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New FDA Approved Drugs & Vaccines
INFECTIOUS DISEASES
Administration: Arexvy is recommended by the Advisory Committee on Immunization Practices (ACIP) as a single dose, using shared clinical deci- sion-making. It is prepared and administered by a trained healthcare provider as a 0.5 mL intramuscu- lar (IM) injection. Safety: The most commonly reported adverse events were injections site pain, fatigue, myalgia, headache, and arthralgia. It is important to note that immunocompromised people, including those receiving immunosuppressant therapy, may have a diminished response to the RSV vaccine. How Supplied: Arexvy is supplied in 2 vials that must be combined prior to administration. Prior to reconstitution, both components should be stored in the refrigerator. To prepare a single dose of the vaccine (Figure 2), reconstitute the lyophilized anti- gen component (a sterile white powder) with the accompanying adjuvant suspension component (an opalescent, colorless to pale brownish sterile liquid. Use only the supplied adjuvant suspension compo- nent for reconstitution. The reconstituted vaccine should be an opalescent, colorless to pale brown- ish liquid. After reconstitution, the vaccine should be administered immediately or stored in the refrigerator between 2°C and 8°C (36°F to 46°F) or at controlled room temperature and used within 4 hours. Discard reconstituted vaccine if not used within 4 hours.
Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted)
Indication and Mechanism of Action: Arexvy is a vaccine indicated for active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. It induces an immune response that protects against LRTD caused by RSV. Arexvy is not approved in people less than 60 years of age or during pregnancy. RSV causes a major burden of respiratory disease world- wide and can lead to serious and sometimes fatal respiratory tract infections, especially in older people (aged ≥65 years), young children (<5 years), and individuals with underlying chronic diseases such as pulmonary disease and circulatory conditions. Previous efforts to develop an RSV vaccine have faced several challenges due to the rapidly changing structure of the F-protein on the viral surface. Arexvy was studied in an international, randomized, phase III trial of adults aged 60 years and older. The results showed that Arexvy was 82.6% effective at decreasing RSV-LRTD compared to placebo, and was up to 94.6% effective in individuals with at least one comorbidity, such as chronic obstructive pulmo- nary disease (COPD), asthma, chronic HF, and type I and type II DM. The trial did not show that the RSV vaccine prevents hospitalizations due to respiratory disease.
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