Moderna, Novavax developing combined COVID-19, flu shots

Moderna Inc. said on Thursday it was developing a single-dose vaccine that combines a booster dose against COVID-19 and a booster against flu.

"Our number-one priority as a company right now is to bring to market a pan-respiratory annual booster vaccine, which we plan to always customize and upgrade," chief executive officer Stphane Bancel said.

The company said the benefits of a pan-respiratory vaccine would be immense, pointing to Centers for Disease Control data that indicates there were over 400,000 hospitalizations due to influenza in the U.S. in the last pre-pandemic year, with the seasonal flu representing an average economic burden of $11 billion US annually.

The drugmaker already had several influenza vaccine candidates in development. The new vaccine combines the experimental flu shot that is furthest along with its COVID-19 vaccine.

Moderna's COVID-19 vaccine received its emergency authorization for people aged 18 and older in Canada and the United States in December 2020. The vaccine was approved by Health Canada for those 12 to 17 in late August, and the company is in an ongoing mid-stage trial testing its authorized COVID-19 vaccine in children aged sixmonths to less than 12 years.

The Massachusetts-based drugmaker signed a memorandum of understanding with the federal government in Ottawa in early August to build an mRNA vaccine manufacturing plant in Canada.

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Novavax Inc. said on Wednesday it had initiated an early stage study to test its combined flu and COVID-19 vaccine.

Its trial, to be conducted in Australia, will enrol640 healthy adults between the ages of 50 and 70and who have either been previously infected with the coronavirus or given an authorized COVID-19 vaccine at least eight weeks prior to the study.

Participants will receive a combination of the company's COVID-19 vaccine candidate, NVX-CoV2373, and its influenza shot NanoFlu, along with an adjuvant or vaccine booster.

"Combination of these two vaccines may lead to greater efficiencies for the health-care system and achieve high levels of protection against COVID-19 and influenza with a single regimen," Gregory Glenn, president of research and development at Novavax, said in a statement.

Novavax trial results expected in first half of 2022

Novavax had said in May it expects seasonal influenza and COVID-19 combination vaccines to likely be critical in combating emerging COVID-19 variants. Its vaccine NanoFlu/NVX-CoV2373 had elicited robust responses to both influenza A and B and protected against the coronavirus in pre-clinical studies.

The company, based in Maryland, expects the trial results in the first half of 2022.

Novavax has yet to file for emergency use authorization of its two-dose COVID-19 vaccine in North America or Europe.

The company signed a deal with the European Union this month to supply up to 200 million doses of its COVID-19 vaccine. Novavax said in its most recent earnings announcement that it planned to submit its data to the EU "within weeks" of its filing to British regulators, setting the likely timeline between late September and early October, a spokesperson said.