Novavax Inc.'s Vaccine Transmission Purity Is Not Up To Standard, It Will Be Delayed Until The End Of Next Year For Approval

Novavax Inc.'s Vaccine Transmission Purity Is Not Up To Standard, It Will Be Delayed Until The End Of Next Year For Approval

Novavax Inc., a US developer of infectious disease vaccine biotechnology, fell 24% due to market rumors that the manufacturing quality of its vaccines was more serious than previously expected. Politico quoted an unnamed source on October 19 as a report that Novavax faced serious challenges in proving that its new coronary pneumonia (COVID-19) vaccine candidate could meet the quality standards of the competent authority. The report pointedly pointed out that Novavax's "problems are more worrying than previously understood." It is predicted that the problems will not be solved until the end of 2022, and only then will it be authorized and approved by the competent authority. The report pointed out that the Global Access Mechanism for New Coronary Pneumonia Vaccines (COVAX) supported by the World Health Organization (WHO) was originally scheduled to provide more than 2 billion doses of vaccine to low- and middle-income countries by the end of next year. The supply was shorter than the target by more than 1 billion doses. The report quoted a source directly saying that the method used by Novavax to test the purity of the vaccine did not meet the standards required by the competent authority, and the company could not prove that the vaccine produced could stably meet the standard. According to reports, the U.S. Food and Drug Administration (FDA) will set a purity standard for each manufacturer in accordance with the new crown vaccine guidelines formulated in June 2020. Generally, the purity of each batch of vaccine must be at least 90%. However, sources familiar with the manufacturing process pointed out that the purity of the vaccine recently produced by Novavax is only about 70%. Low purity will increase the risk of contamination or contain unnecessary substances in the final product, thereby reducing the effectiveness of the vaccine. Unknown substances may also cause adverse reactions to the vaccinators.