Tuesday, September 28, 2021

Pfizer begins late-stage clinical trial of oral drug to prevent COVID-19 in people who have been exposed to symptomatic patients

Pfizer Inc has begun late-stage clinical trials of an oral drug that could prevent COVID-19 among those who have been exposed.

The drugmaker, which developed the first authorized COVID-19 vaccine in the U.S. with Germany's BioNTech SE, has previously said the antiviral candidate showed 'potent' activity against the virus in lab studies.

Pfizer's candidate, which is called PF-07321332, belongs to a class of drugs known as protease inhibitors. The pill would work by inhibiting an enzyme that the coronavirus uses to make copies of itself inside human cells.

The New York-based company and its rivals, including Merck & Co Inc in the U.S. and Swiss pharmaceutical Roche Holding AG, have been racing to develop an easy-to-administer antiviral pill for COVID-19.

Protease inhibitors have been effective at treating other viral pathogens such as HIV and hepatitis C virus, both on their own and in combination with other antivirals, the company said.

Pfizer believes this class of molecules may provide well-tolerated treatments against COVID-19, as currently marketed therapeutics that work on the same lines have not reported safety concerns.

'With the continued impact of COVID-19 around the world, we believe that tackling the virus will require effective treatments for people who contract, or have been exposed to, the virus, complementing the impact that vaccines have had in helping quell infections,' said Dr Mikael Dolsten, chief scientific officer at Pfizer, in a statement.

'If successful, we believe this therapy could help stop the virus early - before it has had a chance to replicate extensively - potentially preventing symptomatic disease in those who have been exposed and inhibiting the onset of infection in others.

The Phase II/III trial is a randomized, double-blind trial in which some participants will be given the drug and others the placebo, but even researchers won't know what pill the volunteers.

The study will test Pfizer's drug in up to 2,660 healthy adult participants aged 18 and older who live in the same household as an individual with a confirmed symptomatic Covid infection.

In the trial, half of the participants will be given the pill plus a low dose of ritonavir, an older medication widely used in combination treatments for HIV infection, and the other half will be given a placebo.

Volunteers will be required to take the pills they are given twice daily for either five days or 10 days.

Scientists will assess whether the pill is effective at preventing infection and its symptoms up to 14 days after being exposed.

Pfizer has also started another study of PF-07321332 in non-hospitalized, symptomatic adult patients.

To date, Gilead Sciences' remdesivir is currently the drug fully approved by the U.S. Food and Drug Administration (FDA) for the treatment of COVID-19.

However, the agency has granted emergency use authorization to two combination therapies, one from Eli Lilly and the other by Regeneron.

Pfizer's announcement comes as Merck and partner Ridgeback Biotherapeutics also recently launched a late-stage trial of their experimental drug molnupiravir for prevention of the COVID-19 infection.

Molnupiravir is also being studied in a late-stage trial in non-hospitalized patients to see if it reduces the risk of hospitalization or death.


Alberta, Canada is counting ANY student who calls out sick as being a COVID case: Those who refuse testing will be added to the list

Students in Alberta who call out sick will be counted as COVID-19 cases as infections in the Canadian province surge - causing furious parents to accuse government officials of fear-mongering to maintain their grip on power after the new ruling by the Chief Medical Officer of Health.

'If individuals choose not to get tested for COVID-19 but are home with an illness they are now counted in the list as being part of that outbreak, and so it's less dependent on needing a test to be part of identifying where there is an issue,' said Deena Hinshaw, the province's top doctor, on Thursday.

In August, Hinshaw apologized for treating the pandemic as an 'endemic' in the early stages of COVID and for the fear and uncertainty that followed in the months after.

In Alberta schools, students who come in contact with others infected with COVID-19 are not required to quarantine and a contract tracing measure is not in place.

The government has also announced that data on how many schools have COVID-19 outbreaks will not be released, prompting outrage from parents who feel they have the right to know.

Hinshaw said the current framework had been implemented based on previous evidence from other jurisdictions.

She has said it is necessary for schools to assume anyone at home is a positive case of COVID-19 because obtaining data on COVID-19 transmissions from pubic health agencies would violate the privacy of students and staff.

Hinshaw insisted that the method was in place so schools could promptly alarm public health officials of a possible outbreak, in order to add an extra layer of protection and mitigate the spread.

