Disclaimer: this is not an all-encompassing list of news updates from the month of April 2021.
To stay up-to-date with current health updates and ongoings, it is helpful to be informed about events of the immediate past. This news recap discusses a few of the key news releases that were announced during the month of April 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 have been seemingly countless news updates in April 2021. To summarize, eight of the most relevant stories from the month are described below. Topics not related to the COVID-19 pandemic are discussed first and COVID-19 topics follow suit.
Sesame Now Considered A ‘Major’ Food Allergen
Prior to April 2021, eight ingredients were considered to be “major allergens” according to the Food Allergen Labeling and Consumer Protection Act of 2004: eggs, fish, milk, peanuts, tree nuts, shellfish, soybeans, and wheat. Because of this legislation, it became required that all packaged food labels in the United States must disclose if it contains one or more of these potential allergens.
On April 23, President Joe Biden signed the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act. As part of this act, sesame officially became the 9th ingredient in the United States considered to be a major allergen. As a result, it must also be identified on packaged food labels.
Although the FASTER Act was passed this month, labeling changes reflecting sesame will appear starting on January 1, 2023.
In addition to requiring labeling changes for sesame, the legislation also requires the federal government to analyze research opportunities for new potential food allergy treatments.
Related links:
- Sesame Allergy and Food Labels
- Why We Need the FASTER Act
- FASTER Act Signed into Law – Asthma & Allergy Network
Reported STDs Reach All-Time High for 6th Straight Year
According to data published by the Centers for Disease Control and Prevention (CDC) on April 13, sexually transmitted diseases (STDs) increased in the United States in 2019 for the 6th straight year.
The CDC report highlighted that there were “2.5 million reported cases of chlamydia, gonorrhea, and syphilis, the three most commonly reported STDs, in 2019.” Additionally, “the sharpest [STD] increase was in cases of syphilis among newborns (i.e., congenital syphilis), which nearly quadrupled between 2015 and 2019.”
Although STDs can be intimidating, most of them can be prevented and treated. If you think you or a loved one may have a STD, it is important to ask your pharmacist or other healthcare provider for details about how and where to get tested.
Related links:
- Get Tested – Find a Treatment Center (CDC)
- A Balancing Act: CDC Updates to Treatment Guidelines for Gonorrhea and Impact on Treatment of Chlamydia
- CDC STD Fact Sheets
FDA Bans Menthol Cigarettes and Flavored Cigars
On April 29, the United States Food and Drug Administration (FDA) announced a new measure to help reduce tobacco use in the United States. With smoking labeled as the leading cause of preventable death in the United States, the FDA announced that it will push to “ban menthol as a characterizing flavor in cigarettes and [also] ban all characterizing flavors (including menthol) in cigars.”
This is a significant step toward helping prevent and reduce smoking-related health conditions. In 2019, it was estimated that just over 24 million adults in the United States smoke cigarettes. In the United States, cigarette smoking is accountable for roughly 1 in 5 deaths.
As part of this announcement, Acting FDA Commissioner Janet Woodcock released the following reflection: “With these actions, the FDA will help significantly reduce youth initiation, increase the chances of smoking cessation among current smokers, and address health disparities experienced by communities of color, low-income populations, and LGBTQ+ individuals, all of whom are far more likely to use these tobacco products.”
Regardless of someone’s age, it is never too late to quit smoking. No matter if somebody has smoked for 1 month or 50+ years, there are health benefits for everyone if they stop smoking. If you or a loved one are a current smoker and are interested in quitting, reach out to your pharmacist or other healthcare provider. Through a combination of medication-based treatments, counseling, and support services, this three-pronged approach can help make a quit attempt successful.
Related links:
- Current Cigarette Smoking Among Adults in the United States
- Quit.com – Your Quit Essentials
- Benefits of Quitting
COVID-19 Crisis in India
Over the last ~2 months, India has experienced a deadly surge in COVID-19 cases. As of May 10, 2021, nearly 246,000 people in India have reportedly died from COVID-19 and reported infections are in surplus of 22.7 million cases.
Similarly to how the United States experienced a supply shortage at the beginning of the pandemic, India is now experiencing a supply shortage. This is worsening patient outcomes and endangering healthcare workers. Just as India helped the US with supply shortages early on, the United States is now sending more than $100 million worth of supplies (oxygen, masks, diagnostic tests, etc.) to India to help combat the effects of the recent outbreak.
As many other parts of the world are beginning to recover from the pandemic, the situation is considered dire in India. Mass cremations are a daily occurrence and many people are turning to unproven and/or black market medical treatments in attempt to help loved ones survive.
This is a developing story. For a history of the current situation, a recent article from The Lancet discusses this in detail.
Related links:
- India Coronavirus Map and Case Count
- India’s COVID-19 Emergency – The Lancet
- WHO Classifies Triple-Mutant COVID-19 Variant from India as Global Health Risk
Expanded COVID-19 Vaccine Eligibility
The Biden-Harris Administration set a goal for all individuals ages 16 years and older to be eligible to receive a COVID-19 vaccine by April 19. This goal has been officially met; phased rollouts are completed and all individuals over this age cutoff are eligible to receive a COVID-19 vaccine in the United States.
