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EU begins real-time review of Sanofi-GSK COVID-19 vaccine

Europe’s drug regulator started a real-time review of the Covid-19 vaccine developed by French drugmaker Sanofi and Britain’s GlaxoSmithKline, the fifth shot currently under such a review as of July 20.

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EU begins real-time review of Sanofi-GSK COVID-19 vaccine

(Reuters) – Europe’s drug regulator said on Tuesday it had started a real-time review of the COVID-19 vaccine developed by French drugmaker Sanofi (SASY.PA) and Britain’s GlaxoSmithKline (GSK.L), the fifth shot under such a review currently.

The decision to start the “rolling review” of the vaccine, Vidprevtyn, was based on preliminary results from lab studies and early stage clinical trials in adults, the European Medicines Agency (EMA) said.

Late-stage global trials for the protein-based coronavirus vaccine candidate began in May.

Sanofi and GSK hope to get approvals by the end of 2021 after early stage results showed the vaccine produces a robust immune response. read more

“EMA will assess the compliance of Vidprevtyn with the usual EU standards for effectiveness, safety and quality,” the regulator said, without giving details on data it had received so far and an expected timeline for approval.

FILE PHOTO: A Sanofi logo is seen during the company’s annual results news conference in Paris, France, February 6, 2020. REUTERS/Benoit Tessier/File Photo

EMA’s rolling reviews are aimed at speeding up the approval process by allowing researchers to submit findings in real-time before final trial data is available.

Vidprevtyn uses the same technology as one of Sanofi’s seasonal influenza vaccines. It will be coupled with an adjuvant, a substance that acts as a booster to the shot, made by GSK.

Other COVID-19 vaccine candidates in EU’s rolling review are those from CureVac (5CV.DE), Novavax (NVAX.O), Sinovac (SVA.O) and Russia’s Sputnik V.

Reporting by Pushkala Aripaka in Bengaluru; Editing by Sriraj Kalluvila

Our Standards: The Thomson Reuters Trust Principles.

 

Reuters source:

https://www.reuters.com/business/healthcare-pharmaceuticals/eu-begins-real-time-review-sanofi-gsk-covid-19-vaccine-2021-07-20

 

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Where Carnival, Norwegian, Royal Caribbean Sit on Covid Vaccines

Do You still need to be vaccinated to go on a Royal Caribbean, Carnival, or Norwegian Cruise?

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Do You still need to be vaccinated to go on a Royal Caribbean, Carnival, or Norwegian Cruise?

Cruise line covid-19 vaccination and testing rules, which were imposed by the Centers for Disease Control and Prevention at the beginning of the pandemic, have been stricter than most. After the pandemic started in early 2020, the CDC signed a No Sail Order on March 14, 2020, which was finally lifted after nearly eight months on Oct. 30, 2020.

After the No Sail Order was lifted, the CDC enacted extremely restrictive rules and regulations to help keep passengers safe with the covid pandemic still raging throughout the world. The rules and regulations were set forth to begin to return cruise lines to operational status.

The cruise lines first had to be staffed accordingly and set up with the ability to test, treat and quarantine for covid medical emergencies. Testing for crew and passengers before embarkment and before dis-embarkment was required. The testing at pre-embarkment was a measure to protect those boarding, while the post-trip testing was for determining if an infection started on the cruise line itself. Being able to track the virus was very important in the prevention of spreading the virus and protecting patrons.

Image source: Shutterstock

Vaccination Still Not a Free Pass to Board

Once the vaccination was developed and approved, it became part of the CDC guidelines for cruise line adult passengers to have their vaccination before boarding. Even with a vaccination, guests still needed to test before they boarded the cruise lines. As the vaccine was approved for younger age groups, those age groups were then also required to have the vaccine to travel. Passengers were required to be fully vaccinated unless they are exempt by some status.

Before boarding, cruise line passengers who tested positive, as well as their travel companions, were not allowed to board, depending on the cruise line and how long the cruise may be. Some passengers were allowed to board and then isolate, others would have to reschedule their trip. Trip insurance is a good buy these days.

Cruise Lines Letting Loose on Vaccine Policies

Carnival Cruise Line  (CCL) - Get Carnival Corporation Report has now removed pre-cruise testing for vaccinated guests and also welcomes unvaccinated guests to travel. Fully vaccinated guests traveling less than 16 nights with the cruise line will no longer be subjected to testing, but still must provide proof of their vaccination status. Unvaccinated travelers will only need to provide a negative covid test result to board the ships. All rules and regulations are still subject to the destination country’s guidelines.

