Vaccine Makers Can Skip U.S. Inspections

The U.S. Food and Drug Administration inspects a few thousand drug manufacturing plants every year to ensure their standards are up to par. Many of those inspections are required before a pharmaceutical company can gain approval of a new drug. They serve as a check on whether drugmakers can produce quality therapies.

But that won’t be the case for Covid-19 vaccine developers that gain emergency authorization of a shot.

FDA regulations don’t require what’s known as a pre-approval inspection for products seeking emergency use, said Jerry Weir, director of the Division of Viral Products in the FDA’s vaccines office. Weir spoke last week at a meeting of FDA advisers to discuss standards for Covid-19 vaccines.

Before approval, FDA inspections ensure compliance with regulations. Once a product is being made—as vaccines already are to get them out as quickly as possible—they can uncover quality breaches and assess whether pharmaceutical companies handled them correctly or are possibly downplaying or ignoring serious issues.

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A New Warning That International Pandemic Responses Are Eroding Freedom

In a year of extraordinary and often terrible actions taken in response to COVID-19, yet another international civil society group warns that governments are leveraging the pandemic to tighten controls over their subjects. Ominously, it’s not the first such warning and comes as even traditionally liberal democratic countries step up surveillance of dissidents and crack down on public opposition.

“The COVID-19 pandemic has had a dire impact on civic freedoms globally,” Civicus, a South Africa-based group that promotes civil society and freedom of association, reported last week. “Our research shows that governments … are using the pandemic as an opportunity to introduce or implement additional restrictions on civic freedoms.”

The United States drops in status from “narrowed” to “obstructed” for “restrictive laws, the excessive use of force against protesters, and an increasingly hostile environment for the press.” The Civicus rating emphasizes militarized tactics and mass arrests in response to the Black Lives Matter protests that erupted this year. While those protests aren’t explicitly linked to the pandemic, they were likely exacerbated by the disruptions and economic pain caused by lockdowns that brought simmering preexisting tensions to a boil.

Unfortunately, Civicus’s ratings criteria seem anecdote-driven and rather arbitrary. While the U.S. is (rightfully) dinged for sometimes heavy-handed treatment of protesters (while police in other locations seemingly surrendered the streets to favored political factions), other countries get a relative pass for cracking down on public expression that was specifically targeted at pandemic responses.

Australia, for example, is classified as “narrowed”—a better ranking than the U.S.—even as authorities arrest people for merely planning to protest against pandemic-related lockdowns. The country is also moving to centralize surveillance of travelers in the name of public health and to ease domestic monitoring of electronic communications.

“Journalists in France have been obstructed in doing their jobs through intimidation and detention while covering protests,” observes Civicus, which ranks the country as “narrowed.”

Last Friday, 142 people were arrested in Paris during demonstrations against a law that would restrict photographing police officers during such events as protests against lockdowns.

Germany‘s arrests of anti-lockdown protesters are acknowledged even as the country gets an “open” rating.

Unmentioned is Germany’s surveillance of opponents to restrictive anti-pandemic measures on the grounds that they have been “infiltrated by extremists.” The “move is effectively a public warning to sympathizers and leaders of the group—which officials described as the ‘epicenter’ of Germany’s coronavirus protests—but it falls short of banning the movement,” notes The Washington Post.

The listing for Israel—ranked as “obstructed”—focuses on the treatment of Palestinians. That’s certainly an important issue. Still, as Civicus emphasizes governments’ exploitation of health concerns to justify expanded authority, it’s worth mentioning that the Shin Bet, the country’s internal security force, presented bogus information to gain authorization to monitor citizens for coronavirus. “In other words, the committee voted and reaffirmed surveillance on Israeli citizens by the Shin Bet based on partial or even misleading data,” according to Haaretz.

That said, the Civicus warning is timely, and the organization’s concerns are shared by others.

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Covid-19 vaccine trial participant had serious neurological symptoms, but could be discharged today, AstraZeneca CEO says

The participant who triggered a global shutdown of AstraZeneca’s Phase 3 Covid-19 vaccine trials was a woman in the United Kingdom who experienced neurological symptoms consistent with a rare but serious spinal inflammatory disorder called transverse myelitis, the drug maker’s chief executive, Pascal Soriot, said during a private conference call with investors on Wednesday morning.

The woman’s diagnosis has not been confirmed yet, but she is improving and will likely be discharged from the hospital as early as Wednesday, Soriot said.

The board tasked with overseeing the data and safety components of the AstraZeneca clinical trials confirmed that the participant was injected with the company’s Covid-19 vaccine and not a placebo, Soriot said on the conference call, which was set up by the investment bank J.P. Morgan.

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Biden’s Reported Domestic Policy Pick Called For ‘Permanent And Comprehensive Assault Weapons Ban’

Former national security adviser Susan Rice, President-elect Joe Biden’s reported pick to lead the White House Domestic Policy Council, called for a “permanent” ban on so-called assault weapons in a June appearance with two anti-gun groups.

Rice, who served in former president Barack Obama’s administration, appeared in a video with Moms Demand Action and Everytown For Gun Safety and concurred with Biden’s firearm plan that seeks to ban certain semi-automatic rifles, prohibit “high-capacity magazines,” and do away with liability protections for weapons manufacturers and sellers. Rice has reportedly been chosen for the domestic policy role, Politico reported Thursday.

“[Biden has] taken on the NRA twice and won,” Rice said in the interview with Moms Demand Action founder Shannon Watts. “When he served with President Obama in the Obama-Biden administration, we implemented over two dozen reforms that put curbs on access to guns, but we need legislation, we need leadership in Joe Biden that understands and is passionate about these issues.”

Rice advocated for laws including “universal background checks, the enactment of a new violence against women act, with a permanent and comprehensive ‘assault weapons’ ban, and a ban on ‘high capacity magazines’ that will work to buy back those assault weapons that are out there and ensure that those that remain are fully registered,” she said.

The former security adviser also went on to say it’s “unthinkable” and “outrageous” that such reforms have not been passed to date.

“It’s unthinkable to me that even though the vast majority of Americans favor common sense gun restrictions, universal background checks, bans on ‘assault weapons’, and we have a very powerful lobby that has effectively prevented so much of that from being enacted,” she said. “It’s absolutely outrageous. It makes me as angry as anything.”

Biden’s gun plan includes a full-scale prohibition on “assault weapons” in addition to re-classifying the guns and “high-capacity magazines” under the National Firearms Act, which would impose registration and a $200 tax for those already in circulation. The total cost to U.S. firearm owners nationwide was estimated to be roughly $34 billion if the law went into effect, according to the Washington Free Beacon.

Rice said it’s “vital” to enact the sweeping gun control.

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Corporate Media Shills For Assassination Of Iranian Scientist

The Trump administration committed another act of war against Iran, and like every U.S. war in the modern era, it began with a lie: that Iran is developing nuclear weapons. It’s a total falsehood we’ve heard get repeated again and again throughout mainstream media and from pundits who personally profit from U.S. aggression.

Jack Keane, who once proclaimed, “Iran with nuclear weapons and missiles that deliver them is absolutely a bonafide existential threat to Israel,” has a cozy relationship with the MEK, an Iranian exile cult that has assassinated Iranian scientists itself and who the U.S. government had listed as a terrorist group until recently. It’s no secret that the MEK pays U.S. officials to advocate on its behalf. Keane is the chairman of the Institute for the Study of War – a think tank funded by arms manufacturers like Raytheon and General Dynamics, which paid Keane more than $200,000 dollars in 2018 alone.

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