The Pfizer-BioNTech COVID-19 vaccine is currently authorized for use in individuals 16 years and older, but it may soon be approved in individuals as young as 12 years. The Moderna COVID-19 vaccine and the Janssen (Johnson & Johnson) COVID-19 vaccine are both approved for individuals ages 18 years and older.
It is welcome news that all individuals over the age of 16 years are eligible to receive a COVID-19 vaccine, but vaccine production is slowly beginning to meet or outweigh demand. If you or a loved one have not yet been vaccinated and have no contraindications to receiving a vaccine, consider scheduling a vaccine appointment. The CDC offers helpful suggestions about resources to utilize to find vaccine availability near you.
Related links:
- Find COVID-19 Vaccines Near You
- How Do I Get a COVID-19 Vaccine
- Get the Free COVID-19 Vaccine (CVS Health)
Yikes – Vaccine Factory Mix-Up
Pharmaceutical companies and contracting companies often work together to manufacture a vaccine. Johnson & Johnson, the parent company of Janssen Pharmaceuticals, partnered with Emergent BioSolutions to help manufacture doses of its COVID-19 vaccine.
On April 1, news broke that up to 15 million doses of the vaccine were contaminated due to a mix-up at a production facility in Baltimore, MD.
The Emergent BioSolutions facility where the mix-up occured manufacturers both the Johnson & Johnson COVID-19 vaccine and the AstraZeneca COVID-19 vaccine. Multiple sources state that that issue at-hand was specifically a mix-up between the vaccine materials that Emergent BioSolutions uses for the Johnson & Johnson and AstraZeneca vaccines, respectively. Of note, the AstraZeneca COVID-19 vaccine is not currently authorized for use in the United States.
Because of this mix-up, shipments of the Johnson & Johnson vaccine were delayed. Despite this, Johnson & Johnson stated that it still “expects to deliver nearly 100 million single-shot doses of its COVID-19 vaccine to the U.S. Government by the end of May.”
Although this was disappointing news in the short-term regarding vaccine access, it is a reminder that quality control processes for vaccine manufacturing are robust and strict and that this error was caught prior to any vaccines leaving the facility.
Related links:
- Johnson & Johnson Statement on U.S. COVID-19 Vaccine Manufacturing (Updated)
- Johnson & Johnson Says Contractor Botched Part Of Vaccine Production – NPR
- Top Official Warned That COVID-19 Vaccine Plant Had to Be ‘Monitored Closely’
Janssen (Johnson & Johnson) COVID-19 Vaccine Pause Lifted
On April 13, the FDA and CDC recommended a temporary pause on the use of the Janssen (Johnson & Johnson) COVID-19 vaccine following rare reports of a certain type of blood clot (cerebral venous sinus thrombosis; CVST) in women between the ages of 18 and 48 years.
According to a joint statement made by the FDA and CDC on April 13, “more than 6.8 million doses of the Johnson & Johnson (Janssen ) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48 [years], and symptoms occurred 6 to 13 days after vaccination.”
The above quote provides context for why the pause was initiated. After the pause was put in place, a group of experts on the CDC’s Advisory Committee for Immunization Practices (ACIP) met on April 23 to discuss the risks and benefits of the Janssen COVID-19 vaccine. After 2 days of dialogue, it was ultimately decided to lift the pause after a thorough safety review was conducted.
Although these rare blood clots were reported, the FDA and CDC concluded that the vaccine is safe and effective for use and that the benefits of the vaccine outweigh the risks. The FDA and CDC will continue to monitor the safety and effectiveness of the vaccine moving forward.
Related links:
- Janssen COVID-19 Vaccine EUA Fact Sheet for Recipients and Caregivers
- CDC Recommends Use of Johnson & Johnson’s Janssen COVID-19 Vaccine Resume
- CVST and Blood Clots Potentially Related to the J&J COVID-19 Vaccine: Know the Symptoms
CDC Eases Outdoor Mask Guidelines for Vaccinated Individuals
On April 27, the CDC announced that individuals fully vaccinated for COVID-19 can gather outdoors without a mask (except in certain crowded settings). Although all recommended preventative measures against COVID-19 are important, this update is in large part due to COVID-19 vaccinations becoming more widely available. It is important for all individuals to get vaccinated as they are able.
The CDC considers someone to be fully vaccinated 2 weeks after receiving a 2nd dose of the Pfizer-BioNTech or Moderna COVID-19 vaccine or 2 weeks after receiving a dose of the Janssen (Johnson & Johnson) COVID-19 vaccine.
CDC preventative measures are routinely updated as more data is obtained and as more knowledge about COVID-19 is learned. It is crucial to follow all guidelines as recommended by the CDC and by other relevant governing authorities in your locale.
Related links:
- When You’ve Been Fully Vaccinated (How to Protect Yourself and Others)
- Use Masks to Slow the Spread of COVID-19
- “A Year into the Pandemic, It’s Even More Clear That It’s Safer to be Outside” – Washington Post