Live vaccine against smallpox and Mpox (monograph)

Live vaccine against smallpox and Mpox (monograph)

Live vaccine against smallpox and Mpox (monograph)

introduction

Uses for smallpox and Mpox live vaccines

The live vaccine against smallpox and Mpox has the following possible uses:

The live smallpox and Mpox vaccine is indicated for the prevention of smallpox and Mpox disease in adults 18 years of age and older who are at high risk for smallpox or Mpox infection.

Live dosing and administration of smallpox and Mpox vaccines

Generally

The live smallpox and Mpox vaccine is available in the following dosage form(s) and strength(s):

Suspension for subcutaneous use: single-dose vial containing a 0.5 ml dose.

dosage

It isessentialFor more detailed information on the dosage and administration of this drug, it is advisable to consult the manufacturer's labeling. Dosage summary:

Adult

Dosage and application

• For subcutaneous injection only, preferably into the deltoid muscle.

• Administer 2 doses (0.5 ml each) 4 weeks apart.

Precautions for smallpox and Mpox live vaccines

Contraindications

None.

Warnings/Precautions

Severe allergic reactions

Adequate medical treatment must be available to manage possible anaphylactic reactions following administration of live smallpox and Mpox vaccines.

Individuals who have experienced a severe allergic reaction after a previous dose of live smallpox and Mpox vaccine or after exposure to any component of the vaccine may be at increased risk of severe allergic reactions to live smallpox and Mpox vaccine. The risk of a serious allergic reaction should be weighed against the risk of illness from smallpox or Mpoxene.

Altered immune competence

Immunocompromised individuals, including those receiving immunosuppressive therapy, may have a reduced immune response to live smallpox and MPox vaccination.

Because the live smallpox and MPox vaccine contains non-replicating viruses, the vaccine can be used in adults with certain immune deficiencies or medical conditions, such as: B. an infection with the human immunodeficiency virus (HIV) or atopic dermatitis.

Limitations on vaccine effectiveness

Live vaccination against smallpox and Mpox may not protect all recipients.

For primary immunization, the live vaccine against smallpox and Mpox is administered in a series of 2 doses 4 weeks apart; Full immunity may not develop until 2 weeks after the second dose.

Specific populations

pregnancy

Risk summary: Available human data on live smallpox and Mpox vaccines administered to pregnant women are insufficient to indicate risks associated with vaccination in pregnancy. All pregnancies are at risk of a birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.

The effect of live smallpox and MPox vaccine on embryo-fetal and postnatal development was examined in 4 developmental toxicity studies in female rats and rabbits. These animal studies found no evidence of fetal harm.

Animal data: Developmental toxicity studies were conducted in female rats and rabbits. In one study, a single human dose of live smallpox and smallpox vaccine (0.5 ml) was administered subcutaneously to female rabbits three times (prior to mating and on gestation days 0 and 14). In three studies, a single human dose of live smallpox and smallpox vaccine (0.5 ml) was administered subcutaneously to female rats twice or three times (before mating and on gestation days 0 and 14; before mating and on gestation day 0; or on days 0 and 6 of pregnancy). No vaccine-related fetal malformations or variations and no adverse effects on female fertility or preweaning development were reported in these studies.

lactation

Risk overview: It is not known whether the live smallpox and Mpox vaccine passes into breast milk. There are no data to assess the effects of live smallpox and Mpox vaccination on the breast-fed infant or on milk production/distribution.

The developmental and health benefits of breastfeeding should be considered together with the mother's clinical need for a live smallpox and MPox vaccine and any adverse effects of the vaccine or underlying maternal disease on the breastfed infant. In preventive vaccinations, the underlying disease is susceptibility to diseases that the vaccine prevents.

Pediatric use

The safety and effectiveness of live smallpox and MPox vaccines have not been established in persons under 18 years of age.

Geriatric use

Clinical trials of live smallpox and MPox vaccination did not include enough adults aged 65 years and older to determine whether they respond differently than younger people.

In a clinical trial, 42 adults aged 65-80 years who had previously been vaccinated with smallpox vaccine received at least one dose of live smallpox and smallpox vaccine.

Common side effects

Healthy adults not previously vaccinated with smallpox vaccine: The most common (>10%) injection site reactions elicited were pain (85%), redness (61%), swelling (52%), induration (45%), and itching (43). %); The most common systemic adverse reactions were myalgia (43%), headache (35%), fatigue (30%), nausea (17%) and chills (10%).

Healthy adults previously vaccinated with smallpox vaccine: The most common (>10%) injection site reactions elicited were redness (81%), pain (80%), induration (70%), swelling (67%) and itching (32%). ); The most common systemic side effects were fatigue (34%), headache (28%) and myalgia (22%).

Adults with HIV infection or atopic dermatitis: The frequency of reported local and systemic adverse reactions was generally similar to that in healthy adults.

Interactions with other medications

Specific medications

It isessentialFor more detailed information about interactions with this drug, including possible dosage adjustments, it is advisable to consult the manufacturer's labeling. Interaction Highlights:

Refer to the product labeling for drug interaction information.

Actions

Mechanism of action

Smallpox and MPox live vaccine is a live, attenuated, non-replicating virus vaccine containing a modified vaccinia virus (MVA-BN) that elicits humoral and cellular immune responses against orthopoxviruses. Vaccinia virus, variola virus (the pathogen that causes smallpox) and Mpoxvirus are all orthopoxviruses.

The live vaccine against smallpox and Mpox does not contain the smallpox virus (Variola) and cannot cause smallpox.

Vaccinia neutralizing antibody responses in humans following live vaccination with smallpox and Mpox vaccine were evaluated to determine the effectiveness of the vaccine in preventing smallpox and Mpox.

The efficacy of the smallpox and live smallpox vaccine was derived by comparing the immunogenicity of the vaccine with the live smallpox vaccine (ACAM2000) based on a plaque reduction neutralization test (PRNT) using the Western reserve strain of vaccinia virus and was supported by efficacy data from Animal challenge studies.

The effectiveness of the live smallpox and Mpox vaccine against Mpox was derived from the immunogenicity of the vaccine in a clinical trial and efficacy data from animal studies.

Advice for patients

• Inform the vaccine recipient about the possible benefits and risks of vaccination with live smallpox and Mpox vaccine.

• Inform the vaccine recipient of the importance of completing the 2-dose vaccination series.

• Instruct the vaccine recipient to report any adverse events to their healthcare provider or the Vaccine Adverse Event Reporting System (VAERS) at 800-822-7967 [Web].

More information

AHFSfirstRelease™. For further information until the creation and publication of a more detailed monograph, the manufacturer's labeling should be consulted. For more detailed information on common uses, dosage and administration, cautions, cautions, contraindications, potential drug interactions, interference with laboratory testing, and acute toxicity, it is important to consult the manufacturer's labeling.

Preparations

Excipients in commercial drug preparations may have clinically significant effects in some individuals; Details can be found on the respective product labeling.

For information about shortages of one or more of these drugs, visit the ASHP Drug Shortages Resource Center.

Live smallpox and Mpox vaccines are stored in the US Strategic National Stockpile (SNS). The SNS ensures that certain medications and medical supplies are readily available to prevent or treat certain diseases, including during public health emergencies, and is administered by the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR).

Smallpox and Mpox vaccine, live vaccine, not replicable

AHFS DI Essentials™. © Copyright 2024, Selected changes March 28, 2023. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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