Materiały źródłowe

• #1

  https://www.who.int/news-room/spotlight/history-of-vaccination/history-of-smallpox-vaccination

  One of the deadliest diseases known to humans, smallpox remains the only human disease to have been eradicated. Many believe this achievement to be the most significant milestone in global public health. […] Smallpox was highly infectious, with no known cure. It began as early as 1350 BCE, with cases being found in the study of Egyptian mummies. […] A cure was never found for smallpox before eradication, with those infected being treated only by cleaning wounds and lessening pain.

• #2 SMALLPOX THERAPEUTIC – BioFactura

  https://www.biofactura.com/pipeline/smallpox-therapeutic/

  With a mortality rate of over 30%, smallpox is one of the most dangerous biological threats. […] Although TPOXX (Tecovirimat, SIGA Technologies, Inc.) received FDA approval for smallpox treatment in 2018, orthopoxviurses, like Variola Virus (VARV), the causative agent of smallpox, can become resistant to treatment suggesting that the best medical countermeasure approach would utilize complementary therapeutics. […] Administration of therapeutic antibodies represents a relevant strategy for treatment and/or prophylaxis of individuals exposed to or infected by viral disease agents of significance to the military and anti-bioterrorism efforts. […] In order to fill the need for additional treatment options, BioFactura is advancing the development of a Smallpox Biodefense Therapeutic (SBT) as an antibody-based countermeasure for the treatment of smallpox in humans using a stepwise approach that builds upon years of early product research and development and strong foundation of cell line, process analytical and manufacturing development experience. […] Ultimately, BioFactura intends to seek FDA approval for the SBT as a treatment of smallpox disease.

• #3 FDA approves drug to treat smallpox | FDA

  https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-treat-smallpox

  The U.S. Food and Drug Administration today approved Tembexa (brincidofovir) to treat smallpox. […] Although naturally occurring smallpox no longer exists, concerns about potential uses of variola virus as a bioweapon has made smallpox drug development an important component of the U.S. medical countermeasures response. […] Because smallpox is eradicated, the effectiveness of Tembexa was studied in animals infected with viruses that are closely related to the variola virus. […] Tembexa is only approved for the treatment of smallpox.

• #4 Treatment of Smallpox | Smallpox | CDC

  https://www.cdc.gov/smallpox/treatment/index.html

  There is no treatment for smallpox that has been tested in people who are sick with the disease and proven effective. […] Some antiviral drugs have been approved to treat smallpox but have not been tested in sick people. […] In July 2018, the FDA approved tecovirimat (TPOXX) for treatment of smallpox. […] Tecovirimat has not been tested in people who are sick with smallpox, but it has been given to healthy people. […] In June 2021, the FDA approved brincidofovir (TEMBEXA) for treatment of smallpox. […] Brincidofovir has not been tested in people who are sick with smallpox, but it has been given to healthy people and people with other viral infections. […] Cidofovir has not been tested in people who are sick with smallpox, but has been tested in healthy people and in those with other viral illnesses.

• #5 Clinical Treatment of Smallpox | Smallpox | CDC

  https://www.cdc.gov/smallpox/hcp/clinical-care/index.html

  Smallpox treatment generally involves supportive care. […] Treatment of smallpox patients generally involves supportive care. Vaccination with replication-competent smallpox vaccines (i.e., ACAM2000 and APSV) can prevent or lessen the severity of disease if given within 2 to 3 days of the initial exposure. […] Treating smallpox patients in a healthcare setting requires isolation and adherence to proper infection and environmental controls. […] There are three primary antiviral therapies that have shown effectiveness against orthopoxviruses including variola (the virus that causes smallpox) in animals and in vitro studies. However, there is no treatment for smallpox disease that has been tested in people who are sick with the disease and been proven effective in this population. […] In July 2018, the U.S. Food and Drug Administration (FDA) approved tecovirimat (also referred to as ST-246 or its brand name Tpoxx), the first drug with an indication for treatment of smallpox.

