https://www.bmj.com/content/375/bmj.n2965
Novavax had a vaccine with big promise. Its more traditional technology and easy storage attracted big global investment but, as year two of the pandemic draws to a close, the company struggles with regulators, disappoints hopeful governments, and lags far behind its competitors.
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Before covid, Maryland based Novavax had worked on vaccines against Middle East respiratory syndrome (MERS), severe acute respiratory syndrome (SARS), H1N1 influenza, Zika virus, and Ebola virus. As early as January 2020 the biotech firm’s president of research and development, Gregory M Glenn, told the press that it was already developing a vaccine against SARS-CoV-2.
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It was an impressive feat for a company that had never brought a product to market and did not own a single manufacturing facility at the time.
But fast forward to today and a series of setbacks has left Novavax lagging far behind its industry rivals Pfizer and Moderna. Its vaccine remains unauthorised by a major regulator, and so it cannot deliver doses to Covax or any other government.
The company’s slow progress in production, in comparison with the leading covid vaccine makers, has created doubts as to its ability to fulfil global vaccine orders. Because most middle and high income countries have already sourced their vaccine supply, has Novavax missed the boat?
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Novavax issued interim results of its large UK phase III trial, reporting 95.6% efficacy against the original variant of the virus.3 That same month the European Medicines Agency started a rolling review of the vaccine, and in March 2021 Erck said he expected clearance by the US Food and Drug Administration (FDA) “as early as May.”4
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Manufacturing issues
How does Novavax explain the delay? Glenn told The BMJ that the company lacked the production expertise of larger corporations: “If I can be a little bit defensive, about two years ago we were a very small company, we didn’t have manufacturing.” Of the production he says, “It’s also somewhat artsy, it takes people with a lot of skills. You can’t just get people off the streets to do it.” Glenn told of struggles with several contractors, some of which worked on clinical trial batches but, for one reason or another, couldn’t keep delivering.
And with each switch of manufacturing facilities came more delay. Merchant told The BMJ that bringing in new manufacturing contractors is considered by regulators to be a “critical change.” He says, “It requires additional studies demonstrating consistency in manufacturing and quality operations and assessment of related risks in efficacy and safety.”
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“Each of the vaccines now available in the UK, EU, and US is associated with side effects. They are very rare, but they do occur. I’m thinking about myocarditis, and vaccine induced thrombosis and thrombocytopenia. Because it is certainly true that no vaccine will be 100% safe, there will always be a risk of reactions, even with the safest vaccine.” And there, the relatively traditional technology used by Novavax may bring advantages, if its jab shows features similar to other protein based biologicals.
多餘的話：
隻有技術，沒有財力和生產能力，是不行的。
沒有強大的社會關係，開公司就是扯淡。Prizer 和JJ都是老牌公司了，底蘊深厚。Moderna與NIH合作，三期臨試及新疫苗開發的合作方是老福頭領導的NIAID，那關係鋼鋼的。
一步趕不上，步步趕不上。
周老大的願望，今年沒戲了。
明年呢？也許疫情會有戲劇性轉折，打不打疫苗沒啥意思了。
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