Drugmaker Merck has said its experimental COVID-19 pill reduced hospitalisations and deaths by half in people recently infected with the coronavirus and that it would soon ask health officials in the United States and around the world to authorise its use.
If cleared, the drug would be the first pill shown to treat COVID-19, a potentially major step forward in global efforts to control the pandemic. All COVID-19 therapies now authorised in the US require an IV or injection.
“With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic,” said Robert Davis, the company’s CEO and president, in a statement on Friday.
A pill that could be taken at home, by contrast, could keep many patients out of the hospital, easing the workload on strained healthcare professionals.
It could also help curb outbreaks in lower-income countries that do not have access to the more expensive infusion therapies.
Merck and its partner Ridgeback Biotherapeutics said early results showed patients who received the drug, called molnupiravir, within five days of COVID-19 symptoms had about half the rate of hospitalisation and death as patients who received a dummy pill.
The study tracked 775 adults with mild-to-moderate COVID-19 who were considered at higher risk for severe disease due to health problems such as obesity, diabetes or heart disease. The results have not been peer-reviewed by outside experts, the usual procedure for vetting new medical research.
Among patients taking molnupiravir, 7.3 percent were either hospitalised or died at the end of 30 days, compared with 14.1 percent of those getting the dummy pill.
There were no deaths in the drug group after that time period compared with eight deaths in the placebo group, according to Merck.
An independent group of medical experts monitoring the trial recommended stopping it early because the interim results were so strong.
That is typical when early results show so clearly that a treatment works that there is no need for further testing before applying for authorisation. Company executives said they plan to submit the data for review by the Food and Drug Administration in the coming days.
Once the submission is complete, the FDA could make a decision within weeks — and, if approved, the drug could be on the market soon after. Merck studied its drug only in people who were not vaccinated.
But FDA regulators may consider authorising it for broader use in vaccinated patients who get COVID-19 symptoms.
“It exceeded what I thought the drug might be able to do in this clinical trial,” said Dr Dean Li, vice president of Merck Research Laboratories. “When you see a 50 percent reduction in hospitalisation or death that’s a substantial clinical impact.”
Peter Horby, a professor of emerging infectious diseases at the University of Oxford, called the interim results “very encouraging”.
“A safe, affordable, and effective oral antiviral would be a huge advance in the fight against COVID,” he said.
Oksana Pyzik, a global health adviser and lecturer at University College London, told Al Jazeera that the Merck pill was “much more convenient than many of the other types of treatments including monoclonal antibodies which were much more expensive and more complicated”.
“So it’s about time that we were able to introduce an easy to take a tablet at home within our tool kit of various medications that can help prevent and fight the coronavirus,” she added.
However, experts have also cautioned they would like to see the complete underlying data, and stressed that if eventually approved, the drug should complement highly effective vaccines, rather than be taken instead of them.
Patients take eight pills per day for five days. Side effects were reported by both groups in the Merck trial, but they were slightly more common among the group that received a dummy pill. The company did not specify the problems.
Earlier study results showed the drug did not benefit patients who were already hospitalised with severe disease.
The US has approved one antiviral drug, remdesivir, specifically for COVID-19, and allowed emergency use of three antibody therapies that help the immune system fight the virus.
But all the drugs have to be given by IV or injection at hospitals or medical clinics, and supplies have been stretched by the latest surge of the Delta variant.
Health experts including the top US infectious disease expert Anthony Fauci have long called for a convenient pill that patients could take when COVID-19 symptoms first appear, much the way the standard flu medication Tamiflu helps fight influenza.
Goldman Sachs moves to full ownership of China securities JV
Goldman Sachs said on Sunday it received approval from China’s securities regulator to take full control of its mainland securities business.
The U.S. bank said it would buy the remainder of Goldman Sachs Gao Hua Securities Company Ltd (GSGH), and rename it as Goldman Sachs (China) Securities Company Ltd.
The migration of its onshore business units to GSGH from Beijing Gao Hua Securities was underway, it added.
“This marks the start of a new chapter for our China business following a successful 17-year joint venture,” Goldman Sachs said in a statement.
It becomes the second Wall Street firm to be granted approval to shift to full ownership of its securities business after JPMorgan Chase & Co moved to 100% in August https://www.reuters.com/business/finance/jpmorgan-gets-beijings-approval-first-fully-foreign-owned-brokerage-2021-08-06.
Securities businesses in China typically house investment banking, research, equities and fixed income businesses.
Unlike most of the other China JVs, Goldman had day-to-day operational control of its business even with its minority ownership.
Lucrative underwriting fees on equity and bond transactions – especially initial public offerings (IPOs) – in China’s expanding capital markets has been the driving force for Western banks to increase stakes in their mainland business.
Full ownership could allow foreign banks to expand their operations in the multi-trillion-dollar Chinese financial sector, and better integrate them with their global businesses.
Morgan Stanley currently owns 90% of its securities joint venture with partner Shanghai Chinafortune Co Ltd after increasing its stake https://www.reuters.com/business/finance/morgan-stanley-nears-full-ownership-china-ventures-with-stake-buys-2021-05-28 in May.
China’s regulators had examined Goldman Sach’s application to move to full ownership https://www.reuters.com/business/finance/goldman-sachs-signs-pact-wholly-own-china-joint-venture-2020-12-11 since the bank flagged its intention to buy out its partner in December.
