Tag: Coronavirus

FDAPharmaceutical

Pharmaceutical Medicine: Pfizer Vaccine Granted FDA Approval

on September 15, 2021

On Monday, August 23, 2021, the Pfizer-BioNTech COVID-19 vaccine was granted approval by the Food and Drug Administration (FDA) for individuals 16 and older. Due to its newly approved status, what was known as the Pfizer-BioNTech COVID-19 vaccine will now be advertised as Comirnaty (koe-mir’-na-ty). According to the BBC, “The approval ultimately came less than four months after the Pfizer-BioNTech filed for licensing in early May – the fastest vaccine approval in the FDA’s more than 100 year history.” The abrupt onset of the Coronavirus last year served as the impetus for a necessary response by medical professionals to reduce spread, infections, and deaths. Even though the vaccine has been distributed since December 11th, 2020, Acting FDA Commissioner, Janet Woodcock, M.D., hopes the FDA approval will cement certainty for concerned individuals to get vaccinated. With insight from FDA Expert Witness, Mr. Alan Schwartz of mdi Consultants, Inc., this blog post will examine the approval process for vaccines before and during COVID-19 as well as enlighten readers about reasons behind Comirnaty’s FDA approval.

Alan Schwartz is a seasoned expert in FDA protocols. He has over 50 years of experience in the field . When asked about the FDA’s general approval process, he states, “The process is NORMALLY very extensive. It could take years from the start of development through laboratory bench testing, animal safety studies, then human safety, and finally efficacy studies.” Mr. Schwartz also noted the avergage costs companies pay for these trials can reach up to $100 million, which these companies were able to actualize due to the Emergency Use Authorization (EUA). “The FDA under the EUA gave the companies a BULLET TRAIN path to get these through the emergency use approval,” he stated. In an ideal situation, the FDA would contact the clinical study participants throughout the duration of a year after receiving a vaccine. However, because of COVID-19, the vaccine has been officially approved after it has been administered to approxiamtely 100 million people. This was most likely due to political pressure and, more importantly, ensuring the well-being of citizens around the globe. In this situation, the long-term follow up was missing in the approval process. Nevertheless, the fact that roughly 100 million people received the Pfizer-BioNTech vaccine before its approval provided the necessary data on its efficacy and safety in real time. “So, did the FDA expedite the approval or did they have more data to use in their decision making process… we hope that they used good science to get this through the approval process since it was already being used for a year,” Mr. Schwartz mentioned.

Some concerns from those expressing doubt include whether the Pfizer vaccine was changed or modified for the purpose of an expedited approval process. Schwartz reassured there was an absence of changes regarding the production and formula of both the EUA and approved vaccinations. “This was all new to the FDA and in the industry… Normally when a vaccine or a drug is under FDA review there are many questions and back and forth that take a lot of time. I don’t think this was necessary under these conditions.” However, since Pfizer is currently manufacturing and advertising Comirnaty, the pharmaceutical company is allowed to continue using the EUA vaccine. The EUA is considered an experimental drug, but as soon as Comirnaty is ready for vaccine administration, Pfizer will be held liable if any problems arise.

A New York Times article stated, “Regulators are still reviewing Moderna’s application for full approval of its vaccine.” Since both Pfizer-BioNTech and Moderna vaccines are based on similar mRNA technology and both had emergency use authorization, there are questions regarding when the public can expect or not expect Moderna’s approval by the FDA. “I would be very surprised if we did not see Moderna approved,” Mr. Schwartz commented. Moderna has submitted their application for full FDA approval which is currently pending review. Announcements about its approval should occur in the near future (NPR).

The FDA has stated that the immunization will continue to be available for children aged 12-15 under Emergency Use Authorization (EUA). It remains uncertain when Comirnaty will be FDA approved for younger people, as the CDC recently announced its vaccine recommendation for said demographic back in May. Although there is not an official timeline, Mr. Schwartz predicts, “It may take until next year to obtain all required safety and efficacy data for pediatric indication.” The lack of data amid clinical trials is the primary reason as to why Comirnaty has not received approval for young people. However, this is not an obstacle for the Los Angeles Board of Education, the second-largest school district, who recently voted on September 9th to require students 12 and older to get vaccinated.

