Among the many milestones achieved by the UAE in the fight against the COVID-19 pandemic, Sotrovimab therapy is notably popular. The UAE health sector provided the therapy to COVID-19 patients across 39 of its healthcare facilities. The therapy has helped 99 percent of the patients in rapid recovery from COVID-19 within 14 days.

Sotrovimab has helped in preventing fatal complications among patients by 97 percent and the need for hospitalisation among 99.5 percent of the recipients, according to statistics issued by the UAE’s National Crisis, Emergencies and Disasters Management Authority (NCEMA) in August. In addition, the duration of hospital stay has been reduced by 20 percent among people hospitalised due to the disease.

During a recent media briefing, UAE officials hailed therapy as one of the most successful global treatments for COVID-19. They noted that the UAE is among the first countries in the world to obtain it. Notably, the first doses of the medicine were administered in the UAE as early as mid-June - within a month of getting approval for emergency use in the UAE and worldwide.

In an exclusive interview with Gulf News, top officials from Sotrovimab co-developer and British pharmaceutical giant GlaxoSmithKline (GSK) talked about the journey of the monoclonal antibody therapy against COVID-19 in the UAE. The drug was developed in collaboration with clinical immunology therapy firm Vir Biotechnology. As of now, it is being used to treat adults, children over the age of 12 who meet the necessary criteria, and groups at risk of developing severe infection including senior citizens, pregnant women and patients with chronic conditions.

According to Jeffrey Kemprecos, head of communications and government affairs at GSK Gulf, the UAE was among a number of nations in the Gulf region choosing to procure Sotrovimab on such a short timeline at a time when global supply was limited.

"A female COVID-19 patient in the UAE was the first to receive the drug outside clinical trials, about three hours after it was brought to the UAE in a special shipment, and she survived,” Jeffrey Kemprecos explained.

He added that since then over 23,000 infusions of Sotrovimab have been administered to UAE people in need.

Dr Averyan Vasylyev, GSK Gulf’s medical affairs director, further underlined that researchers at GSK are working on developing a form of the drug that can be administered as an intramuscular injection.

How does the antibody treatment work?

It helps the body's immune system in developing immunoglobulins to defend against unfamiliar molecules, called antigens. Molecules derived from pathogens such as bacteria and viruses act as antigens that facilitate the production of antibodies which tell specialised cells of the immune system to fight the invading pathogen.

"The SARS-CoV-2 virus’s spike glycoprotein, which sits on its surface, functions to facilitate the virus’s entry into the body’s cells. So SARS-CoV-2 monoclonal antibodies like Sotrovimab bind to the spike protein and block the virus from entering the cell and reproducing in it,” Dr Vasylyev said.

Noting that an antibody is a naturally developed protection, an immune system requires a certain level of antibodies to enhance the level of protection against the disease.

Sotrovimab

How was Sotrovimab developed?

Dr Vasylyev explained immunology firm Vir Biotechnology has been creating monoclonal antibody molecules for years. Last year, as they approached GSK to leverage its scientific capability, it helped in running Phase I and II trials to analyse the efficacy of Sotrovimab.

In March 2021, initial results showed an 85 percent reduction in COVID-19 mortality. The study involved 5,000 patients from the United States and Europe. As per researchers, it was an unprecedented figure, noting that there are a high number of patients who have not been vaccinated or who had been vaccinated but had not developed immunity.

Why was the medicine a game-changer?

Dr Vasylyev stated that the drug unprecedentedly helped in reducing the risk of death and severity of infection among patients.

“It was interesting to note that the drug was also effective against the Coronavirus as it mutated. We were monitoring the variants of concern-the most dangerous mutations and not just the most widely circulating ones-and week after week, we noted that Sotrovimab continued to be resistant," he added.

Kemprecos further noted that as soon as the initial results were achieved in March and early April, the authorities decided to pre-brief the authorities in Gulf countries (under Gulf GSK) such as Kuwait, Qatar, Oman, Bahrain and the UAE about the promising medication against COVID-19.

The UAE granted emergency use authorisation on May 28, just two days after approval by the United States Food and Drug Administration (FDA). The official explained that there was a limited supply of cold chain products in the early stages - only half a million vials globally during the summer. The UAE authorities proactively locked in significant supply commitments. While the delivery would have taken six to eight weeks, Abu Dhabi’s healthcare regulator DoH (Department of Health) followed up with the company to ensure delivery in six to eight days. The delivery was later undertaken by Etihad Cargo and medical supplies procurer Rafed.

“Officials from DoH, GSK, Etihad and Rafed were at the airport when the plane rolled to a stop. The refrigerated containers were taken off and placed on refrigerated trucks and the first patient was infused about three hours later. Since then, more than 20 countries have approved the product, including the United States, United Kingdom, Australia and Singapore," the official added.

What category of COVID-19 patients is Sotrovimab intended for?

Dr Vasylyev highlighted that Sotrovimab is meant for patients with mild-to-moderate COVID-19 infection confirmed by PCR testing within the first ten days of symptom onset. He added that the time frame has been decided in accordance with scientific data that demonstrated monoclonal antibodies work best within this time frame.

Dr Vasylyev noted that Sotrovimab can be given to patients with high-risk infections such as the elderly and with chronic conditions like diabetes, cardiovascular disease, circulatory diseases. COVID-19 can deteriorate their health and result in a fatal situation. It is also likely that this group of patients may not develop sufficient immunity from vaccination.

Why is Sotrovimab not prescribed for children?

According to Dr Vasylyev, the cut-off age and weight recommended by the FDA for all monoclonal antibodies are 12 years and (at least) 40kg of body weight respectively. The therapy is not advised for patients who are older than 12 years, but below 40kg.

"We haven’t studied the drug’s effect on younger populations. We would have if we had known that it was the most impacted population group. There may be individual patients who may benefit from it, but this is the treating physician’s call. Physicians make similar judgements when administering Sotrovimab to pregnant COVID-19 patients with high-risk profiles," Dr Vasylyev added.

With one of the highest COVID-19 vaccination rates globally, the UAE enhanced its preparedness and keenness to boost the provision of the best medical and healthcare solutions for its population.

What is the scope for the future?

Dr Vasylev noted that there is little more data on Sotrovimab. Meanwhile, the UAE and Bahrain will soon be contributing to a real-world, randomised-control study of the drug.

“We are also collecting data on intramuscular Sotrovimab administrations, which means the process will be completed in ten minutes, compared to the two hours needed to give it intravenously. This also means huge cost reductions for the healthcare system," Dr Vasylev added.

Research is also underway to study the drug as a prophylactic for physicians who have not developed full immunity despite receiving the vaccination.

“The UAE and Bahrain were the first countries to infuse patients with Sotrovimab and so they developed a well-studied and well-documented patient pool on the drug’s effects. They will now feedback reliable data on the performance, efficacy and tolerability of the drug," Kemprecos noted.