Lauren Biscaldi is the Managing Editor of Drug Topics. 

Lauren Biscaldi, Managing Editor

 the FDA announced the amendment of the current emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine, now authorizing a single booster dose for children 5 to 11 years of age, at least 5 months after completing the primary Pfizer-BioNTech vaccine series.

This EUA amendment follows the January 3, 2022 authorization for adolescents aged 12 to 15 years and joins the approval of Comirnaty (COVID-19 vaccine, mRNA) for use in those aged 16 and older.

The agency analyzed immune response data in a subset of children age 5 to 11 collected from the ongoing randomized, placebo-controlled trial that supported the October 2021 authorization of the vaccine in this age group. Researchers evaluated antibody responses in 67 participants who received their booster dose 7 to 9 months following the completion of a 2-dose primary vaccine series.

Safety was assessed in 400 children who received a booster dose at least 5 months after their 2-dose primary series. The most commonly reported adverse effects included pain, injection site redness and swelling, and fatigue, headache, muscle or joint pain, and chills and fever.

“[T]he omicron wave has seen more kids getting sick with [COVID-19] and being hospitalized, and children may also experience longer term effects, even following initially mild disease,” said Robert M. Califf, MD, FDA Commissioner. “The FDA is authorizing the use of a single booster dose of the Pfizer-BioNTech COVID-19 vaccine for children 5 through 11 years of age to provide continued protection against COVID-19.”

“The Pfizer-BioNTech COVID-19 vaccine is effective in helping to prevent the most severe consequences of COVID-19 in individuals 5 years of age and older,” added Peter Marks, MD, PhD, director of the FDA Center for Biologics Evaluation and Research. “Since authorizing the vaccine for children down to 5 years of age in October 2021, emerging data suggest that vaccine effectiveness against COVID-19 wanes after the second dose…in all authorized populations.”

“The FDA has determined that the known and potential benefits of a single booster dose…for children 5 through 11 years of age at least 5 months after completing a primary series outweighs its known and potential risks and that a booster dose can help provide continued protection against COVID-19 in this and older age groups,” he continued.

Vaccination, Califf said, remains the most effective way to prevent COVID-19 and related severe consequences.

Coronavirus (COVID-19) update: FDA expands eligibility for Pfizer-BioNTech COVID-19 vaccine booster dose to children 5 through 11 years. News release. FDA. May 17, 2022. Accessed May 17, 2022. 

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-expands-eligibility-pfizer-biontech-covid-19-vaccine-booster-dose

Articles

Children may receive a single booster shot at least 5 months after completing their initial Pfizer-BioNTech 2-dose series. 

Breaking: FDA Authorizes Pfizer-BioNTech Booster Shot for Children Ages 5 to 11 

As cases rise around the country, the Drug Topics® editorial team weekly COVID-19 update is back. Be sure to check in with us every Monday for the latest news to know.

As of May 16, there have been 82,376,975 COVID-19 cases in the United States. In the last 7 days, there have been 632,365 new cases identified. (

As the pandemic death toll approaches another grim milestone of 1 million deaths, cases in the United States are “spreading at an alarming rate” across the Northeast and Midwest. Upwards of 90,000 new cases are being identified daily, representing a 60% increase from 2 weeks ago. (

And according to tracking data, hot spots include New Jersey, New York, western Massachusetts, and western Vermont, as well as areas in Illinois, Wisconsin, and Michigan. As of today, daily case reports are higher today than were reported at the peak of the Delta surge last summer. (

An analysis of real world data from the CDC and the 

 conducted jointly by researchers at Brown School of Public Health, Brigham and Women’s Hospital, Harvard T.H. Chan School of Public Health, and Microsoft AI for Health, found that COVID-19 vaccines could have prevented more than 300,000 COVID-19 related deaths between January 2021 and April 2022. (

New data from the CDC documenting the disparities in COVID-19 related infection, hospitalization, and death by race and ethnicity highlights the way in which health inequity in the United States impacted communities differently. (

New York City is “poised to hit ‘high’ COVID-19 alert level” in the next few days, and city health officials are set to issue an advisory strongly urging residents to once more mask up indoors and in public settings. (

Only 2 months after the release of the Biden Administration’s COVID-19 roadmap, the White House has begun to weigh sacrifices—including limiting next-gen vaccine access to the highest-risk Americans and shifting responsibility for the pandemic response to the private sector—as funding for the COVID-19 fight runs out. (

Although cases are on the rise in California, Los Angeles County remains “far” from meeting the metrics required to reissue a mask mandate—but county officials continue to “strongly recommend” that residents aged 2 and older wear high-quality masks in indoor public settings. (

Novavax officials ae “confident” that the FDA will issue an emergency use authorization for their COVID-19 vaccine in June, following a monthslong review process at the FDA. Novavax CCO John Trizzino is hopeful that the vaccine, which uses conventional protein technology, will offer an alternative option to adults who are hesitant to receive an mRNA shot. (

Check back next Monday for the latest updates and COVID-19 news you need to know.

COVID-19 updates and news to know as of May 16, 2022. 

This Week in COVID-19: FDA Nears Decision on Novavax Vaccine

The FDA has approved an expanded indication for viloxazine extended-release capsules (Qelbree) for the treatment of ADHD in adults, following an initial approval for treatment in children and adolescents age 6 and older.

