Novavax shares plummet on report of further delays in Covid-19 vaccine

(Sharecast News) - Novavax's manufacturing problems may be more serious than previously thought and could hamper global efforts to fight Covid-19.
The company, a key supplier to COVAX, the international effort to supply Covid-19 vaccines to lower and middle-income countries, was reportedly having difficulties showing regulators that it can meet their quality standards, Politico reported citing people with direct knowledge of the matter.

In particular, the company was thought to be facing challenges in scaling-up its manufacturing while maintaining quality levels due to the nature of its vaccine.

Another three people familiar with the discussions between the US, Maryland-based biotechnology outfit and the Biden administration confirmed the delays to Politico.

Politico also cited a "multitude" of people according to whom Novavax had consistently failed to prove that its quality testing was up to scratch.

Novavax had already lowered its vaccine output goal for 2021 from 2.0bn doses to roughly 1.43bn, estimating that its supply could fall about 1.0bn doses short of its initial goal.

In Africa, only 4% of the population has been vaccinated and less than 1% in Nigeria and Uganda.

That deficit may now double across 2022 with the company possibly not being ready until the end of next year, the report from Politico said.

Novavax responded to the report reiterating the company's confidence in its ability to deliver a high-quality vaccine and said it expected to reach manufacturing capacity for 150m doses per month by the end of 2021, including through a partnership with the Serum Institute of India (SII).

It also still expected to file rolling regulatory admissions with the UK and Europe, among others, within the next few weeks.

An application for an Emergency Use Listing (EUL) with the World Health Organization had also been filed.

The WHO EUL would allow Novavax and SII to meet their commitment to deliver a "cumulative" 1.1bn doses of their vaccine.

An EUA application in the US was scheduled for before the end of 2021.

As of 1512 BST, shares of Novavax were plummeting 15.53% to $135.67.