The era of anti-Covid pills begins

 What if a simple pill could help heal Covid?

US pharma giants Merck and Pfizer have announced encouraging results for oral drugs, while an anti-depressant has also shown promise in what could open up a new chapter in the fight against the pandemic.

What are these treatments ?

They are pills taken orally as soon as the first symptoms of Covid-19 appear, to avoid serious forms of the illness, and therefore hospitalisation.

This form of treatment has been sought since the start of the global health crisis.

After months of research, Merck and Pfizer say they have reached that elusive goal.

Early October, Merck said it was seeking authorisation in the United States for its pill molnupiravir, and Pfizer followed suit on Friday with paxlovid.

They are both anti-virals that act by reducing the virus's ability to replicate, slowing down the disease.

Both companies say clinical trials showed a strong reduction in the risk of hospitalisation.

Those who took molnupiravir saw that risk diminish by 50 percent and those who took paxlovid by nearly 90 percent, although direct comparisons of these efficacy rates should be avoided because of the different study protocols.

An anti-depressant which is already available to the public, fluvoxamine, has also shown encouraging results in preventing serious forms of Covid-19, according to a study published in October by Brazilian researchers in the Lancet Global Health journal.

Why are they important?

If the efficacy of these drugs is confirmed, it will be a major step forward in the fight against Covid-19.

They would add to vaccines to bolster the world's therapeutic arsenal against the virus.

Treatments already exist, mostly in the form of synthetic antibodies.

But these drugs, which usually target those who already have severe forms of the disease, are injected and therefore more difficult to administer.

A pill can be quickly prescribed to a patient who will then take it easily at home.

Merck and Pfizer's treatments, which so far have not shown many side effects, would entail taking around 10 doses over five days.

"The success of these antivirals potentially marks a new era in our ability to prevent the severe consequences of SARS-CoV2 infection," British virologist Stephen Griffin told the Science Media Center.

What limitations ?

It is difficult so far to properly evaluate Merck and Pfizer's treatments given both groups have only published statements and have not made the data of their clinical trials available.

French infectious diseases specialist Karine Lacombe warned in September that these types of announcements should be treated with "caution" until the studies can be scrutinised.

She pointed out that these treatments represent a "potentially enormous" market for pharmaceutical groups.

Nevertheless, some elements indicate that Merck and Pfizer are not making empty promises.

For one, they both stopped their clinical trials earlier than expected as the results were so strong, with the okay of independent monitoring committees.

Where fluvoxamine is concerned, the data is available but is not without criticism.

Several researchers have complained that the authors did not just limit themselves to evaluating the frequency of hospitalisations, but also assessed the frequency of prolonged emergency room stays.

This, they say, complicated the interpretation of data.

When? And how much?

Merck's molnupiravir has already been approved in the United Kingdom where health authorities on Thursday gave their green light to its use in patients at risk of developing a serious form of the illness, such as the elderly, obese people, or those suffering from diabetes.

US and EU health authorities are also urgently reviewing the drug.

The European Medicines Agency promised on Thursday to "accelerate" proceedings, without giving a firm date.

Several countries have already ordered stocks of molnupiravir, such as the United States, with 1.7 million courses of the drug.

The US order gives an idea of the steep price of the drug.

It comes to $1.2 billion, which equates to around $700 for a five-day course.

As for Pfizer, while it has not outlined a price for paxlovid, it has promised it will be "affordable" and subject to a tiered pricing approach based on the income level of countries.

https://www.france24.com/en/live-news/20211106-the-era-of-anti-covid-pills-begins

'Dramatic' Decline In All Three COVID-19 Vaccines' Efficacy Over Time

 A study which analyzed the records of nearly 800,000 US veterans of all ages found that the three main Covid-19 vaccines experienced 'dramatic' drops in efficacy over six months, according to the LA Times.

Between early March and Septemper, as the Delta variant rapidly became the dominant strain worldwide, the ability of Moderna's two-dose vaccine to prevent infections dropped from 89% - 58%, Pfizer's went from 87% - 45%, and J&J's single-dose vaccine went from 86% to just 13%.

The findings were published Thursday in peer-reviewed Science.

