Monday, November 23, 2020
US authorities grant emergency approval to Regeneron treatment given to Trump
New York: The Food and Drug Administration has granted emergency authorisation for the experimental antibody treatment given to President Donald Trump shortly after he was diagnosed with COVID-19, giving doctors another option to treat COVID-19 patients as cases across the country continue to rise.
The treatment, made by the biotech company Regeneron, is a cocktail of two powerful antibodies, casirivimab and imdevimab, that have shown promise in early studies at keeping the infection in check, reducing medical visits in patients who get the drug early in the course of their disease. A similar treatment, made by Eli Lilly, was given emergency approval earlier this month.
The emergency authorisation for Regeneron's drug is limited in scope: It is for people who have tested positive for the coronavirus and who are at high risk for developing severe COVID-19. Evidence so far suggests that antibody treatments work best early in the course of the disease, before the virus has gained a foothold in the body. Like Eli Lilly's treatment, Regeneron's is not authorised for use in people who are hospitalised or who need oxygen.
The emergency authorisation raises immediate questions about who will get access to the treatments as an average of more than 168,000 people are diagnosed each day with COVID-19 in the United States and hospitals are running out of beds in some regions of the country. Regeneron has said it will have enough of the drug for only about 80,000 people by the end of November, enough for 200,000 patients by the first week of January, and 300,000 by the end of January. After that, the company said, it will be able to ramp up production thanks to a partnership with Swiss manufacturer Roche.
Regeneron has received more than $US500 million ($685 million) from the federal government to develop and manufacture the treatments. Although the first 300,000 doses will be provided free, patients may be charged for having the treatment administered; it must be infused in a clinic or hospital. For some Medicare beneficiaries, that cost would be $US60, depending on the patient's coverage plan.
Antibody treatments have gotten less attention than vaccines, but health officials have long held out hope that they may serve as a possible bridge until a coronavirus vaccine is more broadly available. Two vaccines, one made by Pfizer and another by Moderna, were recently shown to be more than 90% effective in early analyses. Pfizer, which has completed its trial, submitted an application Friday for emergency authorisation of the vaccine, and Moderna said it planned to apply soon. Still, it will be weeks before a vaccine is available, and even then, access will be limited to people in high-risk groups.
Dr George Yancopoulos, Regeneron's president and chief scientific officer, said in a statement that he was encouraged by the recent vaccine results but that "there remains a need to treat patients who develop COVID-19, especially as some may not have had access to or were not protected by vaccination."
Regeneron enjoyed a burst of publicity in October, when Trump received an infusion of its cocktail and then enthusiastically promoted the drug as lending him a superpower-like feeling. In a video released October 7, the president claimed without evidence that it had cured him and that he had authorised it — something he does not have the power to do.
It remains impossible to know whether the Regeneron treatment helped Trump. He was given multiple drugs while at Walter Reed National Military Medical Centre, and many people recover from the virus on their own.
Since the spring, White House and health officials have been closely watching the development of the antibody treatments. In addition to Regeneron's deal with the federal government, Eli Lilly announced a $US375,000 deal in October to supply the government with 300,000 doses.
A similar antibody treatment that Regeneron developed to fight Ebola was approved by the FDA in October, bolstering confidence that its COVID-19 version would prevail in the ongoing trials of outpatients.
The president and two of his top advisers — Mark Meadows, the White House chief of staff, and Jared Kushner, Trump's son-in-law — have called Dr Stephen Hahn, the FDA commissioner, to press for speed in agency reviews. And Dr. Leonard Schleifer, the billionaire co-founder and chief executive of Regeneron, who has known Trump casually for years, has told associates that Trump calls him to ask about the status of the treatment.
Early data released by Regeneron suggest that its cocktail works best in people who do not appear to be mounting an early immune response to the virus, or who have high levels of the virus, and who are therefore at greater risk of faring poorly.
But early evidence also shows that the antibody treatments do not work well once people are sick enough to be hospitalised. Eli Lilly stopped giving its treatment to hospitalised patients in a government-run trial because, it said, it did not seem to be helping those patients. And Regeneron paused enrolling the sickest hospitalised patients in one of its trials.
This causes a challenge for distributing the drugs, since they are only authorised for people who are not hospitalised yet must be infused intravenously in a clinic or hospital.
Regeneron has suggested that the people who benefit the most from the treatment are those who have not yet mounted an antibody response and who also have high viral loads — but learning who those people are would require separate tests that are not routinely given to patients who test positive for the virus. Company executives have acknowledged that at first, such tests may not be available, and the emergency authorisation notes that people at high risk include those who are over 65 or have underlying conditions such as obesity or diabetes.
Getting the treatment to the right people will require quick turnarounds in testing, as well as coordination among federal, state and hospital officials — many of the same challenges that have complicated the U.S. response to the pandemic.
The distributor AmerisourceBergen will deliver Regeneron's treatment on a weekly schedule based on the number of COVID-19 cases in each state. The federal government plans to work with state health officials to determine which hospitals and clinics should receive it.
In a call with reporters this month to outline how the Eli Lilly treatment would be distributed, Janet Woodcock, a top federal drug official, said the administration was working with hospitals and infusion companies, and acknowledged the logistical complexity of a drug that takes an hour to administer, followed by an hour of observation. The hospitals and clinics will also have to figure out how to safely treat infectious patients without exposing other people to the virus.
