Novavax submits Covid jab for UK approval


Novavax has filed for approval of its Covid-19 vaccine in the UK, saying other global regulatory submissions would follow “shortly”.The move brings the US biotech “significantly closer” to delivering a jab built on a “proven, well-understood vaccine platform that demonstrated high efficacy against multiple strains of the coronavirus”, Novavax’s chief executive Stanley Erck said on Wednesday.Erck said he anticipated a “positive decision” from the UK’s Medicines and Healthcare products Regulatory Agency and that the company would be ready to roll out its vaccines following approval.Novavax’s New York-listed shares shot up 14 per cent shortly after the market open on the news, stabilising at roughly 10 per cent higher.Crucially, the submission, Novavax said, included data on chemistry and manufacturing control. Earlier this year the drugmaker delayed submitting data to the US Food and Drug Administration as it struggled to put together consistent manufacturing information.The prolonged wait for a first regulatory approval for any vaccine made by the company, which has been in business for more than three decades, had its shares whipsawing for the greater part of this year.But on Wednesday, Novavax said it expected to complete additional regulatory filings in Europe, Canada, Australia and to the World Health Organization “shortly following the UK submission”. It expects to submit its US regulatory filing “by the end of the year”.Global health authorities including the head of the European Medicines Agency, Emer Cooke, have said that maintaining a diverse portfolio of vaccines that use different technologies is the best way to hedge against new coronavirus variants and unforeseen developments in the pandemic.Yet the protein-based shot is unlikely to play a key role in the immediate future in countries where primary vaccination programmes have largely been completed and booster campaigns are under way. The UK, where messenger RNA shots such as that from BioNTech/Pfizer have been deployed in a booster campaign, has a deal for up to 60m Novavax shots. In the EU — where authorities have bought a total of 2.1bn doses of the Pfizer and Moderna vaccines — there is an agreement in place for up to 200m shots that can be donated to poorer nations. The US has purchased 100m doses.

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The Novavax shot could prove hugely important for lower-income countries and Covax, the vaccine access scheme backed by WHO that has struggled to deliver doses. Rich nations have received more than 16 times more shots than poorer ones that rely on the programme, according to a Financial Times analysis, but the facility has a deal in place for 350m doses of the shot. If wealthier countries were to redirect the Novavax jabs they are entitled to, this figure could increase significantly.Gavi, the vaccine alliance, welcomed the news, saying it looked forward to the manufacturer applying for WHO approval, a prerequisite for Covax distribution.As tensions between London and Brussels over vaccine supplies escalated earlier this year, Britain struck an agreement with GlaxoSmithKline to contribute to the manufacture of the Novavax doses bought by the UK. The drugmaker will prepare vials and package doses for distribution at its Barnard Castle facility in the north-east of England. The shot is given in two equal doses 21 days apart and stored at conventional fridge temperatures. In Covid trials earlier this year, the vaccine had 89.7 per cent efficacy overall.



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