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FDA Finds Violations and Unsanitary Conditions at Emergent J&J Plant as Lawmakers Open Investigations

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  • The Food and Drug Administration said Wednesday that it found numerous safety violations at Emergent Biosolutions, the Baltimore manufacturing plant responsible for ruining more than 15 million Johnson & Johnson Vaccines.
  • The FDA said it watched security footage of employees ignoring cross-contamination protocols and improperly handling medical waste. It also found brown and black residue on the floors and walls of the plant, respectively. 
  • Separately, top House Democrats launched an investigation into how Emergent won contracts to manufacture two COVID-19 vaccines and whether or not those contracts were the result of an improper relationship between the plant and a former Trump administration official.
  • Democrats are also investigating Emergent’s role as the country’s only provider of the anthrax vaccine in the Strategic National Stockpile.

The FDA’s Unforgiving Report

The U.S. Food and Drug Administration released a damning inspection report Wednesday on Emergent Biosolutions, the Baltimore manufacturing plant that ruined 15 million Johnson & Johnson COVID-19 vaccines.

Among a multitude of violations, inspectors workers hadn’t been properly trained. They also found that medical waste had been improperly handled, saying “such waste was transported through the warehouse before disposal and has the potential to contaminate the warehouse and adjacent areas.”

For example, it found that employees had used their gloved hands to put waste into bags, that they drug the waste through hallways, and that they even allowed it to touch walls.

Made worse was the fact that the FDA found peeling paint on the walls of several sensitive work areas, with inspectors noting that they found paint flecks all along the floors around the walls. As the agency reported, that peeling — as well as additional wall damage — “impacts the firms’ ability to adequately clean and disinfect the area.”

Moreover, inspectors said they found an unknown brown residue attached to the walls, as well as a black residue on the floor.

Through reviewing security footage, inspectors said workers repeatedly failed to follow procedures that were meant to prevent vaccine cross-contamination.

Notably, that backs up information that had been previously reported, particularly that those 15 million Johnson & Johnson vaccines were ruined because of cross-contamination with AstraZeneca’s vaccine. That said, it’s important to note that none of those vaccines were ever distributed to the public because the FDA never gave the plant approval to do so.

It’s possible that the report also describes the event that specifically led to the vaccine cross-contamination, as it mentions that through security footage, it watched an employee travel from one area of the plant where one vaccine was being made, to another area of the plant where the other vaccine was being made — all without that employee changing their protective gear. 

With that finding, the FDA said Emergent didn’t properly investigate its workers’ movements as a potential cause of contamination. More broadly, it also noted that even after the plant was made aware of the contamination, it only performed routine cleaning and didn’t take further decontamination steps.

Congress Investigates Emergent’s Role in Winning Vaccine Contracts

Alongside the FDA’s recent report, top House Democrats have now launched an investigation into how Emergent won several multi-million dollar contracts.

Those lawmakers are specifically looking into what role Dr. Robert Kadlec played in helping the company obtain the contract and if it was influenced by Kadlec’s previous role as a consultant for Emergent. 

Kadlec was the assistant secretary for preparedness and response under former President Donald Trump, and as this group of Democrats alleges, Kadlec “appears to have pushed for this award despite indications that Emergent did not have the ability to reliably fulfill the contract.”

Those Democrats went on to say that after Kadlec’s confirmation, Emergent obtained millions in contracts from his agency — including some that “were awarded without competitive bidding.” In fact, the Trump administration ultimately awarded $628 million to the plant, even though it had fallen short on federal investigations.

Emergent also reportedly tried to encourage oversight of the stockpile to be shifted from the CDC to an office under Kadlec’s control. 

“We are concerned by the costs to taxpayers and the potential impact on our nation’s vaccination efforts caused by Emergent’s failed attempts to manufacture these vaccines,” the Democrats said. 

