#Ivermectin MedinCell Announces Positive Results for the SAIVE Clinical Study in Prevention of Covid-19 Infection in a Contact-Based Population (The company plans to share the final analysis of the study in a peer-reviewed publication at a later date)

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MedinCell collaborates with tier one pharmaceuticals companies and foundations to improve Global Health through innovative therapeutic options.

Based in Montpellier, MedinCell is a public company (Euronext, MEDCL), currently employing 150 people from over 30 different nationalities.
www.medincell.com

https://finance.yahoo.com/news/medincell-announces-positive-results-saive-201000595.html

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Yahoo!Finance

January 6, 2023

MedinCell Announces Positive Results for the SAIVE Clinical Study in Prevention of Covid-19 Infection in a Contact-Based Population

MONTPELLIER, France, January 05, 2023–(BUSINESS WIRE)–Regulatory News:

MedinCell (Paris:MEDCL):

The study conducted in 399 participants met its primary efficacy endpoint with a reduction of 72% of COVID-19 infection in the group treated with daily oral administration of ivermectin compared to the placebo group

Ivermectin administered for 28 days demonstrated acceptable safety and tolerability without any unexpected safety signals

The SAIVE study was conducted to support mdc-TTG program, whose objective is to provide prevention of Covid-19 infection for weeks or months with a single injection of a long-acting formulation of ivermectin based on MedinCell’s proprietary technology, BEPO®

Note: this publication is not a recommendation to use ivermectin against Covid-19.

The SAIVE Trial (NCT 05305560) is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical study, evaluating the safety and efficacy of ivermectin tablets taken orally for 28 days, under the oversight of a U.S. based independent Data Monitoring Committee. The study was conducted in Bulgaria between March and November 2022.

All participants were unvaccinated adults and had been exposed to the virus within 5 days of screening after documented close contact with a person who had a PCR-confirmed SARS-CoV-2 infection.

Participants randomized to ivermectin group showed a highly statistically significant reduction (72%) of laboratory-confirmed infections between baseline and Day 28 (30/200) versus placebo (105/199), the study’s primary endpoint, with p<0,0001.

No safety signals related to daily intake of ivermectin, 200 microgram/kg on Day 1 then 100 microgram/kg daily from Day 2 to Day 28 were identified during the study.

The company plans to share the final analysis of the study in a peer-reviewed publication at a later date.

The SAIVE study provides encouraging data demonstrating efficacy and safety of ivermectin in prevention of Covid-19 infection in a post-exposure situation. It supports the development of a long-acting injectable, said Christophe Douat, CEO of MedinCell. Such a long-acting injectable would provide a complementary tool against Covid-19. Several candidate formulations of ivermectin are ready for clinical batch manufacturing to start regulatory preclinical and clinical development. We will be reviewing the strategy for this asset based on this top line result and the upcoming comprehensive analysis of the study.”


https://finance.yahoo.com/news/medincell-announces-positive-results-saive-201000595.html

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More desperate than ever, Gerakan invites KJ to join them

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Come join Gerakan, Youth chief tells KJ

FMT Reporters

January 28, 2023 12:00

PETALING JAYA: Gerakan has become the first party to court Khairy Jamaluddin following his sacking from Umno last night, with its youth wing saying the former health minister would be a perfect fit for the party.

Acting Gerakan Youth chief Wong Chia Zhen believed that the party’s moderate principles were in line with Khairy’s, while praising the former health minister for his credibility.

“Although Khairy had played up racial issues in the past when he was Umno Youth chief, we are willing to forgive him because we are all human, and we can make mistakes.”

“I believe that Gerakan is the most suitable platform for Khairy at this time. We welcome Khairy to join Gerakan as a member,” he said in a statement.

