Manufacturing woes for Novavax’s Covid jab badly disrupt plans for rollout to the poor — report
Production problems at a Novavax facility in Maryland have led to delays in the Covax vaccine sharing program. Now, a shortage of 1 billion doses is expected, as the supplier tries to navigate producing a shot up to regulators’ standards, Politico reported Tuesday.
The company has run into trouble with the purity of the vaccine. Novavax has had trouble proving it can produce a shot consistently up to standards, and it has caused significant delays in the rollout to low- and middle-income countries. This follows several delays at Novavax that has put the executive crew on the defensive.
Three people between Novavax and the Biden administration confirmed the delays to Politico, though they spoke on the condition of anonymity. Purity levels have hovered around 70%, the source said, and lower purity levels raise the chance of having contaminants or unnecessary substances in the vaccine. That’s disrupting plans to get vaccine supplies more broadly distributed, and after the US government had invested $1.6 billion in 2020 alone.
Novavax’s stock price plunged 21% ahead of the bell.
“In response to a recent news article citing anonymous sources, Novavax confirms our confidence in our ability to deliver our high-quality vaccine,” the company said in a statement released Wednesday. “Further, 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.”
In the statement, the company highlighted its partnership with the Serum Institute of India, a manufacturing site in the Czech Republic and several other manufacturing agreements in South Korea, Japan and “around the world.”
Covax already lowered its 2021 vaccine production goal from 2 billion doses to 1.425 billion, and estimated that a shortfall of up to 1 billion doses is coming. If that is accurate, hundreds of millions of people could be left without protection from the virus and its variants, further extending the pandemic.
“We are confident that our vaccine will soon play a significant role in the global COVID-19 vaccine arsenal, differentiated by its potential to help address two major issues slowing the world’s ability to end the pandemic: global distribution challenges and vaccine hesitancy,” CEO Stanley Erck said in the statement.
Novavax’s SVP of investor relations and corporate affairs Silvia Taylor told Politico that the company’s analytical testing methods have been validated, but did not say whether or not the FDA signed off on them. Novavax said it will still file for emergency use authorization by the end of the year. Novavax has never manufactured a vaccine before. The Novavax jab uses spike proteins, which can be more difficult to manufacture to scale.
The news comes at a tough time. President Joe Biden and his administration are at odds with Cambridge, MA-based drugmaker Moderna after the company has been slow to provide the 176.5 million doses to the vaccine sharing program that have been purchased. The New York Times reported that only about 1 million doses have gone to low-income countries, compared to 8.4 million Pfizer doses and 25 million J&J doses. But much of that shortfall has been blamed on the operating power of Moderna, which doubled its workforce to around 1,600 employees in 2020, and still has far fewer staff than either of the others.
Meanwhile, a mixup at an Emergent plant in Baltimore led to millions of J&J doses being quarantined while the FDA investigated, and many of those were trashed.
In September, after many delays, Novavax submitted its vaccine to the World Health Organization for review. The company’s gone through some ups and downs during the pandemic, including manufacturing struggles that led to other companies beating them to the finish line in the hunt for a vaccine.