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Today, the U.S. Food and Drug Administration approved Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera, a blood disease that causes the overproduction of red blood cells. The excess cells thicken the blood, slowing blood flow and increasing the chance of blood clots.
Treatment for polycythemia vera includes phlebotomies (a procedure that removes excess blood cells though a needle in a vein) as well as medicines to reduce the number of blood cells; Besremi is one of these medicines. Besremi is believed to work by attaching to certain receptors in the body, setting off a chain reaction that makes the bone marrow reduce blood cell production. Besremi is a long-acting drug that patients take by injection under the skin once every two weeks. If Besremi can reduce excess blood cells and maintain normal levels for at least one year, then dosing frequency may be reduced to once every four weeks.
Besremi can cause liver enzyme elevations, low levels of white blood cells, low levels of platelets, joint pain, fatigue, itching, upper airway infection, muscle pain and flu-like illness. Side effects may also include urinary tract infection, depression and transient ischemic attacks (stroke-like attacks).
Interferon alfa products like Besremi may cause or worsen neuropsychiatric, autoimmune, ischemic (not enough blood flow to a part of the body) and infectious diseases, which could lead to life-threatening or fatal complications. Patients who must not take Besremi include those who are allergic to the drug, those with a severe psychiatric disorder or a history of a severe psychiatric disorder, immunosuppressed transplant recipients, certain patients with autoimmune disease or a history of autoimmune disease, and patients with liver disease.
In response to the growing COVID-19 pandemic and shortages of laboratory-based molecular testing capacity and reagents, multiple diagnostic test manufacturers have developed and begun selling rapid and easy-to-use devices to facilitate testing outside\r\n of laboratory settings. These simple test kits are based either on detection of proteins from the COVID-19 virus in respiratory samples (e.g. sputum, throat swab) or detection, in blood or serum, of human antibodies generated in response to infection.\r\n
There is another, more common type of rapid diagnostic test marketed for COVID-19; a test that detects the presence of antibodies in the blood of people believed to have been infected with COVID-19.2-5 Antibodies are produced over days to weeks\r\n after infection with the virus. The strength of antibody response depends on several factors, including age, nutritional status, severity of disease, and certain medications or infections like HIV that suppress the immune system.6-8 In\r\n some people with COVID-19, disease confirmed by molecular testing (e.g. reverse transcription polymerase chain reaction: RT-PCR), weak, late or absent antibody responses have been reported.6,7,9 Studies suggest that the majority of patients\r\n develop antibody response only in the second week after onset of symptoms.2,6,7,10-14 This means that a diagnosis of COVID-19 infection based on antibody response will often only be possible in the recovery phase, when many of the opportunities\r\n for clinical intervention or interruption of disease transmission have already passed. Antibody detection tests targeting COVID-19 may also cross-react with other pathogens, including other human coronaviruses.7,15,16 and give false-positive\r\n results. Lastly, there has been discussion about whether RDTs detecting antibodies could predict whether an individual was immune to reinfection with the COVID-19 virus. There is no evidence to date to support this.
Tests to detect antibody responses to COVID-19 in the population will be critical to support the development of vaccines, and to add to our understanding of the extent of infection among people who are not identified through active case finding and surveillance\r\n efforts, the attack rate in the population, and the infection fatality rate. For clinical diagnosis, however, such tests have limited utility because they cannot quickly diagnose acute infection to inform actions needed to determine the course of\r\n treatment. Some clinicians have used these tests for antibody responses to make a presumptive diagnosis of recent COVID-19 disease in cases where molecular testing was negative but where there was a strong epidemiological link to COVID-19 infection\r\n and paired blood samples (acute and convalescent) showing rising antibody levels.
In response to the growing COVID-19 pandemic and shortages of laboratory-based molecular testing capacity and reagents, multiple diagnostic test manufacturers have developed and begun selling rapid and easy-to-use devices to facilitate testing outsideof laboratory settings. These simple test kits are based either on detection of proteins from the COVID-19 virus in respiratory samples (e.g. sputum, throat swab) or detection, in blood or serum, of human antibodies generated in response to infection.