• #6 FDA approves the first drug with an indication for treatment of smallpox | FDA

  https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-indication-treatment-smallpox

  The U.S. Food and Drug Administration today approved TPOXX (tecovirimat), the first drug with an indication for treatment of smallpox. […] TPOXX’s effectiveness against smallpox was established by studies conducted in animals infected with viruses that are closely related to the virus that causes smallpox, and was based on measuring survival at the end of the studies. […] The safety of TPOXX was evaluated in 359 healthy human volunteers without a smallpox infection.

• #7 Smallpox Medication: Antivirals, Other, Vaccines, Live, Viral, Immune Globulins

  https://emedicine.medscape.com/article/237229-medication

  Tecovirimat (TPOXX) is an antiviral agent; targets and inhibits the activity of the orthopoxvirus VP37 protein and blocks its interaction with cellular Rab9 GTPase and TIP47, which prevents the formation of egress-competent enveloped virions necessary for cell-to-cell and long-range dissemination of virus. It is approved by the FDA and indicated for treatment of human smallpox disease caused by variola virus in adults and children who weigh at least 13 kg. […] Brincidofovir effectively penetrates cells via its lipid conjugate, releasing the nucleotide analog cidofovir, which then acts to inhibit viral replication. Cidofovir diphosphate selectively inhibits orthopoxvirus DNA polymerase-mediated viral DNA synthesis by incorporation of cidofovir into the growing viral DNA chain. This results in reductions in the rate of viral DNA synthesis. It is indicated for treatment of human smallpox disease caused by variola virus in adult and pediatric patients, including neonates.

• #8 Clinical Treatment of Smallpox | Smallpox | CDC

  https://www.cdc.gov/smallpox/hcp/clinical-care/index.html

  Tecovirimat’s effectiveness against smallpox was established with in vitro studies using related orthopoxviruses as well as variola. […] Efficacy of tecovirimat treatment has also been demonstrated within multiple animal model studies measuring survival in animals infected with either variola virus or other closely related orthopoxviruses. […] In June 2021, the FDA approved brincidofovir (also referred to its brand name TEMBEXA) for treatment of smallpox. […] Brincidofovir’s effectiveness against smallpox was established with in vitro studies using related orthopoxviruses as well as variola. […] In laboratory tests, cidofovir has also been shown to stop the growth of the virus that causes smallpox and to be effective in treating animals that had diseases similar to smallpox. […] Cidofovir has not been tested in people who are sick with smallpox, but has been tested in healthy people and in those with other viral illnesses.

• #9 Oral Tecovirimat for the Treatment of Smallpox

  https://pmc.ncbi.nlm.nih.gov/articles/PMC6086581/

  In pilot studies, tecovirimat was shown to provide protective efficacy in multiple small-animal and nonhuman primate models of orthopoxvirus disease. […] The minimum effective dose was determined to be 3 to 10 mg per kilogram, which provided nearly full protection from death and reduced viral loads and lesion counts. […] The dose of 40 mg per kilogram was selected as the standard for fully effective dosing. […] The exposures achieved with a dose of 600 mg twice daily exceeded the efficacious exposures in nonhuman primates. […] This report represents the triangulation of safety, pharmacokinetic, and efficacy data from two animal models and noninfected human volunteers. […] The aggregation of the results from these multiple studies involving animals and humans supports tecovirimat as a potential smallpox antiviral drug.

• #10 Smallpox: Symptoms, Diagnosis, Treatment, And Prevention | ER of Mesquite

  https://erofmesquite.com/blog/smallpox-symptoms-diagnosis-treatment-and-prevention/

  Treatment for smallpox in the past involved isolating the patient until all the scabs fell off to relieve symptoms and stop the illness from spreading. However, researchers have created antiviral drugs to treat smallpox in recent years. […] The medication tecovirimat (TPOXX) was licensed by the U.S. Food and Drug Administration (FDA) in 2018 to treat smallpox. The medication prevents the action of a protein known as p37, which stops virus particles from escaping an infected cell and infecting other cells. […] According to research, tecovirimat can treat illnesses akin to smallpox in animals and is effective against the variola virus in lab conditions (in cell cultures). Additionally, studies demonstrate the safety of tecovirimat, with headache, nausea, and abdominal pain being the most common side effects.