That said, the vaccines' ability to prevent death in older Americans remained somewhat robust over the same period, according to the report.

Among veterans 65 and older who were inoculated with the Moderna vaccine, those who developed a so-called breakthrough infection were 76% less likely to die of COVID-19 compared with unvaccinated veterans of the same age.

Older veterans who got the Pfizer-BioNTech vaccine and subsequently experienced a breakthrough infection were 70% less likely to die than were their unvaccinated peers.

And when older vets who got a single jab of the J&J vaccine suffered a breakthrough infection, they were 52% less likely to die than their peers who didn’t get any shots. -LA Times

For veterans younger than 65, Pfizer and Moderna vaccines prevented death 84% and 82% respectively, while J&J recipients were 73% less likely to die vs. their unvaccinated peers. 

Keep in mind, of course, we're talking about a 70%+ reduction of a < 1% chance of death for Americans under the age of 54, 1.4% for those aged 55-64, and 2.7% for those aged between 65-74.

This, of course, is on top of CDC Director Rochelle Walensky acknowledging last month that the vaccines don't prevent transmission.

Add perpetual boosters to the above, and it's no wonder people - such as former Blackrock money manager Ed Dowd - are skeptical.

https://www.zerohedge.com/covid-19/study-reveals-dramatic-decline-all-three-covid-19-vaccines-over-time

Natera Raises FY21 Sales Outlook After Mixed Q3

• Natera Inc 
  NTRA +4.79%
   (Get Free Alerts for NTRA) posted Q3 sales of $158.1 million, +61% Y/Y, beating the consensus of $151.36 million, driven by an increase in test volume and product revenues.
• Product revenues rose 62% to $150.7 million. Licensing and other revenues rose 53% to $7.5 million.
•  Natera processed approximately 407,300 tests in Q3, a 55% increase from Q3 2020. 
• The firm's Q3 EPS loss widened to $(1.63) from $(0.72) a year ago and missing the consensus of $(1.27).
• The company ended the quarter with $95.1 million in cash and cash equivalents and $928.6 million in short-term investments.
• Guidance: Natera raised its FY21 revenue forecast to $615 million - $625 million, up from its previous forecast of $600 million - $620 million for the year. Analysts, on average, expect revenues of $614.7 million for 2021.

https://www.benzinga.com/news/earnings/21/11/23922916/natera-raises-fy21-sales-outlook-after-mixed-q3-earnings

Tabula Rasa Q4 and 2021 guidance

 Future Outlook

Based on current market conditions and our expectations as of today, we are introducing fourth quarter 2021 guidance and revised full year 2021 guidance, as summarized below.

For the fourth quarter 2021, we expect:

• Total revenue in the range of $84 million to $86 million represents growth of 9% to 12%, all of which is organic.
• Adjusted EBITDA in the range of $4 million to $5 million as compared with $4.7 million a year ago.

For the full year 2021, we expect:

• Total revenue in the range of $329.6 million to $331.6 million represents growth of 11% to 12% with organic growth of 7%.
• Adjusted EBITDA in the range of $19.3 million to $20.3 million as compared with $21.8 million a year ago

https://www.biospace.com/article/releases/tabula-rasa-healthcare-reports-third-quarter-2021-results/

New COVID vaccine design is easier to manufacture, doesn't need cold storage

 Currently available COVID vaccines require cold storage and sophisticated manufacturing capacity, which makes it difficult to produce and distribute them widely, especially in less developed countries. A new type of vaccine would potentially be much easier to produce and would not need refrigeration, report researchers at Boston Children's Hospital in the November 2 issue of PNAS.

The researchers, led by Hidde Ploegh, Ph.D., and first authors Novalia Pishesha, Ph.D., and Thibault Harmand, Ph.D., believe their technology could help fill global vaccination gaps and that the same technology could be applied to vaccines against other diseases.

In mice, the vaccine elicited strong immune responses against SARS-CoV-2 and its variants. It was successfully freeze-dried and later reconstituted without loss of efficacy. In tests, it remained stable and potent for at least seven days at room temperature.

