Novavax files for its first COVID-19 vaccine authorization in UK

 Novavax (NVAX) submitted its first authorization filing for its COVID-19 vaccine in the U.K. Wednesday, and expects to follow suit in several other global markets in the coming week.

The U.S. and its Food and Drug Administration (FDA) is not among those, but CEO Stanley Erck said the company intends to have its U.S. package ready for filing by the end of 2021.

Erck told Yahoo Finance in an exclusive interview Tuesday that he hopes the filings will allay concerns about the company's ability to reach the finish line with its vaccine.

"We've reached a very big milestone for the company, and hopefully for global health," Erck said.

"It allows us to prepare for not only this filing, but also for global filings with various regulatory agencies in Europe and Australia and Canada," he added.

The company has faced several setbacks in the past year, including running into supply chain constraints and building out its manufacturing.

A recent Politico report revealed concerns within the FDA about the quality of the vaccine, which tanked the company's stock. Erck said he hopes the slew of filings this week is a strong enough signal to clear any doubts.

"You don't file for emergency use approval if you haven't solved all of your manufacturing issues. So we feel that the filing today, and the other regulatory agencies this week, should largely put to bed any of those concerns," Erck said.

Novavax's clinical trials showed the vaccine to be 90% effective.

The news comes amid an ongoing global shortage of vaccines, which Erck also said Novavax is ready to tackle. The company has partnered with the Serum Institute of India in order to supply the global COVAX distribution channel as well as for bilateral agreements.

Novavax and the Serum Institute pledged 1.1 billion doses to COVAX earlier this year. "Much of our early production is going to go to low- and middle-income countries through COVAX," Erck said.

The Serum Institute was supposed to produce and ship AstraZeneca's (AZN) vaccine through COVAX, but the Indian government halted exports of the vaccine and forced the company to redirect doses to the sub-continent amid its Delta surge earlier this year. 

That severely hampered the availability of doses in low- and middle-income countries which continue to struggle to gain access.

Erck hopes that will soon change and is confident the Serum Institute will be able to meet demand, as it recently announced delivering its one-billionth dose, doubling its monthly output to 200 million doses.

Novavax has also built up manufacturing capacity in the U.S. and abroad to help with its global distribution.

https://finance.yahoo.com/news/novavax-files-for-covid-19-vaccine-authorization-in-uk-124809823.html