Merck and Ridgeback Biotherapeutics announced on Friday early result that indicate their experimental oral antiviral drug molnupiravir might halve the risk of death or hospitalization from COVID-19.
In a news release, the company said 7.3% of 385 patients who received the antiviral were either hospitalized or died from Covid-19, compared with 14.1% of the 377 patients who received a placebo, which does nothing.
Full data from the molnupiravir trial has not yet been released, and this data has not yet been peer-reviewed or published. But Merck says it will seek authorization from the U.S. Food and Drug Administration, and if it’s granted, the drug could be the first antiviral treatment available orally to fight COVID-19.
“This is the most impactful result that I remember seeing of an orally available drug in the treatment of a respiratory pathogen, perhaps ever,” Dr. Scott Gottlieb, former commissioner of the U.S. Food and Drug Administration, told CNN’s Anderson Cooper on Friday. “I think getting an oral pill that can inhibit viral replication — that can inhibit this virus — is going to be a real game changer.”
Antiviral treatments are a type of antimicrobial — treatments which kill or otherwise inhibit the development of microorganisms such as bacteria (fought by antibiotics), fungi (fought by antifungals), or, in this case, a virus.
Some of the more familiar antivirals are those developed to treat herpes, HIV and the flu.
“Most people have heard of Tamiflu, and they’ve heard of acyclovir,” said Dr. Myron Cohen, a professor of medicine, microbiology, immunology and epidemiology at the University of North Carolina. Acyclovir is a type of antiviral used to treat chickenpox, herpes and shingles.
“We didn’t develop a ton of other antivirals,” he said.
What makes molnupiravir different
Another antiviral, remdesivir, is currently the only drug approved by the FDA for the treatment of COVID-19. Remdesivir, which is made by Gilead Sciences and sold under the name Veklury, is administered by intravenous infusion, so it’s not as simple as swallowing a pill.
And remdesivir doesn’t work for all COVID-19 patients. Studies have shown mixed results; it doesn’t seem to reduce the risk of death, but it does seem to help people feel better faster, when it’s given early in an illness.
The National Institutes of Health’s COVID-19 treatment guidelines recommend remdesivir for hospitalized COVID-19 patients who need supplemental oxygen, but the World Health Organization recommends against using it outside of clinical trials.
Molnupiravir would be simpler for patients — no IV required — and it works differently, by changing the SARS-CoV-2 virus to inhibit replication.
“It actually gets incorporated into the genetic material of the of the virus and introduces errors,” Dr. Daria Hazuda, chief science officer with MSD, Merck’s label operating outside of the U.S. and Canada, said in a briefing with the Science Media Center in the U.K. on Friday.
“So, over a number of incorporations, the errors make the virus less able to replicate.”
Dr. Mark Denison, a virologist at the Vanderbilt Institute for Infection, Immunology, and Inflammation, said the way molnupiravir works, called mutagenesis, is what separates it from remdesivir.
“The two basic mechanisms are either chain termination, which I call the delayed stop sign, or mutagenesis, which is like blowing potholes in the road as the car is driving along. It’s just damaging the genome,” he told CNN.
WHAT AN ANTIVIRAL PILL COULD MEAN FOR COVID-19
Cohen, who has previously worked on molnupiravir, said when looking at results for an antiviral drug like molnupiravir, he wants to see three things.
“Stop progression of disease, so you take them and you forget about it, right?” he said. “The second thing we’d like the pill to do, if you’re taking it for symptomatic disease, is stop long COVID, right? It’s not just ‘Don’t let me get progressed and die — don’t let me have lingering cough, lingering headache.’ “
Cohen said his third goal would be for “treatment to serve as prevention,” so someone with COVID-19 is less likely to transmit it to others.
“We’d like it to wipe out the SARS-CoV-2 replication in the nose so fast that your nose is no longer a danger to me,” he said.
Former Baltimore City Health Commissioner and CNN Medical Analyst Dr. Leana Wen told CNN on Friday that having an antiviral drug which could prevent a COVID-19 infection from becoming severe is “crucial.”
“We already have monoclonal antibodies that do this and actually are pretty effective. The problem is they require an infusion or injections. That’s really burdensome for the individual, that’s burdensome on the health care system,” she said, referring to Covid-19 treatments made by Regeneron, Eli Lilly and GlaxoSmithKline and Vir.
“It would be a total game changer if somebody, when they’re diagnosed with mild Covid, early on in their treatment are able to take a pill at home. That relieves the burden on the health care system. That also really helps the individual.”
Still, an antiviral can’t replace a vaccine.
White House COVID-19 Response Coordinator Jeff Zients said during a briefing on Friday that the best way to think of such a drug is as an additional tool, to be used alongside vaccines.
“This is a potential additional tool in our toolbox to protect people from the worst outcomes of COVID,” Zients said. “I think it’s really important to remember that vaccination, as we’ve talked about today, remains far and away our best tool against Covid-19. It can prevent you from getting COVID in the first place. And we want to prevent infections, not just wait to treat them once they happen.”
WHAT’S NEXT FOR MOLNUPIRAVIR
There’s still a lot to learn about the drug and who it might work for. The trial detailed Friday focused on adult patients who were considered high-risk for severe COVID-19, most commonly because of obesity, older age, diabetes and heart disease. None had been vaccinated against COVID-19.
Molnupiravir is also being studied as post-exposure prophylaxis — researchers are looking at whether it can prevent spread of the virus within households, after someone has been exposed but hasn’t yet tested positive.
Merck said Friday is plans to submit an application to the FDA for emergency use authorization as soon as possible, and to other regulatory bodies around the world.