(Reporting by Scott Murdoch in Hong Kong and Nikhil Kurian Nainan in Bengaluru; editing by Uttaresh.V and Stephen Coates)
From Canada? Want to go to the U.S.A.? Better have the right vaccine – Boing Boing
The last couple of years have been hard on Canadian Snowbirds. Many of us, myself included, are used to heading south in the fall, to escape the icy bullshit of a Canadian winter. Unfortunately, thanks to COVID-19, a lot of us have been trapped, north of the wall, since March 2020.
I’ve been fine with this.
When the land border was closed down to everyone but essential travellers, my mindset was that if I was going to get sick, I’d just as soon do it in my own nation where healthcare is free (yeah, we pay our taxes, but still.) Then, last winter, the vaccines started to roll out. By early spring, both my wife and I had been injected with two doses of Pfizer’s version of the brew. We breathed a sigh of relief and began to hope that we might, one day soon, be able to start our travels again. I’m sure that lots of other folks did too. Unfortunately, depending on where in Canada they live, it wasn’t a sure bet that they’d wind up with two doses of the same vaccine. In the rush to get as many Canadians vaccinated against the plague as possible, many provinces started mixing and matching whichever vaccines that they had on hand.
So, you could wind up with Pfizer for your first jab and Moderna for your second. It’s cool, they told us. Mixing vaccines affords tons of protection, we were assured. Why, we’d all be able to get back to our lives in no time… provided said life doesn’t include travelling to one of many countries where vaccine mixing is considered to be a dangerous load of bullshit. You may have guessed by now, that America is one of those countries.
From The CBC:
…at the same time the U.S. reopens the land border, it will start requiring that foreign land and air travellers entering the country be fully vaccinated.
The U.S. Centers for Disease Control (CDC) currently doesn’t recognize mixed COVID-19 vaccines — such as one dose of AstraZeneca, and one dose of Pfizer or Moderna — and hasn’t yet said if travellers with two different doses will be blocked from entry when the vaccine requirement kicks in.
So that sucks.
According to the CBC, the Centers for Disease Control and Prevention might soon consider changing their stance on mixed vaccines. I’d like to think that a crap load of data on the effectiveness of mixed vaccine dosing will play into such a decision. No matter how badly folks might want to head south for the winter, Americans deserve to be as safe as they can be.
In the meantime, I suspect that, just like last fall, many snowbirds will wind up on Vancouver Island, where I hang my hat, these days. It’s warm enough here that living in an RV is both possible and comfortable.
But I’ll tell ya, it’s a far cry from kicking back in the trade winds on the cusp of Texas’ southern border.
Travel industry, health experts applaud U.S. decision to allow travellers with mixed doses – CTV News
The organization representing Canada’s tourism industry is applauding the U.S. government’s decision to allow Canadian travellers with mixed vaccine doses once the border opens in November.
On Friday, the U.S. Centers for Disease Control and Prevention confirmed that travellers with “any combination” of two doses of vaccines approved by the World Health Organization or the U.S. Food and Drug Administration “are considered fully vaccinated.”
Beth Potter, who is president and CEO of the Tourism Industry Association of Canada, says the announcement is “really good news.”
“What it does is it provides a little bit more clarity, and this is something that we’ve talked about a lot. We know now that if you’ve got that mixed dose, as of November you’re going to be able to enter into the United States,” she told CTV News Channel on Saturday.
Infectious disease expert Isaac Bogoch of the University Health Network in Toronto says allowing mixed dosed travellers is “a smart and data driven approach.”
“This will be a huge relief to many Canadians who did the right thing and got vaccinated and even took those mixed and matched vaccine approaches. It’s safe, it’s effective, and now there’s a recognition of this,” Bogoch said in an interview with CTV News Channel on Saturday.
“I’m really happy to hear this. It’s about time.”
This announcement came after the White House confirmed that the U.S. land borders with Canada and Mexico would be open to fully vaccinated tourists by Nov. 8.
On the American side, the U.S. Travel Association also applauded the Biden Administration’s plans to reopen the border.
“Reopening to international visitors will provide a jolt to the economy and accelerate the return of travel-related jobs that were lost due to travel restrictions,” said association president and CEO Roger Dow in a statement on Friday.
“We applaud the administration for recognizing the value of international travel to our economy and our country, and for working to safely reopen our borders and reconnect America to the world.”
But while the U.S. won’t require Canadians to show proof of vaccination to cross, returning to Canada requires a negative PCR test conducted at most 72 hours before crossing the border.
PCR tests can cost upwards of $200. The Canadian government does not accept rapid antigen tests, which can be had for only $40.
Brian Higgins, a New York congressman whose district includes the border cities of Buffalo and Niagara Falls, wants to see Canada drop the COVID-19 PCR test requirement.
“I think that the U.S. decision to allow Canadians coming into the United States without a test again underscores the potency of the vaccine,” Higgins told The Canadian Press on Friday. “I would like to see that reciprocated by our Canadian neighbours.”
However, Public Safety Minister Bill Blair said that Canada will continue to require PCR tests so long as the Public Health Agency of Canada advocates for it.
“We’ve seen throughout the pandemic that advice has evolved as new evidence and new data is available. We’ll continue to follow the advice in the Public Health Agency Canada,” he said in an interview with CTV’s Question Period on Sunday.
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