• #11 What Is Smallpox? Symptoms, Causes, Diagnosis, Treatment, and Prevention

  https://www.everydayhealth.com/infectious-diseases/smallpox/

  In the past, smallpox treatment focused on relieving symptoms and preventing the spread of the disease by isolating the patient until all the smallpox scabs fell off. […] But in recent years, researchers have developed antiviral medications for smallpox. […] In 2018, the U.S. Food and Drug Administration (FDA) approved the drug tecovirimat (TPOXX) to treat smallpox. The drug works by inhibiting the activity of a protein called p37, which ultimately prevents viral particles from leaving an infected cell and spreading to other cells. […] Research shows that tecovirimat is effective against the variola virus in laboratory settings (in cell cultures) and can treat diseases similar to smallpox in animals. […] Studies also show tecovirimat is safe, with the most frequent side effects being headache, nausea, and abdominal pain.

• #12 Smallpox Treatment | NIAID: National Institute of Allergy and Infectious Diseases

  https://www.niaid.nih.gov/diseases-conditions/smallpox-treatment

  Although smallpox vaccines have been developed and procured for the SNS, they cannot completely prevent disease or attenuate the illness if given too late following exposure. Smallpox antivirals are needed for treatment or post-exposure prophylaxis. Early results from laboratory studies suggest that the drug cidofovir may be an effective treatment against the smallpox virus. […] Based on encouraging study results, NIAID applied to FDA to use cidofovir as an experimental treatment for smallpox in the event of a bioterrorist-initiated re-emergence. […] To circumvent the drug delivery and toxicity problems, NIAID has supported the development of brincidofovir, a derivative of cidofovir that can be given orally instead of by intravenous injection and that may have fewer side-effects. […] NIAID has also provided support from discovery through Phase 2 clinical development for a second therapeutic for smallpox, tecovirimat. Tecovirimat has a different mechanism of action from that of cidofovir or brincidofovir and is specifically active against smallpox and closely related members of the poxvirus family.

• #13 Smallpox – Wikipedia

  https://en.wikipedia.org/wiki/Smallpox

  Smallpox vaccination within three days of exposure will prevent or significantly lessen the severity of smallpox symptoms in the vast majority of people. Vaccination four to seven days after exposure can offer some protection from disease or may modify the severity of the disease. […] Other than vaccination, treatment of smallpox is primarily supportive, such as wound care and infection control, fluid therapy, and possible ventilator assistance. Flat and hemorrhagic types of smallpox are treated with the same therapies used to treat shock, such as fluid resuscitation. […] Antiviral treatments have improved since the last large smallpox epidemics, and as of 2004, studies suggested that the antiviral drug cidofovir might be useful as a therapeutic agent. The drug must be administered intravenously, and may cause serious kidney toxicity. In July 2018, the Food and Drug Administration approved tecovirimat, the first drug approved for treatment of smallpox. […] In June 2021, brincidofovir was approved for medical use in the United States for the treatment of human smallpox disease caused by variola virus.

• #14 Smallpox: Causes, Symptoms, & Vaccines

  https://www.webmd.com/a-to-z-guides/smallpox-causes-treatment

  In the event a case does emerge, there are two antiviral drugs approved by the U.S. FDA to treat the disease: tecovirimat (TPOXX) and brincidofovir (Tembexa). Both have been shown to stop the growth of the virus that causes smallpox. […] The drug cidofovir has been shown to stop the growth of the smallpox virus. It’s not FDA-approved to treat smallpox, but it could be used during an outbreak under certain circumstances, such as an Emergency Use Authorization. […] None of these drugs have been tested in people sick with smallpox. But tecovirimat and cidofovir have been shown to work in animals with diseases similar to smallpox, and it’s believed that brincidofovir would, too. […] Tecovirimat and cidofovir are stockpiled within the U.S. Strategic National Stockpile, which holds medications and medical supplies to protect the American public in the event of a public health emergency, such as a smallpox outbreak.

• #15 Smallpox Treatment & Management: Approach Considerations, Vaccination, Isolation Recommendations From the CDC

  https://emedicine.medscape.com/article/237229-treatment

  The first drug for the treatment of smallpox, tecovirimat, was approved in July 2018 should smallpox ever be used as a bioweapon. […] The antiviral agent cidofovir is available from the SNS as an investigational agent for the treatment of smallpox. […] Some new agents and countermeasures for the prevention and treatment of smallpox have been added to the SNS.

