To stay up-to-date with current health events and ongoings, it is helpful to be informed about events of the immediate past. This news recap discusses a sampling of key news releases that were announced during the month of February 2021 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 February 2021. To summarize, six of the most relevant stories from the month are described below.
Emergency Use Authorization (EUA) Given for Third COVID-19 Vaccine in United States
On February 27th, following a positive meeting conducted by the Vaccines and Related Biological Products Advisory Committee (VRBPAC), the United States Food & Drug Administration (FDA) authorized the Janssen COVID-19 vaccine as the third COVID-19 vaccine authorized for use in the United States. This vaccine is now authorized alongside the Pfizer-BioNTech and Moderna COVID-19 vaccines.
The Pfizer-BioNTech and Moderna COVID-19 vaccines are mRNA vaccines, but the Janssen COVID-19 vaccine uses a type of virus called adenovirus type 26 (Ad26) instead of mRNA.
Additionally, unlike the two mRNA COVID-19 vaccines that require two doses, the Janssen COVID-19 vaccine is a single-dose vaccine. The Janssen COVID-19 vaccine is approved for use in individuals 18 years or older.
According to the FDA and analyzed clinical trial data, the Janssen COVID-19 vaccine is “67% effective [at] preventing moderate to severe/critical COVID-19 occurring at least 14 days after vaccination and 66% effective in preventing moderate to severe/critical COVID-19 occurring at least 28 days after vaccination. Additionally, the vaccine [is] approximately 77% effective in preventing severe/critical COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination.”
Janssen Pharmaceuticals is a subsidiary company of Johnson & Johnson. Thus, when the terms ‘Johnson & Johnson COVID-19 vaccine’ and ‘Janssen COVID-19 vaccine’ are mentioned, they are one in the same.
Related links:
- FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting
- Janssen COVID-19 EUA Fact Sheet for Recipients and Caregivers
- What is VRBPAC?
- Emergency Use Authorization for Vaccines Explained
- Centers for Disease Control and Prevention (CDC) COVID-19 Vaccine Index
Updated CDC Mask Recommendations
Ever since the early days of the COVID-19 pandemic, individuals have adapted to the now-customary practice of wearing face masks to help protect against the spread of COVID-19.
Initially, there were no strict requirements regarding face masks – there were no mask mandates issued by various levels of government and there were no mask types specifically recommended. However, in early February, the CDC updated its masking recommendations.
It is recommended to now layer with masks, and there are two possible ways to layer. One method would be to wear one cloth mask with multiple layers of fabric. Another method would be to wear a disposable mask beneath a cloth mask.
Additionally, the CDC recommends to wear a mask with a nose wire to make masks more secure to the wearer’s face, to use a mask fitter or brace when possible, and to tighten ear straps when possible to make the mask-face seal more secure.
It is important to not combine two disposable masks. Additionally, KN95 masks should not be worn at the same time as other masks.
Related links:
Increasing Cases of COVID-19-Linked Syndrome Noted in Children
Cases of multisystem inflammatory syndrome in children (MIS-C), a possible complication of COVID-19, have spiked over the past several weeks and increasing numbers of patients have become critically ill or passed after developing the condition.
According to the CDC, the specific cause of MIS-C is still being investigated. However, MIS-C can occur as a complication of an acute illness such as COVID-19. It is considered to be an exaggerated inflammatory reaction that can affect many different parts of the body.
If a child is thought to have MIS-C based on described symptoms and is not already under the care of a healthcare provider, the child should seek care as soon as possible. Emergency services are warranted typically if a child is experiencing troubled breathing, pain or pressure in the chest that does not go away, sudden confusion, inability to stay awake, pale/gray/blue-colored skin, lips, or nail beds, and/or severe stomach pain.
Ever since May 2020, the CDC has been tracking cases of MIS-C. Between May 2020 and February 2021, 2,060 cases of MIS-C have been reported across 48 states, New York City, Washington DC, and Puerto Rico.
Related links:
- Health Department-Reported Cases of Multisystem Inflammatory Syndrome in Children (MIS-C) in the United States
- MIS-C For Parents
- Multisystem Inflammatory Syndrome in Children (MIS-C) – Boston Children’s Hospital
Updated Transportation and Storage Conditions for Pfizer-BioNTech COVID-19 Vaccine
When the Pfizer-BioNTech COVID-19 vaccine was initially authorized for use by the FDA in December 2020, a significant part of the vaccine that commanded worldwide media attention was the need for storage at ultra-frozen temperatures. This is troubling from a logistical standpoint as standard freezers are not able to reach ultra-frozen temperatures.
Initially, the preferred storage and transportation states of undiluted Pfizer-BioNTech COVID-19 vaccine vials were at ultra-frozen temperatures between -112ºF and -76ºF (-80ºC to -60ºC). However, since then, Pfizer has obtained additional data about its vaccine’s stability at warmer temperatures than those initially described.
