Clinical Overview: Arexvy for Respiratory Syncytial Virus

Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted) was approved by the FDA on May 3, 2023, for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV).¹ RSV is a common respiratory virus that causes mild symptoms similar to a cold, which starts to outbreak in the fall and peaks during the winter.

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RSV is spread when an infected person sneezes or coughs and someone has direct contact with the infected person or a surface with virus droplets.1 RSV can survive for hours on hard surfaces, such as tables, and live a shorter amount of time on surfaces such as hands.¹

One of the most common places for children to get infected is at daycares, where RSV can spread very easily. This puts family members who come in contact with the child at risk of RSV infection. Vaccinating older adults with Arexvy can provide protection against disease transmission from family members.

Most people recover with no complications from RSV in a couple of weeks.¹ However, RSV can become serious in infants and older adults with weakened immune systems, chronic heart or lung disease, and any other underlying medical conditions.¹ Serious infections, such as pneumonia, can develop and become fatal for older adults. Therefore, it is recommended that older adults receive the vaccine when it becomes available to help prevent serious infections. Arexvy is set to become available in late summer or early fall of 2023.¹

Indication

Arexvy is indicated for the prevention of lower respiratory tract disease caused by RSV. There is no generic available for Arexvy and it is only approved for adults ≥60 years of age. It is an inactive vaccine that needs to be reconstituted prior to injection.²

Mechanisms of Action

It protects against RSV-A and/or B-associated lower respiratory tract disease by promoting active immunization against the RSV prefusion F3 glycoprotein. It has also been shown to increase RSV specific CD4a+ T-cell frequencies.²

Dosing and Administration

Arexvy comes in a single dose of 0.5 mL and is administered intramuscularly into the deltoid muscle. The liquid adjuvant should be removed from the vial and slowly injected into the vial containing the antigen powder. The vial should be gently swirled until the powder dissolves. The 0.5 mL dose should then be drawn from the vial and administered into the deltoid.²

Clinical Studies

There is an ongoing randomized, placebo-controlled clinical study analyzing the safety and efficacy of Arexvy in adults 60 years of age and older in the United States and across the world. A total of 12,500 patients received Arexvy and 12,500 patients received a placebo.

Among the patients who received the vaccine, Arexvy significantly decreased the risk of developing a lower respiratory tract infection from RSV by 82.6%.

Adverse Events (AEs)

The most common AEs these patients experienced were fatigue, muscle pain, injection site pain, and headache. Among all the patients in both groups, some reported atrial fibrillation within 30 days after vaccination. This clinical study will continue to follow these patients through 3 RSV seasons and assess atrial fibrillation in further studies.³

Contraindications

Arexvy is contraindicated in patients who experienced a severe hypersensitivity reaction to the RSV vaccine or any ingredient of it.²

Drug Interactions

There are many drug interactions that can affect the therapeutic effect of vaccines. The following are among the most common:

• Acetaminophen: Should not be used prophylactically but can be used to treat pain and/or fevers that occur after the vaccination.²
• Corticosteroids/immunosuppressants: If patients are vaccinated fewer than 14 days prior to or during therapy, repeat vaccination at least 3 months after therapy if immunocompetence is restored.²

Storage and Handling

This vaccine should be refrigerated between 2°C and 8°C and kept in the original packaging to protect from light. It should be immediately used after reconstitution or kept in the refrigerator. Arexvy can be kept at room temperature for up to 4 hours after reconstitution. If it remains out longer than 4 hours or is frozen, it should be discarded.²

How Pharmacists Can Help

Through the relationship that pharmacists build with their patients, they have the opportunity to educate on the importance of being vaccinated. Pharmacists play a critical role in educating their patients about the importance of RSV immunization.

They can provide education on RSV prevention, how to recognize early symptoms, and when to seek medical help. The patients that specialty pharmacists take care of can have chronic conditions, which puts them at an increased risk of complications from RSV. Therefore, pharmacists can help protect their patients by educating and getting them vaccinated.

About the Author

Abigail Wolfrum is a PharmD candidate at the Duquesne University School of Pharmacy, anticipated to graduate in spring 2024.She completed this article during a virtual Advanced Pharmacy Practice rotation at STACK. For more information about conducting an APPE at STACK, visit www.managewithstack.com.

References

1. Transmission of RSV (respiratory syncytial virus). Centers for Disease Control and Prevention. April 26, 2023. Accessed August 16, 2023. https://www.cdc.gov/rsv/about/transmission.html.
2. Arexvy. Lexi-Drugs. Lexi-comp Online. Hudson, OH, Lexi-Comp; 2020. Accessed August 16, 2023
3. Commissioner O of the FDA approves first respiratory syncytial virus (RSV) vaccine. U.S. Food and Drug Administration. May 3, 2023. Accessed August 16, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytial-virus-rsv-vaccine