expresspharmaApril 15, 2021
Tag: COVID-19 vaccine , Novavax , Supply
Novavax has pushed back the timeline for hitting its production target of 150 million COVID-19 vaccine doses per month until the third quarter due to supply shortages including bags used to grow cells, a company spokeswoman told Reuters.
Novavax executives had previously said full-scale vaccine production could be achieved by mid-year. The company told Reuters in January it expected to reach full production capacity by May or June.
“We said during our earnings call that we expect all capacity being online by around mid-year. We’re continuing to refine that timing as we get closer, which now leads us to think we’re online/at full capacity by Q3,” Novavax communications director Amy Speak said by email.
“There are some supply shortages that come and go that have contributed to the revision in timing,” she added. “These have included things like the bioreactor bags and filters.”
Novavax could receive UK regulatory authorization for its vaccine as early as this month after releasing impressive UK trial data. It anticipates clearance in the US could come as early as May after soon-to-be released data from its US vaccine trial are reviewed by regulators.
The company is one of several COVID-19 vaccine makers that have had to push back production timelines due to industry-wide shortages of raw materials and difficulties getting plants up and running.
Reuters reported last month that Novavax had delayed a planned deal to ship at least 100 million doses of its two-shot vaccine to the European Union, in part because of supply challenges.
In an interview with the Guardian, Novavax Chief Executive Stan Erck said the company has faced difficulties sourcing key production materials including single-use bags used to grow vaccine cells.
“Single-use bags are facing critical shortages and delays,” said Mark Womack, chief business officer of AGC Biologics, a contract manufacturer that is producing materials used in Novavax’s vaccine.
The Novavax COVID-19 vaccine is based on a SARS-CoV-2 protein-subunit antigen and a proprietary adjuvant.
Data released in March from the UK trial showed the vaccine to be highly effective against the original strain of the novel coronavirus, with 90 per cent overall efficacy against disease, as well as 86 per cent efficacy against the more contagious variant B.1.1.7 first discovered in Britain and now rampant in Europe and the United States. The data also suggests the shot provides some protection against a highly concerning variant that emerged in South Africa, which some drugmakers have said may require a booster shot to address.
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