In criticising Umno’s sacking of Khairy, Wong said the former Rembau MP was a politician of calibre and had nearly succeeded in unseating Pakatan Harapan (PH) in its stronghold of Sungai Buloh in the recent general election (GE15).

https://www.freemalaysiatoday.com/category/nation/2023/01/28/come-join-gerakan-youth-chief-tells-kj/

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Andrew Tate, convert to Islam, is still in a Romanian jail, and will stay till end of March

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Videos: The drunk Datuk and his Flying Porsche at IOI City Mall, KL

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Tawau: Woman charged with murder of ex husband, Nurman Bakaratu, whose corpse was found on January 16, 2023. 6 cops and a civilian charged with killing, abetting of same victim

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Six cops, one civilian charged with killing, abetting murder of e-hailing driver

Accused face death penalty if convicted according to Sections 109, 302 of Penal Code

Updated 1 day ago · Published on 08 Feb 2023 8:15PM

TAWAU – Six policemen and a civilian were charged in the magistrates’ court here today with killing and abetting the murder of an e-hailing driver last month at an oil palm estate in Tawau.

The policemen Rosdi Rastam, 44, Dennis Anak Enit, 44, Fabian Anak Rungam, 43, Khairul Azman Bakar, 47, Mohd Azlan Sakaran, 39, and a civilian Vivien Fabian, 34, were charged with killing Nurman Bakaratu, 61, near Jalan Anjur Juara, Jalan Apas Batu 5, Tawau between 7.30pm and 11.30pm on January 13.

A senior police officer Datuk Mat Zaki Md Zain, 58, was charged with abetting the murder under Section 109 of the Penal Code read together with Section 302 of the same code, both carry the death penalty if convicted.

The six other accused were charged under Section 302 of the Penal Code read together with Section 34 of the same code.

No plea was recorded from all the accused after the charges were read out before magistrate Dzul Elmy Mohd Yunus as murder falls under the purview of the high court, and the court set April 11 for re-mention. 
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On January 30, Nurima Juli, 33, an unemployed woman was charged at the same magistrates’ court with murdering Nurman. – Bernama, February 8, 2023

https://www.thevibes.com/articles/news/84977/six-cops-one-civilian-charged-with-killing-abetting-murder-of-e-hailing-driver

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The Federal Aviation Administration (FAA) and the fake claim that pilots have heart damage caused by the COVID-19 vaccines

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The Federal Aviation Administration is the largest transportation agency of the U.S. government and regulates all aspects of civil aviation in the country as well as over surrounding international waters. Wikipedia

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Fake claim: Steve Kirsch falsely claims that a change in FAA guidelines is linked to COVID-19 vaccines.

Fact: The change was made after cardiology consultants provided new scientific evidence showing that anything under 300 milliseconds is not a risk for sudden or subtle incapacitation, the FAA spokesperson said.

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28/1/2033

AP NEWS

NOT REAL NEWS: A look at what didn’t happen this week

By The Associated Press yesterday

New FAA cardiac health rules not prompted by COVID-19 shots

CLAIM: The Federal Aviation Administration loosened the requirements that airline pilots must meet for cardiac health because a large number have heart damage caused by the COVID-19 vaccines.

