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Pfizer Seeks Full FDA Approval For COVID-19 Vaccine



Pfizer-BioNTech is seeking the Food and Drug Administration’s approval for its COVID-19 vaccine, with the goal of getting the agency’s green light “in the coming months.” Ben Hasty/MediaNews Group/Reading Eagle via Getty Images hide caption

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Ben Hasty/MediaNews Group/Reading Eagle via Getty Images

Pfizer and its vaccine partner BioNTech have started an application to request the Food and Drug Administration’s approval for its COVID-19 vaccine.

Pfizer is the first coronavirus vaccine maker in the U.S. to request full approval. Like Pfizer, the Moderna and Johnson & Johnson vaccines had been previously cleared for use under the agency’s emergency use authorization — a less rigorous approval method to aid a swifter response to the pandemic.

An FDA approval for a vaccine means the agency has decided that its benefits outweigh the known risks following a review of the manufacturer’s testing results.

If granted, Pfizer’s full stamp of approval would only apply to the vaccine for people who are 16 and older. Meanwhile, the vaccine maker is seeking emergency use authorization for its COVID-19 vaccine to include children between 12 and 15.

“We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months,” Pfizer CEO Albert Bourla said in a press release Friday.

BioNTech’s CEO, Dr. Ugur Sahin, called the submission of the application for FDA approval “an important cornerstone of achieving long-term herd immunity and containing COVID-19 in the future.”

“We are pleased to work with U.S. regulators to seek approval of our COVID-19 vaccine based on our pivotal Phase 3 trial and follow-up data.”

In that final phase of clinical trials, Pfizer found that its vaccine was 95% effective against COVID-19, the highest efficacy among vaccines authorized for emergency use in the United States.

For the FDA to grant approval, Pfizer-BioNTech will have to comply with a key requirement: providing follow-up data six months after vaccinations.

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The Pandemic Led To The Biggest Drop In U.S. Life Expectancy Since WWII, Study Finds



A COVID-19 vaccination clinic last month in Auburn, Maine. A drop in life expectancy in the U.S. stems largely from the coronavirus pandemic, a new study says. Robert F. Bukaty/AP hide caption

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Robert F. Bukaty/AP

A new study estimates that life expectancy in the U.S. decreased by nearly two years between 2018 and 2020, largely due to the COVID-19 pandemic. And the declines were most pronounced among minority groups, including Black and Hispanic people.

In 2018, average life expectancy in the U.S. was about 79 years (78.7). It declined to about 77 years (76.9) by the end of 2020, according to a new study published in the British Medical Journal.

“We have not seen a decrease like this since World War II. It’s a horrific decrease in life expectancy,” said Steven Woolf of the Virginia Commonwealth University School of Medicine and an author of the study released on Wednesday. (The study is based on data from the National Center for Health Statistics and includes simulated estimates for 2020.)

Beyond the more than 600,000 deaths in the U.S. directly from the coronavirus, other factors play into the decreased longevity, including “disruptions in health care, disruptions in chronic disease management, and behavioral health crisis, where people struggling with addiction disorders or depression might not have gotten the help that they needed,” Woolf said.

The lack of access to care and other pandemic-related disruptions hit some Americans much harder than others. And it’s been well documented that the death rate for Black Americans was twice as high compared with white Americans.

The disparity is reflected in the new longevity estimates. “African Americans saw their life expectancy decrease by 3.3 years and Hispanic Americans saw their life expectancy decrease by 3.9 years,” Woolf noted.

“These are massive numbers,” Woolf said, that reflect the systemic inequalities that long predate the pandemic.

“It is impossible to look at these findings and not see a reflection of the systemic racism in the U.S.,” Lesley Curtis, chair of the Department of Population Health Sciences at Duke University School of Medicine, told NPR.

“This study further destroys the myth that the United States is the healthiest place in the world to live,” Dr. Richard Besser, president of the Robert Wood Johnson Foundation (an NPR funder), said in an email.

