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

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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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Multiple States Crack Down on TikTok With Partial Bans, Lawsuits

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Nearly half a dozen states have taken some kind of enforcement action against the video-sharing platform in the past two weeks alone.


Texas Bans TikTok for State Agencies

A growing number of U.S. states have been cracking down on TikTok in recent weeks amid growing concerns about security threats posed by the popular video-sharing app.

On Wednesday, Texas Gov. Greg Abbott (R) ordered all state agencies to ban the use of the platform on any government-issued phones and computers. In a letter to state officials, Abbott specifically cited concerns over data security on the Chinese-owned app.

“TikTok harvests vast amounts of data from its users’ devices—including when, where, and how they conduct Internet activity—and offers this trove of potentially sensitive information to the Chinese government,” he wrote.

“While TikTok has claimed that it stores U.S. data within the U.S., the company admitted in a letter to Congress that China-based employees can have access to U.S. data,” the governor continued. “It has also been reported that ByteDance planned to use TikTok location information to surveil individual American citizens.”

Abbott also mentioned that China’s 2017 National Intelligence Law requires businesses to help China with intelligence work, “including data sharing,” noting the algorithm already censors certain topics that are politically sensitive to the Chinese government. 

Additional State-Level Bans

Abbott, however, is just the most recent Republican governor to take similar action against TikTok.

Maryland Gov. Larry Hogan (R) on Tuesday issued an emergency directive banning the use of TikTok and other “Chinese and Russian-influenced products” in the executive branch of the state government. 

On Monday, the governor of South Carolina, Henry McMaster (R), also requested that the state’s department of administration block TikTok on all state government devices that it manages. The week prior, South Dakota Gov. Kristi Noem (R) additionally barred all state employees and contractors from using the app on state-owned devices.

The rapid succession of new policies is notable because, according to the Wall Street Journal, before the last two weeks, Nebraska was the only state to impose these kinds of bans, having done so back in 2020.

The latest actions are likely due in part to a public statement last week from FBI Director Chris Wray, who raised concerns about the app and said its algorithm “allows them to manipulate content, and if they want to, to use it for influence operations.”

More bans could be on the horizon: this week, a group of Wisconsin’s members of Congress asked the state’s Democratic governor to ban the app from state devices, and legislators in Arkansas drafted a similar bill for the next session.

Meanwhile, some states are cracking down on the video-sharing app in a different way. Also on Wednesday, Indiana’s attorney general filed two lawsuits against TikTok. The first accuses the company of misleading users about how safe the app is for children, claiming that it exposes them to inappropriate content despite its 12-plus age rating on the App Store. 

The second alleges that the platform deceived customers about China’s ability to access their data, stating it has the ability “to spy on, blackmail, and coerce” users in the name of Chinese national security.

See what others are saying: (The Washington Post) (CBS News) (CNN)

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North Carolina County May Be Without Power for Days After Substation Attacks

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Tens of thousands have been left without power as temperatures drop.


Power Outage Prompts State of Emergency

Two power substations in Moore County, North Carolina were attacked on Saturday and sustained heavy damage from gunfire. The damage has left about 40,000 people without power as the temperatures fall. 

Response to the crisis has been swift. A state of emergency was declared Sunday afternoon, an emergency shelter powered by a generator has been opened, and local schools have canceled classes for Monday. 

Local authorities have partnered with state and federal agencies in an effort to find those responsible for the attack. The North Carolina State Bureau of Investigation as well as the FBI have joined the investigation

The Sheriff of Moore county, Ronnie Fields, said the attack was “targeted” while speaking at a news conference Sunday night.

It wasn’t random,” he told reporters. “The person, or persons, who did this knew exactly what they were doing.”

A representative from Duke Energy, the owner of the substations, informed the public that the damages are significant and will require complete replacement of key parts. Unfortunately, the company will not be able to reroute power as they have during storms. The representative said that, because of this, people in Moore County may be without power until Thursday. 

Investigation Into Perpetrators

As of now, authorities don’t know who is responsible. Sheriff Fields told the press that no group has taken credit for the attack. The investigation is ongoing.

“An attack like this on critical infrastructure is a serious, intentional crime and I expect state and federal authorities to thoroughly investigate and bring those responsible to justice,” Gov. Roy Cooper (D) said in a tweet Sunday night.

On social media, many have speculated that the attack was an effort to stop a local drag show from being performed. The show had reportedly garnered a significant number of protesters and a police presence. The power cut out Saturday evening shortly after the show had started. 

Sheriff Fields reported Sunday night that, so far, no connection has been found between the attack and the drag show. 

See what others are saying: (AP News) (CNN) (Axios)

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Adderall Shortage Sparks Fears of Opioid-Like Crisis

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Experts specifically have expressed concerns that the lack of legal Adderall will force people to turn to black markets as they did when the supply of opioids was cut off.


Ongoing Shortage

Public health experts watching the ongoing Adderall shortage in the U.S. have raised concerns about the possibility that it could cause a major health crisis.

In mid-October, the Food and Drug Administration (FDA) announced that there was a nationwide shortage of immediate-release Adderall. The agency specifically noted that Teva Pharmaceuticals, which is the biggest manufacturer of the drug, was “experiencing ongoing intermittent manufacturing delays.”

Since then, the FDA has also reported that there are other manufacturers experiencing similar problems as well. In statements to the media, Teva has explained that the supply disruptions were triggered by a combination of a since-resolved labor shortage on its packing line this summer, as well as increased demand for the drug.

Adderall prescriptions have skyrocketed over the last two decades. From 2006 to 2016, the prescription of stimulants more than doubled in the U.S., and those numbers have grown since the pandemic. According to figures from the data analytics firm IQVIA, from 2019 to 2021, Adderall prescriptions alone rose by about 16%, surging from 35.5 million to 41.2 million.

