FDA would authorize Pfizer vaccine in 12-15 year olds 0:47
(CNN Spanish) – The United States Food and Drug Administration (FDA) authorized emergency use of a monoclonal antibody therapy called Sotrovimab, as a treatment against covid-19 for patients 12 years of age or older who are in risk of serious illness or death.
The authorization is specifically for those patients who have mild to moderate COVID-19, who are at risk of getting much more ill. But be careful, it is not for those patients who require hospitalization.
What is Sotrovimab?
Sotrovimab is a monoclonal antibody treatment, says the FDA. That means they are laboratory-produced molecules that “serve as substitutes for antibodies” and can restore, enhance or mimic the immune system against attack by pathogens, says the FDA.
“Sotrovimab is designed to block viral adhesion and entry into human cells, thus neutralizing the virus,” says an FDA fact sheet.
Who can use this treatment?
The FDA authorized this therapy for patients 12 years of age and older who are diagnosed with COVID-19, who have moderate coronavirus, but who are at risk of becoming more seriously ill.
The FDA authorized this drug to be administered once a person is diagnosed with COVID-19 “and within 10 days after the onset of symptoms,” the FDA fact sheet says.
However, the FDA does not recommend this treatment for patients who are already hospitalized for COVID-19 and who currently require oxygen or mechanical ventilation.
Is it an authorized treatment against covid-19?
While sotrovimab is a drug licensed for emergency use, the FDA advises that this treatment is an investigational drug that is not cleared by the FDA to treat any disease or condition, including Covid-19.
“Sotrovimab is not licensed to prevent COVID-19,” warns the FDA. He only has emergency authorization.
This drug is currently under medical investigation.
So why was it authorized?
The FDA cited data from a clinical trial in which 7% of patients who received a placebo were hospitalized or died, compared with 1% of participants who received sotrovimab, an 85% reduction.
The tests also showed that sotrovimab worked against variants of the virus first identified in the UK, South Africa, Brazil, California, New York and India.
“It is important to expand the arsenal of monoclonal antibody therapies that are expected to retain activity against circulating variants of COVID-19 in the United States,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research. it said in a statement.
Does it have side effects?
The FDA authorized healthcare providers to distribute the treatment intravenously. Possible side effects include anaphylaxis, rash, and diarrhea.