August 17, 2022

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The European Medicines Agency could approve the Novavax two-dose coronavirus vaccine as early as next...

The European Medicines Agency could approve the Novavax two-dose coronavirus vaccine as early as next week, paving the way for emergency use listing from the World Health Organization, according to people familiar with the matter.
The approvals would provide the US drugmaker with a significant boost after months of delays and share price volatility amid manufacturing issues. The Covid-19 vaccine, also known as Nuvaxovid, would be the Maryland-based company’s first marketed product after more than three decades in business.
A meeting of an EMA panel has been scheduled for Monday, the agency said, adding that it would communicate more details on that day provided there was a conclusion.
Separately, the WHO’s expert panel on vaccines met on Thursday to draft recommendations for use of the vaccine, with the WHO saying it would release its position “in the coming days”.
WHO approval could come once the health body issued its own emergency use listing, or if the EMA gave it a conditional marketing authorisation, people familiar with the matter said.
The step would allow deliveries to begin via global vaccine access scheme Covax. Together with the Serum Institute of India, Novavax has a commitment to supply Covax with 1.1bn doses.
Two people familiar with both approval processes said there were still some “open questions” on manufacturing, but that the EMA should be able to issue a conditional approval. The open questions include so-called potency assays and drug substance characterisation — in essence, the ability of Novavax to ensure the product is the same everywhere and the same as that used in clinical studies.
The people said Novavax had acknowledged these points in meetings and was working to address them.
“It’s nothing serious. It’s not different from situations we have seen with previous vaccines,” one of the people said, while also cautioning that an approval was not certain.
Novavax said both approval processes would consider extensive data on manufacturing as well as clinical and pre-clinical data. The company was “confident that the vaccine meets the stringent regulatory quality, safety and efficacy specifications” needed for authorisation by the WHO and the EMA and it looked forward to their decisions.
The EMA declined to comment. The WHO said it would release its position “in the coming days”.

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One of the people added that the EMA was “racing against time” as the vaccine, which would initially only be approved for a primary series or the first two shots for someone who has not been vaccinated, could play “an important role” this winter.
The Novavax shot has already been approved in the Philippines and Indonesia and the drugmaker has filed for approval in the UK. The company also expects to submit a complete application to the US Food and Drug Administration by year’s end.
In contrast to the novel mRNA vaccines made by Moderna and Pfizer, the Novavax shot uses a more traditional type of technology based on proteins and has been shown to be as much as 90.4 per cent effective in trials, including against previous variants of concern. The company is now testing its efficacy against the new Omicron variant.


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