Morgan Petronelli

With the continuing rise in monkeypox infections in the United States, the US Food and Drug Administration has granted Emergency Use Authorization (EUA) of the Jynneos (Bavarian Nordic) vaccine for pediatric patients <18 years who are at high risk of monkeypox infection.

Now, the vaccine is authorized for a series of 2, 0.5 mL doses via subcutaneous injection administered 28 days apart in patients <18 years and patients of any age who have a history of developing keloid scars under the new EUA. Additionally, an alternative regimen of 2, 0.1 mL doses via intradermal injections administered 28 days apart is authorized for use in patients ≥18 years.

“In recent weeks the monkeypox virus has continued to spread at a rate that has made it clear our current vaccine supply will not meet the current demand,” said FDA Commissioner Robert M. Califf, MD “The FDA quickly explored other scientifically appropriate options to facilitate access to the vaccine for all impacted individuals. By increasing the number of available doses, more individuals who want to be vaccinated against monkeypox will now have the opportunity to do so.”

Jynneos, a Modified Vaccinia Ankara (MVA) vaccine, was approved for the prevention of smallpox and monkeypox in adults 18 years and older in 2019.

This article originally appeared on Contemporary Pediatrics.

1. Monkeypox update: FDA authorizes emergency use of Jynneos vaccine to increase vaccine supply. FDA. Published August 9, 2022. Accessed August 10, 2022. 

https://www.fda.gov/news-events/press-announcements/monkeypox-update-fda-authorizes-emergency-use-jynneos-vaccine-increase-vaccine-supply

Articles

The FDA has granted Emergency Use Authorization EUA of the Jynneos vaccine for pediatric patients <18 years who are at high risk of monkeypox infection.

FDA Gives OK to Pediatric Use of Monkeypox Vaccine

Myovant announced the FDA has approved relugolix combination tablets (Myfembree; Myovant Sciences and Pfizer) for the treatment of moderate-to-severe endometriosis-associated pain.

Previously, Myfembree was only approved for the management of uterine fibroid-related heavy menstrual bleeding in premenopausal women.

“This approval is an important milestone reflecting Pfizer and Myovant’s commitment to women’s health in areas of significant unmet need,” said James Rusnak, MD, PhD, senior vice president, chief development officer, Internal Medicine and Hospital, Global Product Development at Pfizer. “We look forward to making Myfembree available to women with endometriosis and broadening their options in managing this complex disorder.”

This decision by the FDA is supported by positive data from two phase 3 studies (SPIRIT 1 and SPIRIT 2) investigating the combination tablet for treatment of dysmenorrhea.

In both studies, 75% of women using the once-daily relugolix combination therapy experienced a significant reduction in dysmenorrhea, compared to 27% and 30% of women in the placebo groups at Week 24, respectively (both 

 < 0.0001). Relugolix combination therapy also significantly reduced non-menstrual pelvic pain in 59% and 66% of women, compared to 40% and 43% in the placebo groups (

In SPIRIT 1 and 2, the relugolix combination therapy group also showed reductions in dyspareunia and opioid use compared to the placebo groups. Additionally, more women undergoing relugolix combination therapy were opioid free at Week 24 compared with placebo (86% and 82% vs 76% and 66%, respectively).

The most frequently reported adverse events by women in both the relugolix combination therapy and placebo groups included headaches, nasopharyngitis, and hot flashes.

"The data from the SPIRIT studies showed the clinical benefit that relugolix combination therapy can have on moderate to severe pain associated with endometriosis and how it can impact patients,” said Linda Giudice, MD, PhD, distinguished professor at the University of California, San Francisco (UCSF), and chair, SPIRIT Program Steering Committee. “This newly approved option for patients with pain from endometriosis offers the convenience of one pill taken once daily with a mean change in bone mineral density of <1% that did not appear to worsen at 12 months of treatment; however, monitoring is recommended.”

Myfembree is now available with a prescription to patients with moderate-to-severe pain associated with endometriosis.

This article originally appeared on Contemporary OB/GYN.