There is another, more common type of rapid diagnostic test marketed for COVID-19; a test that detects the presence of antibodies in the blood of people believed to have been infected with COVID-19.2-5 Antibodies are produced over days to weeksafter infection with the virus. The strength of antibody response depends on several factors, including age, nutritional status, severity of disease, and certain medications or infections like HIV that suppress the immune system.6-8 Insome people with COVID-19, disease confirmed by molecular testing (e.g. reverse transcription polymerase chain reaction: RT-PCR), weak, late or absent antibody responses have been reported.6,7,9 Studies suggest that the majority of patientsdevelop antibody response only in the second week after onset of symptoms.2,6,7,10-14 This means that a diagnosis of COVID-19 infection based on antibody response will often only be possible in the recovery phase, when many of the opportunitiesfor clinical intervention or interruption of disease transmission have already passed. Antibody detection tests targeting COVID-19 may also cross-react with other pathogens, including other human coronaviruses.7,15,16 and give false-positiveresults. Lastly, there has been discussion about whether RDTs detecting antibodies could predict whether an individual was immune to reinfection with the COVID-19 virus. There is no evidence to date to support this.
Tests to detect antibody responses to COVID-19 in the population will be critical to support the development of vaccines, and to add to our understanding of the extent of infection among people who are not identified through active case finding and surveillanceefforts, the attack rate in the population, and the infection fatality rate. For clinical diagnosis, however, such tests have limited utility because they cannot quickly diagnose acute infection to inform actions needed to determine the course oftreatment. Some clinicians have used these tests for antibody responses to make a presumptive diagnosis of recent COVID-19 disease in cases where molecular testing was negative but where there was a strong epidemiological link to COVID-19 infectionand paired blood samples (acute and convalescent) showing rising antibody levels.
EMA is reminding healthcare professionals and people receiving the vaccine to remain aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within 2 weeks of vaccination. So far, most of the cases reported have occurred in women under 60 years of age within 2 weeks of vaccination. Based on the currently available evidence, specific risk factors have not been confirmed.
The PRAC noted that the blood clots occurred in veins in the brain (cerebral venous sinus thrombosis, CVST) and the abdomen (splanchnic vein thrombosis) and in arteries, together with low levels of blood platelets and sometimes bleeding.
COVID-19 is associated with a risk of hospitalisation and death. The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects.
One plausible explanation for the combination of blood clots and low blood platelets is an immune response, leading to a condition similar to one seen sometimes in patients treated with heparin (heparin induced thrombocytopenia, HIT). The PRAC has requested new studies and amendments to ongoing ones to provide more information and will take any further actions necessary.
The PRAC stresses the importance of prompt specialist medical treatment. By recognising the signs of bloods clots and low blood platelets and treating them early, healthcare professionals can help those affected in their recovery and avoid complications.
As Mosaic reported, the type is so rare that only about 43 people have been reported to have it worldwide, and until 1961, when it was first identified in an Aboriginal Australian woman, doctors assumed embryos with Rh-null blood would simply die in utero.
Here is where things get tricky. The RhD protein previously mentioned only refers to one of 61 potential proteins in the Rh system. Blood is considered Rh-null if it lacks all of the 61 possible antigens in the Rh system. This not only makes it rare, but this also means it can be accepted by anyone with a rare blood type within the Rh system.
As Mosaic reported, golden blood is incredibly important to medicine, but also very dangerous to live with. If a Rh-null carrier needs a blood transfusion, they can find it difficult to locate a donor, and blood is notoriously difficult to transport internationally. Rh-null carriers are encouraged to donate blood as insurance for themselves, but with so few donors spread out over the world and limits on how often they can donate, this can also put an altruistic burden on those select few who agree to donate for others. 2b1af7f3a8