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.

COVID-19 Cases Expected To Surge After Thanksgiving

Published

on

  • With coronavirus cases already on a steep rise in the U.S, experts are warning that Thanksgiving travel and gatherings will likely make things worse. Canada, for example, saw a jump in cases after its citizens celebrated the holiday last month.
  • Surgeon General Jerome Adams said that Americans should hold out for a vaccine, which is on the horizon, and be safe this Thanksgiving.
  • A family in Texas is also waring against gathering, saying they learned how dangerous it is the hard way. After celebrating a birthday together, all 15 people who attended the party tested positive for the virus.
  • On top of this experts are also warning against thinking a negative test clears you for socialization. In reality, you can test negative for the virus and still have and transmit it.

Warning From Surgeon General 

As Thanksgiving looms closer, warnings against family gatherings are being echoed by experts and everyday people alike. 

Health officials have been vocal about the threat the Thanksgiving holiday poses when it comes to the coronavirus. The U.S. has seen 12.4 million cases and lost 257,000 lives to the virus, and cases have been on a steep increase this month. The CDC has already warned against travel and experts have said that based on the spike Canada saw after its October Thanksgiving, America is set to go down a similar, or even worse path. 

“I want the American people to know that we are at a dire point in our fight with this virus by any measure,”  U.S. Surgeon General Jerome Adams said Monday on Good Morning America.Cases, positivity, hospitalizations, deaths. We’re seeing more Americans negatively impacted than ever before.” 

Adams said that with a vaccine on the horizon, Americans should just wait out this homestretch and stay put for the holiday.

“I’m asking Americans, begging you, hold on just a little bit longer,” he said. “Keep Thanksgiving and the celebration small and smart this year.” 

Family in Texas Urges Caution

Health officials are not the only ones preaching this advice. In Arlington, Texas, a family that has lived the consequences of gathering without regard for public health is urging people to not make the same mistake as them. The Aragonez family celebrated a birthday earlier this month indoors without masks or distancing. Now, all 15 people who attended tested positive for the virus. 

“We feel guilty for gathering,” members of the family said in a video encouraging caution. “All this pain that my family is feeling, this loneliness, this sickness, this longing to be healthy could have been prevented.” 

“Please don’t be like my family and ignore the CDC guidelines,” one person said. “By staying apart we can fight this virus together.” 

While most cases in the family were mild, one person was hospitalized for over a week.

“One moment of carelessness has cost us a month of peace, has cost us sleep, has cost us laughs, has cost us a lot of money,” one family member told the Washington Post. 

Testing Negative is Not Enough

Many have still forged on with their gathering plans under the false idea that if everyone tests negative before attending, they are in the clear to socialize. However, experts warn this is far from the case.

Just because a person tests negative does not necessarily mean they do not have the virus. Tests are not 100% accurate and it can take days or even a week to test positive for the virus after exposure. Not to mention, people could come into contract with the virus between their test and the family event. 

“A negative result is a snapshot in time,”  Dr. Paige Larkin, a clinical microbiologist at NorthShore University HealthSystem in Chicago explaining to the New York Times. “It’s telling you that, at that exact second you are tested, the virus was not detected. It does not mean you’re not infected.”

While it might slightly minimize the risk of spread, it certainly does not eliminate it. More than anything, it gives people a false sense of security that they have a free pass to go wherever and see whoever they want, despite the fact that it still poses a large health threat.

See what others are saying: (New York Times) (Washington Post) (Associated Press)

Continue Reading

U.S.

Over 1 Million People Traveled Through U.S. Airports Friday, Despite COVID-19 Warnings

Published

on

  • Over 1 million people traveled through U.S. airports on Friday, marking the second-highest single day of airport traffic since the coronavirus pandemic began.
  • The new record comes despite the fact that the CDC has issued a warning against travel for Thanksgiving, encouraging people to stay home instead because COVID-19 cases are already on a steep rise.
  • In Canada, cases spiked after the country celebrated their Thanksgiving holiday in October.
  • While cases were already increasing in the country, contact tracing has linked outbreaks to holiday gatherings, which likely accelerated the speed of spread.

Cases and Travel Both Increase

The upcoming Thanksgiving holiday is expected to worsen the already increasing coronavirus outbreak in the United States. 

Currently, the country has seen over 12.3 million cases and lost more than 256,000 lives to this virus. On Friday, the U.S. broke its record for new cases in a single day, reporting 198,500 cases. The daily average has reached 171,462 cases a day and roughly one-quarter of all cases in the U.S. have come from just the month of November. 

