The randomized, double-blind, placebo-controlled RENOIR trial (ClinicalTrials.gov Identifier: NCT05035212) evaluated the efficacy and safety of Abrysvo in more than 37,000 adults 60 years of age and older. Findings during the first season showed vaccine efficacy of 88.9% (95% CI, 53.6-98.7) against RSV-associated LRTD with at least 3 symptoms and 65.1% (95% CI, 35.9-82.0) against RSV-associated LRTD with at least 2 symptoms.

After the end of season 2, vaccine efficacy was reported to be 77.8% (95% CI, 51.4-91.1) against RSV-associated LRTD with at least 3 symptoms and 55.7% (95% CI, 34.7-70.4) against RSV-associated LRTD with at least 2 symptoms. Across both seasons, vaccine efficacy against RSV-associated LRTD with at least 3 symptoms was 81.5% (95% CI, 63.3-91.6) after approximately 16.4 months of disease surveillance. 

As for safety, no new vaccine-related adverse events were reported through the second RSV season. 

“We are encouraged by the level of protection that we observed after 2 full RSV seasons for Abrysvo,” said Annaliesa Anderson, PhD, Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. “This new data indicate that broad and durable protection against both types of RSV that cause disease, RSV A and RSV B, is the potential benefit to having a bivalent vaccine.”

Abrysvo is currently approved for the prevention of LRTD caused by RSV in individuals 60 years of age and older. It is also indicated for active immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age. 

Rebecca C. Woodruff, PhD, MPH, from the US Centers for Disease Control and Prevention in Atlanta, and colleagues conducted a cross-sectional study examining surveillance data from the RSV Hospitalization Surveillance Network. To estimate the weighted period prevalence of acute cardiac events, cases of RSV infection in adults aged 50 years and older within 12 states over 5 RSV seasons were examined.

A total of 6248 hospitalized adults with laboratory-confirmed RSV infection were included. The researchers found that the weighted estimated prevalence of experiencing a cardiac event was 22.4%, with weighted estimated prevalence of 15.8, 7.5, 1.3, 1.1, and 0.6% for acute heart failure, acute ischemic heart disease, hypertensive crisis, ventricular tachycardia, and cardiogenic shock, respectively. The risk for experiencing an acute cardiac event was higher for adults with underlying cardiovascular disease (33.0 vs 8.5%; adjusted risk ratio [aRR], 3.51). Of the hospitalized adults with RSV infection, 18.6 and 4.9% required intensive care unit (ICU) admission and died, respectively; those who experienced an acute cardiac event had higher risks for ICU admission and in-hospital death (aRRs, 1.54 and 1.77, respectively).

“Acute cardiac events contribute substantially to the burden of RSV disease; whether RSV vaccination can prevent these complications is an important question as the impact of these vaccines is evaluated,” the authors write.

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Editor’s Note (subscription or payment may be required)

Andrzej Emeryk, MD, PhD, from the Medical University of Lublin in Poland, and colleagues evaluated home monitoring of asthma exacerbations with the use of an AI-aided stethoscope. The analysis included 149 patients with asthma (90 children and 59 adults).

The researchers found that the best single-parameter discriminators of exacerbations were wheeze intensity for young children (area under the receiver operating characteristic curve [AUC], 84%), rhonchi intensity for older children (AUC, 81%), and survey answers for adults (AUC, 92%). The greatest efficacy was seen with a combination of several parameters.

“The AI-aided home stethoscope provides reliable information on asthma exacerbations. The parameters provided are effective for children, especially those younger than 5 years of age,” the authors write. “The introduction of this tool to the health care system might enhance asthma exacerbation detection substantially and make remote monitoring of patients easier.”

Several authors are employees of StethoMe Sp. z o.o., maker of the device used in the study.

Abstract/Full Text

Akorn has initiated a voluntary recall of various within-expiry drug products as the company has shut down operations and is unable to assure the quality of the products.

The recalled products were distributed nationwide to wholesalers, retailers, manufacturers, medical facilities, and repackagers and via the Internet to consumers. The discontinuation of the Company’s Quality program means that it is unable to support or guarantee that the medications will meet all intended specifications through the labeled shelf life of the product.