According to the Healthy Sail Center for Royal Caribbean  (RCL) - Get Royal Caribbean Group Report, the cruise line has updated its covid vaccination protocol. The cruise line will now allow passengers regardless of vaccination status to board in some ports if the travelers meet the testing requirements. Testing requirements vary by cruise departure and destination. Check the cruise lines port departure for updated information on requirements.

There is, however, a major exception, at least for now, which is obvious when you look at the specific wording shared by the cruise line:

"Starting with September 5 departures, all travelers regardless of vaccination status can cruise on the following itineraries, as long as they meet any testing requirements to board.

  • Cruises from Los Angeles, California.
  • Cruises from Galveston, Texas.
  • Cruises from New Orleans, Louisiana.
  • Cruises from a European homeport.

Notice that Florida, a major port for the cruise line, is not currently on the list.

In the U.S. aside from Florida, any guest with a valid negative covid test within the last three days will be able to board. These guests will also not be required to take a second test at the boarding terminal. Fully vaccinated guests do not need to provide proof of a negative covid test for shorter cruises. See the cruise line website for all updated information as it is subject to change.

Beginning Sept. 3, Norwegian Cruise Line  (NCLH) - Get Norwegian Cruise Line Holdings Ltd. Report is dropping its covid vaccine requirements for all its cruises. The cruise line stated that it is continuing to follow requirements for all destination countries, so guests traveling will want to check on destination vaccine and testing requirements. All guests 12 and older regardless of vaccination need to show proof of a negative test within 72 hours. Check NCL online for further instructions prior to travel.

The CDC has taken the stance that travelers are now well informed enough to make their own decisions when it comes to traveling on cruise lines. The travelers are taking their own assumed risk for their health and well-being. Cruise lines are now welcoming this new freedom for their passengers. 

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Here’s Where Carnival, Norwegian, Royal Caribbean Stand on Covid Vax Rules

The three major cruise line have all made big changes to their vaccine policies and some passengers may be very happy (while some won’t.)

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The three major cruise line have all made big changes to their vaccine policies and some passengers may be very happy (while some won't.)

Cruise line covid-19 vaccination and testing rules, which were imposed by the Centers for Disease Control and Prevention at the beginning of the pandemic, have been stricter than most. After the pandemic started in early 2020, the CDC signed a No Sail Order on March 14, 2020, which was finally lifted after nearly eight months on Oct. 30, 2020.

After the No Sail Order was lifted, the CDC enacted extremely restrictive rules and regulations to help keep passengers safe with the covid pandemic still raging throughout the world. The rules and regulations were set forth to begin to return cruise lines to operational status.

The cruise lines first had to be staffed accordingly and set up with the ability to test, treat and quarantine for covid medical emergencies. Testing for crew and passengers before embarkment and before dis-embarkment was required. The testing at pre-embarkment was a measure to protect those boarding, while the post-trip testing was for determining if an infection started on the cruise line itself. Being able to track the virus was very important in the prevention of spreading the virus and protecting patrons.

Image source: Shutterstock

Vaccination Still Not a Free Pass to Board

Once the vaccination was developed and approved, it became part of the CDC guidelines for cruise line adult passengers to have their vaccination before boarding. Even with a vaccination, guests still needed to test before they boarded the cruise lines. As the vaccine was approved for younger age groups, those age groups were then also required to have the vaccine to travel. Passengers were required to be fully vaccinated unless they are exempt by some status.

Before boarding, cruise line passengers who tested positive, as well as their travel companions, were not allowed to board, depending on the cruise line and how long the cruise may be. Some passengers were allowed to board and then isolate, others would have to reschedule their trip. Trip insurance is a good buy these days.

Brittany Murray/MediaNews Group/Long Beach Press-Telegram via Getty Images

Cruise Lines Letting Loose on Vaccine Policies

Carnival Cruise Line  (CCL) - Get Carnival Corporation Report has now removed pre-cruise testing for vaccinated guests and also welcomes unvaccinated guests to travel. Fully vaccinated guests traveling less than 16 nights with the cruise line will no longer be subjected to testing, but still must provide proof of their vaccination status. Unvaccinated travelers will only need to provide a negative covid test result to board the ships. All rules and regulations are still subject to the destination country’s guidelines.