These circumstances paint a grim picture of what could come after all of the traveling and large gatherings that are expected to happen over the holiday, even after repeated warning against doing so.

In fact, the Centers for Disease Control and Prevention has warned against traveling and advised that “postponing travel and staying home is the best way to protect yourself and others this year.”

The CDC told travelers to ask themselves questions, like if cases are high in their home or destination, if their method of travel makes social distancing difficult, and if there are travel restrictions in their area. If the answers to any of those questions are yes, people should “consider making other plans, such as hosting a virtual gathering or delaying your travel.”

Despite these warnings, air travel is on the rise in the country. On Friday, more than 1 million people passed through airports, marking the second-busiest day of air travel since the pandemic began. While this is 1.5 million people less than the same day last year, the travel surge troubles health officials who fear the virus could spread as people gather with their families. 

Case Spike After Canada’s Thanksgiving

All the U.S. has to do is look to its neighbor to the North in order to find out just what kind of impact Thanksgiving can have on coronavirus cases. Two weeks after Canada’s Thanksgiving in October, the country saw a spike in cases. While cases were already on the rise at the time, experts believe that holiday gatherings contributed to and accelerated the spread.

“Cases were indeed increasing already, but we definitely saw an increase in the rate of transmission after Thanksgiving. And we know that Thanksgiving is important for a couple of reasons. One is through contact tracing data,” Dr. Laura Rosella, an associate professor and epidemiologist at the University of Toronto told CBS News.

Contact tracing in the country showed a significant transmission from household gatherings stemming from Thanksgiving. 

“One local health unit that reported about 12 people being infected because of a Thanksgiving gathering,” Rosella explained. 

It’s not the only reason the cases are increasing, it’s not the only setting in which transmission is occurring, but definitely when people gathered indoors it did transmit COVID.”

Superspreading Events

Still, people are more likely to feel safe with their family, no matter how high the COVID-19 risk actually is. Superspreading weddings are among the strongest examples of this, as numerous have led to significant outbreaks because couples thought it was safe to gather with friends, family, and other people they trust.

“Many people don’t believe that you can actually catch it from your family and friends. They feel safe when they are around people that they know,” Karen Potts, the director of the Adams County Health Department in eastern Washington explained to NBC News. “And I think that’s why this sort of event happens. People just feel safe, and they go to the event, and it just spreads so rapidly.”

One August wedding in Maine, for instance, was liked to 177 coronavirus cases and 7 deaths. Many of those cases include people who did not attend the wedding. In fact, none of the deaths traced back to the wedding were attendees. 

An October wedding in Cincinnati led to 32 of the 83 guests getting COVID-19, including grandparents of the bride and groom. In Washington, a 300 person wedding earlier this month has led to 17 people getting the virus so far. 

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

Continue Reading

U.S.

12 Million Americans at Risk of Losing Unemployment Benefits After Christmas as Claims Spike for the First Time Since October

Published

on

  • Unemployment claims have spiked for the first time since early October, with 742,000 people filing last week. Over 20 million Americans are still collecting some kind of joblessness aid.
  • Meanwhile, a new study found that more than 12 million Americans will lose their benefits the day after Christmas when federal unemployment programs are set to expire if Congress does not extend them.
  • Congress is still at an impasse on another coronavirus relief bill.
  • Meanwhile, large companies like Amazon and Walmart are not giving hazard pay to essential workers even as cases spike and both companies saw major quarterly profits increases.

Claims Rise

The Department of Labor (DOL) reported Thursday that another 742,000 Americans filed for unemployment — the highest spike in claims since early October. According to experts, the new figures are a sign that the recent coronavirus spikes are slowing the economy and companies are cutting jobs.

While 742,000 is less than the millions of claims that were filed back in March and April, it is still more than three times higher than the 210,000 new claims that were filed each week for the first two months of the year before all the shutdowns.

Notably, that newly released number does not include every American who filed joblessness benefits in the last week. There are separate programs for federal workers and veterans, among others. 

One of the largest is the Pandemic Unemployment Assistance (PUA) program for freelancers and self-employed people. This week, the DOL reported that the number of people who filed claims under that program had also increased from last week to just over 320,200. 

Even then, those figures only represent claims filed in the course of the last week, not total unemployment. According to the most recent DOL data, at the end of last month, 20 million Americans were still out of work.

Benefits Expiring and Stalled Stimulus 

Further complicating matters is the fact that the remaining federal benefits approved under the CARES Act are set to expire in mere weeks. 