Congress Investigates Emergent’s Role as Sole Anthrax Provider

It doesn’t end there. Those lawmakers are also looking into Emergent’s role as the country’s sole provider of the anthrax vaccine in the Strategic National Stockpile.

“Emergent has raised the government purchasing price of the anthrax vaccine by 800% since acquiring the drug in 1998,” they said. “As a result, through most of the last decade, nearly half of the SNS’s budget has been spent purchasing Emergent’s anthrax vaccine.” 

When Emergent acquired that anthrax vaccine license in 1998, the vaccine was selling for about $3.35 a dose. Today, it’s over $30.

See what others are saying: (The Washington Post) (Wall Street Journal) (CNBC)

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Wisconsin Police Deny Planting Evidence in Viral Video, Release Their Own Body Cam Footage

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The footage police released shows that during a search, officers found a corner tear from a plastic bag inside a backseat passenger’s pocket. An officer then discarded it into the car after determining that it was empty.


Viral Video Appears To Show Officer Planting Evidence

The Caledonia Police Department in Wisconsin has responded to a viral cell phone video that appears to show an officer planting a small plastic baggie inside of a car during a traffic stop.

The now-viral footage was posted to Facebook by a man who goes by GlockBoy Savoo.

The user, who also filmed the clip, wrote in his post’s caption that the officer did this “just to get a reason to search the car” and said the cop didn’t know he was being recorded by the passenger.

Source: Facebook/ GlockBoy Savoo

Police Shut Down Accusations With Their Own Footage

After that video spread across social media, many were outraged, calling the Caledonia police dirty for seemingly planting evidence. All the outrage eventually prompted the department to announce an investigation Saturday.

Within hours, the department provided an update, claiming that officers didn’t actually plant any evidence or do anything illegal.

Police shared a lengthy summary of events, along with two body camera clips from the incident. That statement explained that the driver of the vehicle was pulled over for going 63 in a 45mph zone.

Two passengers in the backseat who were then spotted without seatbelts were asked to identify themselves and step out of the car. During a search of one passenger’s pockets, an officer pulled out “an empty corner tear” from a plastic baggie.

Police claim the corner tear did not contain any illegal substances, though they said this type of packaging is a common method for holding illegal drugs.

In one body cam clip, an officer can be heard briefly questioning the backseat passenger about the baggie. Then, that piece of plastic gets handed off to different officers who also determined it as empty before the officer in the original viral video discarded it into the back of the car.

The officer can also be seen explaining where the plastic came from to the passenger recording him.

“Aye, bro you just threw that in here!” the front seat passenger says, as heard in his version of the events.

“Yeah, cause it was in his pocket and I don’t want to hold onto it. It’s on their body cam that they took it off of him…I’m telling you where it came from, so. It’s an empty baggie at the moment too, so,” the officer replies.

The department went on to explain that while it would discourage officers from discarding items into a citizen’s car, this footage proves that evidence was not planted.

Authorities also noted that no arrests were made in this incident and the driver was the only one issued a citation for speeding. The statement added that since four officers were present at the scene, police have more than six hours of footage to review but they promised to release the footage in full in the near future.

See what others are saying: (Heavy)(CBS 58) (Milwaukee Journal Sentinel)

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Medical Groups, Local Leaders Push for Healthcare Workers and Public Employees To Get Vaccinated

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The move comes as COVID cases have nearly quadrupled in the last month due to the rapid spread of the highly infectious delta variant.


Increased Calls for Mandatory Vaccinations in Certain Sectors

More than 50 of America’s largest medical groups representing millions of healthcare workers issued a statement Monday calling for employers of all health and long-term care providers to require mandatory COVID-19 vaccinations.

The groups, which included the American Medical Association, the American Nurses Association, and 55 others, cited contagious new variants — including delta — and low vaccination rates.

“Vaccination is the primary way to put the pandemic behind us and avoid the return of stringent public health measures,” they wrote.

The call to action comes as new COVID cases have almost quadrupled during the month of July, jumping from just around 13,000 infections a day at the beginning of this month to more than 50,000.

