11-05-2021, 12:57 PM
(11-05-2021, 12:09 PM)BIAD Wrote: Phew...! Finally a miracle pill to shoo the horrible plague away, we can now stop sacking the care-workers and stop
the childish threats of mandates. Everybody come out of your homes and celebrate... the media has finally killed its
golden goose!
Quote:Britain approves Merck's COVID-19 pill in world firstReuters:
*UK approval for molnupiravir comes ahead of U.S. decision
*UK and NHS to confirm deployment plans in due course
*UK secured just under half a million courses last month
*Drug will be given to higher risk patients
*Approval comes as UK struggles to tame infections
'Nov 4 (Reuters) - Britain on Thursday became the first country in the world to approve a potentially game-changing COVID-19
antiviral pill jointly developed by U.S.-based Merck & Co Inc (MRK.N) and Ridgeback Biotherapeutics, in a boost to the fight
against the pandemic.
The cure. (Eh Kenzo... maybe the '82'-number is the year the reset was aimed for!)
Britain's Medicines and Healthcare products Regulatory Agency (MHRA) recommended the drug, molnupiravir, for use in people
with mild to moderate COVID-19 and at least one risk factor for developing severe illness, such as obesity, older age diabetes,
and heart disease.
It will be administered as soon as possible following a positive COVID-19 test and within five days of the onset of symptoms, the
regulator said, citing clinical data. The green light is the first for an oral antiviral treatment for COVID-19 and the first for a COVID-19
drug that will be administered widely in the community.
U.S. advisers will meet on Nov. 30 to review the drug's safety and efficacy data and vote on whether molnupiravir should be authorized.
The pill, which will be branded as Lagevrio in Britain, is designed to introduce errors into the genetic code of the coronavirus that causes
COVID-19 and is taken twice a day for five days. Drugs in the same class as molnupiravir have been linked to birth defects in animal studies.
Merck, known as MSD outside of the United States and Canada, has said animal testing shows that molnupiravir is safe, but the data have
not yet been made public.
Treatments to tackle the pandemic, which has killed more than 5.2 million people worldwide, have so far focused mainly on vaccines.
Other options, including Gilead's (GILD.O) infused antiviral remdesivir and generic steroid dexamethasone, are generally only given
after a patient has been hospitalised.
Merck's Molnupiravir has been closely watched since data last month showed it could halve the chances of dying or being hospitalised for
those most at risk of developing severe COVID-19 when given early in the illness. Professor Stephen Powis, national medical director for
the National Health Service (NHS) in England, said the drug would be administered to patients at higher risk of complications as Britain
heads into one of the most challenging winters ever.
A wider rollout will follow if it is clinically and cost effective in reducing hospitalisations and death, he added.
"We are now working across government and the NHS to urgently get this treatment to patients initially through a national study so we
can collect more data on how antivirals work in a mostly vaccinated population," UK vaccines minister Maggie Throup told parliament.
PRESSURES
The speedy approval in Britain, which was also the first Western country to approve a COVID-19 vaccine, comes as it struggles to tame
soaring infections. Britain has about 40,000 daily cases of COVID-19, according to the latest seven-day average. That is second only to
the roughly 74,000 a day in the United States, which has five times more people, and has fuelled criticism of the government's decision
to abandon most pandemic-related restrictions
Data released on Wednesday night showed COVID-19 prevalence in England hit its highest level on record last month, led by a high
number of cases in children and a surge in the south-west of the country. Pressure is growing on the government to implement its
"Plan B" aimed at protecting the NHS from unsustainable demands, involving mask mandates, vaccine passes and work-from-home
orders.
Many other big economies, including Germany, France and Israel, have either retained some basic COVID-19 measures like mask
mandates or reintroduced them in response to rising cases. The UK government has said its focus remains on administering vaccine
boosters and inoculating 12- to 15-year-olds.
"With no compromises on quality, safety and effectiveness, the public can trust that the MHRA has conducted a robust and thorough
assessment of the data (on molnupiravir)," MHRA chief June Raine said in a statement. Last month, Britain agreed a deal with Merck
to secure 480,000 courses of molnupiravir.
Professor Penny Ward, an independent pharmaceutical physician, welcomed the approval, but said the NHS needed to outline its plans
for rollout and cautioned that supplies were likely to be tight given the strong global demand. "Comments made by Mr Javid today
suggest that it may be made available via a clinical trial, presumably to investigate its effectiveness in vaccinated patients with breakthrough infections, as the original study incorporated unvaccinated adults," she said.
If given to everyone becoming unwell, the nearly half a million courses would not last very long given the more than 40,000 current daily
case rate, she said.
TREATMENT RACE
In a separate statement, Merck said it expected to produce 10 million courses of the treatment by the end of this year, with at least 20
million set to be manufactured in 2022. The U.S.-based drugmaker's shares rose 2.1% to close at $90.54 on Thursday.
Pfizer (PFE.N) and Roche (ROG.S) are also racing to develop easy-to-administer antiviral pills for COVID-19.
Both Merck and Pfizer are studying their drugs in late-stage trials for preventing coronavirus infection.
Viral sequencing done so far has shown molnupiravir is effective against all variants of the coronavirus, Merck has said, including the
more-infectious Delta, which is responsible for the worldwide surge in hospitalisations and deaths recently. While it is not yet clear when
Merck will deliver doses to Britain, the company has said it is committed to providing timely access to its drug globally with plans for tiered
pricing aligned with a country's ability to pay.
Merck has licensed the drug to generic drugmakers for supply to low-income countries.
Antibody cocktails like those from Regeneron (REGN.O) and Eli Lilly (LLY.N) have also been approved for non-hospitalised COVID-19 patients,
but have to be given intravenously...'
Anything that help`s is good. But why they dont want people use the #1 cure Ivermectin since it`s the best and also safe.
I dont trust Merck , it was Merck Pharmaceuticals what made ivermectin originally, but i guess they could not make anymore much money from it, and TPTB did not want a drug that could make vaccines useless . So politics and money prevented ivermectin use against the CCP virus. So now they make new pill to make money, when there was allready the old pill ready .