In anticipation of the trial results, the company said it has been producing molnupiravir at risk, and expects to have 10 million treatment courses available by the end of the year.
Merck has already sold 1.7 million treatment courses to the US government, if it gets authorization or approval from the FDA. The company said it will offer tiered pricing to provide access around the world, and will work with generic drug manufacturers to speed availability to low- and middle-income countries.
Netflix’s ‘Squid Game’ estimated to be worth about $900 million – Bloomberg News
“Squid Game,” Netflix Inc’s biggest original series launch, is estimated to be worth almost $900 million for the streaming giant, Bloomberg News reported late on Saturday, citing figures from an internal Netflix document.
The nine-episode thriller, in which cash-strapped contestants play childhood games with deadly consequences in a bid to win 45.6 billion won ($38.58 million), became an international hit after it launched last month.
In comparison to its estimated net worth, the show cost just $21.4 million to produce, Bloomberg said.
According to the report https://bloom.bg/3lNzxGY, about 132 million had watched at least two minutes of the show in its first 23 days, easily breaking the record set by U.K. costume drama “Bridgerton,” which was streamed by 82 million accounts in its first 28 days.
Netflix had earlier announced the show had amassed 111 million fans, but Bloomberg said those figures were based on slightly older data.
Los Gatos, California-based Netflix estimated that 89% of people who started the show watched more than one episode, the news agency said, and 66% of the viewers finished watching the series in the first 23 days.
Netflix did not immediately respond to Reuters’ request to comment on the report. An attorney for the company told Bloomberg that it would be inappropriate for Bloomberg to disclose the confidential data contained in the documents that it had reviewed.
The series is also the first Korean drama to snatch the top spot on Netflix in the United States, and has even spurred interest among people in learning Korean.
In China, where Netflix is unavailable without a VPN, a Beijing bakery has introduced a Squid Game-themed confection-making challenge in its store.
The show has even drawn positive comments from Amazon Inc founder Jeff Bezos, with the billionaire calling the work “impressive and inspiring.” Amazon’s streaming service Prime Video competes with Netflix.
($1 = 1,182.0700 won)
(Reporting by Shubham Kalia in Bengaluru, Editing by Nick Zieminski)
Bank of England will have to act to contain inflation – Bailey
“Monetary policy cannot solve supply side problems but it will have to act and must do so if we see a risk particularly to medium-term inflation and to medium-term inflation expectations,” Bailey said on Sunday.
“And that’s why we at the Bank of England have signalled, and this is another such signal, that we will have to act,” he said during a panel discussion organised by the Group of 30 consultative group. “But of course that action comes in our monetary policy meetings.”
(Reporting by William Schomberg; Editing by Alex Richardson)
UPDATE: U.S. expected to reopen border November 8, mixed doses eligible – BlackburnNews.com
UPDATE: U.S. expected to reopen border November 8, mixed doses eligible
October 15, 2021 7:25pm
There is word the U.S. will allow fully vaccinated Canadians with mixed doses of the COVID-19 vaccine to enter when the land border reopens to travellers next month.
The Centers for Disease Control and Prevention said early Friday evening that individuals who received doses of two or more different COVID-19 vaccines, including the Astra Zeneca vaccine, will be considered eligible to enter the United States starting in November.
“While CDC has not recommended mixing types of vaccine in a primary series, we recognize that this is increasingly common in other countries so should be accepted for the interpretation of vaccine records,” a statement from the agency read.
Earlier on Friday, a White House official told the Canadian Press on condition of anonymity, since the policy has not yet been made public, that the official reopening date for land borders will be November 8.
However, New York State Congressman Brian Higgins tweeted the date too.
The White House is indicating the U.S. will start allowing vaccinated Canadians to enter the U.S. through land ports of entry beginning on November 8. pic.twitter.com/dlWWZsL1wU
— Brian Higgins (@RepBrianHiggins) October 15, 2021
The Canada Border Services Agency also reminded Canadians what they would need to re-enter the country once land and water border points do open.
Travellers re-entering Canada will have to complete a PCR test within 72 hours of arriving at the border. They will also have to provide proof they are fully vaccinated against COVID-19 using the ArriveCan app.
“Antigen tests, often called ‘rapid tests,’ are not accepted,” said the CBSA statement.
For trips of less than 72 hours, Canadians and those registered under the Indian Act, permanent residents and protected persons can take their PCR test before they leave the country.
“Unvaccinated or partially vaccinated travellers who are eligible to enter Canada must continue to follow pre-arrival, arrival, and Day-8 molecular COVID-19 testing requirements, and quarantine for 14 days,” continued the statement.
Canada reopened its border to American travellers on August 9.
UN envoy says has agreement on drafting new Syrian constitution
Former U.S. President Clinton leaves hospital, will return to New York
UAE’s daily COVID-19 cases fall below 100
Silver investment demand jumped 12% in 2019
Europe kicks off vaccination programs | All media content | DW | 27.12.2020 – Deutsche Welle
Iran anticipates renewed protests amid social media shutdown
News17 hours ago
Coronavirus: What's happening in Canada and around the world on Saturday – CBC.ca
Health20 hours ago
U.S. administers 407.4 million doses of COVID-19 vaccines -CDC
News19 hours ago
Pope pledges to continue being a ‘pest’ in defence of the poor
News19 hours ago
France’s Macron calls 1961 massacre of Algerians an ‘unforgivable crime’
Business19 hours ago
Elon Musk dials into Volkswagen executive conference
News15 hours ago
Mexico finds nearly 2,000 irregular migrants in one day
Business19 hours ago
Iranian supertanker departing from Venezuela to transport heavy oil
Health23 hours ago
Are you planning to get a flu shot this year? – Castanet.net