The U.S. government invested $ 1.6 billion in Novavax (the largest amount it provided to vaccine manufacturers at the time) in 2020, hoping to offer the world another safe and effective vaccine option to help protect against Covid-19. Since then, however, the company has constantly run into production problems, writes Politico. Novavax shares fall by more than 25% in the pre-market.
Although Novavax admitted some problems with analysis and testing in its quarterly report to the Securities and Exchange Commission (SEC), according to two people with direct knowledge of the matter, these problems are worse than previously expected. According to these people, the methods he uses to test the purity of vaccines do not meet regulatory standards, and the company is unable to demonstrate that it can create a vaccine that meets those standards.
“In response to a recent news article citing anonymous sources, Novavax reaffirms our confidence in our ability to deliver our high-quality vaccine. We further emphasize our ongoing commitment to strict manufacturing standards, including the production of COVID-19 vaccine based on recombinant nanoparticulate proteins with Matrix adjuvant. -M ™, “Novavax responded in today’s statement. “Over the past 18 months, we have made significant progress in mobilizing a global manufacturing network, with facilities that now routinely produce high-quality products on a commercial scale in multiple locations around the world. Our global supply chain is expected to reach 150 capacity by the end of Q4. million benefits per month. “
The US Food and Drug Administration (FDA) addresses the purity levels with each manufacturer according to the June 2020 guidelines for coronavirus vaccines, and the general rule is that each batch of vaccine should be at least 90 percent pure. But Novavax has a problem getting closer to this level at all, said one of the people with direct knowledge of the situation. Another person familiar with the company’s production process stated that it had reached a purity level of about 70 percent. At the same time, low levels of purity increase the chance that contaminants or unnecessary substances will be present in the final product, making the vaccine less effective, and increasing the likelihood that patients may react to unknown components.
Senior vice president of investor relations and corporate affairs, Silvia Taylor, said in a statement to Politico that the company’s testing methods had been “validated”, but did not answer the question of whether they were approved by the FDA regulator. The company still plans to apply for emergency approval by the end of the year, Taylor added. Novavax, who had never produced vaccines before, refused to answer specific questions about the level of purity of its product and whether it had been successful in solving its long-term manufacturing problems.
“Vaccine development and regulatory processes are very complex and often take years to get to where we are now. We will meet all of our binding deliveries in the US and around the world,” Taylor added.
However, three people familiar with the matter said they were unsure whether the company had the resources needed to consistently reproduce the high-quality vaccine, a benchmark that Novavax must meet by then. They added that Novavax could probably solve its production problems and achieve a full license by the end of 2022.
Unlike the companies and Moderna, the first manufacturers of vaccines using RNA technology, Novavax uses a previously used but complicated approach to creating a key component in seeded cells. This process, which involves infecting cells to make proteins with peplomers, is known to scientists but is difficult to dose.
Novavax became the last vaccine manufacturer to run into key manufacturing issues. stopped work in April after finding that 15 million doses had been accidentally contaminated with ingredients from a separate Covid-19 vaccine.
Unlike Novavax, however, Novavax is a newcomer to the world of vaccination. After a series of unsuccessful drug developments, he sold his manufacturing facilities in 2019. But then luck smiled on him as Covid-19 began to spread. At the beginning of the pandemic, he was able to grab $ 1.6 billion to help work on the Covid-19 vaccine – the largest transaction ever made by a Covid-19 vaccine maker.
But even then, Trump administration officials involved in Operation Warp Speed on vaccine distribution have repeatedly warned that the company could run into problems in increasing vaccine production, two people with direct knowledge of the discussions said. In particular, they feared that Novavax would have difficulty ensuring that the vaccine consistently met the FDA’s strict quality standards once it went into series production. And this is exactly the problem that society is now stuck on for several months.
“They hastened the process,” said one knowledgeable. “It’s hard to make. And they can’t do it.”
Taylor said in a statement that they had already incorporated feedback from regulators and made “tremendous progress in increasing the volume of our commercial production processes.” It still aims to produce 150 million doses per month by the end of the year and will have tens of millions of doses in stock before regulatory approval in the US and internationally, she added.
The company’s leaders in a recent presentation to investors had a similarly optimistic tone, downplaying production bottlenecks and predicting that vaccine distribution would begin soon. During the investment event on September 29, Chief Commercial Officer John Trizzino said that the company had “solved” its problems and was nearing the submission of a final application to the regulator.
“We’re really continuing to test our batches,” added Gregory Glenn, president of research and development at Novavax. “We think we’re nearing the end.”
According to three people who know about the matter, American officials who work with the company are no longer so sure. According to them, the production problems of Novavax are more difficult to solve than the hygienic and design problems that stopped the production of the J&J vaccine at the beginning of this year.
And while the company is seeking regulatory approvals in other countries, doubts remain in the United States as to whether it will be able to address major deficiencies in vaccine purity. Several batches of vaccines have already been phased out, and four people with knowledge argue that U.S. officials no longer expect the company to get the FDA green before next year.
“At some level, I suspected that efficiency would never be able to outweigh the risk of the impurities that were there,” said one familiar person. “No wonder we’ve got to where we are.”
Source: Politico
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