Friday, November 05, 2021

UK approves Merck's antiviral COVID pill molnupiravir in world first

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Thursday recommended the drug, molnupiravir, be used as soon as possible following a positive COVID-19 test and within five days of the onset of symptoms.

The pill was licensed for adults 18 and older who have at least one risk factor for developing severe disease, such as obesity or heart disease.

It is the first oral antiviral treatment for COVID-19 to get approved, with the green light coming ahead of potential US regulatory clearance.

US advisers will meet this month to vote on whether molnupiravir should be authorised.

Australia's Therapeutic Goods Administration has not yet approved the drug but the federal government announced last month it had ordered 300,000 courses.

The drug, to be branded Lagevrio in Britain, 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.

Merck's COVID treatment drug, molnupiravir, has only passed the first hurdle towards approval in Australia but the federal government has bought 300,000 doses after some promising preliminary results.

"Today is a historic day for our country, as the UK is now the first country in the world to approve an antiviral that can be taken at home for COVID-19," said Britain's health secretary, Sajid Javid.

"We are working at pace across the government and with the NHS to set out plans to deploy molnupiravir to patients through a national study as soon as possible."

The British government and the country's National Health Service have not yet confirmed how the treatment will be deployed to patients.

Last month, Britain agreed to a deal with Merck to secure 480,000 courses of molnupiravir.

In a separate statement, Merck said it was expecting 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.

Then antiviral pill could halve the chances of dying or being hospitalised from COVID-19, but experts warn vaccines are still necessary.

The company and its partner Ridgeback Biotherapeutic have requested clearance for the drug with regulators around the world to treat adults with mild-to-moderate COVID-19 who are at risk for severe disease or hospitalisation.

Merck's preliminary results last month have not yet been peer reviewed or published in a scientific journal.

The company also did not disclose details on molnupiravir's side effects, except to say that rates of those problems were similar between people who got the drug and those who received dummy pills.

The drug targets an enzyme the coronavirus uses to reproduce itself, inserting errors into its genetic code that slow its ability to spread and take over human cells.


The 1.5m myth: alarming distance Covid can travel and stay in the air

As Lidia Morawska stirred awake, her resolve from the night before to act, to shake things up, escaped her momentarily.

Her plan? To marshal eminent scientists from around the globe to pressure one of the world’s most influential groups, the World Health Organisation, to admit that it was wrong. Deadly wrong.

It was late March last year and the virus that causes Covid-19, SARS-CoV-2, was roving across the world and deaths were rising.

Concerned colleagues in China and Italy had been calling Morawska – a physicist and distinguished professor in atmospheric and earth sciences at QUT and one of the world’s foremost authorities on airborne particles and their effects on health – pleading for her help. They couldn’t get authorities in those badly affected countries to listen to the science.

She knew, they knew, that a virus such as SARS-CoV-2 was airborne, capable of hanging in the air for hours and travelling significant distance. They’d done the studies, seen the evidence.

But WHO and national health authorities everywhere were caught in what Morawska, 68, calls “medical dogma”; the long-held belief that viral particles could not travel further than arm’s length. Their advice for such a coronavirus remained as it had for decades; keep a distance of about 1.5m from others, wash your hands and sanitise surfaces.

It infuriated Morawska. “A complete misconception,” she says. But now, her frustration had turned to desperation. That weekend in March, WHO issued a communique, disseminated on Twitter, headlined: “Fact Check: Covid-19 is NOT airborne.”

“Well, this was something,” says Morawska. “It wasn’t disbelief, because I knew the medical community had this view but it was that alarm bells were rung. If WHO was spreading this kind of misinformation; this is wrong, this will lead to more cases.”

That Sunday, she wrote a letter to the WHO. That evening, she contacted colleagues.

Come Wednesday, March 31, she hit send on an email, signed by 36 scientists in fields such as physics, virology, engineering and medicine, urging change in WHO’s thinking – and directives. The virus, they said, could drift and survive in the air, especially in poorly ventilated and crowded indoor spaces.

Within an hour, Morawska had a reply from leaders at WHO headquarters in Geneva, setting up a Zoom meeting a couple of days later.

It didn’t go well. “When you know a group is against you – that was the feeling,” says Morawska.

It would take more than three months of lobbying and writing and badgering and advocacy by Morawska and her colleagues before WHO changed its advice.

Morawska’s dogged work led her to be named by TIME magazine as one of the world’s 100 most influential people for 2021.

It’s an honour for all involved, she says, but clouded by the fact that the delay in WHO altering its advice, meant “we lost people. That’s the tragedy”. And there is still work to be done.