• #16 Smallpox Treatment & Management: Approach Considerations, Vaccination, Isolation Recommendations From the CDC

  https://emedicine.medscape.com/article/237229-treatment

  No known treatment is effective for smallpox. Medical management of smallpox is mainly supportive. Supportive care in patients with symptomatic smallpox consists of the following: […] Oral antiviral agents (ie, tecovirimat, cidofovir) are available from the US governments Strategic National Stockpile (SNS). […] In July 2018, the US Food and Drug Administration approved tecovirimat (TPOXX), the first drug indicated for the treatment of smallpox, should smallpox ever be used as a bioweapon. […] The FDA approved a second antiviral according to the animal rule, brincidofovir, for treatment of smallpox in June 2021. […] Vaccinia immunoglobulin (VIG) does not appear to offer a survival benefit when given to patients during the incubation or active-disease stages of smallpox. However, new drugs are under investigation.

• #17 Smallpox | Washington State Department of Health

  https://doh.wa.gov/emergencies/be-prepared-be-safe/diseases/smallpox

  There is no proven treatment for smallpox, but research to evaluate new antiviral agents is ongoing. Patients with smallpox can benefit from supportive therapy such as intravenous fluids and medicine to control fever or pain, and antibiotics for any secondary bacterial infections. […] If the vaccine is given to a person within four days of exposure to smallpox, it may lessen the severity of–or possibly prevent–illness. Vaccine against smallpox contains a live virus called vaccinia; it does not contain the smallpox virus. […] The vaccine is stored and distributed by the Centers for Disease Control and Prevention through the Strategic National Stockpile of pharmaceutical supplies. In the event smallpox is used as a weapon, the distribution of vaccine would be coordinated by the federal Centers for Disease Control and Prevention state and local health departments.

• #18 Smallpox Virus (Variola) Vaccine, Causes, Symptoms, Incubation

  https://www.medicinenet.com/smallpox/article.htm

  What is the treatment for smallpox? Treatment for smallpox is supportive, meaning that patients should keep hydrated, fever should be treated with acetaminophen (Tylenol) or a similar medication, and the patient should be closely monitoring to determine if there is a need for blood pressure support. Although there are no medications proven to work against human infection, some medications have shown promise in the laboratory, including a derivative of the antiviral drug cidofovir (Vistide), its analogs and virus inhibitor ST-246. Intravenous vaccinia immunoglobulin (VIGIV) has been used in early acquired accidental contaminations of the eyes or mouth. If the patient is hospitalized, strict airborne and contact isolation procedures should be followed; the room should have negative air pressure and HEPA air filters.

• #19 Smallpox Medication: Antivirals, Other, Vaccines, Live, Viral, Immune Globulins

  https://emedicine.medscape.com/article/237229-medication

  The first antiviral for treatment of smallpox disease, tecovirimat (TPOXX), was approved by the US Food and Drug Administration (FDA) in July 2018. The FDA approved a second antiviral according to the animal rule, brincidofovir, for treatment of smallpox in June 2021. […] Certain medications, including topical idoxuridine and cidofovir, can be used under investigational new drug (IND) protocol for the management of smallpox. […] Secondary bacterial infections of the skin can be treated with semisynthetic penicillins (nafcillin, oxacillin, dicloxacillin) or first-generation cephalosporins (eg, cefazolin, cephalexin) or clindamycin. Ampicillin/sulbactam or amoxicillin/clavulanate can also be used. A history of prior adverse reactions or hypersensitivity is the primary contraindication. […] In the event an individual exposed to smallpox is unable to promptly receive the vaccine, tecovirimat or brincidofovir may be obtained from the US governments Strategic National Stockpile for treatment.

• #20 Smallpox – Infections – Merck Manual Consumer Version

  https://www.merckmanuals.com/home/infections/pox-viruses/smallpox

  Treatment involves fluids, relief of symptoms, and treatments to maintain blood pressure and help with breathing. […] Antiviral drugs have not been tested in smallpox because they did not exist when the disease was present. However, if smallpox were to return, doctors think that tecovirimat, cidofovir, or brincidofovir might be helpful. […] Treatment of smallpox is supportive. It includes fluids, symptom relief, assistance with breathing (for example, with a face mask to supply oxygen), and treatments to maintain blood pressure.

