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Pfizer Says Its Vaccine Is 95% Effective, Will Seek FDA Approval

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5 months ago

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  • Pfizer says new data for the COVID-19 vaccine it created with BioNtech shows it is 95% effective. Now, Pfizer plans on asking the FDA for authorization within the next few days, which will be followed by a review process.
  • If approved, it will be distributed to high-risk populations first. So far, data shows that the vaccine is effective across several demographics, including those over the age of 65, where the efficacy rate is 94%.
  • The biggest hurdle in the distribution process could potentially be getting proper funding to states. Many states have said they need more federal funding or are unsure if they have enough to adequately distribute it to their residents.
  • In other good coronavirus news, the FDA has approved its first at-home COVID-19 self-test. The test, which is approved to be used by those ages 14 and older who have received a prescription from their healthcare provider, can show results in 30 minutes or less.

Pfizer Releases New Vaccine Data

New data shows that Pfizer and BioNTech’s COVID-19 vaccine is 95% effective, Pfizer said in an announcement early Wednesday.

Last week, the company said preliminary data showed it was at least 90% effective. It’s not the only company making strides. On Monday, Moderna said it has developed its own vaccine that appears to be 94.5% effective.

Having two prominent companies with success in a vaccine is promising, and Pfizer’s new data only furthers that promise. The company said that of the 170 COVID-19 cases in their trial, 162 were in the placebo group and eight were in the vaccine group. A total of 44,000 people participated in the trial. 

According to a press release, the vaccine’s efficacy was consistent across age, gender, race, and ethnicity demographics, proving to be 94% effective for those over the age of 65. So far, data also shows no serious safety concerns, with the most severe effects found being fatigue in 3.8% of participants and a headache in 2%.

Steps Towards FDA Approval

Pfizer expects to produce up to 50 million doses of its vaccine in 2020 and 1.3 billion by the end of 2021. It also plans to submit the vaccine for review at the Food and Drug Administration within the next few days. As part of their review, FDA scientists will look over the data and evidence along with an external panel of independent experts. Those experts will also hold a public meeting to discuss the data, likely at some point in December. 

Once it is authorized, government and health authorities will offer it to high-risk populations first. This might include people like healthcare workers, essential workers, immunocompromised individuals, those in nursing homes, and public safety officials. However, the decision on who gets priority ultimately falls on the government.

Need for State Funding

While this is great news in the fight against the coronavirus, it does not come without its complications. Say the vaccine is approved to be given to people, states will have one big hurdle to face: getting enough funding to distribute it. 

At least one dozen states confirmed to ABC News that they need or are waiting for more funding, while others suggested they are still working out if they need more. Back in October, a group of local health officials sent a letter to Congress saying they would need $8.4 billion in COVID-19 vaccine funding. 

Trish Riley, the executive director of the National Academy for State Health Policy told ABC News she fears there could be a repeat of what happened at the start of the pandemic when states were competing for essential resources like personal protective equipment and ventilators.

“That’s the wake-up-at-night worry,” she told the outlet. “States can’t do this alone.”

While the CARES Act extended $200 million to states and more money is expected to come for vaccine distribution next month, states do not know how much they will get or how much will be enough. 

“It is essential that we get federal support, and that includes money,” New Jersey Governor Phil Murphy said during a Monday press conference. “As good as the distribution plan may be. We need the feds.”

Claire Hannan, the executive director of the Association of Immunization Managers, told ABC News that she is specifically worried about states not having enough money to hire and train nurses and other staff when the time comes.

“I do fear that the vaccine’s going to get shipped, we’re going to be able to plan out the logistics, but we’re not going to be able to have enough manpower for vaccinating and we’re not going to have robust community engagement,” she said. 

At Home Rapid Test Approved

While the nation waits for a vaccine and the potential to be immune to the coronavirus, other good news regarding the pandemic has also emerged.

