Government needs to act more quickly to acquire Covid-19 antibody drugs


IT is generally acknowledged that with new, more transmissible and potentially lethal variants spreading worldwide, vaccines are also unlikely to be the complete solution to managing the pandemic.

Countries urgently need a broader armoury of effective drugs, particularly those that act early in the disease or as prophylaxis.

Accordingly, the developing world is now moving towards administering antibody combinations to treat patients with mild to moderate Covid-19, to better manage emerging variants of concern, stop deaths and reduce the burden on overstretched healthcare systems.

One type of intervention that has shown promise is monoclonal antibodies (mAbs). Research overseas has shown that mAbs treatment – when given at an early stage to mild-to-moderate patients – can reduce the progression rate to severe Covid-19 requiring hospitalisation, oxygen therapy and even reduce risk of death.

According to a study published in Nature in April 2021, there are currently more than 50 mAbs, targeting SARS-CoV-2, in various stages of development with four mAbs (etesevimab, casirivimab, imdevimab and sotrovimab) and two mAb combinations (bamlanivimab plus etesevimab and casirivimab plus imdevimab) approved by the US Food and Drug Administration for emergency use in the treatment of mild to moderate Covid-19 in non-hospitalised patients.

Numerous pharmaceutical companies – including Vir, Celltrion, GlaxoSmithKline, Brii, Sorento, Regeneron, Eli Lilly and AstraZeneca – are already conducting trials that are underway or forthcoming on them.

In June 2021, Singapore announced that there may soon be another treatment option available for Singaporeans at risk of developing severe Covid-19, signing an advance purchase agreement with GlaxoSmithKline Singapore (GSK) and Vir Biotechnology for their antibody drug sotrovimab, a type of monoclonal antibody, which are laboratory-made proteins that act like antibodies in helping the body to fight off infection.

It is a single-dose drug administered intravenously that can be used to treat patients who do not require oxygen and have mild to moderate Covid-19.

In mid-July 2021, Japan announced it has approved an antibody combination, Ronapreve, co-developed by Roche and Regeneron, which is also administered intravenously to treat patients with mild to moderate Covid-19.

As per the open-label Phase III recovery trial led by the University of Oxford, the Ronapreve lowered mortality risk in hospitalised patients with severe Covid-19.

Meanwhile, in another Phase III trial (REGN-COV 2069) for Covid-19 prophylaxis, the treatment administered subcutaneously lowered the risk of developing symptomatic disease by 81%.

Currently, Ronapreve is authorised for emergency use or temporary pandemic use in multiple regions, including the EU, the US, India, Switzerland and Canada.

The Canadian government has also committed to financially supporting Unitaid to procure 3 million doses of monoclonal antibodies once trials are completed.

Additionally, the World Health Organization (WHO) and the access to Covid-19 tools accelerator (ACT-A), led by the Wellcome Trust and Unitaid, are including monoclonal antibodies in ongoing clinical trials and are proactively planning deployment.

Efforts apparently are not just concentrated on developing mAbs but in other more effective and efficient candidates, such as DARPins – a small synthetic protein scaffold drugs currently in development by Molecular Partners and Novartis – and Aeronabs, a nanobody agent that is smaller in size and easier to produce than traditional monoclonal antibodies.

When questioned in January 2021 whether the country was a laggard in securing vaccines, Science, Technology and Innovation Minister Khairy Jamaluddin said we are not, because we only order after assessing clinical data, compared to developed countries who paid even before the availability of safety and efficacy data.

Then in June 2021, the minister admitted the insufficient supply of Covid-19 vaccine was the reason why the government did had not opened more vaccination centres sooner.

For sure the country will face fierce competition for treatment courses from wealthy countries if more robust efficacy is proven in ongoing trials in the future.

Thus, it is critical for the government to start developing solutions to address access to these, including the supply and costs, distribution and administration, to prevent severe delays and deepening inequities when some of these are made available to the market.

I hope the government is not going to wait for more robust data on the efficacy and optimal dosing of monoclonal antibodies for widespread use before we order as in the procurement for the vaccines.

Given the vast expenditure incurred to manage the pandemic including the procurement of the vaccines to date, admittedly the government may struggle to find the budgets for procuring these.

If support is needed from the private sector, which is likely to invest in return for trade-offs with other essential investments, the government should then define a prioritised framework on how and where to allocate these treatments to areas/sectors that will have the greatest and most equitable impact, taking into account the complexities of administering these drugs and the realities of our local health system.

With multiple Covid-19 treatments in development, any decision by the country to invest now has potential for broad impact in the future.

While our collective attention remains focused on vaccinating as many Malaysians as possible in this moment, investing in the future capacity of these treatments now will also lead to improved access to lifesaving monoclonal antibody drugs that treat other diseases in the future. – July 29, 2021.

* FLK reads The Malaysian Insight.

* This is the opinion of the writer or publication and does not necessarily represent the views of The Malaysian Insight. Article may be edited for brevity and clarity.


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