Experts say the big spike over the last few years has been driven by the fact that more people are seeking these drugs to help cope with stress and distraction. Telehealth regulations that were relaxed during the pandemic also made it much easier for people to get diagnosed and prescribed in shorter periods of time.

A growing number of new start-ups have been taking advantage of lax rules, flooding social media — and specifically TikTok — with advertisements telling people to get ADHD meds if they feel distracted or tired. Many professionals say these apps pose issues because they are designed for such quick diagnosis so it can be hard to tell if ADHD is actually the problem people who present those symptoms are dealing with.

The resulting effect has been renewed speculation that stimulants are being overprescribed — a factor some believe could also be driving this shortage.

Additionally, Adderall is a Schedule II controlled substance, so it is highly regulated by the Drug Enforcement Administration (DEA), meaning there are caps on how much each company can produce so they can’t just ramp up production to make up for the backlog. It is also difficult for pharmacies to just pivot and start carrying new brands because of the regulations on this drug.

Potential Crisis

Leo Beletsky, a professor of law and health sciences at Northeastern University and faculty director of the Health in Justice Action Lab, worries all these elements could create the perfect storm for a full-blown crisis.

In an interview with Rogue Rocket, he outlined two overarching concerns.

 “One is that you have lots of people who had access, sort of regular access to medication that they may not now have access to, and there are individual-level risks that sort of cascade from that,” he said. “Insomnia, depression, in some instances, you could even see suicidal ideation. So all of these are kind of, you know, health risks that result from rapid tapering or discontinuation, discontinuation of taking Adderall.”

“What is an even bigger concern or, an equally important concern, is that lots of people without access to the pharmaceutical supply will turn to the illicit market and counterfeit Adderall is readily available on the illicit market and other forms of unfettered means. Specifically, methamphetamine is available, widely available on the illicit market 24/7. You know, there’s no shortage in that market,” he continued.

Beletsky explained that there are a number of harms that can come as a result of people turning to the black market — and there is first-hand evidence of this from the opioid crisis. As he noted, opioids were also widely criticized as being overprescribed, and so when access was cut for prescription opioids, people turned to illegal markets and there was a massive spike in the use of heroin, counterfeit opioids, and fentanyl contamination.

“The public health, sort of population-level concern is that we might see similar patterns here where lots of folks are being pushed into the market and they’re, you know, it’s the Wild West. Counterfeit Adderall oftentimes does have methamphetamine,” he stated. Counterfeit Adderall can also be cross-contaminated with other dangerous drugs like fentanyl.

“Methamphetamine is even cheaper than counterfeit Adderall pills, and so the concern is that folks might start smoking meth and even injecting meth, which is, you know, increasingly common,” Beletsky continued. “It would be a huge public health disaster if thousands or even millions of people started taking methamphetamine in or trying to replace this pharmaceutical supply.”

Prevention Options

Beletsky pointed out a number of tools the FDA has at its disposal to address the possible crisis and clear up the shortage, including encouraging other competitors to create new sources of production, as well as encouraging the importation of Adderall from abroad.

However, while the agency would have the power to fast-track these actions to skirt regulatory hurdles, so far, they have not taken any of these steps. In response to questions as to whether the FDA will intervene and speed up the process, a spokesperson told Rogue Rocket  that the agency “evaluates all its tools and determines how best to address each shortage situation based on its cause and the public health risk associated with the shortage.”

When asked when the FDA thinks the shortage will be resolved, the spokesperson said it is “expecting the supply issues to resolve in the next 30-60 days.”

But Beletsky said he does not buy that timeline.

“I’m afraid that they may be over overly optimistic given the scale of the problem,” he told Rogue Rocket. “My guess is it’s going to take months to resolve. And I hope that, you know, most folks are able to kind of make do and not start kind of purchasing alternatives from the illicit market.” 

The professor emphasized that the current shortage is a symptom of broader problems with America’s overall system for drug regulation that goes beyond the FDA and centers on the powers granted to the DEA. 

Unlike the FDA, the DEA is a law enforcement agency, and Beletsky notes it has a long history of focusing on controlling the supply of these kinds of drugs rather than ensuring there is adequate access for the people who need them.

As a result, the DEA has very little control over both the legal and illegal markets for controlled substances. Because of this, people lack proper access to the prescriptions they need while the massive, unregulated black market is thriving.

Beletsky argued it is imperative that we use this latest shortage as yet another wake-up call to highlight the need for rethinking how drug access is structured in America.

“I think that it’s really important to highlight the failures of the DEA in this context, because the DEA, much more than the FDA, is responsible for finding that balance between access and control,” he said. “I think that we really need to reevaluate the role of the DEA in our drug regulatory system. And the FDA, on the other hand, probably could use additional authority.” 

“When it comes to essential medicines, we really need much more authority for governmental regulation to step in and sort of help to stabilize access to these particular medications, as well as many others.” 

How to Seek Help

Beletsky noted that there are several steps people who need Adderall can take until the shortage clears up.

“I think it’s important to note that there are other alternatives in the pharmaceutical supply that are not in shortage,” he explained. “And so talk to your provider about what additional tools may be available, you know, other stimulants that you can […] try to kind of bridge the gap.” 

“I think it’s also important to note that if you do turn to, you know, folks are turning to buying Adderall or other alternatives on the illicit market, it’s really important to test that supply, especially for fentanyl.”

For more information on obtaining test strips and other harm reduction tools, Beletsky recommended visiting Next Distro or finding your local harm reduction agency, which can be done on the National Harm Reduction Coalition website.

For those suffering the impact of the Adderall shortage, The Washington Post has a guide with helpful tips and ideas from professionals.

See what others are saying: (WIRED) (The New York Times) (Axios)

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