Tag: pandemic

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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CDC to encourage ‘Vaccinated for COVID-19’ buttons

If there are “I Voted” stickers, why not “Vaccinated for COVID-19” buttons?

The Centers for Disease Control and Prevention is planning to offer health care providers a template they can use to print buttons or stickers that would advertise a person’s vaccination status. The idea is that the button would be handed out to patients after they receive their vaccination shots.

The effort is part of a “toolkit” that the CDC plans to provide healthcare systems to “educate and promote vaccination,” a CDC spokesperson told ABC News.

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Gov’s order makes COVID vaccine registry mandatory

Governor Chris Sununu last week signed an executive order requiring everyone who receives a COVID-19 vaccine to have their immunizations registered with the state.

New Hampshire has been the only state without a vaccine registry, a list of who has received which vaccines. Though state law directed the Department of Health and Human Services to create the registry years ago, the state only began building the registry this year.

Sununu’s executive order will require health care providers to report every COVID-19 vaccine, suspending a part of the state vaccine registry law that allows patients to opt out of registering vaccines.

But the order will allow patients to have their immunization records removed from the registry after the pandemic is over.

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COVID-19 Vaccine Approved In Under a Year As Gov’t Keeps Cannabis Schedule 1 Drug

Because they work on the front lines, healthcare workers are eligible to skip to the front of the line to receive the jab of the vaccine that was developed in record time. However, despite assurances from vaccine makers and their revolving door friends in the Food and Drug Administration, many of these front line workers are leery of this rushed product.

“I think I would take the vaccine later on, but right now I am a little leery of it,” nurse Yolanda Dodson, 55, who works at the Montefiore Hospital in New York City and spent the spring in the heart of the deadly fight against the virus told AFP.

“Vaccine studies so far “look promising but I don’t think there is enough data yet,” Dodson said.

“This is a vaccine that was developed in less than a year and approved under the same administration and government agencies that allowed the virus to spread like a wildfire,” Diana Torres, a nurse at a Manhattan hospital who saw several of her co-workers die of the virus this spring, said.

“They didn’t have enough time and people to study the vaccine,” she said. “This time around I will pass and watch how it unfolds.”

“They failed miserably with PPE (personal protective equipment) and testing and now they want you to be guinea pigs for the vaccine,” Torres friend added.

These are front line health care workers, experiencing the pandemic every day of their lives, and yet they remain skeptical — and rightfully so.

What’s more, the government’s selective approval process has been less than stellar given the opioid epidemic, and the millions of people harmed by FDA-approved medications. Highlighting the lapse in their judgement is the fact that as the government fast tracks this vaccine to market, cannabis — that has never killed a single person and has been around as long as we have — remains classified as follows:

a drug with no currently accepted medical use and a high potential for abuse.

Seems legit.

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