Novavax gets green light for updated COVID vaccine

Novavax has been given the go-ahead by regulators in the US for an updated version of its COVID-19 vaccine that targets the XBB.1.5 variant of the coronavirus.

The FDA has signed off on the new protein-based shot, which joins two XBB.1.5-directed mRNA-based vaccines from Pfizer/BioNTech and Moderna as options for the upcoming immunisation campaign in the US.

Novavax’s vaccine has been approved for people aged 12 and over, while the two mRNA shots have been backed for individuals aged six months and over.

Ordinarily, the Centers for Disease Control and Prevention (CDC) would also need to clear use, but the agency has said its earlier decision to back the mRNA jabs will apply to all FDA-licensed COVID-19 vaccines.

The approval is a big boost for Novavax, which was unable to benefit from the massive sales amassed by other COVID-19 vaccines during the pandemic because the development of its first-generation product was held up by manufacturing complications.

It marks a continued turnaround for the company, which just a few months ago was warning it may not survive until the end of the year.

Since then, it reported sales of $424 million in the second quarter from historic vaccine purchase agreements outside the US and, while it is expecting minimal sales in the third quarter, the US approval gives it a chance of building revenues in the fourth quarter as it works on other vaccine candidates, including a combination influenza/COVID-19 jab.

The company’s internal analyses predict that the US demand for COVID vaccines this autumn will range from 80 million to 100 million doses. It will have to battle for a share of that market with its rivals, now that the government is no longer providing jabs for free and people will either have to have insurance coverage or pay for the vaccine out of pocket.

The three vaccines have been priced at around $120 to $130 per dose now that a regular commercial environment is in place - considerably higher than their cost to the US government in prior years.

The FDA said that the emergency use authorisation (EUA) for Novavax’s jab “provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness, and manufacturing quality.”

The director of the agency’s Center for Biologics Evaluation and Research (CBER), Peter Marks, said: “We strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants.”

The approvals have come at a time when infections are starting to rise in the US as the colder months of the year approach and health authorities are keeping a close eye on case numbers and hospitalisation rates.

All three vaccines target a strain of the SARS-CoV-2 virus that was prevalent earlier this year, but has now been displaced by newer variants, including EG.5 (known as Eris), FL.1.5.1, and XBB.1.16.6. Nevertheless, the FDA reckons that vaccination will help to protect people from developing severe COVID-19.