1. Myovant Sciences and Pfizer Receive U.S. FDA Approval of MYFEMBREE, a Once-Daily Treatment for the Management of Moderate to Severe Pain Associated With Endometriosis. Myovant Sciences. August 5, 2022. Accessed August 5, 2022. 

https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-and-pfizer-receive-us-fda-approval-myfembreer

2. Giudice LC, As-Sanie S, Arjona Ferreira JC, et al. Once daily oral relugolix combination therapy versus placebo in patients with endometriosis-associated pain: two replicate phase 3, randomized, double-blind, studies (SPIRIT 1 and 2). 

. 2022;399(10343):2267-2279. doi:10.1016/s0140-6736(22)00622-5

Myovant Sciences and Pfizer announces the FDA has approved the therapy for the once-daily treatment of moderate-to-severe endometriosis-associated pain.

Myfembree Approved by FDA for Treating Endometrial Pain

HRA Pharma, a Perrigo company, has announced it submitted an application to the US Food and Drug Administration (FDA) for possible future approval of the first-ever OTC birth control pill.

This application is for an Rx-to-OTC switch for Opill (HRA Pharma), which is a progestin-only (or non-estrogen) daily birth control pill. Currently, Opill is approved by the FDA in 1973

 to prevent pregnancy and has been an available progestin-only option for more than 50 years.

In a company press release announcing the submission, HRA Pharma said that removing the prescription hurdle to the pill would in turn improve access to a contraceptive “that is well tolerated and notably more effective at preventing pregnancy than all current methods available OTC.”

American College of Obstetricians and Gynecologists

, have all voiced support for making birth control pills available OTC.

"As a doctor, I am dedicated to empowering people to make decisions about pregnancy prevention. For many, a birth control pill may be the best option for them but requiring a prescription is an unnecessary obstacle that can put it out of reach," said obstetrician-gynecologist, Melissa J. Kottke, MD, MPH, MBA. "Removing the prescription requirement for a progestin-only birth control pill will be a historic advancement for pregnancy prevention and a remarkable achievement in community public health."

An approval decision is expected sometime next year, according to the company.

1. Perrigo’s hra pharma submits application to fda for first-ever otc birth control pill. HRA_Pharma. Published July 11, 2022. Accessed July 11, 2022. 

https://www.hra-pharma.com/articles/perrigos-hra-pharma-submits-application-to-fda-for-first-ever-otc-birth-control-pill-66

Perrigo’s HRA Pharma has submitted an application to the FDA for possible future approval of the first-ever OTC birth control pill.

Perrigo Submits Application to FDA for First-ever OTC Birth Control Pill

The FDA has approved oteseconazole (Vivjoa) to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC), commonly referred to as chronic yeast infection, in women with a history of RVVC who are not of reproductive potential, according to a company press release announcing the approval.

This approval makes oteseconazole the first and only medication approved by the FDA for RVVC. Additionally, this is Mycovia’s first product approved by the FDA.

Oteseconazole is a medication intended to inhibit fungal CYP51, which is required for fungal cell wall integrity. This interaction is also toxic to fungi, which results in the inhibition of fungal growth. Oteseconazole has a lower affinity for human CYP enzymes compared to fungal CYP enzymes due to its chemical structure. Previously, the FDA granted oteseconazole Qualified Infectious Disease Product and Fast Track designations.

“After nearly two decades of living with chronic yeast infection and feeling like there was no hope from the itchiness, irritation, and constant dread of when the next yeast infection would return, I was overjoyed to even be a part of this clinical trial,” said Leslie Ivey, a patient with RVVC and clinical trial participant. “It is gratifying to see RVVC finally get the attention it deserves.”

The decision was based on positive results from 3 phase 3 clinical trials investigating oteseconazole—2 global VIOLET studies (NCT03561701 and NCT03562156) and 1 US-based ultraVIOLET (NCT03840616) study which comprised 875 patients at 232 sites across 11 countries.

