Le Monde Reveals Contents of Pfizer Covid Vax-Related Docs Stolen From EU Medicine Watchdog

Last month, the European Medicines Agency - the EU agency tasked with evaluating and regulating medicinal products - said its networks had been breached, with hackers copying a trove of Covid-19 vaccine-related documents. On Friday, the agency claimed that, after being accessed, the documents were also “manipulated” before being leaked online.

Covid-19 vaccine-related documents accessed and copied from the EMA last month suggest that the agency appeared to have been pressured into approving the Pfizer-BioNTech vaccine as quickly as possible despite a range of concerns, Le Monde reports, after investigating files found on the dark web.

The files reportedly include 19 letters sent between 10 and 25 November by agency employees, including among them emails sent to multiple recipients (whose potential for manipulation is therefore deemed more difficult).

These include a letter dated 12 November between EMA staff and EU health commissioner Stella Kyriakides, who reportedly told the regulator that European countries should “receive the vaccine at the same time,” and advised against “forcing” countries to apply national regulatory procedures to avoid further delays in drugs' approval.

A second letter, dated, 19 November, features a senior EMA official describing a “rather tense,” “sometimes even unpleasant” conference call with European Commission officials which gave “an idea of what the EMA may face if expectations, realistic or not, are not met” on the timeframe for approval.

In correspondence dated 20 November, the same official was said to have told members of the Danish Medicines Agency that they were “surprised” by European Commission President Ursula von der Leyen’s move to say publicly that the Pfizer-BioNTech and Moderna vaccines would receive approval before the end of 2020, despite lingering concerns by EMA regulators “with both drugs.”

For the Pfizer-BioNTech preparation, the documents said these “problems” included a lack of inspections at manufacturing facilities, lack of data on commercial lots, “and most importantly, the fact that there are differences in quality between commercial batches and those used in clinical trials,” and in particular – a decrease in the integrity of its main active ingredient – RNA.

The latter issue, Le Monde says, was said to have “caused the greatest concern among researchers tasked with evaluating the vaccine’s quality,” with fears reportedly related not only to effectiveness, but to safety.

US, Canadian, UK Regulators Reportedly More Lax

The Documents also found that the issues brought up by the Europeans were not considered serious by the US Food and Drug Administration, as well as by Canadian and British regulators, as the emergency approval for a vaccine’s temporary use in the three countries are less restrictive than those of the European Union. For this reason, health authorities were urged to “align the general requirements” more closely with the FDA and the Canadian agency “to avoid” a hypothetical situation in which one region “receives all the sub-optimal material.”

Pfizer and BioNTech reportedly responded to the EMA’s concerns in a report dated 26 November, with the review saying that inspections at production sites had begun, and proposing the creation of a 60-percent RNA minimum integrity rate, with one manufacturer saying differences in the amount of RNA “should not affect” the preparation’s effectiveness or safety.

https://sputniknews.com/science/202101171081796150-le-monde-reveals-contents-of-pfizer-covid-vax-related-docs-stolen-from-eus-medicines-watchdog/

Austrians must wear FFP2 respirators in malls & on public transport, govt says amid lockdown extension

Austria has introduced tighter rules on social distancing and mask-wearing, with a nationwide lockdown extended until February 7. Life will hopefully return to normal in the summer, Chancellor Sebastian Kurz has said.

The new rules “don’t make anyone happy and are anything but popular, yet they are necessary, even if everyone is already fed up,” Kurz said on Sunday.

Beginning January 25, Austrians will have to wear respirator-type FFP2 masks in supermarkets, pharmacies, gas stations, and on public transport. The FFP2s offer better protection against airborne infections than cheaper, single-use surgical masks.

The FFP2 masks, which are currently sold in pharmacies, will be available at a “really low” price in supermarkets, according to Health Minister Rudolf Anschober.

People will also have to stay two meters apart from each other, instead of one meter.

Kurz said the decision to bring in stricter rules was made in light of the more contagious variant of the coronavirus that was discovered in Britain at the end of last year, and because officials need to curb the rise of Covid-19 cases across the country.

It would be “reckless” to relax the restrictions now, Kurz said, expressing hope that with the ongoing immunization campaign Austria can return to “complete normality” in the summer.

The news of the tighter rules came a day after some 10,000 people, many of whom were maskless, marched in Vienna, protesting against the lockdown.

Medical officials reported 1,267 new Covid-19 cases in Austria on Sunday, including 281 in Vienna.

