Connect with us

U.S.

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

Published

on

  • 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)

U.S.

Uvalde Puts Police Chief on Leave, Tries to Kick Him Off City Council

Published

on

If Pete Arredondo fails to attend two more consecutive city council meetings, then he may be voted out of office.


Police Chief Faces Public Fury

Uvalde School District Police Chief Pete Arredondo was placed on administrative leave Wednesday following revelations that he and his officers did not engage the shooter at Robb Elementary for over an hour despite having adequate weaponry and protection.

Superintendent Hal Harrell, who made the announcement, did not specify whether the leave is paid or unpaid.

Harrell said in a statement that the school district would have waited for an investigation to conclude before making any personnel decisions, but chose to order the administrative leave because it is uncertain how long the investigation will take.

Lieutenant Mike Hernandez, the second in command at the police department, will assume Arredondo’s duties.

In an interview with The Texas Tribune earlier this month, Arredondo said he did not consider himself in charge during the shooting, but law enforcement records reviewed by the outlet indicate that he gave orders at the scene.

Department of Public Safety Director Steve McCraw told state senators on Tuesday that some officers wanted to enter the classrooms harboring the shooter but were stopped by their superiors.

He said officer Ruben Ruiz tried to move forward into the hallway after receiving a call from his wife Eva Mireles, a teacher inside one of the classrooms, telling him she had been shot and was bleeding to death.

Ruiz was detained, had his gun taken away, and was escorted off the scene, according to McCraw. Mireles later died of her wounds.

Calls for Arredondo to resign or be fired have persisted.

Emotions Erupt at City Council

Wednesday’s announcement came one day after the Uvalde City Council held a special meeting in which community members and relatives of victims voiced their anger and demanded accountability.

“Who are you protecting?” Asked Jasmine Cazares, sister of Jackie Cazares, a nine-year-old student who was shot. “Not my sister. The parents? No. You’re too busy putting them in handcuffs.”

Much of the anger was directed toward Arredondo, who was not present at the meeting but was elected to the city council on May 7, just over two weeks before the massacre.

“We are having to beg ya’ll to do something to get this man out of our faces,” said the grandmother of Amerie Jo Garza, a 10-year-old victim. “We can’t see that gunman. That gunman got off easy. We can’t take our frustrations out on that gunman. He’s dead. He’s gone. … Ya’ll need to put yourselves in our shoes, and don’t say that none of ya’ll have, because I guarantee you if any of ya’ll were in our shoes, ya’ll would have been pulling every string that ya’ll have to get this man off the council.”

One woman demanded the council refuse to grant Arredondo the leave of absence he had requested, pointing out that if he fails to attend three consecutive meetings the council can vote him out for abandoning his office.

“What you can do right now is not give him, if he requests it, a leave of absence,” she said. “Don’t give him an out. We don’t want him. We want him out.”

After hearing from the residents, the council voted unanimously not to approve the leave of absence.

On Tuesday, Uvalde’s mayor announced that Robb Elementary is set to be demolished, saying no students or teachers should have to return to it after what happened.

We make it a point to not include the names and pictures of those who may have been seeking attention or infamy and will not link out to websites that might contain such information.

Continue Reading

U.S.

Texas Public Safety Director Says Police Response to Uvalde Shooting Was An “Abject Failure”

Published

on

New footage shows officers prepared to engage the shooter one hour before they entered the classroom.


Seventy-Seven Deadly Minutes

Nearly a month after the mass shooting in Uvalde, Texas that killed 19 children and two teachers, evidence has emerged indicating that police were prepared to engage the shooter within minutes of arriving, but chose to wait over an hour.

The shooting at Robb Elementary began at 11:33 a.m., and within three minutes 11 officers are believed to have entered the school, according to surveillance and body camera footage obtained by KVUE and the Austin American Statesman.

District Police Chief Pete Arredondo reportedly called a landline at the police department at 11:40 a.m. for help.

“It’s an emergency right now,” he said. “We have him in the room. He’s got an AR-15. He’s shot a lot… They need to be outside the building prepared because we don’t have firepower right now. It’s all pistols.”

At 11:52 a.m., however, the footage shows multiple officers inside the school armed with at least two rifles and one ballistic shield.

Law enforcement did not enter the adjoined classrooms to engage the shooter until almost an hour later, at 12:50 p.m. During that time, one officer’s daughter was inside the classrooms and another’s wife, a teacher, reportedly called him to say she was bleeding to death.

Thirty minutes before law enforcement entered the classrooms, the footage shows officers had four ballistic shields in the hallway.