Unlike current COVID-19 vaccines, the new design is completely protein-based, making it easy for many facilities to manufacture. It has two components: antibodies derived from alpacas, known as nanobodies, and the portion of the virus's spike protein that binds to receptors on human cells.

"We could also attach the whole spike protein or other parts of the virus," notes Pishesha. "And we can change the vaccine for SARS-CoV-2 variants quickly and easily."

Targeting antigen-presenting cells

The nanobodies are the key part of the vaccine technology. They are specially designed to target antigen-presenting cells, critical cells in the immune system, by homing to class II major histocompatibility complex (MHC) antigens on the cells' surface. This brings the business end of the vaccine—in this case, the segment of the spike protein—directly to the very cells that will "show" it to other immune cells, sparking a broader immune response.

Current COVID-19 vaccines stimulate production of the spike protein at the site in the body where they're injected, and are presumed to stimulate antigen-presenting cells indirectly, says Ploegh.

"But taking out the middleman and talking directly to antigen presenting cells is much more efficient," he says. "The secret sauce is the targeting."

In experiments in mice, the vaccine elicited robust humoral immunity against SARS-CoV-2, stimulating high amounts of neutralizing antibodies against the spike protein fragment. It also elicited strong cellular immunity, stimulating the T helper cells that rally other immune defenses.

A manufacturing advantage

Because the vaccine is a protein, rather than a messenger RNA like the Pfizer/BioNTech and Moderna vaccines, it lends itself much more to large-scale manufacturing.

"We don't need a lot of the fancy technology and expertise that you need to make an mRNA vaccine," says Harmand. "Skilled workers are currently a bottleneck for production of the COVID vaccine, whereas biopharma has a lot of experience producing protein-based therapeutics at scale."

This could potentially enable production of the vaccine at many sites around the world, close to where it would be used. The team has filed a patent on their technology and now hopes to engage biotech or pharmaceutical companies to take their work into further testing and, eventually, a clinical trial.

"It may be that initial application is something else other than COVID-19," says Ploegh. "This study was the proof of concept that our protein-based approach works well."

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Explore further

Microneedle patch delivers COVID-19 DNA vaccine, doesn't require cold storage

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More information: Novalia Pishesha et al, A class II MHC-targeted vaccine elicits immunity against SARS-CoV-2 and its variants, Proceedings of the National Academy of Sciences (2021). DOI: 10.1073/pnas.2116147118

https://medicalxpress.com/news/2021-11-covid-vaccine-easier-doesnt-cold.html

Appeals court stays Biden vaccine mandate for businesses

 An appeals court ruled on Saturday to temporarily halt President Biden’s coronavirus vaccine mandate for businesses with 100 employees or more.

The ruling came from the U.S. Court of Appeals for the Fifth Circuit after Texas Attorney General Ken Paxton (R) filed a challenge to the mandate requiring employers with over 100 or more employees to get vaccinated or undergo frequent testing directly with the court.  

The challenge included the states of Louisiana, Mississippi, Utah and South Carolina. 

The Biden administration announced that it would issue the law through the Occupational Safety and Health Administration (OSHA) in September. Companies who meet the criteria are required to get their employees fully vaccinated by Jan.4, or workers must test negative for the virus once per week. 

OSHA’s rule includes sending agents to inspect businesses to determine if they are abiding by the mandate. If a business is found to not be in compliance, a company could be fined $136,532.

Paxton argued in the announcement of Texas’s challenge that the mandate goes outside of OSHA’s “limited power and specific responsibilities” and is “flatly unconstitutional.”

The appeals court ruled there are "grave statutory and constitutional” with the OSHA rule. 

Paxton took to Twitter Saturday to celebrate the ruling by the court.

“Yesterday, I sued the Biden Admin over its unlawful OSHA vax mandate,” Paxton tweeted.

“WE WON. Just this morning, citing 'grave statutory and constitutional issues,' the 5th Circuit stayed the mandate. The fight is not over and I will never stop resisting this Admin’s unconstitutional overreach!” he added.

Louisiana Attorney General Jeff Landry (R) also celebrated the appeals court's decision. 

