Novavax further delays its plan to seek Covid vaccine approval


Covid-19 vaccine update

Novax As the biotech company continues to work hard to collate consistent manufacturing information, it has further delayed the submission of its Covid-19 vaccine data to U.S. regulators.

After the announcement, its stock price fell 12% in after-hours trading.

Stanley Erck, CEO of Novavax, told the Financial Times: “It makes all manufacturing, all analyses, potency and purity tests meet the requirements, and are qualified and effective. This is a time-consuming process.”

He said that Novavax will submit emergency use approval data for its dual-dose vaccine to the US Food and Drug Administration in the fourth quarter of this year, which further delayed the previous delay from the second quarter to the third quarter.

Erck said that Novavax will apply for approval from the UK in September and apply for approval from other regulatory agencies including Europe and Canada “within a few weeks.”

Novavax’s Covid vaccine is touted as an important supplement to the global vaccine demand, but the company has not yet received approval from any drug regulatory agency.The company’s protein-based Covid vaccine is 90% effective In the prevention of serious diseases.

“We have a traditional method for potency determination, which takes x time and can be used for [UK’s Medicines and Healthcare products Regulatory Agency] Erck said: “We are working with the FDA to develop a second-generation version that has not yet been verified.”

Laboratory tests are tests to determine the quality and effectiveness of drugs. The company must demonstrate to the regulator that the manufacturing processes of all its facilities are consistent.

On Thursday, the Maryland-based company cooperated with the Serum Institute of India and said it had sent data to institutions in India, Indonesia, and the Philippines. This is the first time the drugmaker has submitted regulatory documents. “We are in the best position in the world,” Erck said. “Now we have the first [data] The packaging is complete, I think the rest will be very simple. “

Erck’s remarks came when Novavax reported a loss of US$352 million in the second quarter, higher than the loss of US$18 million in the first quarter of this year, and lower than analyst expectations. Wall Street analysts had previously expected earnings per share to be negative $3.63 instead of the reported negative $4.75.

The drugmaker also revealed enhanced data, which showed that the third injection six months after full vaccination increased neutralizing antibodies by more than four times compared to the original vaccine regimen. Novavax said that compared to the main vaccine series, cross-reactive antibodies against the Delta variant have increased sixfold.

Erck stated that the booster data was “very good” and echoed the views of the CEOs of Moderna and Pfizer, who emphasized Need booster 6 to 12 months after full vaccination.

Novavax must apply to the FDA for an additional booster injection authorization. Last month, Pfizer said it plans to apply for approval of the third dose in August.

The pharmaceutical company said it will apply to the World Health Organization for an emergency use list in August, which will allow Novavax to contribute to the World Health Organization’s Covax vaccine procurement plan.

Novavax said that by the end of the third quarter, it can produce 100 million doses of vaccine per month, and by the end of the fourth quarter, it can produce 150 million doses of vaccine per month.

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Pay attention to the on-site report and analysis of the British “Financial Times” on the global epidemic and the rapidly evolving economic crisis here.


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