In the VIOLET studies, 93.3% and 96.1% of RVVC patients who received oteseconazole did not have a recurrence during the 48-week maintenance period vs 57.2% and 60.6% of patients who received placebo (

In the ultraVIOLET study, 89.7% of RVVC patients who received oteseconazole displayed clearance of their initial infection and did not experience recurrence during the 50-week maintenance period vs 57.1% of patients who received fluconazole followed by placebo (

Commonly reported side effects in the phase 3 trials included headache (7.4%) and nausea (3.6%). It is important to note that oteseconazole is contraindicated in patients with a hypersensitivity to the medication, based on data collected from rat studies. The medication is also contradicted in females who pregnant, lactating, or who are of reproductive potential.

“A medicine with Vivjoa’s sustained efficacy combined with the clinical safety profile has been long needed, as until now, physicians and their patients have had no FDA-approved medications for RVVC,” stated Stephen Brand, PhD, chief development officer of Mycovia. “We are excited to be the first to offer a medication designed specifically for RVVC, a challenging and chronic condition that is expected to increase in prevalence over the next decade.”

According to a company press release, Mycovia plans on commercially launching oteseconazole during the second quarter of 2022.

This article originally appeared on Contemporary Ob/Gyn.

1. FDA approves Mycovia Pharmaceuticals’ Vivjoa (oteseconazole), the first and only FDA-approved medication for recurrent vulvovaginal candidiasis (chronic yeast infection). Published online April 28, 2022. Accessed April 29, 2022. 

https://mycovia.com/wp-content/uploads/2022/04/FINAL-Press-Release_04.28.22.pdf

Oteseconazole (Vivjoa) reduces the incidence of recurrent vulvovaginal candidiasis.

FDA: First Drug Approved for Recurrent Vulvovaginal Candidiasis

The American College of Obstetricians and Gynecologists (ACOG) is urging its members to help fight the spread of medical misinformation—especially when it comes to COVID-19 vaccination and pregnancy, according to a recently published guidance from ACOG.

“The spread of misinformation and mistrust in doctors and science is contributing to staggeringly low vaccination rates among pregnant people,” ACOG writes.

The organization states members are reporting that they are “extending themselves in time-consuming and often creative ways to convert one unvaccinated pregnant person at a time.”

To help fight medical misinformation, as well as encourage vaccination against COVID-19, ACOG is asking its members to sign an open letter endorsing COVID-19 vaccination. The organization plans to share this letter with patients, policymakers, and the media to display the robust consensus among obstetrician—gynecologists. They are also urging physicians to continue to advise patients, including those who are pregnant, trying to become pregnant, or lactating, to receive the vaccine.

Both ACOG and the Society for Maternal-Fetal Medicine recommend that pregnant people receive the COVID-19 vaccine since pregnancy is a risk factor for severe COVID-19 complications, according to a 

 They also stated that the vaccine has no impact on fertility. 

“As experts in reproductive health, we continue to recommend that the vaccine be available to pregnant individuals,” ACOG states in a February 4 

 “We also assure patients that there is no evidence that the vaccine can lead to loss of fertility. While fertility was not specifically studied in the clinical trials of the vaccine, no loss of fertility has been reported among trial participants or among the millions who have received the vaccines since their authorization, and no signs of infertility appeared in animal studies. Loss of fertility is scientifically unlikely.”

When it comes to spreading misinformation about the vaccine, the Federation of State Medical Boards, the American Board of Obstetrics and Gynecology, and other organizations have released statements about the significance of medical and professional ethics, as well as the dangers of spreading vaccine misinformation. If physicians are found promoting false vaccine information, they are at risk disciplinary action, possibly including the loss of their medical licenses.

For obstetrician—gynecologists partaking in the spread of vaccine misinformation that violates the ACOG Code of Professional Ethics, physicians are subject to disciplinary action by the College, ACOG states.

