Politico: Novavax might unlock the global war on COVID-19

AP Photo/Craig Ruttle)

Now that we’ve all but gutted the enthusiasm for Johnson & Johnson’s vaccine, what could take its place? That vaccine showed great promise for underdeveloped countries as well as more rural and hesitant areas of this country, as it only required one dose and does not need freezing for distribution and storage. AstraZeneca had similar promise before running into the same worries over rare blood clot events, which prompted the EU to restrict access and stalled FDA approval in the US.

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The best option now might be with a new vaccine that can get wide distribution without the reputational baggage of the other two alternatives to Pfizer and Moderna’s mRNA vaccines. Politico hails the soon-to-be submitted Novavax candidate, which already has a global manufacturing network in place:

The vaccine’s developer, Novavax, has never brought a product to market. The shot entered late-stage clinical trials months after candidates from bigger names like Pfizer and Moderna. But the Novavax vaccine proved just as potent as those mRNA shots in a U.K. trial, and the company is now preparing to file for U.S. authorization in a matter of weeks — potentially leapfrogging AstraZeneca, a former frontrunner.

Novavax’s rise comes as pressure to increase the supply of Covid-19 vaccines is growing amid concerns that unequal access globally will extend the pandemic. The company has pledged to provide 100 million doses of its shot to the U.S. later this year, after receiving $1.6 billion for development and manufacturing. It’s also one of a handful of manufacturers to promise significant deliveries worldwide, including 1.1 billion doses for low- and middle-income countries like India, where cases are skyrocketing.

The next few months will determine whether Novavax can overcome its bumpy start and deliver on those increasingly high expectations. The company has enlisted production partners worldwide after struggling to scrape together the tens of thousands of doses needed for its clinical trials. Those hired factories are still getting up to speed with Novavax’s vaccine technology, which uses moth cells to brew batches of the coronavirus spike protein. In non-pandemic times, such retrofitting can take years. The company is aiming to pump out 150 million doses a month by the second half of the year.

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The Novavax platform has percolated quietly for a while, and seems to be on a rather slow track. They actually announced their Phase 3 trial data one day before J&J, but in the UK rather than the US. It’s been three months since Novavax’ study showed it 89% effective against COVID-19, and by March the UK data showed it was 96% effective, with 100% effectiveness at preventing death.

So what’s the hold-up? For the moment, it doesn’t appear that the US needs Novavax for our own full-vaccination program. The more the merrier, of course, but we have secured more than enough doses from Pfizer, Moderna, and J&J to cover our entire population. That’s why the Biden administration has decided to start giving away our AstraZeneca hoard to India, as it looks like approval won’t be immediately forthcoming for use within the US, and it appears not to be a high priority at this point for the FDA.

Novavax might work better in this instance as a replacement for J&J, if consumer confidence doesn’t return for that product. The biggest strategic use for Novavax will be overseas, however. It already has production lined up in India for one billion doses by the end of the year, although most of those will go to COVAX, the international consortium that will quarterback the global vaccination response. AstraZeneca has pledged another billion doses, and J&J plans to kick in 500 million, meaning that we could get 1.5 billion people fully vaccinated by the end of 2021. If COVAX uses a triage strategy to suppress transmissions in the hottest spots first — India and Brazil, for instance — we could make real progress against variants that might render earlier vaccines less potent.

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Novavax has shown a lot of promise, but we’re getting to the point where potential needs to be realized — quickly and massively.

Yesterday, I spoke with epidemiologist Dr. Robert Tiballi about COVID-19 and vaccines on Relevant Radio’s Drew Mariani Show, and we spent considerable time discussing Novavax. You can listen to the podcast here.

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