"BREAKING: In a major win for liberty, the 5th Circuit U.S. Court of Appeals just halted Biden's mandate on businesses with 100 or more workers. This is a stay. We will continue to see this case through. The gov't should not force, or coerce, medical procedures. #lalege #lagov," Landry tweeted. 

Paxton’s legal challenge followed at least 26 states that came out against the administration’s vaccine mandate.

Several coalitions of states filed four challenges to OSHA’s rule.

The states alleged the Biden administration does not have the authority to issue the public health order and argue it will lead to staffing shortages and economic blowback.

“Its unlawful mandate will cause injuries and hardship to working families, inflict economic disruption and staffing shortages on the States and private employers, and impose even greater strains on struggling labor markets and supply chains,” a filing from a coalition of attorneys general led by Missouri Attorney General Eric Schmittthe alleged.

The White House referred The Hill to the Labor Department when asked for comment. 

The Labor Department was not immediately available for comment

The Biden administration initially announced the rule after several major pushes by the federal government to convince the public to get the jab on their own. President Biden himself made several appeals to Americans, but did not issue a wide-reaching mandate at first. 

The Labor Department rule was announced during a surge of the highly contagious delta variant.

https://thehill.com/policy/healthcare/580403-appeals-court-stays-biden-vaccine-mandate-for-businesses

COVID-19 Spreads To 31 Provinces In China, Residents Panic-Shopping, Communities Locked-Down

 by Alex Wu via The Epoch Times,

Just days before the ruling Chinese Communist Party (CCP)’s top conference, COVID-19 has spread to more than a dozen provinces in China.

In a southern city, there were reports of people panic shopping, while in the northeast province Heilongjiang authorities forced the lockdown of residential neighborhoods.

The communist regime’s National Health Commission reported 93 locally transmitted cases in one day on Nov. 3, which is the highest this year. With the largest number of cases, Heihe City in Heilongjiang Province reported 35 cases, and 51 local communities have been shut down.

This comes as the ruling CCP’s conclave—the Sixth Plenary Session—is set to be held in Beijing on Nov. 8–11.

Heihe City held an epidemic press conference on Nov. 2, saying that after the COVID-19 outbreak on Oct. 27, traffic checkpoints were set up on eight roads in and out of the city to strictly control people and vehicles leaving the local area. All hotels used as quarantine sites will be stationed by the epidemic control team and will be under 24/7 lockdown.

For people quarantined at home, the authorities put seals on their doors or installed door sensors on their home and apartment doors to prevent them from going out. Since Oct. 27th, six nucleic acid tests for all residents in the city have been carried out.

Meanwhile, reports in the southern Changzhou City of Jiangsu Province said residents have been panic buying food and supplies, emptying out local supermarkets, after a report of local COVID-19 cases.

“People are mainly grabbing rice, cooking oil, instant noodles, and dried noodles,” said a staff member of a local supermarket.

The Epoch Times has obtained a video showing residents panic buying at a supermarket in Changzhou.

A shop clerk surnamed Liu (alias) at RT-Mart Supermarket in Wujin District of Changzhou City told the Chinese language Epoch Times that the panic buying began on the evening of the 2nd, and all the supermarkets were emptied out on the morning of Nov. 3. Liu said: “Now there is not much rice left in the supermarket, and the vegetable section has been emptied. The supermarket has placed an urgent (purchase) order, but it’s hard to tell if it will be supplied in time.”

On Nov. 3, Changzhou City officially reported 3 new locally transmitted cases. The staff of the Market Operation and Consumption Promotion Office of the Changzhou Municipal Bureau of Commerce told local media that the panic buying in the city was mainly because of the COVID-19 outbreak, and the fear of food and supply shortage in the winter caused by a “Notice on Doing a Good Job in Maintaining Supply and Stabilizing Prices of Vegetables and Other Daily Necessities in the Market this Winter and Spring” issued by the Ministry of Commerce.

Since the Chinese communist regime has consistently covered up the real situation of the COVID-19 epidemic in China since the start of the outbreak in Wuhan, official statistics may not reflect the real number of cases and deaths.

https://www.zerohedge.com/covid-19/covid-19-spreads-31-provinces-china-residents-panic-shopping-communities-locked-down