The US Food and Drug Administration last night (Wednesday) approved the world's first vaccine for corona - for those who have suppressed the immune system.
It was also reported that the Israeli Ministry of Health is in advanced negotiations to purchase the antibody, which is a "passive vaccine."
It is an "Abrahield" antibody from the Astraznica company, which is a vaccine against the corona virus for populations with a weakened immune system who have failed to develop antibodies or for those who have suffered severe side effects after receiving Pfizer or Modern vaccines.
The approval is given to those aged 12 and over and the drug is given by injection.
Among other things, the antibody can also be used as a medicine for people who have had corona.
In addition, studies have shown that between 1% and 2% of the population do not develop adequate immunity to the corona virus even after receiving three doses of vaccine.
The main populations that do not develop an adequate immune response include people with immune system failure or those whose immune system is weak, usually due to receiving immunosuppressive therapies such as organ transplant recipients, hematooncology patients, chemotherapy patients and the like.
Also, there is a population that develops severe side effects from corona vaccines and it cannot get the vaccines that exist today.
Abushald is a passive vaccine that combines two antibodies that bind to different sites in the virus and prevent its binding to the receptor found on the cells, thus preventing the virus from entering the cells and preventing its culture.
The antibodies in the vaccine have undergone a change that allows them to be in the bloodstream for six months thus providing protection for the population with a weakened immune system who are unable to produce the antibodies themselves.
The U.S. Food and Drug Administration approved the vaccine based on a third-phase study conducted in the U.S., UK, Spain, Belgium and France and included about 5,200 participants.
According to the findings, after three months of follow-up, there was a 77% reduction in the rate of symptomatic corona cases.
After 6 months of receiving from the antibody phase, an 83% reduction in the rate of symptomatic corona cases was observed.
The vaccine is given by injection into the muscle at a dose of 300 mg.
The director of the FDA's Center for Drug Evaluation and Research, Dr. Patricia KwaZuni, says that "vaccines have proven to be the best protection available against COVID-19.
However, there are some people whose immune systems are suppressed and their bodies do not respond to existing vaccines. "
She added that "there are populations that have a history of serious side effects to the COVID-19 vaccine and therefore need a different type of protection. Abushald's approval based on a combination of two monoclonal antibodies may reduce the risk of these populations developing Corona."
"Abushield" is used not only as a vaccine but as a medicine for corona patients with mild to moderate illness.
The Food and Drug Administration is expected to approve in the coming weeks also the label of the preparation as a medicine for patients based on a study conducted in 96 countries including: USA, England, Hungary, Mexico, Poland, Japan, Italy, where bio-permits participated as approx. 900 people with mild-to-moderate symptomatic disease.
Corona Department, Photo: Oren Ben Hakon
According to the findings, the drug demonstrated an 88% reduction in chance of deterioration or death in patients treated three days or less from the moment of diagnosis and a 67% reduction in patients treated five days or less from the moment of diagnosis.
The drug is given by injection into the muscle at a dose of 600 mg.
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