ACAM2000

Last updated

ACAM2000
Vaccine description
Target Smallpox, Mpox
Vaccine type Live virus
Clinical data
Trade names Acam2000
AHFS/Drugs.com Acam2000
License data
Routes of
administration
Percutaneous
ATC code
Legal status
Legal status
Identifiers
DrugBank
UNII
KEGG
Smallpox vaccine needle Smallpox vaccination needle.jpg
Smallpox vaccine needle

ACAM2000 is a smallpox vaccine and an mpox vaccine manufactured by Emergent Biosolutions. It provides protection against smallpox for people determined to be at high risk for smallpox infection. [1] [2] ACAM2000 is a live replicating vaccinia virus vaccine. [3]

Contents

Medical uses

ACAM2000 is indicated for active immunization against smallpox disease for individuals determined to be at high risk for smallpox infection. [1] [2] [3] It is also indicated for the active prevention of mpox disease in individuals determined to be at high risk for mpox infection. [3]

History

ACAM2000 is a vaccine developed by Acambis, which was acquired by Sanofi Pasteur in 2008, before selling the smallpox vaccine to Emergent Biosolutions in 2017. Six strains of vaccinia were isolated from 3,000 doses of Dryvax and found to exhibit significant variation in virulence. The strain with the most similar virulence to the overall Dryvax mixture was selected and grown in MRC-5 cells to make the ACAM1000 vaccine. After a successful Phase I trial of ACAM1000, the virus was passaged three times in Vero cells to develop ACAM2000, which entered mass production at Baxter. The United States ordered over 200 million doses of ACAM2000 in 1999–2001 for its stockpile, and production is ongoing to replace expired vaccine. [4] [5]

Emergent Biosolutions developed ACAM2000 under a contract with the US Centers for Disease Control and Prevention (CDC). [6]

The US Food and Drug Administration (FDA) approved ACAM2000 in August 2007. [1] [2] By February 2008, it replaced Dryvax for all smallpox vaccinations. [7]

As of 2010, there were over 200 million doses manufactured for the US Strategic National Stockpile. [7]

According to the US FDA, "The approval and availability of this second-generation smallpox vaccine in the Strategic National Stockpile (SNS) enhances the emergency preparedness of the United States against the use of smallpox as a dangerous biological weapon." [8]

In August 2024, ACAM2000 was approved for mpox prevention in the United States. [9]

Administration of ACAM2000

The ACAM2000 vaccine is produced from the vaccinia virus, which is sufficiently closely related to smallpox to provide immunity, but the ACAM2000 vaccine cannot cause smallpox because it does not contain the smallpox virus. [8] Other vaccines containing live viruses include measles, mumps, rubella, polio and chickenpox. [10]

The vaccine is administered using a bifurcated stainless steel needle. The needle is dipped into the vaccine solution and used to prick the skin several times in the upper arm. The vaccinia virus will begin to grow at the injection site. It will cause a localized infection, with a red itchy sore produced at the vaccination site within three to four days. If the infection occurs, that is an indication that the vaccine was successful. Ultimately, the sore turns into a blister and then dries up. A scab forms and then falls off in the third week, leaving a small scar behind. [8]

Risks

Administration of ACAM2000 poses risks and may cause side effects. Most people who have taken the vaccine only report mild reactions. Reactions may include a sore arm, fever, and body aches. Some people may have more serious side effects, including effects that may be life-threatening. [11]

According to the FDA-approved prescribing information leaflet, "Common adverse events include inoculation site signs and symptoms, lymphadenitis, and constitutional symptoms, such as malaise, fatigue, fever, myalgia, and headache." [1] These reactions are less frequent in people being revaccinated than those receiving the vaccine for the first time. [1]

No known contraindications exist to receiving the vaccine in case of an outbreak emergency. Furthermore, it is recommended that the vaccine should be given to pregnant women who have been exposed to smallpox. "Because the risk of maternal serious illness or death, prematurity, miscarriage, or stillbirth from a smallpox infection are greater than the risk of the vaccination, smallpox vaccine is recommended and should be offered to pregnant women in case of an outbreak emergency." [12]

Related Research Articles

<span class="mw-page-title-main">Smallpox vaccine</span> Vaccine against Variola virus

The smallpox vaccine is used to prevent smallpox infection caused by the variola virus. It is the first vaccine to have been developed against a contagious disease. In 1796, British physician Edward Jenner demonstrated that an infection with the relatively mild cowpox virus conferred immunity against the deadly smallpox virus. Cowpox served as a natural vaccine until the modern smallpox vaccine emerged in the 20th century. From 1958 to 1977, the World Health Organization (WHO) conducted a global vaccination campaign that eradicated smallpox, making it the only human disease to be eradicated. Although routine smallpox vaccination is no longer performed on the general public, the vaccine is still being produced for research, and to guard against bioterrorism, biological warfare, and mpox.

