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Gareth Carpenter
20 Oct 2021

Novavax defends COVID-19 vaccine manufacturing processes after claims of quality issues

According to unnamed sources in Politico report, company’s vaccine batches have not met FDA purity level standards

US biotech Novavax has defended its manufacturing processes after a recent report which claimed the company was struggling to meet US Food and Drug Administration quality standards in the production of its COVID-19 vaccine.

According to the report on news website Politico, which cited anonymous sources, the company has failed to produce a vaccine with purity levels required by the US regulatory agency.

“Since March 2020, Novavax has worked diligently, methodically and transparently to develop our novel COVID-19 vaccine candidate, taking on the challenge of developing and producing at large scale a proven biologic-based vaccine amid unprecedented circumstances,” the company said in a statement. “Throughout, we have maintained active conversations with various regulatory agencies in key markets and have incorporated their feedback into the submissions for authorization that we are in the process of completing.”

In July 2020, Novavax – which has never previously produced a vaccine -- was awarded $1.6 billion by the US government to help finance development and manufacturing of its COVID-19 shot.

And in August, the company signed an advance purchase order with the European Union for 100 million doses of the vaccine, with an option for a further 100 million doses.

Novavax is expected to submit data for approval by the European Medicines Agency in the next couple of weeks.

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