On Tuesday night, the FDA authorized the first at-home COVID-19 self-test. That test, the Lucira COVID-19 All-In-One Test Kit, has been authorized for home use with a self-collected nasal swab by individuals ages 14 and older who are suspected to have COVID-19. The test will require a prescription and can be used by those younger than 14, but in those cases, it must be done by a healthcare provider. 

Those who take the test will swirl their self-collected sample in a vial that’s placed in the test unit and results will come in 30 minutes or less. Individuals who test positive are asked to isolate and seek guidance from their healthcare provider. Those who test negative are still encouraged to speak to their doctor, as the FDA says “negative results do not preclude an individual from SARS-CoV-2 infection.”

According to Lucira’s website, the test achieved a 94% positive percent agreement and a 98% negative percent agreement. Lucira says that if samples with very low levels of virus that could be past the point of activity are taken out of the picture, the test achieved a 100% positive percent agreement.

As far as cost, reports indicate that it will be $50 or less. It will initially be available in California and Florida, but will roll out to other states over time.

“This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” FDA Commissioner Stephen M. Hahn said in a statement. “Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”

Jeff Shuren, the director of the FDA’s Center for Devices and Radiological Health, also applauded the news. 

“Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to COVID-19. A test that can be fully administered entirely outside of a lab or healthcare setting has always been a major priority for the FDA to address the pandemic,” he said.

“Now, more Americans who may have COVID-19 will be able to take immediate action, based on their results, to protect themselves and those around them.”

See what others are saying: (ABC News) (Associated Press) (NPR)

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Bodycam Footage Shows Adam Toledo Wasn’t Holding Gun When an Officer Shot Him

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3 days ago

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April 16, 2021

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  • Chicago officials released body camera footage Thursday which showed that 13-year-old Adam Toledo, who was shot and killed by police last month, had put his hands up in the air right before the officer opened fire.
  • The graphic video showed the officer, who has now been identified as Eric Stillman, yelling at Adam to stop as he chases him through an alley.
  • The teenager obeyed and stopped by a fence, where he can be seen holding what appears to be a gun behind his back. Stillman ordered him to drop it, and then shot him a split second after Adam raised his empty hands in the air.
  • The footage prompted renewed outrage, protests, and calls for an investigation. A lawyer for the Toledo family called the killing “an assassination,” while Stillman’s lawyer defended the officer, and claimed he acted appropriately.

Officer Bodycam Footage Made Public

Body camera footage released by Chicago officials Thursday showed that Adam Toledo, a 13-year-old boy killed by police last month, had his hands up when he was fatally shot.

The footage, which was released as part of a report by the city’s Civilian Office of Police Accountability (COPA), showed officers chasing Adam, who was Latino, through an alley in the predominantly Latino neighborhood of Little Village during the early hours of March 29.

The officer ordered Adam to stop. The teenager complied and halted by the side of a fence, holding what looks like a gun in one of his hands behind his back. The policeman yelled at him to drop it and show his hands.

Adam turned and lifted his empty hands, and the officer fired his weapon, striking the teenager once in the chest. The policeman is then seen administering CPR and asking him, “You alright? Where you shot?” while blood poured out of his mouth.

The COPA report published Thursday also identified the officer who shot Adam as 34-year-old Eric Stillman, who is white, and whose lawyer said he had been put on administrative duties for 30 days.

Stillman’s lawyer also argued that the shooting was justified, as did John Catanzara, president of the Fraternal Order of Police.

“He was 100% right,” Catanzara said. “The offender still turned with a gun in his hand. This occurred in eight-tenths of a second.”

Renewed Backlash and Protests

Adeena Weiss Ortiz, an attorney obtained by Adam’s family, said they are looking into taking legal action against Stillman. 

“If you’re shooting an unarmed child with his arms in the air, it’s an assassination,” she said at a news conference Thursday. 

Ortiz acknowledged the bodycam footage did appear to show Adam holding something that “could be a gun,” but argued the video must be independently analyzed to confirm.