Republicans Crush in Numerous Races Across America, Prove the Red Wave Is Here

It appears, in an ironic twist, President Joe Biden has succeeded in the goal he stated during his inaugural address in January to unify the country.

Unfortunately for him and the Democratic Party, the unity is in opposition to their radical agenda.

Everywhere up and down-ballot from New York and New Jersey to Virginia and Texas, the GOP made improbable gains.

Of course, at the very top of the red wave is the governor’s race in Virginia where Republican Glenn Youngkin upset former Democratic Virginia Gov. Terry McAuliffe.

Keep in mind Biden won the Old Dominion State over former President Donald Trump by 10 percent just a year ago.

Youngkin wasn’t the only Republican to win statewide in Virginia for the first time in over a decade

U.S. Marine veteran Winsome Sears took the lieutenant governor’s race, becoming the first African-American woman elected to statewide office in the commonwealth’s history.

Additionally, GOP candidate Jason Miyares, who is Hispanic, is currently in the lead in the attorney general’s contest.

Republicans are also on track to take back control of Virginia’s House of Delegates, where the Democrats held a 55 to 45 majority.

The news keeps getting worse for Dems in VA, where the correction of a reporting error appears to have flipped another House of Delegates seat to the GOP. Republicans now on track for 52R-48D, pending provisionals/recounts.

Moving north, the GOP also had an impressive night in deep-blue New Jersey, which Biden carried by nearly 16 points.

The race between incumbent Gov. Phil Murphy and Republican Jack Ciattarelli is, as of Wednesday afternoon, too close to call.

Murphy had been well ahead in the polls, so Ciattarelli surging into a Tuesday night lead shocked political poll watchers.

Still votes to be counted in NJ but it appears the GOP’s Jack Ciattarelli could flip Morris, Atlantic, Gloucester and Cumberland counties after Biden carried them last fall.

Still, looks like Murphy is in the driver’s seat for a victory

Meanwhile, the GOP picked up multiple seats in the state General Assembly and Senate with others, including Democratic Senate President Steve Sweeney’s race, too close to call, according to

In neighboring New York, Republicans won four contested city council races in Brooklyn, Queens and Staten Island with the potential of picking up a fifth, the New York Post reported.

One winner was Inna Vernikov, an unabashed Trump supporter, who trounced her Democratic opponent Steve Saperstein by nearly 30 points for an open seat in Brooklyn’s 48th Council District.

Former New York Assemblyman Dov Hikind tweeted on Monday ahead of the election, “For the first time in a century, a Republican has a good chance to win a seat for office in ultra liberal Brooklyn. Electing @InnaVForNYC would send a strong message to Democrats that their destructive reign in major American cities will not go unchallenged!”

Next door in Pennsylvania, The Philadelphia Tribune reported that Republicans are poised for a clean sweep in statewide judicial elections, including picking up a seat on the Keystone State’s Supreme Court.

You’ll recall that’s the same Democrat-controlled Supreme Court that kept rubber-stamping all the changes to Pennsylvania’s election laws and procedures Democratic Gov. Tom Wolf’s administration made during the 2020 election cycle, contrary to the state’s constitution, which vests that power in the legislature.

Republicans also received good news coming out of the Lone Star State, where John Lujan won his special election, flipping a state House seat located in San Antonio from blue to red.

Our story: Republican John Lujan wins special election runoff to flip Texas House seat in San Antonio

Biden carried the district by 14 points last November, The Texas Tribune reported.

Overall, it was a very bad night for Democrats, and at least part of the blame undoubtedly falls on Biden.

Americans, by a wide margin, are dissatisfied with the current direction of the country with seven in 10 respondents (71 percent), including nearly half of Democrats polled (48 percent), saying the U.S. is “off on the wrong track,” according to an NBC News poll released over the weekend.

Just 42 percent approve of Biden’s job performance and 54 percent disapprove.

Biden’s approval number is down 7 percentage points, and his disapproval is up 6 percentage points since August.

The change comes after the chaotic and deadly pullout in Afghanistan, rising inflation, slowing economic growth and disappointing September jobs numbers.

Gallup reported last week that the 46th president’s approval rating dropped from 56 percent in the first quarter of this year to 44.7 percent in the third quarter, an 11.3 percent drop — the largest registered by any president since World War II.

Based on Tuesday’s election results, Biden has succeeded in unifying the country in the belief that he is leading it in the wrong direction.

Short of a major course correction, Democrats better prepare to run smack into a mighty red wave in next year’s midterms.




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