<span class="mw-page-title-main">Mpox</span> Viral disease of humans and animals

Mpox is an infectious viral disease that can occur in humans and other animals. Symptoms include a rash that forms blisters and then crusts over, fever, and swollen lymph nodes. The illness is usually mild, and most infected individuals recover within a few weeks without treatment. The time from exposure to the onset of symptoms ranges from three to seventeen days, and symptoms typically last from two to four weeks. However, cases may be severe, especially in children, pregnant women, or people with suppressed immune systems.

<span class="mw-page-title-main">Vaccinia</span> Strain of poxvirus

The vaccinia virus is a large, complex, enveloped virus belonging to the poxvirus family. It has a linear, double-stranded DNA genome approximately 190 kbp in length, which encodes approximately 250 genes. The dimensions of the virion are roughly 360 × 270 × 250 nm, with a mass of approximately 5–10 fg. The vaccinia virus is the source of the modern smallpox vaccine, which the World Health Organization (WHO) used to eradicate smallpox in a global vaccination campaign in 1958–1977. Although smallpox no longer exists in the wild, vaccinia virus is still studied widely by scientists as a tool for gene therapy and genetic engineering.

<span class="mw-page-title-main">DPT vaccine</span> Combination vaccine

The DPT vaccine or DTP vaccine is a class of combination vaccines to protect against three infectious diseases in humans: diphtheria, pertussis, and tetanus (lockjaw). The vaccine components include diphtheria and tetanus toxoids, and either killed whole cells of the bacterium that causes pertussis or pertussis antigens. The term toxoid refers to vaccines which use an inactivated toxin produced by the pathogen which they are targeted against to generate an immune response. In this way, the toxoid vaccine generates an immune response which is targeted against the toxin which is produced by the pathogen and causes disease, rather than a vaccine which is targeted against the pathogen itself. The whole cells or antigens will be depicted as either "DTwP" or "DTaP", where the lower-case "w" indicates whole-cell inactivated pertussis and the lower-case "a" stands for "acellular". In comparison to alternative vaccine types, such as live attenuated vaccines, the DTP vaccine does not contain any live pathogen, but rather uses inactivated toxoid to generate an immune response; therefore, there is not a risk of use in populations that are immune compromised since there is not any known risk of causing the disease itself. As a result, the DTP vaccine is considered a safe vaccine to use in anyone and it generates a much more targeted immune response specific for the pathogen of interest.

Modified vaccinia Ankara (MVA) is an attenuated (weakened) strain of the vaccinia virus. It is being used as a vaccine against smallpox and mpox, having fewer side effects than smallpox vaccines derived from other poxviruses.

Orthopoxvirus is a genus of viruses in the family Poxviridae and subfamily Chordopoxvirinae. Vertebrates, including mammals and humans, and arthropods serve as natural hosts. There are 12 species in this genus. Diseases associated with this genus include smallpox, cowpox, horsepox, camelpox, and mpox. The most widely known member of the genus is Variola virus, which causes smallpox. It was eradicated globally by 1977, through the use of Vaccinia virus as a vaccine. The most recently described species is the Alaskapox virus, first isolated in 2015.

Emergent BioSolutions Inc. is an American multinational specialty biopharmaceutical company headquartered in Gaithersburg, Maryland. It develops vaccines and antibody therapeutics for infectious diseases and opioid overdoses, and it provides medical devices for biodefense purposes.

<span class="mw-page-title-main">Zoster vaccine</span> Vaccine to prevent shingles

A zoster vaccine is a vaccine that reduces the incidence of herpes zoster (shingles), a disease caused by reactivation of the varicella zoster virus, which is also responsible for chickenpox. Shingles provokes a painful rash with blisters, and can be followed by chronic pain, as well as other complications. Older people are more often affected, as are people with weakened immune systems (immunosuppression). Both shingles and postherpetic neuralgia can be prevented by vaccination.