“It’s not relevant because he tossed the gun,” she said. “If he had a gun, he tossed it.”

The American Civil Liberties Union of Illinois also echoed Ortiz’s demands on Thursday, calling for a “complete and transparent” investigation.

“The video released today shows that police shot Adam Toledo even though his hands were raised in the air,” said Colleen Connell, executive director of the ACLU of Illinois.

“The people of Chicago deserve answers about the events surrounding this tragic interaction. The anger and frustration expressed by many in viewing the video is understandable and cannot be ignored.”

Hours before the video was released, Chicago Mayor Lori Lightfoot pleaded for calm in the city, where anti-police protests have taken place in the weeks following the shooting.

“We must proceed with deep empathy and calm and importantly, peace,” she said. “No family should ever have a video broadcast widely of their child’s last moments, much less be placed in the terrible situation of losing their child in the first place.”

Some businesses in downtown Chicago boarded prepared for violence ahead of the video’s publication by boarding up their windows. City vehicles stood by to block traffic.

However, the demonstrations that took place Thursday were small, peaceful, and spread out over several parts of the city. Organizers said they plan to hold more protests Friday.

See what others are saying: (The Chicago Sun-Times) (The New York Times) (The Chicago Tribune)

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Eight Dead in Indianapolis Shooting

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3 days ago

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April 16, 2021

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  • Eight people were killed and several more were injured after a gunman opened fire at a FedEx Ground Facility in Indianapolis late Thursday.
  • The gunman took his life after opening fire. Authorities have not identified his motive yet. 
  • According to the Gun Violence Archive, in 2021, there have been 147 U.S. mass shootings, defined as verified incidents with four or more gunshot victims.
  • President Joe Biden released a statement calling gun violence “an epidemic in America,” adding, “We should not accept it. We must act.”

Eight Killed in Shooting

Eight people were killed and several others have been wounded after a gunman opened fire at a FedEx Ground Facility in Indianapolis late Thursday.

The gunman killed four people in the parking lot then four people inside before taking his own life, according to local officials. Authorities have identified the gunman and are searching his home, but have not disclosed any potential motives.

“There was no confrontation with anyone that was there,” Deputy Chief Craig McCartt of the Indianapolis Metropolitan Police Department said during a press conference. “There was no disturbance, there was no argument. He just appeared to randomly start shooting.”

Several witnesses told local outlets they initially thought the gunshots were engines backfiring or another type of mechanical noise until they saw the gunman. Some said they heard him shouting indistinctly before opening fire. The investigation is still in very early stages and victims have not yet been identified. 

The facility employs 4,500 team members. It is unclear how many were working at the time of the shooting. FedEx released a statement expressing its condolences to the victims and their families. 

“We are deeply shocked and saddened by the loss of our team members following the tragic shooting at our FedEx Ground facility in Indianapolis,” the statement read. “Our most heartfelt sympathies are with all those affected by this senseless act of violence. The safety of our team members is our top priority, and we are fully cooperating with investigating authorities.”

Gun Violence in the U.S.

This tragedy follows a recent string of mass shootings in the U.S., including in Atlanta, Colorado, Southern California, and Texas. According to the Associated Press, this is at least the third in Indianapolis this year. 

The Gun Violence Archive has logged a total of 147 mass shootings in the U.S. so far in 2021. The organization defines mass shootings as reported and verified incidents with at least four gunshot victims.

Several politicians have released statements about the shooting, including Vice President Kamala Harris, who said this pattern “must end.”

“Yet again we have families in our country that are grieving the loss of their family members because of gun violence,” she said. “There is no question that this violence must end, and we are thinking of the families that lost their loved ones.”

President Joe Biden also released a statement saying that, “Too many Americans are dying every single day from gun violence. It stains our character and pierces the very soul of our nation.”

“Gun violence is an epidemic in America,” Biden added. “But we should not accept it. We must act.”