Current protocols include a mask mandate during in-person classes and frequent COVID-19 testing as a precaution against the virus. According to U.S. News, “Under LA Unified’s plan, all students age 12 and up will be fully vaccinated by the time they return to class following winter break on Jan.11. Those who are participating in sports and other activities need to receive a first dose of vaccine by Oct. 3 and a second dose by Oct. 31, while other students need to get their first dose by Nov. 21 and a second dose no later than Dec. 19.” Board members believe the implementation of this plan is the best course of action to responsibly protect children under the age of 12, the demographic not yet eligible for vaccinations. There are some parents who agree with the Los Angeles Board of Education’s vote, as it is similar to other immunizations students are required to receive such as chickenpox, polio, and measles to name a few. Other parents not only think the vote was rushed, but also believe the choice for their child receiving COVID-19 vaccine or not should be a parental decision.

So, we continue on this journey of uncertainty with COVID-19, the vaccines, and their aftereffects. It is only a matter of time before future vaccine mandates are implemented in school districts and businesses across the country. A special thanks to Mr. Alan Schwartz for his insight on the FDA approval process of the Pfizer-BioNTech produced Comirnaty vaccine.

Emergency MedicineExpert Witness

Emergency Medicine: Medical Malpractice Lawsuits During COVID-19

on June 16, 2021

According to the U.S. National Library of Medicine, “Medical malpractice is defined as any act or omission by a physician during treatment of a patient that deviates from accepted norms of practice in the medical community and causes an injury to the patient.” Medical malpractice is a component of tort law, which addresses professional negligence and offers reparations for civil offense. Some common examples of medical malpractice include misdiagnosis / delayed diagnosis, prescription drug errors, surgical / procedural errors, and failure to treat. However, until the recent COVID-19 outbreak, medical malpractice suits related to a pandemic have rarely been discussed. In this blog post, Experts.com aims to shed light on the topic with insight from Emergency Medicine Members, Sajid R. Khan, MD, and Vipul Kella, MD, MBA FACEP.

The COVID-19 pandemic brought about a plethora of problems for citizens, businesses, and industries all over the globe. According to Dr. Kella, “The pandemic placed enormous strain on our health systems: hospitals were operating at maximum capacity, supply shortages were well-publicized, and healthcare providers were scarce and overworked.” To add, during the pandemic, medical professionals had to simultaneously learn about the nature of the virus, its symptoms, and how it affected people of all ages. Despite the circumstances, essential workers in the medical field have abided by their ethical duty to commit no harm and to save their patients to the best of their ability. With the mystery of an unprecedented illness, and the learning curve associated with it, should the medical community be held to the same medical malpractice standard for COVID-19 as for other illnesses?

To his knowledge, Dr. Khan is unaware of any COVID-related malpractice lawsuits. However, to make a medical malpractice claim in most states, deviation from the standard of care must be demonstrated. Dr. Khan confirmed that the standard of care has frequently changed throughout COVID-19 due to the oddity of the situation. “Therapeutic recommendations change from month to month, making establishment of medical malpractice that more challenging,” he added. During the pandemic’s inception, healthcare professionals had to care for patients and prioritize their own physical well-being. Especially in populated areas like New York City, the medical community faced a scarcity of supplies. Dr. Khan, and many other Emergency Medicine professionals, have participated in a multitude of discussions about how to best select the patients who had the strongest chance of surviving. This of course is not the preferred method of treatment, but desperate times call for desperate measures. He stated, “It would be irresponsible to hold providers responsible for failing to provide optimal care to patients with such an illness.” Through the news and social media, the whole world has seen the medical community in action to help minimize the spread of COVID-19. Has the United States government taken any action to minimize the legal ramifications towards the healthcare industry? What measures can healthcare providers take to reduce the risk of medical malpractice involvement?

According to Dr. Kella, there have been a few acts passed by the federal government to alleviate the stress of the medical community. He mentions the Public Read and Emergency Preparedness (PREP) Act and the Coronavirus Aid Relief and Economic Security (CARES) Act. The PREP Act, amended by the US Department of Health and Human Services, provides legal protections to medical providers, whereas the CARES Act protects healthcare providers offering volunteer services during the pandemic against liability. “These regulations were good news for physicians as they allowed more leeway for trying to deliver care during difficult circumstances that were often out of their direct control,” Dr. Kella mentioned. Although there is protective legislation, this does not mean the medical community should not maximize efforts to minimize medical malpractice lawsuits. COVID-19 is known to advance a patients’ pre-existing or chronic disease. For instance, the standard of care has altered throughout the pandemic and, as such, Dr. Kella has suggested healthcare providers to meticulously check the documentation and routines of their patients to avoid negligence.