He said wide differences in life expectancy rates were evident before COVID-19. “For example, life expectancy in Princeton, NJ—a predominantly White community—is 14 years higher than Trenton, NJ, a predominantly Black and Latino city only 14 miles away,” Besser said.

Life expectancy in the U.S. had already been declining — albeit slowly — in the years leading up to the pandemic. And the U.S. has been losing ground compared with other wealthy countries, said Magali Barbieri of the University of California, Berkeley, in an editorial published alongside the new study.

The study estimates that the decline in life expectancy was .22 years (or about one-fifth of a year) in a group of 16 peer countries (including Austria, Finland, France, Israel, the Netherlands and the United Kingdom) compared with the nearly two-year decline in the United States.

“The U.S. disadvantage in mortality compared with other high income democracies in 2020 is neither new nor sudden,” Barbieri wrote. It appears the pandemic has magnified existing vulnerabilities in U.S. society, she added.

“The range of factors that play into this include income inequality, the social safety net, as well as racial inequality and access to health care,” Duke’s Curtis said.

So, what’s the prognosis going forward in the United States? “I think life expectancy will rebound,” Woolf of Virginia Commonwealth said.

But it’s unlikely that the U.S. is on course to reverse the trend entirely.

“The U.S. has some of the best hospitals and some of the greatest scientists. But other countries do far better in getting quality medical care to their population,” Woolf said. “We have big gaps in getting care to people who need it most, when they need it most.”

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Heart Inflammation In Teens And Young Adults After COVID-19 Vaccine Is Rare, CDC Says



A teenager enters a pop-up COVID-19 vaccine site this month in the Jackson Heights neighborhood of Queens in New York City. Scott Heins/Getty Images hide caption

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Scott Heins/Getty Images

The Centers for Disease Control and Prevention says 323 cases of heart inflammation have been verified in people who received the Pfizer or Moderna COVID-19 vaccine.

The cases of myocarditis and pericarditis have been seen mostly in teens and young adults between 12 and 39 years old — mostly after the second vaccine dose.

Most people who have experienced this side effect have recovered from symptoms and are doing well, according to data presented Wednesday at a public meeting of the CDC’s vaccine advisory committee. Of the 323 cases, 295 were discharged from the hospital, nine remained hospitalized as of last week and 14 were not hospitalized at all. Outcome data was missing for five of the cases. No deaths have been associated with this side effect.

Symptoms include chest pain or pressure and difficulty breathing, says Dr. Kristen Sexson Tejtel, a cardiologist at Texas Children’s Hospital who has treated people with the vaccine-related condition. For people experiencing symptoms, “the best thing to do is to talk to their physician or come to the emergency room for evaluation,” Tejtel says, where blood tests and heart imaging results can confirm the diagnosis.

The CDC says there have been some cases of heart inflammation reported after the Johnson & Johnson vaccine to the Vaccine Adverse Events Reporting System, though not as many as with the Moderna and Pfizer vaccines.

The number of cases has not risen much from last week when CDC Director Rochelle Walensky told reporters at a White House briefing that the agency knew of “over 300” cases.

Officials say the side effect is extremely rare

The CDC says the findings do not change the basic recommendation that all people 12 and older should receive either the Pfizer or Moderna vaccine. However, the CDC recommends that if a person develops myocarditis after the first dose, a second dose should be delayed until the condition has fully resolved and the heart has returned to a normal state.

“The facts are clear: this is an extremely rare side effect, and only an exceedingly small number of people will experience it after vaccination,” officials said in a statement. “Importantly, for the young people who do, most cases are mild, and individuals recover often on their own or with minimal treatment. In addition, we know that myocarditis and pericarditis are much more common if you get COVID-19, and the risks to the heart from COVID-19 infection can be more severe.”

Health experts agree that the benefits of being protected from COVID-19 outweigh the risks of developing this temporary heart condition from a vaccine. “There’s no zero risk proposition,” says Dr. Brian Feingold, medical director of the heart transplant program at Children’s Hospital of Pittsburgh. “If you’re statistically going after what’s safest, the data right now stacks up [to show] that vaccines are absolutely the safer route.”

