New Delhi: Early on in the pandemic, many of us hoped that India would help vaccinate the world. India’s pharmaceutical sector, dominated by companies capable of churning out generic medicines in vast quantities, looked like the obvious location for vaccine production at the scale needed to inoculate the developing world.
That hasn’t worked out, partly because the Indian government restricted vaccine exports after the Delta variant emerged here — but also because of the unexpected and early success of the mRNA-based shots from Moderna Inc. and Pfizer Inc. These came on the market early and set high standards for efficacy against the original variant of the virus. But they were remarkably ill-suited for production and distribution in the emerging world. They need to be stored at untenably low temperatures, and their novel and unfamiliar production process isn’t easy to replicate.
Given their effectiveness as the mainstay of rich-world vaccination programs, it isn’t surprising that, on the infrequent occasions that the West thinks about vaccines for developing countries, the focusis on how to expand mRNA’s footprint. The emergence of Delta and then the Omicron variant — against which booster mRNA shots seem to work better than many alternatives — has led some to the conclusion that, unless the entire world switches to mRNA, effective global vaccination is impossible. Certainly, that’s what both activists and rich-country policy makers seem to think.
But we shouldn’t be too sure. Indian regulators have just approved two shots — both, as it happens, developed largely in the United States — which might turn out to be a safer bet than mRNA for much of the world.
The first has been developed by Maryland-based Novavax Inc. It encodes genetic sequences from the spike protein into a virus that targets insects, then loads that virus into cultured moth cells. Novavax — which received $1.6 billion in 2020 from the Trump administration’s Operation Warp Speed, the largest such payout at the time — took some time scaling up this fiddly process. Its Indian partner, the Serum Institute of India, complained last year that the Biden administration was holding back the raw materials India needed to produce the shot, delaying its rollout by six months or more.
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The vaccine has now been approved by India, the European Union and the World Health Organization — and is already being administered in Indonesia and the Philippines. Like the mRNA vaccines, the Novavax shot retains efficacy against the Omicron variant. A booster shot ups protection 73-fold, a higher multiple than mRNA boosters provide.
Moreover, protein subunit shots such as Novavax’s can be stored in regular refrigerators. And the technical process behind such vaccines has been described as “old-school,” far better understood than that for mRNA vaccines. That has allowed Novavax to enroll manufacturing partners in countries across the world, though Serum Institute will be its workhorse, producing 150 million shots a month.
The other new vaccine is called Corbevax. While its Phase III trial data is not yet public, its potential is exciting. It’s also a protein subunit vaccine but, instead of baculoviruses and moth cells, the manufacturing process uses yeast — similar to the methods that have been used for decades for Hepatitis B vaccines. It was originally developed by researchers at Texas Children’s Hospital and Baylor University, and co-developed subsequently by India-based Biological E Ltd., a major producer of Hepatitis B vaccines.
Perhaps most importantly, the technology to make Corbevax is not just easy to understand and replicate, it involves no complicated intellectual property questions. That means production can be scaled up quickly in many different parts of the world. The vaccine’s developers have already transferred the technology to manufacturers in developing countries such as Indonesia, Bangladesh and Botswana.
Here’s what’s strange: Corbevax wasn’t on policy makers’ radar. The vaccine took only $7 million to develop, mostly raised from Texas philanthropists. You can’t help wondering if “old-school” vaccines had received a fraction of the billions handed out by G-7 countries to “innovative” vaccines, whether we would be a lot further toward ending the pandemic than we are. One of the vaccine’s developers told NPR that government officials weren’t interested in their shot: “People were so fixated on innovation that nobody thought, ‘Hey, maybe we could use a low-cost, durable, easy-breezy vaccine that can vaccinate the whole world.’”
We shouldn’t make that mistake twice. Accelerating global vaccinations is the only way to ensure we don’t ruin 2022 or 2023 with yet worse variants. To ramp up production globally, we need to focus on processes that are easy to replicate and where the technology can swiftly be transferred. mRNA isn’t the only game in town. -Bloomberg
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