As the United States produces and administers vaccinations, the medical community’s knowledge of COVID-19 expands. Medical malpractice may not have played a large role throughout the beginning of the pandemic. As the days pass and perhaps more litigation arises, holding COVID-19 medical professionals to a strict standard of care, unless it is an egregious departure, could have a chilling effect on the medical community. As was apparent in the middle of the outbreak, the last outcome our country needs is fewer doctors and nurses.

MarketingPsychology

Consumer Psychology and Streaming Services: The Rise of Disney+ and Netflix

on February 17, 2021

Despite the daunting aspects of COVID-19, the pandemic provided millions of people around the world with an escape from reality: streaming service subscriptions. Netflix, Disney+, and others alike are dominating the entertainment industry. Within the first year after its inception, Disney+ accumulated 86.8 million users and predicts a trajectory of 260 million by 2024 (Variety). In 2020 alone, nearly 37 million people bought Netflix subscriptions, bringing the total number of subscribers to more than 200 million (BBC). On January 20th, 2021, its shares increased by 15% in its fourth quarter earnings (Business Insider). 

What is the catalyst for the success of these two streaming services? Insight from one of our very own Members at Experts.com will help answer these questions. Before delving into these insights, however, it is important to acknowledge the differences between the two streaming services.  

Disney+ is significantly cheaper than its rivals due to its slim library of around 600 movies and shows. However, the type of content it acquires is the gravitational element for its growing audience. Disney+ is the leading content provider for fans of Disney Original Movies, Marvel, Pixar, and “Star Wars” franchises. 

Netflix is known for its high-quality original shows and movies such as “Bridgerton,” “The Queen’s Gambit,” and “Marriage Story.” Its international content, like “Lupin” and “La Casa De Papel,” has increasingly appealed to audiences. Unlike Disney+, Netflix also allows consumers to stream movies with family and friends for free with Teleparty. This service may be more expensive, but its library of nearly 4,000 shows is worth the subscription. With these crucial differences in mind, let’s delve into our Experts’ contributions.  

Disney+ leads US brand awareness and subscriber race for new video streaming services | The Drum

Dr. Brent Coker is an Online Consumer Psychologist with a PhD in Electronic Commerce. He is also a Digital Marketing and Digital Business Models professor at the University of Melbourne. Based on his extensive knowledge on consumer behavior, Dr. Coker believes the rise in streaming entertainment services is indirectly correlated to COVID-19 for a couple of reasons:  

The first is the unexpected lifestyle imposed onto the world by the pandemic. National emergency calls made by various world leaders have induced policies including stay-at-home orders, remote learning and work, as well as limited in-person interaction. This new reality forced consumers to alter purchasing habits from before the virus, like spending more on internet bandwidth for work (which varies by country as some lack unlimited speed plans) rather than tickets for movies or other live performances. “Consumers ‘rationalise’ the extra cost out of necessity (they convince themselves the extra cost is needed not just wanted),” a direct quote from Dr. Coker. This high quality and faster internet further justifies subscribing to streaming services. Disney+ and Netflix’s stellar financial performances are due to the millions of people adjusting to more confined circumstances. 

The second reason is the lack of entertainment options. Because of the new social-distancing guidelines, in-person music festivals, sporting events, and dining at restaurants without restrictions are limited. Coker states, “People divide their entertainment options according to gratification – live performances, stage shows, cinema, and TV.” He then explains the absence of in-person events leads people to search for substitutes. It appears Netflix and Disney+ were the perfect replacement for millions of people this past year.  

MUST-WATCH SHOWS AND MOVIES – THE WATCHDOG

Dr. Coker also alluded to a slight change in advertising and endorsements. Instagram, Facebook, and Twitter are a few of many social media platforms people use to stay informed and connected. It is also the arena in which influencers use their online presence to promote trends and brands. Dr. Coker mentions Tiger King, one of the first Netflix Original shows to be released just before COVID-19, as a prime example of endorsement through social media. The documentary, especially its eccentric and bizarre main subject, Joe Exotic, became a meme used to draw more attention to audiences around the globe. Memes are “amusing or interesting items (such as captioned picture or video) or genre of items that are spread widely online especially through social media,” (Merriam-Webster). Dr. Coker finalizes his thoughts on social media connectedness by stating, “This is essential endorsement and word-of-mouth thus herding effects as people jump on board to experience what they perceive is the new norm.” 

The requirements of greater internet bandwidth for work, the loss of outdoor entertainment, and the implementation of stay-at-home policies have kindled the need for home entertainment. In 2020 alone, both companies have accrued millions of subscribers. Thanks to our Experts.com Member, Dr. Brent Coker, his insight on Consumer Behavior and Digital Marketing shed light on how the unanticipated lifestyle engendered by COVID-19 indirectly played a role in the purchasing decisions of people around the world and shapes how citizens perceive this new reality through social media. It remains to be seen whether Netflix and Disney+ will perform as well post-pandemic. 

