Abu Dhabi: As the UAE crosses several milestones in the fight against the Covid-19 pandemic, the Sotrovimab therapy is much talked about.
Across 39 health-care facilities in the UAE, COVID-19 patients were administered the drug and it helped 99 per cent of them recover within 14 days.
Sotrovimab prevented fatal complications in recipients by 97 per cent and also prevented the need for hospitalisation among 99.5 per cent of them, based on statistics issued in August by the UAE’s National Crisis, Emergencies and Disasters Management Authority (NCEMA). Additionally, the duration of hospital stay was reduced by 20 per cent among those who had to be admitted.
At a recent press briefing, officials said the drug “is considered to be one of the most successful global treatment for COVID-19”, and that the UAE was among the first countries to obtain it. In fact, the first doses of the medicine were administered in the UAE as early as mid-June — within a month of it receiving emergency use authorisation internationally and in the UAE.
Journey of the monoclonal antibody
In an exclusive interview with Gulf News, top officials from Sotrovimab co-developer and British pharmaceutical giant GlaxoSmithKline (GSK) discussed the journey of the monoclonal antibody to the UAE. The drug, which was developed in collaboration with clinical immunology therapy firm, Vir Biotechnology, now has emergency use approval in the UAE for adults, children over the age of 12 who meet certain criteria, and those at risk of developing severe Covid-19, such as senior citizens, pregnant women and patients with other chronic conditions.
“The UAE was among a number of Gulf countries that chose to source Sotrovimab on a very compressed timeline, at an early stage when global supply was still limited. In fact, 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, head of communications and government affairs at GSK Gulf, said.
Since then, more than 23,000 infusions of Sotrovimab — which is delivered intravenously in infusions of 500 milligram doses — have so far been provided in the country. Researchers at GSK are now looking at developing a form of the drug that can be administered as an intramuscular injection, which will further enhance access, added Dr Averyan Vasylyev, GSK Gulf’s medical affairs director.
The officials also clarified other key facts about the drug being used in the UAE as part of an arsenal of measures to combat COVID-19.
How does the antibody treatment work?
The body’s immune system generates antibodies — specific protein molecules also known as immunoglobulins — as a defence mechanism against unfamiliar molecules, called antigens. Molecules from pathogens such as bacteria and viruses can act as antigens, prompting the production of antibodies that bind to antigens. These antibodies tell specialised cells of the immune system to kill the invading pathogen. Monoclonal antibodies are immunoglobulins that work specifically against a particular portion on an antigen called the epitope, thereby exerting very targeted action.
Dr Vasylyev said: “For example, 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.
An antibody is a naturally developed protection. You need to have a certain level of the antibodies, and normally, when a person is infected or is vaccinated, they have the protective level required. When this is not the case, we have to supply them in the form of monoclonal antibodies.
How was Sotrovimab developed?
Dr Vasylyev said: “Vir Biotechnology, [as an immunology company], had been developing monoclonal antibody molecules for years. In 2020, they approached GSK to leverage its scientific capability and reach to run the Phase I and II to demonstrate the efficacy of Sotrovimab.
“Initial results obtained in March 2021 showed an 85 per cent reduction in COVID-19 mortality and progression among 5,000 patients scattered across the United States and Europe. This was an unprecedented figure, and at the time, there were a high number of patients who were not vaccinated or who had been vaccinated but had not developed immunity. So we began to engage with authorities immediately to indicate that we had an effective product with demonstrated efficacy and safety.”
Why was the medicine considered to be a game-changer?
Dr Vasylyev said: “The product dramatically reduced the risk of death and severity of symptoms in a COVID-19 patient. The study was placebo-controlled to demonstrate safety and the medicine was proved to be as safe as a placebo, which is very rare.
“It was interesting to note that the drug was also effective against the [SARS-CoV-2] virus as it mutated. We were monitoring the variants of concern — the most dangerous mutations and not just the most widely circulating ones (known as the variants of interest) — and week after week, we noted that Sotrovimab continued to be resistant.
“This is because Sotrovimab binds to the site of the spike protein, which is in a site of the virus body that is unlikely to change. There is a theory that if the virus mutates in that area, it will [automatically] become less virulent. So, if the virus mutates [in the spike protein] and Sotrovimab becomes ineffective, [COVID-19] will not happen.”
Abu Dhabi was the first place outside the trials to receive Sotrovimab shipments. How did this come about?
Kemprecos said: “Once we had the initial results in March and early April, we decided to pre-brief the authorities in the Gulf — Kuwait, Qatar, Oman, Bahrain and the UAE, which are under GSK Gulf — about what could be a promising new treatment against Covid-19, and there was immediate interest.
“In the UAE, emergency use authorisation was granted on May 28, two days after it was given by the United States Food and Drug Administration (FDA). In the early stages, there was limited supply of the cold chain product — only half a million vials globally during the summer. The UAE had already locked in certain supply commitments, and contractually, this would have been delivered in six to eight weeks. But the [Abu Dhabi’s health-care regulator, the Department of Health (DoH), called us, asking to have it delivered in six to eight days. The delivery was then 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. Dr Vasylyev and his team had already done expedited and thorough trainings of hundreds of UAE physicians by then. Since then, more than 20 countries have approved the product, including the United States, United Kingdom, Australia and Singapore.
What category of Covid-19 patients is Sotrovimab intended for and why is it not given to others?
Dr Vasylyev said: “Sotrovimab is intended for mild-to-moderate COVID-19 infection that has been PCR-confirmed within the first ten days of symptom onset. This is not a trivial task, but the whole system in the UAE is designed to get patients to hospital as early as possible.
“The time frame has been fixed in accordance with scientific data that state that monoclonal antibodies work best within this time frame. In theory, the viral load increases outside the window and the dose of the medicine given to block the virus becomes disproportionately smaller than the number of viruses in the body. There are studies looking into the severity of cases, but they have not yet been finalised.
“Patients also have to be high-risk to receive Sotrovimab. This is because younger COVID-19 patients mostly recover with just Panadol. For high-risk patients, such as those who are older or have conditions such as diabetes, cardiovascular disease, circulatory diseases, their condition can deteriorate very quickly and the disease can become fatal. This group of patients may also not develop sufficient immunity from vaccination. We also look at whether the patients who are high-risk have key symptoms such as fever, cough and pulmonary impact.”
Why is Sotrovimab not prescribed for children?
According to Dr Vasylyev: “In general, the cut-off age and weight recommended by the FDA for all monoclonal antibodies is 12 years and at least 40kg of body weight. Even for patients who are older than 12 years, but below 40kg, we do not advise monoclonal antibody therapy. 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.”
As a pharmaceutical firm, what else can be done?
Dr Vasylyev said: “The UAE has one of the highest COVID-19 vaccination rates globally. We now need to know what more needs to be done to protect those who cannot be vaccinated? Also, do past COVID-19 patients have the immunity to fight new variants of concern? These are the things that health authorities monitor and decide on.
“The UAE also has the preparedness and keenness to provide the best solutions possible to its population. It is one of the best systems to combat the disease and I say this based on the comparisons we have done of other systems.”
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Now that Sotrovimab is being widely prescribed, what happens next?
Dr Vasylev feels: “We now have a little more data on Sotrovimab. The UAE and Bahrain will soon contribute to a real-world, randomised-control study of the drug. The data is already collected by the authorities, and we can use it to perform extended research on it.
“We are also collecting data, [to come in by the end of the year,] 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 health-care system.
There is also work on studying the drug as a prophylactic for physicians who have not developed full immunity despite being vaccinated.”
Kemprecos says: “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 feed back reliable data on the performance, efficacy and tolerability of the drug.”