According to the Healthy Sail Center for Royal Caribbean  (RCL) - Get Royal Caribbean Group Report, the cruise line has updated its covid vaccination protocol. The cruise line will now allow passengers regardless of vaccination status to board if the travelers meet the testing requirements. Testing requirements vary by cruise departure and destination. Check the cruise lines port departure for updated information on requirements.

In the U.S., any guest with a valid negative covid test within the last three days will be able to board. These guests will also not be required to take a second test at the boarding terminal. Fully vaccinated guests do not need to provide proof of a negative covid tests for shorter cruises. See the cruise line website for all updated information as it is subject to change.

Beginning Sept. 3, Norwegian Cruise Line  (NCLH) - Get Norwegian Cruise Line Holdings Ltd. Report is dropping its covid vaccine requirements for all its cruises. The cruise line stated that it is continuing to follow requirements for all destination countries, so guests travelling will want to check on destination vaccine and testing requirements. All guests 12 and older regardless of vaccination need to show proof of a negative test within 72 hours. Check NCL online for further instructions prior to travel.

The CDC has taken the stance that travelers are now well informed enough to make their own decisions when it comes to travelling on cruise lines. The travelers are taking their own assumed risk for their health and well-being. Cruise lines are now welcoming this new freedom for their passengers. 

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US: The New Real Hoaxes?

US: The New Real Hoaxes?

Authored by Pete Hoekstra via The Gatestone Institute,

The investigative reporting by these two organizations…

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US: The New Real Hoaxes?

Authored by Pete Hoekstra via The Gatestone Institute,

  • The investigative reporting by these two organizations [the New York Times and the Washington Post] was so thorough and groundbreaking it turned up things that were not even there.

  • For having refused to rescind these awards, the Pulitzer Committee should receive its own Pulitzer -- for fraud.

  • The real hoax appears to have been the CCP's ostensible good behavior and the now-hugely-discredited initial reporting on the virus.

  • Or how about the Hunter Biden laptop cover-up? Once again, On October 14, 2020, just weeks before the 2020 presidential election, a critical story of possible extensive influence-peddling with senior intelligence officers in the CCP, Russia and Ukraine by the son of a presidential candidate. The contents of the laptop raised questions that the candidate at the time, Vice President Joe Biden, could be compromised. The entire subject was decisively pushed aside, along with the potential threat to national security that such an eventuality might entail.

  • Also not allowed during the January 6th hearings have been any witnesses for the defense, any cross-examination, or any exculpatory evidence.

  • One wonders, for instance if the January 6th Committee will consider the July 29, 2022 tweet by General Keith Kellogg, that on January 3, 2021, Trump, in front of witnesses, did indeed ask for "troops needed" for January 6. Kellogg wrote: "I was in the room."

  • The January 6th Committee has also not released any information about government informants or FBI undercover law enforcement officers who might have been in the crowd, and Pelosi is also said to be blocking access to a massive quantity of documents. Finally, according to attorney Mark Levin, under the Constitution's separation of powers, Congress, has no legitimacy even to hold a criminal investigation: that power belongs to the Judiciary. The entire proceeding is illegitimate and a usurpation of power.

  • Is it surprising that after the Pulitzer decision, the Russia collusion hoax, the Whitmer kidnapping hoax, the Covid origin hoax, the Hunter Biden laptop hoax, and now the January 6th Committee hoax, that many Americans believe there is something wrong with the system?

Recently former US President Donald Trump challenged the award of Pulitzer Prizes to the New York Times and the Washington Post for their investigative reporting on alleged collusion between the 2016 Trump campaign and Russia.

The investigative reporting by these two organizations was so thorough and groundbreaking it turned up things that were not even there.

You have to hand it to them for this so-called "great reporting": the Pulitzer Committee sure did.

We now know, of course, the grand conspiracy pushed by these papers is nothing more than thoroughly debunked disinformation. For having refused to rescind these awards, the Pulitzer Committee should receive its own Pulitzer -- for fraud.

The intractability of the Pulitzer Committee is only the latest example of why so many Americans have been losing trust in their institutions, both public and private. Rather than admitting that these awards were a mistake, and that much of the reporting was not investigative reporting, but merely a recitation of fabrications put forward by political hacks for campaign purposes, the Pulitzer Committee announced that it will stand by its initial decision, facts be dammed.

The Russia hoax is emblematic of the model built by the anti-Trump, anti-America First, anti-populist movement that the American people have experienced for the last six years. It embodies many of the characteristics that have frustrated Americans. It is a combination of influential forces -- media, social media, political players, and government -- that put forward information detrimental to one -- oddly always the same -- political viewpoint. In this instance, populists -- believers in the rights, wisdom or virtues of the common people, according to Merriam Webster -- who might embrace the concept of personal freedom espoused by the Constitution, a free market economy, economic growth, energy independence, school choice, equal application of the law and decentralized governance.