• #21 Smallpox Medication: Antivirals, Other, Vaccines, Live, Viral, Immune Globulins

  https://emedicine.medscape.com/article/237229-medication

  Vaccinia immunoglobulin (VIG) is used for amelioration of some vaccinia-related complications. VIG has been effective when administered early in cases of vaccinia necrosum and eczema vaccinatum. VIG has not been effective in cases of encephalopathy. The use of VIG for generalized vaccinia reactions is usually not necessary. Intravenous VIG (CNJ-016) has been approved by the FDA. […] VIGIV is indicated to treat rare adverse reactions and aberrant infections caused by vaccinia virus, including accidental implantation in the eyes, mouth, other potentially hazardous areas; eczema vaccinatum; progressive vaccinia; severe, generalized vaccinia; and vaccinia infections in immunocompromised individuals.

• #22 Treatment | Smallpox | CDC

  http://medbox.iiab.me/modules/en-cdc/www.cdc.gov/smallpox/clinicians/treatment.html

  There is no proven treatment for smallpox. There are three antiviral therapies that have shown effectiveness against poxviruses in animals and in vitro studies; however, their effectiveness in treating smallpox disease in humans is unknown. […] Treatment of smallpox patients generally involves supportive care. Vaccination can prevent or lessen the severity of disease if given within 2 to 3 days of the initial exposure. It may decrease symptoms if given within the first week of exposure. […] Treating smallpox patients in a healthcare setting requires isolation and adherence to proper infection and environmental controls.

• #23 Smallpox: Treatment, Procedure, Cost, Recovery, Side Effects And More

  https://www.lybrate.com/topic/smallpox

  The patient should be isolated until all scabs have fallen off (about 3-4 wk after rash onset) to prevent transmission of the variola virus to nonimmune persons. The fluid and electrolyte balance should be monitored and maintained to avoid dehydration. Medications should be given for fever and pain. Good nutritional support should be maintained. Skin care should be instituted. Complications should be monitored for and treated. […] There is no cure for the smallpox virus. As a result of worldwide, repeated vaccination programs, the variola virus (smallpox) has been completely eradicated. The only people considered to be at risk for smallpox are researchers who work with it in a laboratory setting. In the unlikely event that an exposure to the smallpox virus occurs, vaccination within one to three days can keep the illness from being so severe. In addition, antibiotics can help to reduce the bacterial infections associated with the virus. Treatment of smallpox is left more to nature than to medicine. This is because it is a viral infection and not much is known about smallpox viruses. The spread of smallpox, however, is checked by vaccination. If smallpox is left uncontrolled, it may become an epidemic and even a pandemic. Hence, timely prophylactic treatment for smallpox is very necessary.

• #24 Smallpox – Infectious Diseases – Merck Manual Professional Edition

  https://www.merckmanuals.com/professional/infectious-diseases/pox-viruses/smallpox

  Treatment of smallpox is generally supportive, with antibiotics for secondary bacterial infections. The antiviral drug tecovirimat was approved by the US Food and Drug Administration (FDA) in 2018 […] Treatment is mainly supportive, but tecovirimat and brincidofovir have been approved for use; cidofovir may be considered. […] Isolation of people with smallpox is essential. In limited outbreaks, patients may be isolated in a hospital under airborne transmission precautions in an airborne-infection isolation room. In mass outbreaks, home isolation may be required. Contacts should be placed under surveillance, typically with daily temperature measurement; if they develop a temperature of 38 C or other sign of illness, they should be isolated at home.

• #25 Smallpox – Symptoms and causes – Mayo Clinic

  https://www.mayoclinic.org/diseases-conditions/smallpox/symptoms-causes/syc-20353027

  Vaccines can prevent smallpox, but because most people are unlikely to come in contact with smallpox naturally, routine vaccination isn’t recommended. […] New antiviral medications can be used to treat people who develop smallpox. […] A vaccine can protect you from getting sick or cause you to get less sick if you get smallpox. The vaccine should be given before or one week after exposure to the virus. […] The ACAM2000 vaccine uses a live virus that’s like smallpox, but less harmful. It can sometimes cause serious side effects, such as infections in the heart or brain. […] A second vaccine (Jynneos) uses a very weakened strain of virus and is safer than ACAM2000. It can be used in people who can’t take ACAM2000 due to compromised immune systems or skin disorders.