THE FACTS: In October, the FAA widened the acceptable parameters it uses when screening pilots for a specific heart condition called heart block, or AV block. This change was made in response to new scientific evidence about the condition from its cardiology consultants, not adverse reactions to COVID-19 vaccines. The update prompted speculation, with some falsely claiming that it is connected to the vaccines. AV block can make it difficult for one’s heart to pump blood effectively by delaying or blocking the electrical signal that controls one’s heartbeat. It is classified as first, second or third degree and is often diagnosed with an electrocardiogram test, also referred to as an EKG or ECG, which measures the heart’s electrical activity. A normal EKG result is generally defined as having a PR interval — how long it takes the electrical signal to travel from the top part of the heart to the bottom — of between 120 and 200 milliseconds. A PR interval of more than 200 milliseconds typically indicates AV block. However, first-degree AV block only delays the electrical signal, rather than blocking it, and often does not have noticeable effects. “In an otherwise healthy heart, this is usually a benign condition and rarely causes any symptoms,” said Dr. Roland Assi, a cardiac surgeon and assistant professor at Yale University. Previously, pilots with first-degree AV block were required to submit documentation proving that they had “no evidence of structural function or coronary heart disease” before they could be certified to fly. The FAA’s recent update to its guidelines specifies that pilots with first-degree AV block and a PR interval of less than 300 milliseconds can be certified without additional documentation if they are not exhibiting symptoms and if their medical examiner does not have any concerns. This decision was not made because pilots are developing heart problems from COVID-19 vaccinations. “When making changes to medical requirements and guidance, the FAA follows standard processes based on data and science,” the agency told the AP in an emailed statement. “Our cardiology consultants provided information that anything under 300ms requires no additional testing and is not a risk for sudden or subtle incapacitation.” If a pilot has first-degree AV block with a PR interval of 300 milliseconds or more, further data still must be submitted to the FAA before a final decision on their certification can be made. According to Rossi, certifying a pilot with first-degree AV block carries “no real risk,” as long as there are no other issues. Dr. Richard Kovacs, chief medical officer at the American College of Cardiology, agreed that the FAA’s new guidelines are not worrisome. “The FAA’s updated criteria for widening the ECG parameters regarding AV Block are reasonable and consistent with ACC guideline recommendations,” he wrote in an email to the AP. Severe reactions to COVID-19 vaccines, such as sustaining heart damage, are rare, according to the CDC. Rossi and Adler explained that scientific evidence does not point to AV block being linked to the COVID-19 vaccine. The FAA also said in its statement that it “has no evidence of aircraft accidents or incapacitations caused by pilots suffering medical complications associated with COVID-19 vaccines.”

— Associated Press writer Melissa Goldin in New York contributed this report.


https://apnews.com/article/health-ap-fact-check-texas-7bfba50209c5b423f7a2c9f4ea2a5904?utm_campaign=SocialFlow&utm_source=Twitter&utm_medium=APFactCheck

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USA Today

Fact check: Post falsely claims change in FAA guidelines linked to COVID-19 vaccine

Sudiksha Kochi

USA TODAY

Jan 24, 2023

The claim: FAA loosened pilot ECG parameters due to COVID-19 vaccine impact

A Jan. 17 Instagram post (direct link, archived link) shows a screenshot of a tweet that portrays two pilots in a cockpit.

“The FAA just telegraphed the fact that a substantial number of airline pilots have had serious heart damage from the COVID vaccine by widening the ECG parameters for pilots,” reads the tweet.

The tweet includes a link to a Substack article from Steve Kirsch, a tech millionaire who has previously spread misinformation about the COVID-19 vaccines and makes the same claim about the FAA and the vaccine. 

Our rating: False

A spokesperson for the Federal Aviation Administration told USA TODAY the agency relaxed electrocardiogram parameters because of new information presented by cardiology consultants. The change had nothing to do with the COVID-19 vaccine.
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The requirements were relaxed due to new information regarding the speed of electrical signals called “PR intervals” that move from the upper chamber to the lower chamber of the heart and are measured by an electrocardiogram test, Dr. Christopher Kramer, chief of the cardiovascular division at the University of Virginia, told USA TODAY in an email.
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The change was made after cardiology consultants provided new scientific evidence showing that anything under 300 milliseconds is not a risk for sudden or subtle incapacitation, the FAA spokesperson said.
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There’s also no evidence of a large number of pilots suffering heart damage from the COVID-19 vaccine as the post claims, Kramer added.

The FAA spokesperson said that there is “no evidence of aircraft accidents or incapacitations caused by pilots suffering medical complications associated with COVID-19 vaccines.” Multiple airlines have told USA TODAY the same.

USA TODAY has debunked other claims falsely linking pilots and the COVID-19 vaccines, including baseless assertions that pilots started training for sudden death during a flight in 2022 and that COVID-19 vaccinated American Airlines pilots died during flights.

USA TODAY reached out to the social media users who shared the claim for comment.

The Associated Press and PolitiFact also debunked the claim. 

https://www.usatoday.com/story/news/factcheck/2023/01/24/fact-check-post-falsely-links-new-faa-guidelines-covid-19-vaccine/11105247002/

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Ong Ye Kung: Singapore did not see spike in COVID-19 cases over Chinese New Year

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Auckland is drowning! State of Emergency declared

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Nuclear Disasters: Should You Get Iodide Now?

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Singapore’s Mustafa expands to Malaysia

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