While the vast majority of new infections and hospitalizations are among those who have not received the vaccines, many healthcare workers remain unvaccinated. According to data collected by the Centers for Medicare and Medicaid Services, over 38% of nursing home staff were not fully vaccinated as of July 11. 

An analysis by WebMD and Medscape Medical News found that around 25% of hospital workers who were in contact with patients had not been vaccinated by the end of May when vaccinations became widely available.

In addition to calls for medical professionals to get vaccinated, some local leaders have also begun to impose mandates for public employees as cases continue spiking.

Last month, San Francisco announced that it was requiring all city workers to get vaccinated. Also on Monday, New York City Mayor Bill de Blasio said that all municipal employees — including police officers and teachers — must either get the jab or agree to weekly testing by the time school starts in September.

Dr. Fauci Says U.S. Officials Are Considering Revising Mask Guidance for Vaccinated People

Numerous top U.S. health officials have applauded efforts by local leaders to mitigate further spread of the coronavirus, including the nation’s top infectious disease expert, Dr. Anthony Fauci, who confirmed Sunday that federal officials are actively considering whether to revise federal masking guidelines to recommend that vaccinated Americans wear face coverings in public settings.

In May, the Centers for Disease Control and Prevention said people who are vaccinated do not need to mask in public. Although that was a non-binding recommendation, many states and cities that had not already lifted restrictions on masking began to do so shortly after.

But now, local leaders in areas seeing big spikes have begun reimposing mask mandates — even for those who are vaccinated — including major counties like Los Angeles and St. Louis.

In his remarks Sunday, Fauci also emphasized that, despite claims from many conservatives, those efforts are in line with the federal recommendations, which leave space for local leaders to issue their own rules.

While Fauci and other top U.S. public health officials have encouraged local governments to take action, Republican lawmakers in several states are taking steps to limit the ability of local leaders and public health officials to take certain mitigation measures.

According to the Network for Public Health Law, at least 15 state legislatures have passed or are considering bills to limit the legal authority of public health agencies — and that does not even include unilateral action taken by governors.

Some of the leaders of states suffering the biggest spikes have banned local officials from imposing their own mask mandates, like Arkansas, which has the highest per capita cases in the country right now, as well as Florida, which currently ranks third.

Notably, some of the laws proposed or passed by Republicans could go beyond just preventing local officials from trying to mitigate surges in COVID cases and may have major implications for other public health crises.

For example, according to The Washington Post, a North Dakota law that bans mask mandates applies to other breakouts — even tuberculosis — while a new Montana law also bars the use of quarantine for people who have been exposed to an infectious disease but have not yet tested positive.

See what others are saying: (The Washington Post) (The New York Times) (The Guardian)

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Couple Slammed Over Slavery-Themed Pre-Wedding Photoshoot

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Many have expressed outrage at the duo for trying to romanticize slavery while others were left completely dumbfounded by the entire ordeal.


Photoshoot Goes Viral

A couple has come under fire after sharing images on Instagram from their slavery-themed pre-wedding photoshoot.


The photos show a Black man in shackles looking deeply into his white fiancé’s eyes before she works to releases him.


1842. Days passed and everything changed, our love got stronger and stronger, he was no longer a slave, he was part of the family,” the post’s caption reads.


To indicate his transition from “slave” to family, a fourth image shows him wearing a long coat and top hat with well-shined shoes, as opposed to the white shirt, trousers, and straw hat he wore in the previous images.

Social Media Users React

It’s not immediately clear who these people are since the social media handle is redacted in the images circulating online.

Still, many have expressed outrage at the duo for trying to romanticize slavery while others were left just completely dumbfounded by this entire ordeal. Some also directed criticism at the photographer who agreed to the shoot, along with the hundreds of Instagram users who liked the original posts.

See what others are saying: (The Daily Dot) (Black Enterprise) (BET)

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