Novavax announced it would delay the timeline for seeking approval for its COVID-19 vaccine from the U.S. Food and Drug Administration until the fourth quarter, Reuters reported Friday.
The biotechnology company had previously disclosed it would seek emergency use authorization from the FDA in the third quarter this year.
Shares of Novavax fell 10% after the close of trade on Thursday.
According to chief executive officer Stanley Erck, seeking emergency use approval is a matter of "getting validation work done" to prove consistency in the manufacturing process of the vaccine to the FDA.
Erck said Novavax plans to apply for EUA with British regulators next month and follow shortly after in Australia and Canada.
The Maryland-based company's vaccine can be stored at normal refrigerator temperatures without the need for freezers that other vaccines require.
If given the clearance by regulators, the vaccine could deliver a much-needed boost to worldwide initiatives to inoculate people against the disease, which has shown increased discrepancies between developed and developing nations.
Despite promising clinical data, Novavax has lagged behind competitors like Johnson & Johnson and Pfizer. It has, repeatedly, deferred regulatory submissions and the timeframe for accelerating production as the company grapples with access to raw materials and the machines required to make the vaccine.
Data by Novavax from clinical tests suggest a booster dose of the vaccine candidate gives a four-fold increment in neutralizing antibody levels after administering a two-shot regimen of an approved vaccine.
The data also suggest a booster shot of six months after a two-dose regimen of an approved vaccine could give added protection against the highly transmissible Delta variant.
Erck said the company remained on course to manufacture 100 million shots a month and 150 million doses by the fourth quarter of 2021.
The European Union has approved an agreement with Novavax to produce around 200 million doses of its protein-based vaccine after more than six months of discussions, officials said.
Meanwhile, Novavax has said it is looking for final approval from India's regulators to allow its COVID-19 vaccine for emergency use.
Apart from India, Novavax has asked the Philippines and Indonesia to grant EUA of its vaccine, the Covovax.
