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Letters | Why coronavirus vaccine patent waivers are not a panacea
- Unless there is a simultaneous technology transfer between the originator companies and generic partners, it will be very difficult and time-consuming for generic companies to surpass the technology barrier, particularly for vaccines based on mRNA technology
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Global leaders have an uncanny talent for distracting the world from real issues and solutions. The patent waiver for vaccines is one such issue (“US moves won’t solve vaccine access problem for poor soon: experts”, May 8). Those who hope the patent waiver will result in quick mushrooming of multiple vaccine options for the developing world are in for a big disappointment, particularly for vaccines based on the new mRNA technology.
Unless there is a simultaneous technology transfer between the originator companies and generic partners, it will be very difficult and time-consuming for generic companies to surpass the technology barrier, an equally high hurdle. Even if the wheel is reinvented and the technology gets developed, the scaling up, quality assurance, clinical development and regulatory approvals will take time, money and huge efforts and resources.
The big issues that will then stick out are product quality, efficacy and safety. The hallmark of modern pharmaceuticals and vaccines is high quality and consistency, batch after batch, week after week, month after month.
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Vaccines are not like chemical compounds, where generic companies can simply show a bioequivalence by in vitro and in vivo tests and get regulatory approval. Newer vaccines will have to demonstrate safety and efficacy in clinical trials.
All of this means that even if work started today, one might not see the first generics of mRNA vaccines for a couple of years. This will be too late as by then numerous mutations of the virus will have emerged.

04:12
What do we know so far about the Covid-19 variants?
What do we know so far about the Covid-19 variants?
The solution, therefore, lies in more than a patent waiver. It will take a simultaneous ramping up of current manufacturing, rationalising of pricing based on affordability and sharing of vaccines instead of hoarding them to vaccinate the global population in an accelerated fashion.
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