More information and resources on how to stop the spread of vaccine misinformation can be found at 

Covid-19 vaccination, pregnancy, and medical misinformation: how you can help. Accessed October 12, 2021. 

https://www.acog.org/en/news/news-articles/2021/10/covid-19-vaccination-pregnancy-medical-misinformation-how-you-can-help

ACOG and SMFM recommend covid-19 vaccination for pregnant individuals. Accessed October 12, 2021. 

https://www.acog.org/en/news/news-releases/2021/07/acog-smfm-recommend-covid-19-vaccination-for-pregnant-individuals

Medical experts continue to assert that covid vaccines do not impact fertility. Accessed October 12, 2021. 

https://www.acog.org/en/news/news-releases/2021/02/medical-experts-assert-covid-vaccines-do-not-impact-fertility

"The spread of misinformation and mistrust in doctors and science is contributing to staggeringly low vaccination rates among pregnant people," said the American Colleges of Obstetricians and Gynecologists.

Encourage Pregnant Patients to Get Vaccinated for COVID-19, ACOG Says

Valisure, a pharmacy dedicated to batch testing medications before they reach consumers, found in a recent test that 78 different sunscreen and after-sun care products contained benzene, a potential carcinogen.

According to the U. S. Center for Disease Control and Prevention (CDC), the World Health Organization (WHO), U.S. Department of Health and Human Services, and various other regulatory agencies, benzene is known to cause cancer in humans. The National Institute for Occupational Safety and Health (NIOSH) also defines benzene as a carcinogen and exposure can include “inhalation, skin absorption, ingestion, and skin and/or eye contact.”

In the laboratory test conducted by Valisure, 294 unique batches of sun care products from 69 different companies were examined.

Results of the test found 27% of samples tested contained detectable benzene, while some batches contained up to 3 times the FDA concentration limit of 2 parts per million (ppm). With the benzene-detected product batches ranging from gels, sprays, and lotions in both mineral and chemical formulations.

“There is not a safe level of benzene that can exist in sunscreen products,” said Christopher Bunick, MD, PhD, associate professor of dermatology at Yale University and member of 

’ editorial advisory board. “Even benzene at 0.1 ppm in a sunscreen could expose people to excessively high nanogram amounts of benzene.”

Benzene has been associated with blood cancers such as leukemia. What makes these findings "particularly concerning", according to Valisure, is that these products are absorbed through the skin and multiple studies conducted by FDA researches have shown chemicals in sunscreen products are found in the blood at high levels following skin application.

TikTok from Dustin Portela, DO (@208skindoc) discussing these findings.

This is not the first time Valisure has identified harmful contaminants in consumer products. In March , it released a 

 asking the FDA to recall various brands of hand sanitizer after detecting benzene contamination in multiple batches.

Scentsational Soaps & Candles issued a voluntary recall

 of its scented hand sanitizers, due to the presence of benzene, methanol, and acetaldehyde.

Valisure is now requesting the FDA recall the identified sunscreens and after-sun care products and are asking for more defined limits for benzene contamination in cosmetic and drug products. Valisure also notes that not all sunscreen products contain benzene and urges the continued use of uncontaminated products available to help protect against ultraviolet radiation (UV).

“Benzene is one of the most studied and concerning human carcinogens known to science,” said David Light, founder and CEO of Valisure. “Its association with forming blood cancers in humans has been shown in numerous studies at trace levels of parts per million and below. The presence of this known human carcinogen in products widely recommended for the prevention of skin cancer and that are regularly used by adults and children is very troubling.”

Watch our interview with Valisure Founder and CEO David Light, here.

 for a comment, a spokeperson said "the FDA does not comment on third-party research, but evaluates it as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health."

While additional testing is needed, Bunick added that sunscreen should still be utilized, as well as other forms of sun protection to protect against UV radiation.

Click the documents below to find out which products contain and do not contain benzene, as well as tips for responsible disposal of potentially contaminated products.

List of products where benzene was detected.

List of products where benzene was not detected.

Responsible Disposal of Potentially Contaminated Products.

Check back for the latest updates on this story on 

Valisure detects benzene in sunscreen. Valisure. Published May 20, 2021. Accessed May 25, 2021. 

https://www.valisure.com/blog/valisure-news/valisure-detects-benzene-in-sunscreen/

A recent test found various brands and batches of sunscreen and after-sun care products contained benzene, a potential carcinogen.
