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ACAM2000 is a smallpox vaccine manufactured by Sanofi Pasteur Biologics Co. The vaccine provides protection against smallpox for people determined to be at high risk for smallpox infection. [1]
Smallpox is considered a biological threat. Biological agents are toxins or organisms that can cause illness or death in humans, animals and plants. Exposure can come from an intentional biological terrorist attack, accidental release of the agent, or a natural accident. [2]
Smallpox was eradicated in 1980. However, there has been interest in the development of vaccines due to the possible use of smallpox as a bioweapon. [3]
Smallpox vaccine development is now in its second generation. First-generation vaccines were derived from calf-lymph, and include Dryvax, APVS, Lancy-vaxina and Lister. Second-generation vaccines are cell-cultured and include ACAM2000 and CCSV. [3]
Both Dryvax and ACAM2000 come from the New York City Board of Health strain of vaccinia. Dryvax was grown on calf skin and then freeze-dried for storage. Dryvax was first licensed by the FDA in 1931; however, it is no longer manufactured. ACAM2000 is a second generation smallpox vaccine. It comes from a clone of Dryvax which is purified and produced using modern cell culture technology. [4]
Emergent BioSolutions developed ACAM2000 under a contract with the U.S. Centers for Disease Control and Prevention (CDC). [5]
The U.S. Food and Drug Administration (FDA) approved ACAM2000 in August 2007. By February 2008, it replaced Dryvax for all smallpox vaccinations. [6]
As of 2010, there were over 200 million doses manufactured for the U.S. Strategic National Stockpile. [6]
According to the U.S. 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." [4]
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. [4] Other vaccines containing live viruses include measles, mumps, rubella, polio and chickenpox. [7]
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. [4]
Administration of ACAM2000 can pose risks and cause side effects. Most people who have taken the vaccine report normal, usually mild reactions. These reactions include a sore arm, fever, and body aches. Some people may have side effects ranging from serious to life-threatening. [8]
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." [9] These reactions are less frequent in people being revaccinated than those receiving the vaccine for the first time. [9]
As far as pregnancy goes, it is recommended that the vaccine should be given to pregnant women who have been exposed to smallpox. No contraindications exist to receiving the vaccine in case of an outbreak emergency. "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." [10]
Vaccination is the administration of a vaccine to help the immune system develop immunity from a disease. Vaccines contain a microorganism or virus in a weakened, live or killed state, or proteins or toxins from the organism. In stimulating the body's adaptive immunity, they help prevent sickness from an infectious disease. When a sufficiently large percentage of a population has been vaccinated, herd immunity results. Herd immunity protects those who may be immunocompromised and cannot get a vaccine because even a weakened version would harm them. The effectiveness of vaccination has been widely studied and verified. Vaccination is the most effective method of preventing infectious diseases; widespread immunity due to vaccination is largely responsible for the worldwide eradication of smallpox and the elimination of diseases such as polio and tetanus from much of the world. However, some diseases, such as measles outbreaks in America, have seen rising cases due to relatively low vaccination rates in the 2010s – attributed, in part, to vaccine hesitancy. According to the World Health Organization, vaccination prevents 3.5–5 million deaths per year.
A vaccine is a biological preparation that provides active acquired immunity to a particular infectious or malignant disease. The safety and effectiveness of vaccines has been widely studied and verified. A vaccine typically contains an agent that resembles a disease-causing microorganism and is often made from weakened or killed forms of the microbe, its toxins, or one of its surface proteins. The agent stimulates the body's immune system to recognize the agent as a threat, destroy it, and to further recognize and destroy any of the microorganisms associated with that agent that it may encounter in the future.
Antiviral drugs are a class of medication used for treating viral infections. Most antivirals target specific viruses, while a broad-spectrum antiviral is effective against a wide range of viruses. Antiviral drugs are one class of antimicrobials, a larger group which also includes antibiotic, antifungal and antiparasitic drugs, or antiviral drugs based on monoclonal antibodies. Most antivirals are considered relatively harmless to the host, and therefore can be used to treat infections. They should be distinguished from viricides, which are not medication but deactivate or destroy virus particles, either inside or outside the body. Natural viricides are produced by some plants such as eucalyptus and Australian tea trees.
The smallpox vaccine is the first vaccine to be 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 to guard against bioterrorism, biological warfare, and monkeypox.
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 Organisation 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.
The Strategic National Stockpile (SNS), originally called the National Pharmaceutical Stockpile (NPS), is the United States' national repository of antibiotics, vaccines, chemical antidotes, antitoxins, and other critical medical supplies. Its website states:
"The Strategic National Stockpile's role is to supplement state and local supplies during public health emergencies. Many states have products stockpiled, as well. The supplies, medicines, and devices for life-saving care contained in the stockpile can be used as a short-term stopgap buffer when the immediate supply of adequate amounts of these materials may not be immediately available."
Eczema vaccinatum is a rare severe adverse reaction to smallpox vaccination.
Modified vaccinia Ankara (MVA) is an attenuated (weakened) strain of the vaccinia virus. It is being used as a vaccine against smallpox and monkeypox, 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 monkeypox. 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.
The rabies vaccine is a vaccine used to prevent rabies. There are a number of rabies vaccines available that are both safe and effective. They can be used to prevent rabies before, and, for a period of time, after exposure to the rabies virus, which is commonly caused by a dog bite or a bat bite.
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 it the only human disease to be eradicated.
The Biomedical Advanced Research and Development Authority(BARDA) is a U.S. Department of Health and Human Services (HHS) office responsible for the procurement and development of medical countermeasures, principally against bioterrorism, including chemical, biological, radiological and nuclear (CBRN) threats, as well as pandemic influenza and emerging diseases. BARDA was established in 2006 through the Pandemic and All-Hazards Preparedness Act (PAHPA) and reports to the Office of the Assistant Secretary for Preparedness and Response (ASPR). The office manages Project BioShield, which funds the research, development and stockpiling of vaccines and treatments that the government could use during public health emergencies such as chemical, biological, radiological or nuclear (CBRN) attacks.
Myopericarditis is a combination of both myocarditis and pericarditis appearing in a single individual, namely inflammation of both the pericardium and the heart muscle. It can involve the presence of fluid in the heart.
Tecovirimat, sold under the brand name Tpoxx among others, is an antiviral medication with activity against orthopoxviruses such as smallpox and monkeypox. It is the first antipoxviral drug approved in the United States. It is an inhibitor of the orthopoxvirus VP37 envelope wrapping protein.
Vaccinia immune globulin (VIG) is made from the pooled blood of individuals who have been inoculated with the smallpox vaccine. The antibodies these individuals developed in response to the smallpox vaccine are removed and purified. This results in VIG. It can be administered intravenously. It is used to treat individuals who have developed progressive vaccinia after smallpox vaccination.
SIGA Technologies, Inc. is an American pharmaceutical company founded in 1995, currently based in New York City, which develops and sells pharmaceutical solutions for the antiviral treatment of smallpox, monkeypox, cowpox, and vaccinia complications.
Ring vaccination is a strategy to inhibit the spread of a disease by vaccinating those who are most likely to be infected.
The 2022 monkeypox outbreak in the United States is part of the larger outbreak of human monkeypox caused by the West African clade of the monkeypox virus. The United States was the fourth country, outside of the African countries with endemic monkeypox, to experience an outbreak in 2022. The first case was documented in Boston, Massachusetts, on May 17, 2022. As of August 22, monkeypox has spread to all 50 states in the United States, as well as Washington, D.C., and Puerto Rico. The United States has the highest number of monkeypox cases in the world. California has the highest number of monkeypox cases in the United States.