Express Pharma

With Omicron, the SARS-CoV-2 virus ups the ante

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VOCs like Omicron are only to be expected as the divide between the vaccine haves and have-nots, and the Global North-South, widens

As Express Pharma’s Anniversary marks the end of a tumultuous year, the WHO designated B.1.1.529/Omicron has emerged as a SARS-CoV-2 variant of concern (VOC). Countries have once again issued travel advisories and shut down flights to and from affected areas.

Sadly, the emergence of Omicron in southern Africa coincides with World AIDS Day on December 1. Due to its “very unusual constellation of mutations,” scientists are leaning towards the theory that it could have evolved during chronic infections among immunocompromised patients, most likely HIV/AIDS patients. Similarities are being drawn to last year’s beta variant, also identified first in southern Africa, which has the highest number of people infected with HIV.

As data on the Omicron variant increases by the day, cases have already been detected in Belgium, Israel and Hong Kong, in patients with travel histories including southern Africa. While our experience of the past two years of coping with COVID-19 will hopefully help us find the right treatments faster, one cannot deny the uncertainty that every variant brings to our world. Memories of last year’s stock markets crashes, travel bans and supply chain shocks due to COVID-19 are already once again a reality and should serve as a wake-up call.

Because even if Omicron proves to not be as infectious, countries cannot take chances. It is too early to be congratulating ourselves on rolling out vaccines, diagnostics tests and pills for the vaccine hesitant and immunocompromised. Even as developing nations struggle to give their entire populations at least the first shot, fully vaccinated developed nations, initially complacent about their booster shots, may now prefer to wait for rejigged shots to combat these new variants.

Omicron’s emergence led to the WTO postponing its in-person 12th Ministerial Conference (MC12), and while alternative arrangements are being worked out, this will definitely impact efforts to form a meaningful consensus on the two-year-old TRIPS waiver proposal. The operative word being ‘meaningful’.

First proposed by India and South Africa, and now backed by more than 100 low-income developing countries, will the proposal to waive off certain intellectual property (IP) rights on COVID therapeutics for the duration of the pandemic, be once again relegated to ‘simmer on the back burner’?

Ironically, if the waiver had been approved earlier, more vulnerable populations, like those in southern Africa, would have possibly had better access to COVID-19 vaccines and medicines. VOCs like Omicron are thus only to be expected as the divide between the vaccine haves and have-nots, and the Global North-South, widens.

Mirroring COP-26, India was expected to become the voice of choice for the Global South at the MC12. It may seem strange that India is seeking an IP waiver, even while encouraging, and part-funding IP related to COVID-19 vaccines and medicines. Why fund IP in vaccine efforts like Bharat Biotech’s Covaxin and Zydus Cadila’s ZyCov-D, (and many more such candidates in the pipeline), only to agree to waive this IP when the demand is highest? But this stance is being seen as proof that India is acting like a responsible global citizen.

A waiver will further enhance India’s reputation as a global vaccine manufacturer, but this was India’s calling card even before the pandemic. If there was scant interest in that responsibility pre-pandemic, then why are so many blocks being raised now? The fact is, COVID-19 therapeutics and vaccinations will remain important for at least the next few years.

It may be argued that a TRIPS waiver is no longer required, as voluntary licences (VLs) could serve the same purpose to improve access to COVID medicines. Recent examples include Merck’s VL for molnupiravir and Pfizer’s VL for Paxlovid, to Medicines Patent Pool (MPP).

But Médecins Sans Frontières/Doctors Without Borders (MSF) has highlighted many limitations in these VLs. Not only does the territory exclude nearly half of the world population and important upper-middle-income countries with manufacturing capacity, such as in Brazil and China, it also contains a provision undermining the right of generic companies who sign the licence to challenge patents to facilitate generic-drug production, as per an MSF release. Legal experts have since cautioned that these recent VLs for COVID-19 therapeutics, while being projected as replacements for compulsory licences (CLs), have actually served to “blunt” the true spirit and original intent of such agreements.

After successfully creating a world of COVID-19 vaccine haves and have-nots, we should expect many more situations of what’s being termed “vaccines apartheid”. For example, at the now postponed MC12, as per a November 16 circular from the WTO Secretariat, only participants vaccinated with European Medicines Agency (EMA) approved vaccines could apply for the Swiss COVID certificate required to attend the Geneva-based MC12. This was a neat way to create logistical nightmares for representatives from the global south, who would need to undergo PCR tests every 72 hours to attend the meetings.

Do we dare look at 2022 with hope? It is worth remembering that this is a world without borders. And none of us are safe, till everyone is safe.

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