Much of the material used to foster the Russia hoax originated from the discredited "Steele Dossier," pedaled by former British spy Christopher Steele, funded by Clinton-linked opposition research firm FusionGPS, and pushed by Clinton campaign lawyer Michael Sussman. This discredited information was shared widely -- and often, it seems, with prior knowledge of its falseness -- through the mainstream media and social media when it was leaked to the press early in 2017 just before Donald Trump was sworn in as president. The material contributed to the launching of the Mueller "Russiagate" investigation, which cast a shadow over the first two years of the Trump administration. Government officials were involved as CIA Director John BrennanFBI Director James Comey and DNI James Clapper all lent their credibility to the supposed authenticity or seriousness of the Russian materials. All of this did tremendous damage to the effectiveness of the Trump administration, as it sought to govern, by putting it under a cloud of suspicion and illegitimacy from the outset.

This, however, was not the only example. Consider the disrupted kidnapping plot against Michigan Governor Gretchen Whitmer in her key swing state for presidential elections. "The FBI got walloped [in April]", according to the New York Post, " when a Michigan jury concluded that the bureau had entrapped two men accused of plotting to kidnap Gov. Gretchen Whitmer. Those men and others were arrested a few weeks before the 2020 election in a high-profile, FBI-fabricated case...."

The media, however, for the most part portrayed the kidnapping plot as the work of domestic terrorists, with the implied inference being they were right-wing Trump supporters. Whitmer went so far as to accuse Trump of being complicit in the plan, even though it emerged that these alleged plotters had also supposedly wanted to hang Trump. The FBI, it was later shown, had been heavily involved in the plot through informants and individuals it had placed in the group. By the time the case came to trial after the election, Biden had won Michigan's electoral votes and the damage had been done.

Consider, also, the COVID pandemic. The "facts" at the time were supposedly that it came from "nature" and that the Chinese Communist Party (CCP) government had supposedly known nothing about its human-to-human transmissibility, even though it had "made whistleblowers disappear and refused to hand over virus samples so the West could make a vaccine."

The CCP, early on, was portrayed as a constructive player in controlling the spread of the virus, even as it was recalling and hoarding all of its Personal Protective Equipment (PPE). This fiction was reinforced by Dr. Anthony Fauci, the World Health Organization, and other prominent participants – apart from Taiwan, which futilely tried to warn the WHO of the coronavirus's fierce human-to-human transmissibility, only to be dismissed.

The mainstream media and social media also quickly began parroting the "official" story line. Social media companies suspended the accounts of whoever might have had a different opinion and some were even canceled.

For the 10 months leading up to the November 2020 election, the narrative was set: COVID-19 was a naturally occurring virus and the CCP was in the clear. Imagine how different the 2020 presidential election might have been if the debate was how the world would have held the CCP accountable for the leak and coverup of COVID from the Wuhan Institute of Virology. Now in 2022, a lab-leak is considered the most "likely cause" of the coronavirus, but again the political damage, and a gigantic amount of non-political damage, has already been done. The real hoax appears to have been the CCP's ostensible good behavior and the now-hugely-discredited initial reporting on the virus.

Or how about the Hunter Biden laptop cover-up? Once again, On October 14, 2020, just weeks before the 2020 presidential election, a critical story of possible extensive influence-peddling with senior intelligence officers in the CCP, Russia and Ukraine by the son of a presidential candidate. The contents of the laptop raised questions that the candidate at the time, Vice President Joe Biden, could be compromised. The entire subject was decisively pushed aside, along with the potential threat to national security that such an eventuality might entail.

Discussion of Hunter Biden's laptop with its reportedly incriminating information about the Biden family business dealings with the CCPRussia, and other actors in what appeared to be a model of pay-for-play, was instantly shut down. Fifty-one former government intelligence officials , who we now know were perfectly well aware that the laptop was real – the FBI had been holding it for months -- wrote a letter describing the contents of the laptop as having "all the classic earmarks of a Russian information operation" designed to damage Joe Biden.

NPR famously downplayed the story, and once again, if you used social media to post information originally reported by the New York Post, you were canceled.

A year and a half after the election, the facts were finally "officially" accepted: Well, what do you know, it really was Hunter Biden's laptop and the material on it "is real!"