According to a new report from the progressive think tank The Century Foundation, more than half of those 20 million unemployed Americans — roughly 12 million — will lose their benefits entirely the day after Christmas if those programs are not renewed by Congress and President Donald Trump.

One of those programs is the PUA program, which The Century Foundation estimates would leave 7.3 million people without unemployment benefits. The other program is the Pandemic Emergency Unemployment Compensation (PEUC), which allowed out of work Americans to collect benefits for an extra 13 weeks beyond the usual 26 weeks provided by states.

The loss of that program would leave another 4.6 million without benefits when it expires, the study estimates. Notably, the 12 million Americans who will lose their benefits on Dec. 26 is in addition to the estimated 4.4. million who will have already exhausted their CARES Act benefits before these programs expire. 

While The Century Foundation did find that 2.9 million people who had been on the federal extended benefits would be eligible for state-level extended benefits once the deadline hits, states would have to pick up the tab for those benefits at a time when their funds are totally depleted and Congress has also not helped them since the CARES Act.

But after months of deadlock, the talks largely stalled ahead of the election and in the chaotic aftermath. While key Democrats are seeking to restart those talks this week with Senate Majority Leader Mitch McConnell (R-Ky.) — who has said he wants to pass some kind of bill before the end of the year — it is unclear how the problems that existed for months throughout these negotiations will just go away.

Democrats have been pushing for one large, comprehensive bill worth about $2.2 trillion, and while in the lead up to the election the White House had agreed to a number very close to that, McConnell has refused to bring anything even remotely near that price to that to the floor.

Instead, he has continually pushed for a so-called “skinny” bill that would provide about $500 billion worth of funding.

In other words: despite the repeated abject failures by those in power to give Americans the help they have needed since March, it appears that Congress is still no closer to a deal.

“Congress is set to cut off 12 million Americans from the only thing holding them back from falling into financial wreckage and disaster,” Andrew Stettner, a co-author of The Century Foundation’s study told NPR, adding that Congress’ inability to come up with a deal comes “at a time when things are getting worse with the virus rather than better, making it harder and more dangerous for people to go back to work.”

Lack of Hazard Pay

To that point, it is not just Congress that’s giving American workers a lot of grief. 

Even as the number of coronavirus cases are rising dramatically, retail workers have not been receiving hazard pay, even though major retailers have recently been seeing increased profit margins, and that trend is expected to continue as the holiday season approaches.

According to The New York Times, Amazon — which stopped its $2-an-hour hazard-pay raise for workers earlier this year — has said it was not planning any new hazard pay bumps. The world’s second-largest retailer made this decision despite the fact that it has thrived during the pandemic, reporting last month that its quarterly profit had increased by nearly 200%. 

Amazon has also been subject to much criticism over its treatment of essential retail workers during the pandemic. Among other issues, there have been numerous outbreaks at Amazon warehouse facilities, some of which have been fined as recently as last month for pandemic workplace safety violations.

Meanwhile, the world’s largest retailer, Walmart, also reported a significant increase in quarterly sales this week. While the company said it had paid a series of special cash bonuses to employees throughout the pandemic, it also has not raised wages for workers who are on the frontlines endangering their lives.

Those two companies are not alone: many other large corporations like Lowes and Kroger have also come under fire for refusing to give their employees hazard pay while enjoying high profits. Experts have said that many of these companies can afford to share their earnings, but instead, many are reportedly helping out wealthy shareholders through stock buybacks.

While some lawmakers have tried to step in and help compensate retail workers, efforts to provide hazard pay both in the stimulus bills and in separate legislation have failed.

States Take Action

Notably, some states have been rolling out programs to help their unemployed residents and fill the void left by Congress.

On Wednesday, New York Gov. Andrew Cuomo (D) launched a new online training platform that will provide access to nearly 4,000 online courses and programs to provide New Yorkers with new skills and certificates to advance their careers at no cost.

The tool will specifically focus on training up people for jobs growing, in-demand economic sectors like manufacturing, technology, and health care.

“This new training platform will be key in this effort by ensuring unemployed and underemployed New Yorkers are not left behind by providing access to the resources and training they need to get back on their feet,” Cuomo said in a press release announcing the launch.

While many cheered the new program as a helpful long-term solution to the unemployment crisis, others noted that it will do little to help people in the short term if the federal unemployment benefits expire, underscoring the need for another coronavirus relief bill immediately.

See what others are saying: (NPR) (The New York Times) (The Associated Press)

Continue Reading