Report: Moderna excluded infection data from FDA advisory group during booster approval meetings

"Data that was relevant" was allegedly not presented to officials

Bio-engineering company Moderna reportedly withheld important data in meetings with U.S. Food and Drug Administration advisors last year when the agency was debating whether or not to authorize a COVID-19 vaccine booster shot.

A CNN report on Wednesday claims that a group of doctors that advise the FDA on vaccine matters are "disappointed" that "pharmaceutical company Moderna didn’t present a set of infection data on the company’s new Covid-19 booster during meetings last year."

The data in question indicated that "1.9% of the study participants who received the original booster became infected," while "among those who got the updated bivalent vaccine – the one that scientists hoped would work better – a higher percentage, 3.2%, became infected."

The data were allegedly "included in a preprint study that was posted online in June, again in September in an FDA document and then later that month in a top medical journal," but Moderna apparently did not share the data with advisers when meeting with them.

The advisers who spoke with CNN told the network that the data "wouldn’t have changed how they voted, because the data had such limitations," but they reportedly argued that it "still should have been presented to them."

Philip Krause, the former deputy director of the FDA’s Office of Vaccine Research and Review, told CNN that he didn't think there was "any excuse for excluding" the data from the full review process.

“The company’s failure to present this information at the [FDA advisers meeting] and the omission of discussion about the data at that meeting raises questions about the ability of the process to provide a full and transparent review of the data,” he told the network.

https://justthenews.com/government/federal-agencies/report-moderna-excluded-infection-data-fda-advisory-group-during

GOP Sen. Johnson demands CDC hand over data on COVID vaccine side effects

Johnson gave the agency untilJan. 17 to comply with his request.

Wisconsin Republican Sen. Ron Johnson has repeated his demand that the Centers for Disease Control and Prevention supply him with complete data on the side effects of COVID-19 vaccines, alleging that the agency has withheld material information from his office.

"Since June 2022, despite multiple requests for information, the Centers for Disease Control and Prevention (CDC) has repeatedly failed to provide my office with complete data regarding its surveillance of COVID-19 vaccine adverse events," reads Johnson's Tuesday letter to CDC Director Rochelle Walensky.

Johnson has previously sought the agency's data regarding Proportional Reporting Ratio (PRR) analyses that could help to identify potential side effects. The senator contends in the letter that the CDC has ignored his requests for information or only partially complied with them.

He further pointed to an Epoch Times report publishing some of the very data he requested, asserting that the PRR tables the Time published showing "hundreds of adverse events" "appear to be responsive to my previous letters," before questioning why the CDC has withheld the same data from him.

Johnson also recalled a previous reply he received from the CDC claiming that the PRR analyses revealed "no additional unexpected safety signals," which then contrasted with the "hundreds of adverse events" the Times highlighted in that data. The Wisconsin lawmaker demanded the CDC define "unexpected safety signals" and reconcile the disparate interpretations of the data.

"The American people have a right to know the extent to which your agency was aware of and tracked COVID-19 vaccine adverse events. Your lack of transparency is unacceptable," he continued. "Without immediately providing complete and reliable information about COVID-19 vaccine adverse events, you are obstructing Congressional oversight and leaving the public in the dark."

Johnson gave the agency until Jan. 17 to comply with his request.

https://justthenews.com/politics-policy/gop-sen-johnson-demands-cdc-hand-over-data-covid-vaccine-side-effects

American Gas Association Says Possible Ban On Gas Stoves 'Reckless,' Not Based On 'Sound Science'

The American Gas Association (AGA) has taken aim at what it calls a”reckless” potential ban on gas stoves, and said a report linking the use of natural gas for cooking with asthma is “not substantiated by sound science.”

AGA represents more than 200 local energy companies that deliver natural gas to more than 73 million customers throughout the United States.

In a statement on Jan. 10, the association criticized research in the International Journal of Environmental Research and Public Health that linked indoor gas stoves with an increased risk of respiratory illnesses like asthma in children.

The research was led by researchers at RMI, an organization that advocates for climate-friendly, carbon-free buildings, and other environmental groups. The research, which has been peer-reviewed, concluded that 12.7 percent of current childhood asthma nationwide is attributed to gas stove use.

AGA, in its statement on Tuesday, took aim at the report, noting that “any discussion or perpetuation of the allegations in this report which is funded by nongovernmental organizations to advance their agenda to remove consumer energy choice and the option of natural gas is reckless.”

“The authors conducted no measurements or tests based on real-life appliance usage, and ignored literature, including one study of data collected from more than 500,000 children in 47 countries that detected no evidence of an association between the use of gas as a cooking fuel and either asthma symptoms or asthma diagnosis,” the statement read.

https://www.zerohedge.com/medical/american-gas-association-says-possible-ban-gas-stoves-reckless-not-based-sound-science

Computer "Outage" Hits Canadian Flight System Hours After US System Went Down

Update (1426ET):

Nav Canada, the not-for-profit corporation that operates Canada's civil air navigation system, reports the Candian real-time safety alerts system for pilots, otherwise known as NOTAM short for Notice to Air Mission has been hit with an outage.

So far, no delays have been attributed to the outage.

"We are assessing impacts to our operations and will provide updates as soon as they are available," Nav Canada said.

pic.twitter.com/xLCZ0CVwvz

— NAV CANADA (@navcanada) January 11, 2023

This is the second NOTAM system in North America over the last 12 hours that has been hit with outages. As we explained below, the US grounded all planes earlier this morning due to NOTAM outages but restored departures around 0900 ET.

The disruption was enough to spark a travel nightmare for US travelers today and is worsening by the hour. The latest figures from flight tracking website FlightAware show 8,000 flights have been delayed and another 1,200 canceled.

