U.K. COVID-19 vaccine to be delivered by skin patch approved for human trials

 A U.K. company that developed a new COVID-19 vaccine intended to be delivered via a small skin patch with microneedles has been granted approval for human trials.

Oxfordshire-based company “Emergex” developed a vaccine for SARS-CoV-2 that is designed to prime T-cells (white blood cells that are part of the immune system) in the body to rapidly remove virus-infected cells.

Most current vaccines used in Canada like Pfizer work by creating an antibody immune response in the body by exposing the vaccine-recipient's cells to the spike protein of COVID-19.

The vaccine may offer broad immunity from variants and provide long-lasting immunity that would not require booster vaccines, according to a release.

Emergex announced Monday that it had acquired the proper authorization to move into its Phase 1, double-blind, randomised clinical trial into two groups of 13 volunteers at high and low doses conducted at the Centre for Primary Care and Public Health at the University of Lausanne, Switzerland.

The first patient is expected to receive the first dose of the Emergex vaccine at the start of January 2022, the release said.

“Although current COVID-19 vaccines have made significant progress in reducing mortality and morbidity challenges still remain, especially with the development of new variants,” said principal trial investigator Blaise Genton in the release. “This exciting new scientific approach to developing a vaccine against SARS-CoV-2 addresses the need to generate a T-Cell response to elicit long-term immunity. We look forward to evaluating the results as when they are available.”

The Emergex vaccine, similar to other skin patch technology, is aiming to use microneedles to deliver the vaccine to the body, in devices usually about the size of a thumbnail.

The company said in its release that the vaccine will also be stable at room temperature for more than three months, which makes distribution and storage simpler. 

https://www.ctvnews.ca/health/coronavirus/u-k-covid-19-vaccine-to-be-delivered-by-skin-patch-approved-for-human-trials-1.5667401

No matter how old you are, two shots of Pfizer vaccine don’t last – study

People vaccinated with two shots of the Pfizer coronavirus vaccine in January and February had a 51% increased chance of contracting the virus in July compared to those who were vaccinated in March or April, a new Israeli study published in Nature Communications has shown.

The team of researchers from KI Institute worked with doctors from KSM Research and Innovation and used data provided by Maccabi Health Services to conduct a retrospective cohort study comparing the incidence rates of breakthrough infections and COVID-19-related hospitalizations between people vaccinated toward the beginning of the country’s campaign (January and February) and those vaccinated toward the later stages (March and April). The study included more than 1.3 million records.

As noted, the risk of infection was significantly higher for people the earlier they were vaccinated, with an additional trend for high risk of hospitalization. The results, the researchers said, are consistent with other studies on the subject that show a decline in antibody levels and immune system compounds after four to six months.

Moreover, people’s ages had no effect on the vaccine’s waning, meaning that the vaccine waned for everyone and not just older people.

"The vaccine's effectiveness wanes equally for everybody, according to the study,"  Dr. Barak Mizrahi, a researcher in computational health for KI Institute who led the study, said.

Israel set a policy to administer a third shot to all individuals over the age of 12, in contrast to many other countries and the recommendation of the World Health Organization only to give the third jab to people at the highest risk of contracting the virus or developing serious disease.

More than four million Israelis have taken a booster shot. The results were that the infection rate dropped significantly.

Mizrahi explained that the vaccine waned more the further one got away from the original second dose, meaning that people vaccinated in January were more at risk of contracting corona than people vaccinated in February and so forth.

The study was done as the Delta variant was burning across the country and many believed that the variant may be the cause of increased infection in Israel. Mizrahi said the study shows that the variant was likely less of a factor than assumed – though this is still not confirmed.

Will the third dose last longer?

Mizrahi said that it is difficult to tell at this stage. Very preliminary data has started to be collected in various studies that shows antibodies are waning after the third shot, too. However, he said that the level of antibodies is not the only factor when it comes to immunity. Officials will need to watch and see if infections start going up and then set vaccination policy accordingly, Mizrahi said.

“I don’t think it will take us that long to know,” he concluded.

https://www.jpost.com/health-and-wellness/coronavirus/no-matter-how-old-you-are-two-shots-of-pfizer-vaccine-dont-last-study-685141

Japan vaccination rate is highest in G7

 　Matsuno Chief Cabinet Secretary , the new corona for the second time of vaccination rate, Japan in the international statistics were revealed that it is now in first place in the G7 countries by far Canada.

