Novavax Is Facing Funding Issues In The US But Seeking Emergency Approval In Needy Countries
Novavax’s vaccine has not received approval for vaccine distribution in the US yet; as per reports, it has been unable to show that its manufacturing process complies with America’s FDA regulations.
However, it has urged regulators in India, Indonesia and the Philippines to authorise emergency use of its Covid-19 vaccine.
The American company Novavax, which won a $1.75 billion federal contract to research and manufacture a Covid-19 vaccine, said on 5 August that the United States government would not support more vaccine manufacturing unless the company settles issues with federal regulators about its work. This company has a vaccine manufacturing agreement with Serum Institute of India, which has been manufacturing the Oxford-AstrZeneca vaccine’s Indian version Covishield, which is currently being administered in the country.
The company revealed its information in a quarterly filing with the Securities and Exchange Commission. As part of the crash vaccine development initiative, the previous administration headed by Donald Trump decided to purchase 110 million doses of vaccine from Novavax. Even though the company reported earlier that its vaccine has a 90 per cent efficacy against symptomatic Covid-19 cases and a 100 per cent efficacy against severe disease, Novavax has struggled for months to mass-produce the jabs.
As of now, Novavax’s vaccine has not received approval for vaccine distribution in the United States, and federal officials have stated that it is unclear when or if it will be. The American authorities so far have approved three vaccines—Pfizer-BioNTech, Moderna and Johnson & Johnson.
According to the New York Times, people familiar with the company’s operation said that so far, Novavax has been unable to show that its manufacturing process complies with America’s Food and Drug Administration (FDA) regulations.
Novavax said in its SEC filing: “The government has recently instructed the company to prioritise alignment with the FDA on the company’s analytic methods before conducting additional US manufacturing and further indicating that the US government will not fund additional US manufacturing until such agreement has been made.”
According to an unnamed official from the Department of Health and Human Services, which oversees Novavax’s federal contract, the United States government wanted the company to improve its testing and quality control operations.
However, in a statement, the company said that the federal government continued to fund other projects it was working on, such as clinical trials. Additionally, Novavax said: “We don’t count on any impression on our funding associated with the US authorities to assist general improvement and manufacturing of 110 million doses of our vaccine candidate.”
Meanwhile, Novavax has urged regulators in India, Indonesia and the Philippines to authorise emergency use of its Covid-19 vaccine, putting some low-income countries ahead of richer countries with sufficient supply. The company teamed with India’ SII to submit applications in the three nations and expects to apply to the World Health Organization (WHO) later this month to become a part of the COVAX global vaccine programme.
Stanley Erck, the CEO of the company, said the submission is an important step toward access to millions of vaccine doses of “a safe and effective vaccine for countries with an urgent need to control the pandemic.”
Novavax also aims to submit applications in the United Kingdom soon, followed by Europe, Australia, Canada and New Zealand, but not in the United States until later this year.
The Novavax two-dose vaccine, which is made with lab-grown copies of the virus’ spike protein, are easier to store and transport compared to some other jabs. The vaccine has long been predicted to play a key role in expanding vaccination supplies in impoverished countries.
However, in the case of the highly contagious Delta variant, Novavax claimed that giving a booster six months after the second shot increased virus-fighting antibodies capable of combating the mutated version of SARS-CoV-2. According to the company, Indonesia has already shown interest in utilising the Novavax vaccine as a booster after receiving some made-in-China doses. It also said that the company is awaiting final approval from Indian regulators to allow its vaccine for emergency use.
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