Once again, the leadership at the FBI, the media, social media, and former government officials had developed a hoax to damage their political opposition and the people who supported it.

Finally, there is the January 6th Committee, a one-sided investigative body, sometimes called "the third (attempted) impeachment." The Committee appears to have been put in place to stop Trump from running for office again. Before the proceeding even began, its outcome was predetermined: Trump was to be found guilty of -- something. As Stalin secret police chief, Lavrentiy Beria used to say during Soviet Russia's reign of terror, "Find me the man and I'll find you the crime." So the US show trial commenced.

Even its start was ominous. House Speaker Nancy Pelosi, in an unprecedented move, vetoed the committee appointments of Representatives Jim Banks and Jim Jordan. This rebuff led House Minority Leader Kevin McCarthy to pull his five Republican candidates from participating. Pelosi, it appeared, wanted only anti-Trump folks to serve on the Committee. Also not allowed during the January 6 hearings have been any witnesses for the defense, any cross-examination, or any exculpatory evidence.

One wonders, for instance if the January 6th Committee will consider the July 29, 2022 tweet by General Keith Kellogg, that on January 3, 2021, Trump, in front of witnesses, did indeed ask for "troops needed" for January 6. Kellogg wrote:, "I was in the room:"

"Great OpEd. Reinforces my earlier comment on 6 Jan Cmte. Has quote from DOD IG Report regarding 3 Jan 2021 meeting with Actg Def Secy Miller/CJCS Milley in the Oval on the 6 Jan NG request by POTUS on troops needed. I was in the room."

While purportedly examining in detail every decision and action by Trump and his team, the Committee refuses to question Pelosi, among the leading figures responsible for the security of the Capitol. She reportedly "turned down" requests for greater security. According to the Federalist:

"Four days after the riot, former Capitol Police Chief Steven Sund, who resigned his post in the aftermath, told The Washington Post his request for pre-emptive reinforcement from the National Guard ahead of Jan. 6 was turned down. Sund said House Sergeant at Arms Paul Irving, overseen by Pelosi, thought the guard's deployment was bad "optics" two days before the raid.... Despite the Associated Press and Washington Post's best efforts to run interference for the speaker, suddenly exonerating her of duties overseeing Capitol security, the riot on Jan. 6 was a security failure Pelosi owns. If the "speaker trusts security professionals to make security decisions," then why, as the police breach unfolded, did Irving feel compelled to seek the speaker's approval to dispatch the National Guard, as The New York Times reported? How could Pelosi also order the extended shut down of the Capitol to visitors, citing coronavirus, and install metal detectors in the House chamber?"

The Committee has not evaluated the performance of the Capitol Police or other law enforcement agencies, but it has targeted the "private records of individuals with no connection to the violence."

The January 6th Committee has also not released any information about government informants or FBI undercover law enforcement officers who might have been in the crowd, and Pelosi is also said to be blocking access to a massive quantity of documents. Finally, according to attorney Mark Levin, under the Constitution's separation of powers, Congress, has no legitimacy even to hold a criminal investigation: that power belongs to the Judiciary. The entire proceeding is illegitimate and a usurpation of power. The Committee's narrative is clear: Donald Trump is responsible for the events of January 6, now let us manufacture the evidence to prove it.

This article has not even delved into the 28 states that "changed voting rules to boost mail-in ballots." Some States apparently omitted both state law and the need for states' legislatures to be the sole arbiters of election law, as required by the Constitution; the $400 million spent by Facebook founder Mark Zuckerberg; the 2000-plus "mules" and the algorithms that sent conservative emails to spam while emails with liberal content went through to the addressees.

Is it any wonder that many Americans have lost faith in their institutions and leaders? Is it surprising that after the Pulitzer decision, the Russia collusion hoax, the Whitmer kidnapping hoax, the Covid origin hoax, the Hunter Biden laptop hoax, and now the January 6th Committee hoax, that many Americans believe there is something wrong with the system? The media, social media, government officials and others have been complicit in undermining our rule of law and possibly even subverting an election.

*  *  *

Peter Hoekstra was US Ambassador to the Netherlands during the Trump administration. He served 18 years in the U.S. House of Representatives representing the second district of Michigan and served as Chairman and Ranking member of the House Intelligence Committee. He is currently Chairman of the Center for Security Policy Board of Advisors and a Distinguished Senior Fellow at Gatestone Institute.

Tyler Durden Fri, 08/12/2022 - 23:55

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