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FDA's Regulatory Delay Is The Reason For Novavax, Lucira Health's Failure: WSJ Report

FDA's Regulatory Delay Is The Reason For Novavax, Lucira Health's Failure: WSJ Report

美国食品药品管理局的监管延迟是Novavax、Lucira Health失败的原因:《华尔街日报》报道
Benzinga ·  2023/03/07 13:31

Failures of Covid vaccine maker Novavax Inc (NASDAQ:NVAX) and diagnostic start-up Lucira Health Inc (NASDAQ:LHDX) show that companies often succeed or fail, owing to the whims of the government.

Covid疫苗制造商的失败 Novavax Inc. (纳斯达克股票代码:NVAX)和诊断初创公司 露西拉健康公司 纳斯达克股票代码:LHDX)表明,公司的成功或失败往往是由于政府的异想天开。

Last week, while reporting Q4 earnings, Novavax raised doubts about its ability to remain in business and announced plans to cut spending.

上周,在公布第四季度财报时,Novavax对其继续经营的能力表示怀疑,并宣布了削减支出的计划。

The Covid-19 vaccine was Novavax's first and only commercial product in its 36-year history, Wall Street Journal writes. However, the product flopped after successful trials thanks to regulatory delays and manufacturing hiccups.

《华尔街日报》写道,Covid-19疫苗是Novavax在其36年历史上的第一款也是唯一的商业产品。但是,由于监管延误和制造问题,该产品在成功试用后失败了。

Operation Warp Speed awarded Novavax $1.6 billion to cover testing and manufacturing costs of its experimental vaccine in exchange for 100 million doses if the FDA authorized it.

Operation Warp Speed向Novavax拨款16亿美元,用于支付其实验疫苗的测试和制造成本,如果美国食品药品管理局批准,则换取1亿剂疫苗。

Novavax's struggled to scale manufacturing, which delayed the start of its late-stage U.S. trial to December 2020.

Novavax努力扩大制造规模,这将其后期美国试验的开始推迟到2020年12月。

By then, the FDA had authorized COVID-19 vaccines from Moderna Inc (NASDAQ:MRNA) and Pfizer Inc (NYSE:PFE). Yet there was still expected to be enormous demand for its vaccine in low-income countries and among Americans hesitant to get mRNA shots.

那时,美国食品药品管理局已经批准了来自 COVID-19 疫苗 Moderna Inc (纳斯达克股票代码:MRNA)和 辉瑞公司 (纽约证券交易所代码:PFE)。然而,预计低收入国家和对接种mRNA疫苗犹豫不决的美国人仍将对其疫苗有巨大的需求。

Novavax announced in June 2021 that its vaccine was 90.4% effective against symptomatic infection and offered 100% protection against moderate and severe illness—similar to the mRNA vaccines. But Novavax struggled to procure raw ingredients for its vaccine, including plastic bags to grow cells.

Novavax在2021年6月宣布,其疫苗对症状感染的有效性为90.4%,对中度和重度疾病的保护率为100%,类似于mRNA疫苗。但是Novavax很难为其疫苗采购原料,包括用于生长细胞的塑料袋。

Rather than help Novavax increase manufacturing, Wall Street reported that Biden officials bullied Moderna to donate more doses to low-income countries to compensate for the Novavax shortfall.

华尔街报道说,拜登官员没有帮助Novavax提高制造量,而是欺负Moderna向低收入国家捐赠更多剂量以弥补Novavax的短缺。

The Moderna and Pfizer vaccines have been enormous commercial successes because of their flexible mRNA technology and support from regulators who have accelerated their reviews.

Moderna和辉瑞疫苗因其灵活的mRNA技术以及加快审查的监管机构的支持而在商业上取得了巨大的成功。

The FDA hinders rather than promotes innovation. Consider Lucira Health. In an investor report, Lucira blamed the FDA's "protracted" authorization process for its combination Covid and flu at-home test.

FDA阻碍而不是促进创新。以露西拉健康为例。在一份投资者报告中,Lucira将Covid和流感在家联合测试归咎于FDA的 “漫长” 授权程序。

Lucira applied to the FDA for authorization of its novel test last May and expected to receive a thumbs-up by the end of summer before the flu season started. Canada authorized Lucira's test last August.

Lucira于去年5月向美国食品和药物管理局申请批准其新测试,预计将在流感季节开始前的夏末获得大拇指。去年8月,加拿大批准了Lucira的测试。

The FDA finally authorized Lucira's test two days after it filed for bankruptcy and past the flu season peak.

在Lucira申请破产两天后,FDA终于批准了Lucira的测试,并且已经过了流感季节的高峰期。

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