FDA finally okays Novavax's COVID-19 jab, with restrictions

The FDA has granted full approval to Novavax's COVID-19 vaccine after a delay, but has limited its use to older adults and people aged 12 and over who have underlying conditions that make their risk of getting severely ill greater.

The review of Novavax's Nuvaxovid shot has attracted a lot of attention amid what appears to be toughening up by the FDA on the review of vaccines, although earlier rumours that the agency had planned to require a new clinical trial of the product at a cost of tens of millions of dollars proved unfounded.

After the FDA missed a 1st April deadline to complete its review of the Sanofi-partnered vaccine, there was speculation that the FDA – under the leadership of Health and Human Services (HHS) Secretary Robert F Kennedy Jr, who has a history of vaccine scepticism – was minded to place obstacles in front of its approval.

Senior leadership across the agencies overseen by the HHS, including the FDA, are now being led by people who are recognised as holding views contrary to prevailing scientific wisdom on COVID-19 immunisation programmes.

As it turned out, Novavax secured approval for its vaccine after providing the FDA with additional data and agreeing to carry out post-marketing trials, including one to explore whether it can cause heart complications.

The company told Reuters it was not concerned about the limited label, as it is representative of those people who are currently seeking COVID-19 vaccination. Under its emergency use authorisation (EUA), Nuvaxovid – which is based on a conventional vaccine technology – was approved for use in anyone aged 12 and over.

Rival mRNA-based shots from Moderna and Pfizer/BioNTech already have full approval for use in the over-12s.

Earlier this month, Novavax said it was modelling full-year sales of Nuvaxovid of around $1 billion, after posting $608 million in first-quarter sales. Meeting that potential will hinge on a meeting of the CDC next month at which recommendations on the use of COVID-19 vaccines in the 2025/26 season will be laid out, and the restricted label for Nuvaxovid gives an indication of direction the Trump administration is likely to take.

"Market research and…CDC statistics indicate that older individuals and those with underlying conditions are the populations most likely to seek out COVID-19 vaccination seasonally," commented Novavax's chief executive, John Jacobs.

"This significant milestone demonstrates our commitment to these populations and is a significant step towards availability of our protein-based vaccine option," he added.