A representative from the Food and Drug Administration attending the meeting, Dr. Doran Fink, said the agency would add a warning to vaccine fact sheets reflecting the risk of this rare complication.

Naturally occurring heart inflammation is rare, but it does occur from time to time in teens and young adults. The rate seen after these vaccines is slightly higher than would be expected for these ages, prompting concern.

Teenagers get vaccination cards after receiving a first dose of the Pfizer COVID-19 vaccine last month at a mobile clinic at the Weingart East Los Angeles YMCA in Los Angeles. Patrick T. Fallon/AFP via Getty Images hide caption

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Patrick T. Fallon/AFP via Getty Images

Officials are also looking at booster shots

The group is also looking at the issue of booster doses. A report from the CDC presented to the expert panel says that the agency would recommend a booster dose only after seeing evidence that people who’ve gotten the vaccines have started getting infected in significant numbers. The agency would not rely solely on a decline in antibodies.

The Advisory Committee on Immunization Practices issues recommendations for the use and scheduling of all approved and authorized vaccines in the United States. It did not vote on any recommendations Wednesday regarding the use of the Pfizer or Moderna vaccines.

Pien Huang contributed to this report

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4th of July During Covid — How to Celebrate Independence Day Safely With the Help of Technology



Skywell Software

The 4th of July is one of the year’s biggest holidays, and many people have been looking forward to it all year. However, with the Covid crisis still going on, we still need to take precautions and celebrate the 4th of July safely. Fortunately, many technologies exist to help us enjoy the holiday while adhering to precautions like social distancing and many others as well. Today we will share with you how to celebrate the 4th of July during Covid with the help of technology to make sure that you receive maximum enjoyment while staying safe.

Large gatherings of family and friends are a 4th of July tradition. However, you don’t have to let Covid prevent you from coming together like you normally would. There are many VR solutions available that allow you to host a party in VR or just a simple gathering. The great thing about VR is that it allows you to interact with other people as if you were standing next to them, allowing you to get a life-like experience. For example, Oculus, one of the leaders in developing VR headsets, offers rooms and parties for Gear VR where you can meet with your friends in a virtual private space. This type of technology can also be used for things like business meetings and getting together at other times during the year with VR development services.

Since Oculus is owned by Facebook, it is easy to connect with your friends. Just link your Facebook and Oculus accounts or search for people by their real name or Oculus username. Once you join and become Oculus friends, you can see when your friends are online, start a voice call, or jump into an experience together. Best of all, such headsets do not cost a fortune. You can get a Gear VR headset for $129 on Amazon.

One of the biggest 4th of July festivals is hosted by Macy’s every single year. In fact, this year marks the 45th anniversary of the Macy’s 4th of July Festival, but, just like last year, this one will be offered in VR as well. This is a fun-filled event with an all-star cast such as Coldplay, Onerepublic, and many more. Macy’s is partnering with to create virtual experiences through HTC Vive headsets and tools like the Google Tilt Brush. For those who may not be familiar with Google Tilt Brush, it is one of the first VR experiences of its kind and caliber, allowing its user to create 3D paintings within a virtual space. This means that attendees can create their own fireworks that suit their tastes and share this experience with family and friends.

Another major benefit of virtual reality is that you do not have to make a physical trip to any particular location to enjoy the festivities. This offers a lot of convenience and cost savings, and you are not taking any unnecessary risks by traveling. It is important to note that while in this article we are focusing on the 4th of July Festivities, you can take advantage of VR to enjoy a wide range of experiences all year round.

Another way you can celebrate the 4th of July in virtual reality is by taking a trip across America and seeing virtually any point in the US. Not only can you enjoy places like Mount Rushmore, the Statue of Liberty, but you can also experience the fireworks display at almost any location in the United States. This also opens the door for all kinds of new ways to enjoy the 4th of Juley during Covid since you can also take a tour of various museums in the US and the world as well.