"We're all going to need to get the word out that people at high risk have a therapeutic option now as outpatients, because until this point people have been told to stay home unless they get very sick," she said.
The emergency use authorisation, or EUA, was previously an obscure corner of regulatory law that mostly escaped broad public attention. But during the pandemic, it has become a centrepiece of the administration's health policy: Since February, the agency has granted hundreds of emergency authorisations related to COVID-19, many for diagnostic tests and others for personal protective equipment, blood-purification devices, ventilators and therapies.
In signing off on the emergency authorisations, FDA scientists in the agency's Office of Infectious Diseases had to weigh the need for clear evidence that the treatments worked with the increasing desperation for useful drugs as the pandemic accelerated again in the United States. Unlike a full FDA approval, which requires a rigorous vetting of clinical trial data showing a drug is safe and effective, an emergency authorisation simply requires the potential benefits of a drug to outweigh its risks.
The emergency authorisation for Regeneron may still have the unintended effect of complicating the role of clinical trials in proving the treatment's effectiveness for different age groups. If the drug becomes available more broadly, fewer people may want to sign up for clinical trials and risk the possibility that they may receive a placebo
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Masks 'DON'T stop you getting Covid': Top experts criticise 'troubling lack of evidence' to justify wearing them after major Danish study concluded they don't protect the wearer
Top scientists have warned there is a 'troubling lack of evidence' that face masks prevent Covid-19 infection, after a major study in Denmark found they don't protect people who wear them.
Governments around the world — including the UK — have made it mandatory to wear a face covering in indoor public spaces, despite a dearth of rigorous trials into their effectiveness.
The rationale has been that masks must be better than nothing because they block at least some virus being exhaled or inhaled by the wearer.
But a randomised study published by scientists at Copenhagen University, thought to be the best of its kind so far, found no statistical evidence that they offer any protection whatsoever.
Reacting to the finding in a column in The Spectator today, Oxford University's Professor Carl Heneghan and Dr Tom Jefferson said there had been 'a troubling lack of robust evidence on face masks and Covid-19'.
There have only been three 'real life' studies comparing mask-wearers to non-mask-wearers — one in Guinea-Bissau, one in India and the new Denmark study. All have shown masks to have no benefit in preventing the disease.
But the experts added: 'Now we have properly rigorous scientific research we can rely on, the evidence shows wearing masks in the community does not significantly reduce the rates of infection.'
The Copenhagen experts recruited 6,000 volunteers in the spring — before masks were mandatory there — and split the them into two groups, with half wearing masks in public and half not.
After a month, the mask-wearing volunteers were tested for current and previous Covid-19 infection and compared with the control group who didn't wear them.
Results showed that, after one month, 1.8 per cent of the people wearing masks had been infected with the virus.
By comparison, 2.1 per cent of the people in the unmasked group had tested positive for Covid-19. The difference between the two groups was not found to be statistically significant.
'The study does not confirm the expected halving of the risk of infection for people wearing face masks,' the authors wrote in a press release.
'The results could indicate a more moderate degree of protection of 15 to 20 [percent], however, the study could not rule out that face masks do not provide any protection.'
The team, from Copenhagen University Hospital, said the findings should not be used to argue against their widespread use, however, because masks may prevent people infecting others.
The results from the Danish study - called Danmask-19 - mirror the findings of studies into influenza.
Nine other trials looking at the efficacy of masks on influenza have found that masks make little or no difference in whether people catch the virus.
Professor Heneghan and Dr Jefferson added: 'The low number of studies into the effect different interventions have on the spread of Covid-19 – a subject of global importance – suggests there is a total lack of interest from governments in pursuing evidence-based medicine.'
They said the only trials which have shown masks to be effective in stopping airborne diseases have been 'observation studies' which are considered a much less accurate form of research.
In these studies, scientists compare people who normally wear masks with people who say they don't, rather than attempting to create a randomised control group.
The experts said these types of studies are flawed because 'in the heat of a pandemic, not very many people will recall if and when they used masks and at what distance they kept from others'.
Previous studies have concluded similar findings, saying masks provide only limited protection for the person wearing it, but can dramatically reduce the risk to others if the wearer is infected, even when showing no symptoms.
But some experts disagree and say they are weaknesses to the study such as the authors not independently verifying mask use or that users wore them correctly.
'There is absolutely no doubt that masks work as source control,' Dr Thomas Frieden, former director of the CDC, who wrote in an editorial.
'The question this study was designed to answer is: Do they work as personal protection? An N95 mask is better than a surgical mask. A surgical mask is better than most cloth masks. A cloth mask is better than nothing.'
Last week, the CDC updated its guidelines saying masks protect wearers from contracting COVID-19, not just those around them.
Health officials said cloth masks block droplets from being exhaled by the wearer and also provide 'filtration for personal protection' by preventing droplets from reaching others.
The team from the new study says the findings 'should not be used to conclude that a recommendation for everyone to wear masks in the community would not be effective in reducing SARS-CoV-2 infections, because the trial did not test the role of masks in source control of SARS-CoV-2 infection.'
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