Frustrated Cops Want to Go Inside

Some of the officers felt agitated because they were not allowed to enter the classrooms.

One special agent at the Texas Department of Public Safety arrived about 20 minutes after the shooting started, then immediately asked, “Are there still kids in the classrooms?”

“It is unknown at this time,” another officer replied.

“Ya’ll don’t know if there’s kids in there?” The agent shot back. “If there’s kids in there we need to go in there.”

“Whoever is in charge will determine that,” the other officer responded.

According to an earlier account by Arredondo, he and the other officers tried to open the doors to the classrooms, but found them both locked and waited for a master key to arrive. But surveillance footage suggests that they never tried to open the doors, which a top Texas official has confirmed were never actually locked.

One officer has told reporters that within minutes of the police response, there was a Halligan bar, which firefighters use to break down locked doors, on-site, but it was never used.

At a special State Senate committee hearing Monday, Texas Department of Public Safety Director Steve McCraw called the police response an “abject failure” and “antithetical to everything we’ve learned over the last two decades since the Columbine massacre.”

“The only thing stopping a hallway of dedicated officers from (entering rooms) 111 and 112 was the on-scene commander who decided to place the lives of officers before the lives of children,” he said. “The officers have weapons, the children had none.”

We make it a point to not include the names and pictures of those who may have been seeking attention or infamy and will not link out to websites that might contain such information.

Continue Reading

U.S.

Ohio Governor Signs Bill Allowing Teachers to Carry Guns With 24 Hours of Training

Published

on

“They will have blood on their hands,” Ohio State Senator Theresa Fedor said.


Teachers to Bear Arms

Ohio’s Republican Governor Mike DeWine signed a bill into law Monday allowing teachers and other school staff to carry firearms on campus with a fraction of the training previously required.

The Ohio Supreme Court ruled last year that school employees need to complete 700 hours of training as a peace officer, as well as the permission from their school board before arming themselves, but Monday’s law changes that.

Starting in the fall, school staff will only have to complete up to 24 hours of initial training plus eight hours of requalification training each year.

DeWine directed the Ohio School Safety Center, which must approve any training programs, to order the maximum 24 hours and eight hours.

Four of those hours consist of scenario-based training and 20 more go toward first-aid training and history of school shootings and reunification education.

Individual school districts can still decide not to allow their staff to carry firearms. Last week, Cleveland’s mayor said the city will refuse to arm teachers, and Columbus has signaled it will not change its policy either.

Another Ohio law went into effect Monday allowing adults over the age of 21 to carry a concealed firearm without a permit, training, or background checks. It also ended the requirement for gun carriers to inform police officers if they have a concealed weapon on them unless specifically asked.

Communities shocked by Legislation

Coming just weeks after the mass shooting at an elementary school in Uvalde, Texas that killed 19 students and two teachers, Monday’s law was not welcome by many Ohioans.

“I think it’s a horrible idea to arm our teachers,” Columbus Police Chief Elaine Bryant told The Columbus Dispatch. “There’s a lot of training that’s involved in that. It’s naïve to believe that is something we can put on them and expect them to respond to from a law enforcement perspective.”

More police, teachers, and gun control advocates expressed opposition to the legislation, with Democratic State Senator Theresa Fedor telling ABC the bill’s supporters “will have blood on their hands.”

“I’m a veteran classroom teacher of 18 years, been a legislator 22 years,” she said. “I have never seen a bill so poorly written, hurdled through the process. There’s so many flaws in the bill. There’s no minimum education standard, no psychological evaluation, no safe storage.”

A teacher identified as “Coach D” also spoke out against the law on YouTube.

“It took me 12 years of grade school, four years of undergrad, and two years of graduate school, not to mention continued education and professional development for years to be able to teach in my classroom,” he said. “I’ve now been doing that for over 20 years. But now, with only 24 hours of training in Ohio, I could be authorized to bring a lethal weapon into the classroom and expected to take on an active shooter, and then what? Go back to teaching word problems?”

At a Monday press conference, reporter Josh Rultenberg confronted DeWine with challenging questions, posting several videos of the exchange in a Twitter thread.

When asked if he would take accountability if this law allowed for a teacher to shoot the wrong kid, Dewine said that “in life we make choices, and we don’t always know what the outcome is going to be.”

“What this legislature has done, I’ve done by signing it, is giving schools an option based on their particular circumstances to make the best decision they can make with the best information they have,” he continued.

See what others are saying: (The Guardian) (The Columbus Dispatch) (ABC)

Continue Reading