Covid-19: The United Arab Emirates has approved a novel therapy for high-risk pediatric children.

On Saturday, the UAE's health ministry approved the use of a highly effective new treatment for Covid-19 in an emergency situation.

The Ministry of Health and Prevention (MoHAP) has approved the use of Sotrovimab (Vir-7831) for emergency purposes, making it the first country in the world to do so. The US Food and Medication Administration just approved the drug.

Sotrovimab is a single-dose monoclonal antibody that is being studied for the treatment of mild-to-moderate Covid-19 in adults and children aged 12 and up who weigh at least 40 kg. GlaxoSmithKline (GSK) and Vir Biotechnology collaborated on the drug's development.

According to clinical trials, the medicine exhibits positive results in direct Sars-CoV-2 viral testing and is an effective treatment for people who are at high risk of developing severe Covid, which can lead to hospitalization or death.

When given to patients as an early treatment against the coronavirus, the medication has the potential to reduce hospitalization for more than 24 hours and mortality by up to 85%, according to Mohap.

According to George Scangos, chief executive officer of Vir, Sotrovimab has also shown efficacy as a monotherapy against widely circulating forms of the disease, including the one from India, in pre-clinical tests.

“The new pharmaceutical would considerably contribute to speeding up the recovery of patients, lowering Covid-19-related mortality and hospitalization length in intensive care units,” said AbdulRahman bin Mohamad Al Owais, Minister of Health and Prevention.

He went on to say. “It will also aid the country's efforts to conduct Covid-19 tests and administer vaccines,” says the statement.

The Ministry has already established protocols to assure early access, as well as recommendations for clinicians on how to administer the drug appropriately.

“We have been glad to cooperate with GSK to guarantee that crucial aspects are in place to ensure early access, from licensing and shipments to training and new guidelines for doctors,” said Dr Mohamed Salim Al Olama, Mohap's Under-Secretary. New guidelines are also in place to advise clinicians on how to use sotrovimab appropriately and how to refer patients to centers where it will be available.

Gizern Akalin, Managing Director and Vice President, GSK Gulf, based in Dubai, said, “We are working in close partnership with the MOHAP to guarantee that our innovative medicines and vaccines are available to the people who need them.”

Clinical evidence of Sotrovimab's effectiveness

Based on an interim review of efficacy and safety results from the Phase 3 Covid-19 Monoclonal antibody Efficacy Trial – Intent to Care Early (COMET-ICE) trial in high-risk adult outpatients, the FDA granted Sotrovimab emergency use authorization.

The primary endpoint of the experiment, hospitalization for more than 24 hours or death, was reduced by 85% in individuals receiving sotrovimab compared to placebo, according to interim research results.

In COMET-ICE, the most prevalent adverse effects in the sotrovimab therapy group were rashes (2%) and diarrhoea (1%), both of which were rated as mild or moderate.

“Monoclonal antibodies like sotrovimab are possibly one of our most powerful tools for battling the coronavirus,” said Adrienne E. Shapiro, M.D., Ph.D., an infectious disease expert at Fred Hutchinson Cancer Research Center and investigator in the COMET-ICE trial. While immunizations and other preventive measures can help to minimize the overall number of infections, sotrovimab is an important therapy option for those who fall ill with Covid-19 and are at high risk of hospitalization or worse.”