All NDCs and Lots of the following Akorn products have been recalled:

• Acetaminophen & Codeine Phosphate Oral Solution 120mg & 12mg/5mL
• Acetic Acid Otic Solution
• Acyclovir Oral Suspension, 200mg/5mL
• Albuterol Sulfate Syrup, 2mg (base)
• Amantadine HCl Syrup, USP 50mg per 5mL
• Apraclonidine Ophthalmic Solution 0.5%
• Artificial Tears
• Atropine Sulfate Ophthalmic Solution
• Azelastine Hydrochloride Nasal Spray, 0.1%
• Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, 3.5g
• Calcipotriene Scalp Solution, 0.005%
• Calcitriol Injection 1mcg and 2mcg
• Cetrorelix Acetate for Injection, 0.25mg/vial, Single-Dose Vial
• Ciclopirox Topical Solution 8%
• Cimetidine HCl Oral Solution
• Clobetasol Propionate Cream 0.05%
• Clobetasol Propionate Ointment, 0.05%
• Clobetasol Propionate Shampoo, 0.05%
• Cromolyn Sodium Ophthalmic Solution 4%
• Detomidine Hydrochloride 20mL and 5mL
• Dicyclomine Hydrochloride Injection USP, 20mg/2 mL (10mg/mL)
• Diuril^® (chlorothiazide sodium) Injection
• DOCU LIQUID- docusate sodium liquid
• Ephedrine Injection 50mg/mL
• Fentanyl Citrate Injection
• Ferrous Sulfate Elixir and Iron Supplement
• Fluticasone Propionate Nasal Spray
• Gonak Hypromellose Ophth Sol
• Granisetron HCl Injection 1mg/mL
• Guaifenesin and Codeine Phosphate Liquid
• Hydralazine HCl Injection
• Hydrocortisone and Acetic Acid Otic Solution
• Hydromorphone High Potency Injection USP – Ampule and Vial
• IC-Green Sterile Indocyanine Green Injection USP
• Ketorolac Tromethamine Ophthalmic Solution, 0.5%
• Lactulose Syrup (Oral) and (Oral/Rectal)
• Levetiracetam Injection USP, 500mg/5 mL (100mg/mL) single-dose vial
• Levocarnitine Oral Solution, USP
• Levofloxacin Injection, 25mg/mL
• Levofloxacin Oral Solution
• Levofloxacin Opth Solution
• Lidocaine 2.5% & Prilocaine 2.5% Cream
• Lidocaine Ointment
• Lidocaine HCl Jelly USP, 2%
• Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%
• Lorazepam Injection 2mg/mL vial
• Lorazepam Oral Concentrate, 2mg
• Megestrol Acetate Oral Suspension 40mg/mL
• Midazolam Injection USP 1mg/mL & 5mg/mL – vial
• Moxifloxacin HCl Solution 0.5%  
• Naloxone Injection 0.4mg/mL; 1mL and 10mL Vial
• Neomycin & Polymyxin B Sulfates & Bacitracin Zinc Ophthalmic Ointment
• Olopatadine HCl Nasal Spray, 665mcg/spray
• Olopatadine Solution 0.1% and 0.2%   
• Oxcarbazepine Oral Suspension USP, 300mg/5 mL
• Pilocarpine 1, 2, & 4%         
• Prednisolone Sodium Phosphate Oral Solution
• Promethazine HCl & Codeine Phosphate Oral Solution
• Promethazine HCl Oral Solution
• Proparacaine HCl Ophthalmic Solution, 0.5%
• Rifampin Capsules USP, 150mg & 300mg
• Ropivacaine Hydrochloride Injection USP, 0.2% and 5mg/mL
• Sodium Chloride Ophthalmic Ointment
• Sodium Chloride Solution Drops
• Sodium DIURIL
• Sufenta (Sufentanil Citrate Injection, USP) 50 mcg/mL
• Sulfamethoxazole & Trimethoprim Oral Suspension USP, 200mg/40mg per 5mL
• Timolol Maleate Ophthalmic Solution 0.5%, 2.5, 5, 10, & 15mL
• Tobramycin Inhalation Solution USP, 300mg/5 mL
• Tobramycin Ophthalmic Solution 0.3%
• Trihexyphenidyl HCl Oral Sol
• Tropicamide Ophthalmic Solution 0.5% and 1%
• Valproic Acid Oral Solution
• Vitamin D Suppl. Drops 50mL
• Xopenex– levalbuterol hydrochloride solution, concentrate

Further distribution or use of these recalled products should be discontinued immediately. To date, the Company has not received any reports of adverse events related to this recall.

Adverse events or quality issues should be reported to the FDA’s MedWatch Adverse Event Reporting program. Consumers with questions regarding this recall can contact Akorn at (800) 932-5676.