Novavax labs in Gaithersburg, Maryland
AFP via Getty Images
Shares of U.S. biotech Novavax were falling more than 23% in premarket trading Wednesday on a report the company was still struggling to show that it can manufacture its Covid-19 jab with quality standards that meet U.S. regulator’s requirements.
Maryland-based Novavax (ticker: NVAX), which has never produced a vaccine before, has submitted its vaccine for approval to U.S. and European Union regulators after successful phase 3 trials showed it had a 93% efficacy against predominantly circulating variants of the virus.
The U.S. government awarded Novavax $1.6 billion in July 2020 to help finance testing and manufacturing of its vaccine.
According to news website Politico, which quoted people familiar with the matter, Novavax, which has met production problems, has failed to produce a vaccine with the purity levels demanded by the Food and Drug Administration.
In a release published in response to the Politico report, Novavax said that it has an “ongoing commitment to the stringent standards of production and manufacturing, and that it has engaged in ” active conversations with various regulatory agencies in key markets.”
The company said its global supply chain is now ” expected to achieve a capacity of 150 million doses per month by the end of the fourth quarter.”
The U.S. biotech signed an “advanced purchase agreement” with the European Union in August for the sale of 100 million doses of its vaccine with an option with 100 million more. It is expected to submit data for a possible approval by the European Medicines Agency this month.
Novavax’s potential failure to meet its production targets compromises the efforts of the international consortium known as COVAX to distribute more than 2 billion doses of vaccine in lower and middle-income countries by the end of next year, Politico noted.
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