In addition to this, another experience in VR that you can enjoy is to actually experience the founding of the country in VR. During the Covid 4th of July weekend, you can take a trip back to 1776 and witness all of the founding fathers signing the Declaration of Independence and actually get the feeling of what it would have been like to live during that tumultuous time period. This is a fun and exciting way to make history come alive and allow the entire family to enjoy an experience unlike any other.

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The 4th of July celebrations would not be complete without a spectacular fireworks display. However, even though this year you may not be able to gather and see the show at a particular location, you can now do so in augmented reality. This is one of the most interesting Covid 4th of July ideas since you can create a firework show wherever you may be. There are already apps like TotalAR that allow you to light up the sky through your smartphone or tablet and give you a 12-minute fireworks display. A lot of state governments have already partnered with the company that created the TotalAR app, HoloPundits, including 20 states and 60 communities across the country.

You don’t have to let the coronavirus ruin the 4th of July weekend for you since you can do pretty much anything you would usually do in AR and VR. With a lot of the experiences we mentioned earlier, such as fireworks displays and virtual get-togethers, the experiences have already been created, and all you have to do is put on a headset. However, if you have an idea for a new experience you would like to create, you will need to partner with an experienced AR and VR development company like Skywell Software to make your vision a reality. We have created AR and VR products for some of the world’s leading brands and can actualize even the most innovative projects. Contact us today to learn more about how we can help you.

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A COVID Outbreak At The U.S. Embassy In Kabul Has Sickened 114 People And Killed 1



A general view of the U.S. Embassy in Kabul, Afghanistan in 2013. The embassy is facing a coronavirus outbreak, according to the State Department. Ahmad Nazar/AP hide caption

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Ahmad Nazar/AP

The U.S. Embassy in Kabul says it is suffering from a major COVID-19 outbreak that has largely confined staff to their quarters and is disrupting many of its operations. Earlier this week, the embassy announced that it was suspending in-person visa interviews for Afghans who had worked for the U.S. military.

In a note sent to staff, seen by NPR, the embassy says 114 people “have COVID and are in isolation; one has died, and several have been medevaced.” The note goes on to say that military hospital ICU resources are at full capacity and that the embassy has been forced to “create temporary, on-compound COVID-19 wards to care for oxygen-dependent patients.” Most of the cases involve individuals who are unvaccinated or not fully vaccinated.

“We are saddened by the deaths of many valiant Afghans, who have been sickened by this pandemic and we in fact grieve the passing of an embassy local staff member,” said Ned Price, the State Department’s spokesperson.

The embassy requests staff to get vaccinated, stay six feet from others, suspends the use of pools and gyms, and demands strict mask compliance from staff. “Wear your masks, correctly! We are seeing a lot of noses.”

Failure to comply could see staff on the next flight home. The embassy asks them to make sure others are following protocols and to report those who aren’t.

Eric Rubin, who heads the American Foreign Service Association — the State Department’s union — says he’s hearing from members, who are “very concerned that their safety has been endangered by fellow employees, who have chosen not to be vaccinated.”

“Our understanding is that there is enough vaccine at every embassy and consulate in the world for anyone, who wants to get it,” Rubin told NPR.

The State Department does not disclose how many people are at the embassy, but it is one of the U.S.’ largest. The embassy reportedly faced a smaller coronavirus outbreak in June 2020.

The State Department and the embassy in Kabul did add some staff in recent months to handle a surge in visa applications for Afghan interpreters who worked with the U.S.

As the U.S. military pulls out – and is expected to fully do so by July, with a symbolic end date of Sept 11 – many of those who helped U.S. forces over the past two decades believe their lives are in danger, with the Taliban controlling greater swaths of the country.

Testifying before a congressional committee recently, Secretary of State Antony Blinken said there are currently 18,000 Afghans who have expressed interest in moving to the U.S. and about half were in the early stages of their application process.

Trying to reassure Congress, he added that while the military was leaving, the embassy would continue with its job and was focused on getting those who helped the U.S. out: “We’re not withdrawing. We’re staying. The embassy staying. Our programs are staying. We’re working to make sure that other partners stay. We’re building all of that up.”

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