ComputersEmploymentHuman ResourcesOrganizational Development

The Future of the Office in a Post-Pandemic World

on December 10, 2020

As we endure almost ten months of living through a pandemic, we can all agree COVID-19 has brought about various changes and challenges. The pandemic has affected every aspect of daily life. Worrying when items will be restocked in local grocery stores, wondering when the next stimulus check will arrive in the mail, and keeping ourselves and families safe from the virus have been at the forefront of everyone’s minds. Although millions of jobs have been lost this year, people who are lucky enough to either have found or kept his/her job now deal with working-from-home. Because the workforce is now conducting a 180 towards online practices, the future of offices in a post-pandemic world is pending. 

According to Nicholas Bloom, a Stanford Economist, “we’re in the middle of a structural, seismic shift,” in the workplace. Working-from-home is not a new concept, there are jobs that are designed specifically for remote locations and travel. The problem is millions of people are now forced to adapt to new working conditions in order to slow the spread of the virus, putting the world’s technological advancements to the test. To ensure productivity through a tumultuous time, businesses are instantly tasked with reimagining the role of work and creating a positive environment for their employees. Both individuals and organizations face benefits and drawbacks from this uncontrollable shift.  

Some employees love the working-from-home lifestyle. For busy individuals or employees who have families, working-from-home creates flexibility in his/her work schedule, allowing time to complete daily errands and appointments. A surprising “36% (of employees) would choose it (remote work) over a pay raise,” a statistic from Global Workplace Analytics. Working-from-home also allows people to save money on clothes, gas, and food costs that they would otherwise need for the workplace. Lastly, working remotely does not necessarily mean people are tethered to their homes. Computers and smartphones allow people to work from any location, including coffee shops, parks, and even planes. Having the choice of when and where you work is the appealing aspect of working remotely.  

While working from home has been successful for some people, it has caused great strife for others. Merging the personal and professional components of life is not an easy feat. This sudden disruption of daily routines adds physical, mental, and emotional anxiety. For those with families, balancing the work load may be difficult with children under foot. To add, the lack of in-person communication creates a sense of isolation and loneliness, which could decrease productivity. To combat these hardships, employees and employers who work-from-home must dedicate some time to maintain his/her health and wellness by exercising, connecting with family and friends, and finding activities that bring happiness to the day.  

Although companies who adopt the work-from-home method implement different policies, the general pros and cons seem to be consistent for most businesses. According to Global Workplace Analytics, “A number of states, including Virginia, Georgia, and Oregon offer financial incentives for businesses to adopt telework.” The benefits are not limited to financial incentives. States such as Arizona and Connecticut offer free training to businesses willing to convert to remote work. Also, working from home is environmentally friendly. The rate of office equipment energy consumption is twice that of energy consumption from a person’s home. Businesses save money by participating in the work-from-home method and improving the conditions of the planet one step at a time. Finally, remote work is slowly increasing the hiring pool because it provides geographic diversity that would not have been possible pre-pandemic. 

For CEOs, managers, and other team leaders within an organization, being unable to convene at an office can be difficult. The absence of a physical space forces people on all levels of the organizational hierarchy to interact through digital means. Face-to-face communication has been limited to video conferences on sites such as Zoom, Skype and Google Hangouts. Projects, presentations, sales pitches, settlements, and other types of meetings are conducted through a computer or phone, which increases the chance of miscommunication and technological difficulties. This quick transition to telework also increases management mistrust.  As many as “75% of managers say they trust their employee, but a third say they’d like to be able to see them, just to be sure,” stated by Global Workplace Analytics. Working from home provides a flexible schedule for employees, but it is also their responsibility to accomplish the required tasks and not abuse the time allotted to do so. Companies must make strides to embrace remote work as part of the new norm by setting and measuring goals for employees.  

Ultimately, there are advantages and disadvantages to working from home and the office. Many companies adopt the hybrid model where employees do both, and this is most likely what the future holds in store for the modern-day workforce. For both businesses and employees, the balance between work and personal life has become a priority during the height of the pandemic. The work-from-home model not only relieves some of the stress imposed by the pandemic but allows people who work in non-online industries, such as healthcare and construction, to safely tend to their job. Whether businesses go back to the office or not, it has been reassuring to know that many industries and individuals have the technological capability and resources to work from home during a global pandemic.