So how do authorities explain the US and Canada's NOTAM systems experiencing outages on the same day?

​* * *

Update (1210ET):

This is one travel mess the airlines can deflect and blame the federal government.

Three hours after the FAA reopened the skies after a nationwide grounding of all commercial jets following a computer outage, there are 7,000 flights delayed and another 1,000 canceled, according to flight tracking website FlightAware.

https://www.zerohedge.com/markets/flights-across-us-affected-after-faa-computer-system-failed

>>18126188

Is this ban to protect Jews?

Israel: Right-Wing MK Calls to Arrest Leftists for “Treason” as Leftists call for Civil War

A Knesset member (MK) of Israel’s new patriotic government has called for Israel-hating leftist politicians to be arrested for “treason” because they are “talking about civil war”. A far-left former MK called for “a large-scale civil uprising.” Returning Prime Minister Benjamin Netanyahu called for a softening of public discourse.

Yesterday, MK Tzvika Fogel of the Jewish Strength (Otzma Yehudit) party called for opposition MKs Yair Lapid, Benny Gantz, Yair Golan, and Moshe Ya’alon to be arrested for “treason.” “These four need to be arrested. They are the most dangerous people out there right now,” Fogel told Kan News on Tuesday evening.

“They are not talking about a demonstration, not about flags or anything else. They are now talking about civil war and calling for war. If they were calling for a demonstration, I would grant them the right to demonstrate. But they treat me as an enemy. This is treason against the state and this is grounds for arrest,” Fogel said, according to Arutz Sheva.

At a press conference with Finance Minister Bezalel Smotrich, Prime Minister Benjamin Netanyahu called the statement “unfortunate”, “I completely deny it.” Netanyahu also called on the opposition to desist from radical attacks on Justice Minister Yariv Levin, who wants to defang the leftist Supreme Court, which has usurped power over the other branches of government.

Netanyahu called on both sides to tone down their rhetoric. “I would like to calm the public discourse. The state will not be destroyed, democracy will not be destroyed, the essence of democracy is more than the balance between the three branches of government and, of course, majority rule is the respect of individual rights. The essence of democracy is that debates, including the one we are having today, are not held with bullets, they are actually decided at the polling stations and decided by votes in the Knesset or the Parliament.”

Former MK Yair Golan of the left-wing Meretz Party has called for “rebellion” and “blocking roads”, tweeting on Tuesday, “My friends, against this evil government there is only one method to be used, and that is a widescale public rebellion. The destruction of the judiciary, unlimited political appointments, permitting the haredim to do whatever they please using our tax money … why should we agree to this? Why should we allow this to rain down on our heads, to hit our pockets, to affect our lives? We will never agree to this.” Calling Netanyahu’s government “malicious and evil,” Golan said that the only to fight against it is “a large-scale civil uprising.”

Knesset member Ariel Kallner (Likud) filed charges against Golan for incitement, and tweeted: “It is inconceivable that threats will replace discussions! The Israel Police must show zero tolerance towards calls for rebellion against the elected government and explicit threats that it not carry out the policies it is committed to. I call on the leaders of the left to come to their senses and show responsibility. The path of incitement is not a substitute for the dialogue and discussion that we are starting these days in the Knesset. It will not succeed either.”

Opposition leader Yair Lapid has accused Justice Minister Yariv Levin of “extreme regime change”, “canceling the Declaration of Independence”, and “cutting Israel off from the family of liberal countries” for trying to stop the lawfare practiced by leftist judges against Benjamin Netanyahu and other conservative politicians.

https://www.thegatewaypundit.com/2023/01/israel-right-wing-mk-calls-arrest-leftists-treason-leftists-call-civil-war/

Moderna CEO Announces New mRNA Shot for Heart Failure Patients to Help “Grow Back New Blood Vessels”

Stéphane Bancel, CEO of Moderna, announced the development of a new mRNA shot to treat patients suffering from heart failure.

In a statement released on Monday, the pharmaceutical company said it currently has 48 programs in development, including 36 programs that are currently being tested in clinical trials.

These programs include mRNA infectious disease vaccines and mRNA therapeutics that span seven different modalities.

“We enter 2023 in a great position, with significant momentum across our clinical pipeline, a highly energized team and a strong balance sheet of over $18 billion of cash and cash equivalents,” said Stéphane Bancel, Chief Executive Officer of Moderna.

“With our infectious disease franchise continuing to accelerate with exciting near-term catalysts for RSV Phase 3 data and Flu Phase 3 data, and recent breakthroughs in the development of individualized cancer treatments, as well as our rapid advancement in rare diseases and promising cardiology programs, the Moderna platform is delivering across several modalities. Our progress is meeting the high expectations we set out a few years ago, and with encouraging clinical data across the entire Moderna platform, we are accelerating our investments to deliver the greatest possible impact to people through mRNA medicines. Our board has approved a significant increase to our R&D investments, with a budget for 2023 of around $4.5 billion. 2023 is going to be a very exciting year for Moderna, and most importantly, for patients.”

One of the vaccines that the US-based company is working on is the treatment for patients suffering from heart failure.

In an interview with Sky News, Bancel said, “We are now in a super exciting program where we inject mRNA in people’s heart after a heart attack to grow back new blood vessels and re-vascularize the heart.”

In short, Moderna will fix the problem it created.

https://www.thegatewaypundit.com/2023/01/go-moderna-ceo-announces-new-mrna-shot-heart-failure-patients-help-grow-back-new-blood-vessels/

https://investors.modernatx.com/news/news-details/2023/Moderna-Announces-Advances-Across-mRNA-Pipeline-and-Provides-Business-Update/default.aspx