<span class="mw-page-title-main">Hepatitis A vaccine</span> Vaccine to prevent hepatitis A

Hepatitis A vaccine is a vaccine that prevents hepatitis A. It is effective in around 95% of cases and lasts for at least twenty years and possibly a person's entire life. If given, two doses are recommended beginning after the age of one. It is given by injection into a muscle. The first hepatitis A vaccine was approved in Europe in 1991, and the United States in 1995. It is on the World Health Organization's List of Essential Medicines.

<span class="mw-page-title-main">Smallpox</span> Eradicated viral disease

Smallpox was an infectious disease caused by variola virus, which belongs to the genus Orthopoxvirus. The last naturally occurring case was diagnosed in October 1977, and the World Health Organization (WHO) certified the global eradication of the disease in 1980, making smallpox the only human disease to have been eradicated to date.

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<span class="mw-page-title-main">Monkeypox virus</span> Species of double-stranded DNA virus

The monkeypox virus is a species of double-stranded DNA virus that causes mpox disease in humans and other mammals. It is a zoonotic virus belonging to the Orthopoxvirus genus, making it closely related to the variola, cowpox, and vaccinia viruses. MPV is oval, with a lipoprotein outer membrane. The genome is approximately 190 kb. Smallpox and monkeypox viruses are both orthopoxviruses, and the smallpox vaccine is effective against mpox if given within 3–5 years before the disease is contracted. Symptoms of mpox in humans include a rash that forms blisters and then crusts over, fever, and swollen lymph nodes. The virus is transmissible between animals and humans by direct contact to the lesions or bodily fluids. The virus was given the name monkeypox virus after being isolated from monkeys, but most of the carriers of this virus are smaller mammals.

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References

  1. 1 2 3 4 5 6 "ACAM2000 (smallpox- vaccinia vaccine, live injection, powder, lyophilized, for solution". DailyMed. U.S. National Library of Medicine. 21 March 2018. Retrieved 10 January 2023.
  2. 1 2 3 4 "ACAM2000". U.S. Food and Drug Administration (FDA). 29 August 2024. Retrieved 1 September 2024.
  3. 1 2 3 4 "FDA Roundup: August 30, 2024". U.S. Food and Drug Administration (FDA) (Press release). 30 August 2024. Retrieved 1 September 2024.
  4. Monath TP, Caldwell JR, Mundt W, Fusco J, Johnson CS, Buller M, et al. (October 2004). "ACAM2000 clonal Vero cell culture vaccinia virus (New York City Board of Health strain)--a second-generation smallpox vaccine for biological defense". International Journal of Infectious Diseases. 8 (Suppl 2): S31–S44. doi:10.1016/j.ijid.2004.09.002. PMC   7110559 . PMID   15491873.
  5. Nalca A, Zumbrun EE (May 2010). "ACAM2000: the new smallpox vaccine for United States Strategic National Stockpile". Drug Design, Development and Therapy. 4: 71–79. doi: 10.2147/dddt.s3687 . PMC   2880337 . PMID   20531961.
  6. "About ACAM2000" (PDF). Emergent Biosolutions. Archived from the original (PDF) on 14 August 2018. Retrieved 8 September 2018.
  7. 1 2 Nalca A, Zumbrun EE (May 2010). "ACAM2000: the new smallpox vaccine for United States Strategic National Stockpile". Drug Design, Development and Therapy. 4: 71–79. doi: 10.2147/dddt.s3687 . PMC   2880337 . PMID   20531961.
  8. 1 2 3 "ACAM2000 (Smallpox Vaccine) Questions and Answers". U.S. Food and Drug Administration (FDA). Retrieved 8 September 2018.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  9. "Emergent Biosolutions' ACAM2000, (Smallpox and Mpox (Vaccinia) Vaccine, Live) Receives U.S. FDA Approval for Mpox Indication; Public Health Mpox Outbreak Continues Across Africa & Other Regions" (Press release). Emergent Biosolutions. 29 August 2024. Retrieved 1 September 2024 via GlobeNewswire.
  10. "Smallpox Vaccine Basics". U.S. Centers for Disease Control and Prevention (CDC). 13 July 2017. Retrieved 8 September 2018.
  11. "Smallpox Vaccine Safety". U.S. Centers for Disease Control and Prevention (CDC). 13 July 2017. Retrieved 8 September 2018.
  12. "Smallpox vaccine Use During Pregnancy". Drugs.com. Retrieved 8 September 2018.