• #26 Smallpox – Control | Occupational Safety and Health Administration

  http://www.osha.gov/smallpox/control

  The principles of Standard Precautions are generally applied for the cleaning, disinfection, and sterilization of equipment and environmental control in facilities. […] Specific biosafety procedures, including vaccinating laboratory personnel against smallpox if there is potential work involving receiving and handling smallpox specimens, personal protective equipment (PPE), engineering controls, and additional work practices that have been established for handling smallpox virus in laboratories. […] Various actions may be taken by public health authorities to treat and prevent further infections due to a release of the smallpox virus. These measures may include mass distribution of vaccinations, surveillance, quarantine, and communication procedures. […] Currently, the smallpox vaccine is the only approved way to prevent the disease. The vaccine was used to successfully eradicate smallpox from the human population, and therefore routine vaccination of the American public stopped in 1972. However, the U.S. government has recently implemented plans to ensure there is sufficient vaccine available, and procedures in place to immunize everyone who might need it in the event of an emergency. […] Vaccination within 3 days of exposure will completely prevent or significantly modify smallpox in the vast majority of persons. Vaccination 4 to 7 days after exposure likely offers some protection from the disease or may modify the severity of the disease.

• #27 Smallpox | Mass.gov

  https://www.mass.gov/info-details/smallpox

  There is no specific treatment for smallpox. Patients would be given fluids, medicine to control fever and pain and antibiotics for other infections that may occur as a result of smallpox. […] The best way to prevent smallpox is through vaccination. If given to a person before exposure to smallpox, the vaccine can completely protect them. Vaccination within 3 days after exposure will prevent or greatly lessen the severity of smallpox in most people Vaccination 4 to 7 days after exposure likely offers some protection from disease and may decrease the severity of disease. Vaccination will not protect smallpox patients who already have a rash.

• #28 Treatment of Smallpox | Smallpox | CDC

  https://www.cdc.gov/smallpox/treatment/index.html

  Because these drugs were not tested in people sick with smallpox, it is not known if a person with smallpox would benefit from treatment with them. […] Tecovirimat and brincidofovir are currently stockpiled by the Assistant Secretary for Preparedness and Response (ASPR) Strategic National Stockpile, which has medicine and medical supplies to protect the American public if there is a public health emergency, including one involving smallpox.

• #29 TPOXX | SIGA

  https://www.siga.com/tpoxx

  Our lead product, TPOXX (tecovirimat), is a highly targeted antiviral treatment against orthopoxviruses, including smallpox. […] TPOXX was among the first novel small molecule therapies delivered to the Strategic National Stockpile (SNS) under Project BioShield, a U.S. government program designed to accelerate the research, development, purchase, and availability of effective medical countermeasures against chemical, biological, radiological, and nuclear (CBRN) agents. […] As the first antiviral agent specifically indicated for the treatment of smallpox, TPOXX would play a critical role in responding to a smallpox bioterror attack. […] Oral TPOXX is considered safe and well-tolerated in patients. […] Smallpox is one of the worlds deadliest threats and an outbreak cannot be addressed with vaccines alone. Both medicines and vaccines are essential to combat orthopoxviruses.

• #30 Smallpox: History, cause, vaccine, and does it still exist?

  https://www.medicalnewstoday.com/articles/smallpox

  There was no treatment for smallpox before the creation of vaccines. Doctors gave people supportive care to help them manage the symptoms, but that was all they could do. […] Smallpox vaccines prevented people from getting smallpox, but they were not a cure for existing cases. Only with widespread immunization did the disease begin to die out around the world. […] Researchers also continue to work on developing treatments for smallpox, even though there is a vaccine. In 2018, the United States approved tecovirimat (Tpoxx) as the first antiviral treatment for smallpox. Safety trials for this drug are ongoing.

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