Viloxazine extended-release capsules are a novel nonstimulant medication administered once daily. Both efficacy and symptom improvement were noticed “early in treatment,” according to a Supernus Pharmaceuticals press release. The expanded approval was based on the positive results of a randomized, double-blind, placebo-controlled phase 3 study of viloxazine extended-release in adults with ADHD, representing the first approval of a novel nonstimulant ADHD therapy for adults in the last 20 yeas.

Viloxazine extended-release capsules are available in flexible doses between 200 mg and 600 mg. In the phase 3 trial, the drug met the primary endpoint, with a statistically significant reduction in change from baseline of the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score by the end of the study in adults treated with viloxazine extended-release capsules vs placebo. The drug also met the key secondary efficacy endpoint—change from baseline in the Clinical Global Impression—Severity of Illness scale at week 6—with statistical significance.

“As a leader in the field of CNS, we are fully committed to better understanding how to treat complex diseases such as ADHD,” said Jack Khattar, Supernus Pharmaceuticals president and CEO. “Today’s approval marks a major advancement in the treatment of ADHD and is an important milestone just 1 year after the approval of Qelbree to treat pediatric patients. We are proud to bring a new novel nonstimulant option for adults into the market after 2 decades.”

Supernus announces FDA approval of Qelbree® for the treatment of ADHD in adults. News release. Supernus Pharmaceuticals. Published May 2, 2022. Accessed May 13, 2022. 

https://www.prnewswire.com/news-releases/supernus-announces-fda-approval-of-qelbree-for-the-treatment-of-adhd-in-adults-301537152.html

The approval makes the drug the first novel nonstimulant ADHD therapy approved in the last 20 years. 

FDA Approves Expanded Indication for Viloxazine Extended-Release Capsules for Adults With ADHD

How Socioeconomic Factors Can Impact Depression Treatment

Home environments have a clear impact on depression treatment outcomes.

Are COVID-19 Rapid Tests Capable of Detecting Variants of Concern?

Investigators examined whether rapid antigen tests were less sensitive to variants of concern. Though the tests detected Omicron, all but 1 were less effective in detecting the Delta variant.

The Link Between Food Insecurity in Young Adulthood and Obesity, Diabetes Risk Later in Life

An analysis of data from more than 3500 individuals followed for more than 20 years provides insight into the impact of food insecurity on risk of cardiometabolic conditions, including obesity and type 2 diabetes.

A Look at Drug-Drug Interactions in Patients with Bipolar Disorder

Up to 20% of patients with bipolar disorder have 4 or more medications, so it is important to be aware of these common drug-drug interactions.

Many Biologics for Severe Asthma Can Be Self-Administered at Home — Patients Prefer It

Xolair (omalizumab), Fasenra (benralizumab), Dupixent (dupilumab) and Nucala (mepolizumab) can now be self-administered.

Your weekly roundup of the latest news from Drug Topics®.

News Roundup: May 9 to May 13

People living with asthma may have a higher risk of developing dry eye disease compared with those living without asthma, according to results of a meta-analysis published in 

Through a systematic review and meta-analysis, researchers sought to further evaluate the relationship between dry eye disease and asthma as, to the best of their knowledge, no previous meta-analyses had been performed.

In total, 231 citations were identified; after exclusion criteria were applied, 6 met the requirements for inclusion in the current study.

Study cohort sizes ranged from 1174 to 105,794, with a total of 45,215 patients with asthma and 232,864 without. Participant ethnicities were varied and included patients who were Arabian, Australian, Asian, and Caucasian.

Using a random effects model, investigators found that the overall asthma group had a significantly higher prevalence of dry eye disease compared with the control group (odds ratio [OR], 95% CI, 1.20-1.38). However, due to a lack of data, it was “not possible to detect an association between asthma and diverse subtypes” of dry eye disease.

Subgroup analyses were performed based on participant ethnicity. Results of these stratified analyses showed a statistically significant correlation in Australians, Caucasians, and Asians (ORs, 1.60, 1.54, and 1.29, respectively).

Study limitations included those inherent to meta-analysis of observational studies and a lack of universal diagnostic criteria due to geographic and cultural differences.

“The results of our meta-analysis show that asthma patients have a higher risk of developing [dry eye disease] than those without asthma, and this relationship is significant in Australians, Caucasians, and Asians,” the researchers wrote. “However, this association may not reflect the cause and effect if unidentified confounders account for the results.”

“These data suggest that patients with asthma may be at risk of developing a comorbid diagnosis of [dry eye disease] and should try to avoid risk factors and strengthen the prevention of [dry eye disease].”

Association between asthma and dry eye disease: A meta-analysis abased on observational studies.

2021;11(12):e045275. Doi:10.1136/bmjopen-2020-045275

Asthma may increase a person’s risk of developing dry eye disease. 

Relationship Between Dry Eye Disease, Asthma Explored

Flip the Pharmacy Transforms Community Practice, One Pharmacy at a Time

As payment models change, pharmacies must adapt to receive reimbursement for the services they offer.

Ease The Way for Administration of Challenging Medications

Medications like inhalers and nasal sprays can be challenging for patients to administer correctly.

Positive Topline Results in Early Phase Study of Investigational Treatment for Opioid Overdose Announced

OPNT003 is a nasal spray that works to reverse respiratory depression from synthetic opioid overdose.

New Research Reveals Gut Microbiome-Diabetes Link

The role of altered gut microbiota on functions, ranging from hormone secretion to metabolic function, remains unclear.

NSAID Use May Reduce Effectiveness of Osteoporosis Therapies

Data from a cohort of 5000 patients indicates that NSAID use may negatively effect clodronate therapy in older women.