'In schools, we are taking the approach that an illness that fits that definition - respiratory illness- is treated the same way whether it is COVID or not, so additional measures can be put into place,' Hinshaw said.

Social media users on Twitter disapproved of the measure they deemed alarmist and panic-driven.

Ezra Levant, a reporter for Rebel News, shared a clip of Hinshaw and tweeted: 'To maintain a mass psychology of panic and fear, Alberta's corrupt public health bureaucrat now automatically counts anyone staying home from any illness as a Covid case.'

Others complained about the continued restrictions. 'These 'So Called Experts' are power hungry and will never give us back our freedoms,' said Dougle Affan.

Another user wrote: 'Broken leg, refuse covid test, counted as a Covid case. FFS, the world is careering down a very dark path. How are they getting away with this, why are journalists not taking them to task?'

Alberta, a province that aggressively advertised its 'best summer ever,' is now struggling with a surge in COVID-19 cases.

With its healthcare system strained, and anti-vaccine and anti-mask sentiments growing among residents, public health officials are urging politicians to improve the loose restrictions that are in place.

There were 1,061 people hospitalized with COVID-19 in Alberta on Thursday. Of the 818 non-ICU, 75.5% were unvaccinated or partially vaccinated. Of the 243 in ICU, 91.7% were unvaccinated or partially vaccinated.

More than 60 doctors penned a letter to premier Jason Kenney, who has fervently opposed a lockdown, warning him about the dire conditions and low-room capacity at hospitals.

'Our healthcare system is truly on the precipice of collapse. Hospitals and ICUs across the province are under enormous strain and have reached a point where it is unclear if, or for how much longer, we can provide safe care for Albertans.' The Guardian reported.

A public health emergency has now been declared and military help has been requested to transport patients to others provinces as hospitals are working on full capacity.

Kenney has retracted his triumphant approach during the summer but still refused to order a lockdown because it made 'no sense for the 80 percent of the population that is vaccinated.'

'I know that we had all hoped this summer that we could put Covid behind us once and for all, that was certainly my hope,' he said. 'It is now clear that we were wrong, and for that I apologize.'

Kenney introduced some restrictions and promised to give more resources to hospitals when cases rose exponentially, but it was too little too late, medical officials have said.

In Alberta, there are currently 22,320 COVID-19 cases and 2,622 people have died of of the illness since the pandemic started. In May, the province had the worst rate of COVID-19 in North America



Joe Biden slams horse-mounted agents who are overwhelmed because of his own policies (CNS News)

Border agents “dumbfounded” by Biden’s promise to “fry our agents”: “He just started a war with Border Patrol” (Not the Bee)

Jen Psaki: It’s not “constructive” for the president to visit the southern border (Daily Wire)

DHS secretary: We probably released around 12,000 Haitians (Hot Air)

Biden defends his social agenda bill, wrongly claiming the cost will be zero (Washington Post)

Nancy Pelosi sets Thursday vote on “infrastructure,” eyes smaller social spending bill (Reuters)

House Democrats pass bill to end nearly all restrictions on abortion (CNS News) | Abortion bill protects “transgender men” (Free Beacon)

AOC apologizes for “present” vote on Israel’s Iron Dome, explains her crocodile tears (Fox News)

Runs in the family: Chris Cuomo accused of sexually harassing former boss at 2005 party (New York Post)

Under U.S. sanctions, Iran and Venezuela strike oil export deal (Reuters)

The United States and Pakistan face each other again on Afghanistan threats (AP)

Turkey’s president defiant about acquiring Russian missile defense system despite potential risk for U.S. (CBS News)

Chairman disbands panel investigating COVID-19’s origins, saying its links to a nonprofit that worked with a Chinese lab raises bias concerns (Business Insider)

WHO relaunching probe into pandemic origins (Daily Wire)

Social Democrats narrowly beat Angela Merkel’s bloc in German vote (Fox News)

New video of January 6 depicts disorder and disrespect, not violent insurrection (Just the News)

Police academies face recruiting drought after year of relentless cop demonization (National Review)

Delta wants airlines to share no-fly lists to keep crap passengers out of the skies (Gizmodo)

Policy: Pelosi’s “abortion for all” bill is more radical than Roe (Heritage Foundation)


Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)

http://australian-politics.blogspot.com/ (AUSTRALIAN POLITICS

http://snorphty.blogspot.com/ (TONGUE-TIED)


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