The onset of the new calendar year brings with it a sense of hope and an urgent need for improved health outcomes. To help keep abreast with current health events, it is helpful to be informed about events of the recent past. This news roundup discusses a few of the key news releases that were announced during the month of December 2020 that affected the world of pharmacy and public health.
The ongoing COVID-19 pandemic is crowding out many other relevant news stories across all industries, and this sentiment also rings true for the healthcare professions. Although there were many exciting announcements about new therapeutics and advancements unrelated to COVID-19, this discussion has a heavy emphasis on pandemic-related content.
There has been a plethora of news releases that have been announced in December 2020. To help summarize, five of the most relevant stories from the month are described below.
Pfizer-BioNTech COVID-19 Vaccine Obtains Emergency Use Authorization (EUA)
On December 11, 2020, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.
Following a thorough yet succinct approval process, the Pfizer-BioNTech COVID-19 vaccine obtained an EUA after data showed that the vaccine is safe and effective in the described patient population. A future Pharmacist Consult article will discuss the logistics of how the vaccine was granted an EUA through a general process called ‘trial stacking’.
Following the issuance of the EUA, FDA Commissioner Dr. Stephen M. Hahn stated “The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world. Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization. The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited time frame after its emergence is a true testament to scientific innovation and public-private collaboration worldwide.”
Related Links:
- Pfizer-BioNTech COVID-19 Vaccine Information
- Pfizer-based COVID-19 Resources
- FDA COVID-19 Vaccine News and Updates
- CDC COVID-19 Vaccine Directory Page
- Who Gets Vaccinated First?
- American Pharmacists Association (APhA) Guide to Coronavirus
- Emergency Use Authorization (EUA) Process Explained
Moderna COVID-19 Vaccine Obtains EUA
Seven days after announcing the issuance of an EUA for the Pfizer-BioNTech COVID-19 vaccine, the FDA announced the issuance of a second COVID-19 vaccine on December 18, 2020 from biotechnology company Moderna. This second vaccine is indicated for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.
Although the Moderna COVID-19 vaccine has a different minimum age requirement than the Pfizer-BioNTech COVID-19 vaccine, the two are considered to be equally effective.
In an additional press briefing, FDA Commissioner Dr. Stephen M. Hahn stated: “With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day. Through the FDA’s open and transparent scientific review process, two COVID-19 vaccines have been authorized in an expedited time frame while adhering to the rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization that the American people have come to expect from the FDA. These standards and our review process, which are the same we have used in reviewing the first COVID-19 vaccine and intend to use for any other COVID-19 vaccines, included input from independent scientific and public health experts as well as a thorough analysis of the data by the agency’s career staff.”
Related Links:
- Moderna COVID-19 Vaccine Information
- FDA COVID-19 Vaccine News and Updates
- CDC COVID-19 Vaccine Directory Page
- Who Gets Vaccinated First?
- American Pharmacists Association (APhA) Guide to Coronavirus
- Emergency Use Authorization (EUA) Process Explained
FDA Approves Second Treatment for Ebola Virus
The Ebola virus obtained significant attention in the media throughout the 2010 decade, but it has a history dating back to 1976. Although the virus has fallen out of the media’s focus during 2020, it remains an issue that is impacting individuals across multiple countries.
On December 21, 2020, the FDA approved Ebanga (ansuvimab-zykl), a human monoclonal antibody, for the treatment for Zaire ebolavirus (Ebolavirus) infection in adults and children. Ebanga blocks binding of the virus to the cell receptor, preventing its entry into the cell.
This is the second medication approved by the FDA to treat Ebola. The first Ebola treatment, Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), was approved by the FDA on October 14, 2020.
Zaire ebolavirus is one of four Ebolavirus species that can cause a potentially fatal human disease. It is transmitted through blood, body fluids, and tissues of infected people or wild animals, and through surfaces and materials, such as bedding and clothing, contaminated with these fluids.
Ridgeback Biotherapeutics, a company based in Miami, FL, produces the therapy. It was granted an Orphan Drug designation, which provides incentives to assist and encourage drug development for rare diseases. Additionally, the FDA granted Ebanga a Breakthrough Therapy designation.
Related Links:
- What is Ebola Virus Disease?
- History of Ebola Virus Disease
- Ebola Signs and Symptoms
- AGILE Trial Background
U.S. Sues Walmart, Alleging Role in Fueling Opioid Crisis
On December 22, 2020, the United States and the Trump administration sued Walmart, accusing the retailer of helping to fuel the nation’s opioid crisis by inadequately screening for questionable prescriptions despite repeated warnings from its own pharmacists. This is a currently developing situation.
The Justice Department’s lawsuit claims that Walmart “sought to boost profits” by understaffing its pharmacies and pressuring employees to fill prescriptions quickly. That made it difficult for pharmacists to reject invalid prescriptions, enabling widespread drug abuse nationwide, the suit argues.
Walmart Corporate issued a statement on December 22, 2020 in response to the news. “There are a lot of problems with the lawsuit—as we will explain in court, it is wrong on the law and riddled with factual inaccuracies, mischaracterizations and cherry-picked documents taken out of context. And it is outrageous the Department is trying to shift blame for DEA’s own well-documented failures in policing the very doctors it gave permission to prescribe opioids,” the Walmart press release described.
As this situation progresses, additional news will be released.
Related Links:
- Walmart Statement in Response to DOJ Lawsuit
- Walmart Sues Department of Justice (DOJ) and Drug Enforcement Agency (DEA) in October 2020
- Additional Case Background
Emerging SARS-CoV-2 Variants
Throughout the month of December 2020 and in months prior, there has been discussion of SARS-CoV-2 variants that have appeared in multiple countries worldwide.
Variant of Concern (VOC) 202012/01 (a.k.a. B.1.1.7), was first noted in the UK in September 2020. Since December 20, 2020, several countries have reported cases of the UK VOC 202012/01, including the United States and Canada. The first 2 cases of the variant in the United States were reported to be in Colorado and cases have also been reported in California. Other variants have also been identified, per the CDC, in Nigeria and South Africa.
However, there is no evidence that the UK-based variant will impact vaccinations in any way, per the US Surgeon General. As COVID-19 vaccines become more and more available to individuals through the planned distribution phases, it is important for individuals to receive the 2-dose vaccine series as soon as they are able.
To help combat this, the CDC is emphasizing the importance of strain surveillance. The CDC posted a statement related to this: “National SARS-CoV-2 Strain Surveillance (“NS3”): Since November 2020, state health departments and other public health agencies have been regularly sending CDC SARS-CoV-2 samples for sequencing and further characterization. This system is now being scaled to process 750 samples nationally per week. One strength of this system is that it allows for characterization of viruses beyond what sequencing alone can provide.”
Related Links:
- SARS-CoV-2 Evolution (World Health Organization)
- Dr. Anthony Fauci Interview
- Johns Hopkins Tips to Deal with New COVID-19 Virus Strains
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