Tag: covid-19

FDAPharmaceutical

Pharmaceutical Medicine: Pfizer Vaccine Granted FDA Approval

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

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.