(Reuters) -Shares of Novavax (NASDAQ:NVAX) Inc fell 16% after a report from Politico said the company faces significant hurdles in proving it can manufacture its experimental COVID-19 vaccine that meets regulators' quality standards, resulting in production delays.
The methods Novavax used to test the efficacy of its vaccine have fallen short of U.S. regulators' standards, according to the Politico report, citing people familiar with the matter.
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The production delays are likely to affect deliveries to the COVAX facility, which aims to provide equitable access to COVID-19 vaccines for low- and middle-income countries, the report added.
Novavax and India's Serum Institute, the world's largest vaccine producer, had together committed to providing more than 1.1 billion doses to COVAX.
Novavax in a statement said https://ir.novavax.com/Novavax-Reconfirms-Confidence-in-Regulatory-Filing-Timelines-and-Manufacturing-Quality it was confident in its ability to deliver its high-quality vaccine.
"We underscore our ongoing commitment to the stringent standards of production and manufacturing for our recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M adjuvant," the company said.
The company said it has filed for regulatory authorization for its shot in India, Indonesia and the Philippines, and reiterated that it expects to file for emergency use authorization in the United States before the end of 2021.
It has fallen behind in the race for authorization in the United States and Europe, which have already vaccinated most of their residents.
Last month, the company and its partner Serum Institute of India applied to the World Health Organization for an emergency use listing of Novavax's COVID-19 vaccine, potentially clearing the way for the shot to be shipped to many poor countries.
Novavax said on Wednesday its global supply chain is expected to achieve a capacity of 150 million doses per month by the end of the fourth quarter.
The company's shares fell nearly 17% to $133.62 in early trading.