Overall, the country has had 388,719 cases and 7,082 deaths from the virus since the start of the pandemic, according to government data.

https://www.rt.com/news/512810-austria-lockdown-mask-rules/

Bernie Sanders just revealed his plan to enact socialism under Biden’s presidency

Bernie Sanders wants to bring socialism to America.

He is hoping to use Joe Biden in the White house to achieve that.

And he just revealed his plan to enact socialism under Biden’s presidency.

For decades, Bernie Sanders has been screaming for socialism.

And previously, he was looked at as the crazy Senator from Vermont who would never be able to achieve his plans.

But in the current political climate, he continues to be looked to as a serious figure.

And even without him in the White House, he is hoping to use Joe Biden as a vehicle to get his agenda implemented in America.

Speaking on CBS’ Late Show, he spoke about how he will use coronavirus relief bills to enact his agenda.

Sanders said, “My first priority is to work on a comprehensive reconciliation bill . . . and I’m going to make that reconciliation bill as bold and aggressive as I possibly can.”

He explains that he wants to use that bill to enact swift changes, which likely won’t be too highly controversial, at least compared to what he actually wants.

But he goes on to explain that he will follow up with a second bill, which will enact his entire socialist playbook.

He continued, “And, in addition to that, probably in a second reconciliation bill, we have to deal with some of the systemic, long-term, ongoing problems facing this country. People can’t live on $10 an hour. We’ve got to raise the minimum wage to a living wage. Insane that we are the only major country on earth not to guarantee health care to all, or have paid family and medical leave. You know what? We’ve got to deal with climate change, with countries around the world, or we’re not going to leave much of a planet to our kids and our grandchildren. In other words, at this particular moment in history, Congress is going to have to rise up and be extremely bold in addressing major crises facing working families and the middle class, and I intend to be very active in that process.”

Socialism and communism have killed hundreds of millions of people.

And the United States has fought against it time and time again.

Yet, the Left hopes to bring it here from the inside, with Bernie Sanders being their top fighter.

https://patriotpulse.net/bernie-sanders-just-revealed-his-plan-to-enact-socialism-under-bidens-presidency/

Biden adviser defends liberal agenda items in $1.9T coronavirus relief plan, dodges on ending filibuster

Relief package includes $20 billion for public transit, $9 billion for cybersecurity, and a $15 minimum wage

President-elect Joe Biden’s proposed coronavirus relief package would cost taxpayers $1.9 trillion, and his economic adviser defended the inclusion of several Democratic agenda items.

During an interview with "Fox News Sunday," Brian Deese insisted that items including $1,400 payments to all Americans, $20 billion for public transit, $9 billion for cybersecurity, and a $15 minimum wage were all important means of helping Americans hurting during the pandemic.

"Let's look at each of those," Deese said. "The cybersecurity resources there are in the wake of the SolarWinds hack. We have seen, and now understand significant vulnerabilities that are exacerbated by COVID, and the fact that so much federal operations are happening online. We need those resources to secure our systems now."

Deese did not explain what transit funding had to do with COVID-19 relief, other than to say that "our transit systems across the country are facing acute crisis" and that improving them now while people are working remotely will prevent difficulties when people eventually start commuting again.

As for the increased minimum wage, Deese said it "is a concrete and direct way to help support those workers who are out there on the front lines right now, providing services to all of us, and give them direct support and a direct boost right now."

Direct support already came in the form of $600 payments to individual Americans, and Biden is proposing an additional $1,400. Deese pointed to bipartisan support for the increased payments. President Trump himself had called for $2,000 checks instead of the $600 that ended up in the most recent stimulus package.

Host Chris Wallace noted that Republicans were unwilling to spend more than $1 trillion in the last package, and that was with a Republican president. With Biden himself saying "there’s not time to waste" and that "we have to act now," Wallace asked if Biden would support ending the filibuster if the GOP said no to his $1.9 trillion plan. Deese did not give a direct answer, pointing to Biden’s past calls for unity, but he also said that acting "quickly" is the incoming administration’s priority.

"Well look, we think we need to move quickly here, but I would also say there’s a lot of skepticism that the president-elect’s call for unity and working together was going to resonate and he won the election resoundingly," Deese said. "There’s a lot of skepticism that Congress would come together in a bipartisan way and deliver a down payment on this relief, and that happened. So let's see where we can get here. There is a lot of, again, a lot of elements of this plan that have support across the board, both in Washington and in state capitals and around the country. But we need to act. We need to act quickly. That's what the economy is telling us, that's what the experts are telling us and so that's our priority."

https://www.foxnews.com/politics/biden-economic-adviser-coronavirus-relief-plan