Indianapolis Mayor Joe Hogsett echoed those remarks in a news conference. 

“The scourge of gun violence that has killed far too many in our community and in our country,” he said.

“Our prayers are with the families of those whose lives were cut short,” he added on Twitter. 

Hogsett is among 150 U.S. mayors who recently signed a letter asking the Senate to take up gun legislation, including expanding background checks.

Editor’s Note: At Rogue Rocket, we make it a point to not include the names and pictures of mass murders or suspected mass murderers who may have been seeking attention or infamy. Therefore, we will not be linking to other sources, as they may contain these details.

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Soldier Charged With Assault After Shoving Black Man in Viral Video

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4 days ago

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April 15, 2021

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  • Authorities charged Army soldier Jonathan Pentland with third-degree assault and battery on Wednesday after a viral video showed him shoving a Black man while yelling at him to leave a South Carolina neighborhood.
  • Many people, including dozens who protested outside Pentland’s home this week, condemned the confrontation as another instance of someone being attacked for “walking while Black.”
  • Pentland and others claimed the unidentified man was picking a fight with neighbors, which the man denied, but police said nothing that may have happened earlier justified Pentland’s actions.
  • If convicted, Pentland faces a $500 fine and 30 days in jail.

Viral Video

A U.S. soldier was charged with assault on Wednesday after a video that circulated online showed him yelling at and shoving a Black man in a South Carolina neighborhood.

Footage of the April 8 incident was posted to social media Monday. It shows the Army soldier, Jonathan Pentland, confronting the unidentified man and telling him to leave the neighborhood. 

The other man explains that he’s just walking through the area and doing nothing wrong, but Pentland becomes increasingly aggressive. “You better walk away,” he shouts at the man after shoving him.

“You either walk away, or I’m gonna carry your ass out of here,” he continues before adding, “You’re in the wrong neighborhood motherf*ker. Get out!”

The man then tries to tell Pentland that he lives in the neighborhood, and Pentland then asks for his address, which he does not give.

The confrontation continues with Pentland cursing and getting in the man’s face. As he does so, the man says that Pentland smells drunk. 

It’s unclear what exactly led up to the confrontation, but in the video, a woman off-camera says the man “picked a fight with some random young lady that’s one of our neighbors.”

“I don’t even know who she is. Nobody picked a fight when someone ran up on me,” the man replies. Another woman off-screen then encourages the man to leave with her, saying, “What’s your name? Come on. You don’t want no trouble.”

Video Triggers Protests Outside Pentland’s Home

After this video spread online, many social media users condemned it as another instance of someone being attacked for “walking while Black.”

In fact, protesters even began demonstrating outside of Penland’s home. Those protests started off peaceful, but deputies were then called after 8 p.m. because unknown individuals vandalized the house. That forced police to shut down access to the area and remove Pentland’s family to another location.

As far as the viral video, deputies were told that the man approached “several neighbors in a threatening manner” and that someone had asked Pentland to “intervene.”

Police did confirm that there are two reports of alleged assault against the unnamed man Pentland shoved that are being investigated. However, they also added that the man has “an underlying medical condition that may explain the behavior exhibited in the alleged incidents.”

Pentland Charged

Either way, police said whatever happened earlier did not justify Pentland’s actions. He was ultimately arrested Wednesday morning and was charged with third-degree assault and battery. He faces a $500 fine and 30 days in jail if convicted.

“We’re not going to let people be bullies in our community,” Richland County Sheriff Leon Lott said at a news conference Wednesday. “And if you are, you’re going to answer for it, and that’s what we’ve done in this case.”

On top of that, the Justice Department reportedly was investigating. Pentland’s Commanding General even issued a statement condemning his behavior, adding that Pentland “brought disrespect to @fortjackson our Army and the trust with the public we serve.”

See what others are saying: (The Washington Post) (ABC News) (Huffpost)

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