The compiled data was interpreted and deemed acceptable by the FDA, so now the Pfizer-BioNTech COVID-19 vaccine can be transported and stored at temperatures found in standard freezers for up to 2 weeks. This news is promising to help alleviate certain logistical, transportation-based concerns while concurrently helping to reduce vaccine waste due to temperature excursion issues.
Related links:
- Pfizer-BioNTech COVID-19 Vaccine Storage and Handling Summary
- Information about the Pfizer-BioNTech COVID-19 Vaccine
- Pfizer-BioNTech COVID-19 Fact Sheet for Recipients and Caregivers
FDA Approves 6 Novel Drugs in February 2021
The month of February 2021 was a hectic one for the FDA. Their hands were incredibly full with COVID-19 work alone, but their other workstreams were carrying on in their customary capacity as well.
Throughout the month of February, a total of 6 novel drugs were approved by the FDA: Tepmetko (tepotinib), Ukoniq (umbralisib), Evkeeza (evinacumab-dgnb), Cosela (trilacicilib), Amondys 45 (casimersen), and Nulibry (fosdenopterin).
Tepmetko (tepotinib), made by EMD Serono, is used to treat non-small cell lung cancer. Lung cancer is noted to be one of the most deadly and common types of cancer, so this is a welcome addition to current treatment options for patients fighting non-small cell lung cancer. To learn more about non-small cell lung cancer, consider referencing this resource from the American Cancer Society.
Ukoniq (umbralisib), made by TG Therapeutics, is used to help treat certain subsets of patients with marginal zone lymphoma and follicular lymphoma. Marginal zone lymphoma and follicular lymphoma are two types of lymphoma – a cancer of the lymphatic system. To learn more about lymphoma, consider referencing this resource from the American Cancer Society.
Evkeeza (evinacumab-dgnb), made by Regeneron Pharmaceuticals, is used to treat patients with homozygous familial hypercholesterolemia (HoFH). Patients with HoFH have markedly high levels of cholesterol, specifically low-density lipoprotein (LDL). To learn more about HoFH, consider referencing this resource from FH Foundation.
Cosela (trilacicilib), made by G1 Therapeutics, is used to help control myelosuppression (a decrease in bone marrow activity) caused by chemotherapy in adults with small cell lung cancer. Myelosuppression is a common side effect of many different anticancer treatments and often times it is an effect that can cause treatment delays or stoppages in therapy. By minimizing the incidence of myelosuppression when possible, patients with small cell lung cancer have a better chance to obtain their cancer treatments as scheduled. To learn more about myelosuppression, consider using this resource from the International Myeloma Foundation.
Amondys 45 (casimersen), made by Sarepta Therapeutics, is used to treat Duchenne muscular dystrophy (DMD). DMD is a genetic disorder that causes muscle weakness and breakdown over time. To learn more about DMD, consider referencing this resource from the Muscular Dystrophy Association (MDA).
Nulibry (fosdenopterin), made by Origin Biosciences, is used to treat molybdenum cofactor deficiency (MoCD) Type A. This is the first treatment approved to treat MoCD Type A; MoCD Type A is a rare genetic mutation that can cause severe and rapid neurologic deterioration. To learn more about MoCD, consider referencing this resource from MedLine Plus.
Related links:
- Innovations in Pharmacy: Describing Novel Drug Approvals Between 2015 and 2020
- Novel Drug Approvals for 2021
- Drug Development & Approval Process
Mourning the Loss of a Pharmacy Legend: Dr. Joseph A. Oddis
On February 24th, the world of pharmacy mourned the loss of Dr. Joseph A. Oddis. Dr. Oddis, 92, was a longtime CEO of the American Society of Health-System Pharmacists (ASHP) from 1960 to 1997. Throughout this time period, Dr. Oddis was one of the trailblazers that helped lead the charge of advancing pharmacy practice during this progressive time period for pharmacy.
For reference’s sake, ASHP is a professional organization for pharmacists, pharmacy technicians, and pharmacy students. The purpose of ASHP is to support the practice of pharmacy in various hospitals and health systems.
The current CEO of ASHP, Paul W. Abramowitz, released the following statement following Dr. Oddis’ passing: “This is an extremely sad day for the profession of pharmacy. Dr. Oddis’ contributions to pharmacy practice in the United States and globally are innumerable and have touched every corner of the profession. He embraced pharmacists’ societal roles as the medication experts and committed his life to advancing that vision. Dr. Oddis believed that pharmacists could improve the lives of patients through the safe and optimal use of medications. Dr. Oddis was a visionary who imagined ASHP as a professional organization that would offer the highest-caliber continuing education, pharmacy residency training, evidence-based drug information, pharmacist-led research, and so much more. He had that unique ability to articulate his vision, achieve consensus around it, and lead its highly successful implementation.”
Dr. Oddis will be missed. The profession of pharmacy would be entirely different without the strikingly positive influence of Dr. Oddis.
Related links:
- Celebrating Former ASHP CEOs: Joseph A. Oddis, Sc.D. (Hon.)
- ASHP Foundation
- Goodbye to a hero, mentor, and friend (American Pharmacists Association)
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