick Bright, a prominent government scientist, has alleged he was ousted from his vaccine-development role after he opposed the initial emergency approval for hydroxychloroquine. At a March press conference, Trump said his belief in the drug was “just a feeling,” contradicting Tony Fauci, the country’s top infectious disease researcher, who told reporters minutes before there was no reliable evidence supporting hydroxychloroquine’s use.
Asked for comment, an FDA spokesman directed STAT to an online list of current emergency use authorizations for Covid-19 medical products. The list no longer includes hydroxychloroquine.
In a letter to Gary Disbrow, the acting director of the Biomedical Advanced Research and Development Authority, a top FDA official said the withdrawal of the hydroxychloroquine approval was based on recent science that showed the drug to be ineffective.
“Today’s request to revoke is based on new information, including clinical trial data results, that have led BARDA to conclude that this drug may not be effective to treat [Covid-19] and that the drug’s potential benefits for such use do not outweigh its known and potential risks,” wrote Denise Hinton, the FDA’s chief scientist.”
FDA revokes emergency use ruling for hydroxychloroquine, the drug touted by Trump as a Covid-19 therapy
Novavax raises $200 million to advance vaccine candidates
Novavax (NVAX +8.7%) raises ~$200 million from the direct sale of ~4.4M shares of Series A convertible preferred stock to RA Capital (~$45.57/share).
The capital will help fund the advancement of its COVID-19 vaccine candidate and flu vaccine NanoFlu.
Closing date was June 12.
https://seekingalpha.com/news/3583051-novavax-raises-200-million-to-advance-vaccine-candidatesBayer Starts Phase III Study for Finerenone in Heart Failure Patients
Bayer AG said Monday that it is starting a phase III study for
Finerenone for the treatment of patients who suffer from heart failure.
The FINEARTS-HF study’s main goal is to show Finerenone’s superiority over a placebo regarding cardiovascular death and hospitalization or emergency treatment for heart failure, the German pharmaceutical company said.
The study involves 5,500 patients with a left ventricular ejection fraction of at least 40%from 34 countries.
Finerenone is also being studied in two long-term trials in patients with chronic kidney disease and type 2 diabetes.
https://www.marketscreener.com/BAYER-AG-436063/news/Bayer-Starts-Phase-III-Study-for-Finerenone-in-Heart-Failure-Patients-30772556/
The FINEARTS-HF study’s main goal is to show Finerenone’s superiority over a placebo regarding cardiovascular death and hospitalization or emergency treatment for heart failure, the German pharmaceutical company said.
The study involves 5,500 patients with a left ventricular ejection fraction of at least 40%from 34 countries.
Finerenone is also being studied in two long-term trials in patients with chronic kidney disease and type 2 diabetes.
https://www.marketscreener.com/BAYER-AG-436063/news/Bayer-Starts-Phase-III-Study-for-Finerenone-in-Heart-Failure-Patients-30772556/
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