Why is the number of infected people in Tokyo decreasing rapidly? Ask a corona countermeasure expert [News feature] According to the 　Prime Minister's Office, " Hour World Inn " calculated the new corona vaccination rate in each country based on the UN population estimate. According to the " Data ", Japan's second vaccination rate was 75.5%, surpassing Canada at 75.3% to become the top among the G7 countries. The first inoculation rate is 78.7% in Japan and 78.9% in Canada. In addition, the inoculation rate in Japan announced on the homepage of the Prime Minister's Office is calculated based on the population of the Basic Resident Register, and the second inoculation rate for Japanese citizens is 75.1%. Chief Cabinet Secretary Matsuno says that the second vaccination to applicants is expected to be almost completed by the end of this month.

https://news.yahoo.co.jp/articles/f7c042f3cd5506287bd673309ed177ae48d2ad2b

Roche terminates partnership with Atea to develop COVID-19 pill

 Roche Holding AG has ended a partnership with drug developer Atea Pharmaceuticals Inc to jointly develop a COVID-19 antiviral pill, the Swiss drugmaker said on Tuesday, a month after the drug failed to help patients in a small study.

The rights and licenses will return to Atea after the partnership ends in February, and the company said it would continue to develop the treatment and expects data from a late-stage trial in the second half of 2022.

Atea shares were halted for trading ahead of the announcement.

The companies, in October, said the treatment did not show a clear reduction in SARS-CoV-2 viral load in the overall population of patients with mild or moderate COVID-19, compared to a placebo in a mid-stage study.

https://finance.yahoo.com/news/1-roche-terminates-partnership-atea-215820089.html

Pfizer Asks FDA To Authorize Its Merck-Rivaling Covid Pill

 Pfizer stock inched higher Tuesday after the company asked the Food and Drug Administration to authorize its Covid pill for emergency use.

The two-pill regimen, dubbed Paxlovid, could be the first in its class to gain authorization. Merck (MRK) also has an oral antiviral under FDA review, but it uses a different mechanism to fight the virus that causes Covid.

https://www.investors.com/news/technology/pfizer-stock-drug-giant-asks-fda-to-authorize-its-merck-rivaling-covid-pill/

Biden Admin Plans 'Imminent' Booster Expansion; Orders 10M Courses Of 'Pfizermectin'

 As governments worldwide continue to ratchet up authoritarian punishments for the unvaccinated and undervaccinated...

 ...health officials are once again moving the goalposts when it comes to the definition of 'fully vaxxed.'

To that end, the Biden administration is expected to 'begin the process of expanding the booster authorization to all adults' as early as this week, according to Axios.

The decision comes amid data which makes clear that vaccine efficacy wanes over time, requiring a booster three-shot course in order to protect against infection and infecting others reduce the < 1% risk of death in most adults under the age of 50, while marginally reducing transmission until it wears off again in 90 days. 

More via Axios:

Despite disagreement among experts about who needs a booster, there's broad consensus that older people and at least some with underlying health conditions should get an additional dose around six months after their first series.

• But only 36% of Americans 65 and older have received a booster shot, according to the CDC.
• "As every month goes by, the immunity wanes more and more. So as time goes by, you’re going to see more vaccinated people" becoming more vulnerable to the virus, NIAID director Anthony Fauci told Axios.
• The vast majority of breakthrough cases — particularly among younger people — aren't severe. But "as is always the case, the elderly are more vulnerable, because they're more likely to have waning of protection over time," Fauci said.

Pfizermectin

Meanwhile, the Biden administration has also ordered 10 million courses of Pfizer's new Covid-19 antiviral pill - which immediately triggered the highly conflicted fact checker industrial complex at the mere mention that it's anything like Ivermectin - despite doing the exact same thing (inhibiting protease).

On Tuesday, Pfizer announced its plan to ask the US FDA to authorize its emergency use.

U.S. officials see this antiviral pill, and another by Merck and Ridgeback Biotherapeutics, as potential game-changers to help restore a broader sense of normalcy and are eager to add them to a small arsenal of treatments for Americans who contract the coronavirus. With breakthrough cases rising and 30 percent of American adults not fully vaccinated, health officials believe the pills will help tame the pandemic because of their ability to thwart the virus’s most pernicious effects.

Pfizer announced earlier this month that its experimental pill, which will be sold under the brand name Paxlovid, reduced the risk of hospitalization and death by 89 percent in high-risk people when taken within three days of the onset of symptoms. The company said it planned shortly to file an application for emergency use authorization with federal regulators. -Washington Post

Being the altruistic types, Pfizer has also allowed generic drug companies to start cranking out their new antiviral in what couldn't possibly be an effort to unseat Ivermectin as the world's go-to early treatment option.

If one is interested in an in-depth analysis of the similarities between Pfizer's new "game-changer" and Ivermectin, watch below:

We can't wait for more fact checks that benefit big pharma!

https://www.zerohedge.com/covid-19/biden-admin-plans-imminent-booster-expansion-orders-10m-courses-pfizermectin

Spruce Biosciences cut to Market Perform by Leerink

 From Outperform

https://finviz.com/quote.ashx?t=SPRB