Novavax’s COVID-19 vaccine receives MHRA approval for use as a booster

Novavax has announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has expanded the conditional marketing authorisation of its COVID-19 vaccine – Nuvaxovid – for use as a homologous and heterologous booster in adults aged 18 years and older.

Novavax’s protein-based vaccine contains the SARS-CoV-2 spike protein and Matrix-M adjuvant to enhance immune response and stimulate high levels of neutralising antibodies.

The MHRA’s decision was based on positive results from two phase 2 trials, conducted in the US and Australia and South Africa, and from the UK-sponsored COV-BOOST trial.

As part of the phase 2 trials, healthy adult participants were given a single booster dose of Nuvaxovid, approximately six months after their primary two-dose vaccination series of Novavax’s vaccine.

The study showed that the third dose produced increased immune responses against the original ancestral strain of SARS-COV-2 comparable to or exceeding levels associated with protection in phase 3 clinical trials, the company reported.

In the COV-BOOST trial, Nuvaxovid increased antibody levels when used as a heterologous third booster dose after a primary two-dose vaccination series of an mRNA vaccine or adenoviral vector vaccine.

In the Novavax-sponsored trials, following the booster, local and systemic reactions were generally short-lived with a median duration of approximately two days, the company reported. Additionally, safety reporting of reactogenicity events showed an increasing incidence across all three doses of Nuvaxovid, reflecting the increased immunogenicity seen with a third dose.

Crucially, medically attended adverse events (AE), potentially immune-mediated medical conditions, and severe AEs occurred infrequently following the booster dose and were balanced between vaccine and placebo groups.

Stanley Erck, president and chief executive officer, Novavax, said: "Our protein-based vaccine, developed using an innovative approach to traditional technology, may have a prominent role to play in COVID-19 boosting.

"As we continue to explore best practices for managing COVID-19 long term, we have ongoing trials further exploring Nuvaxovid's immunogenicity as a booster dose. Currently available clinical and preclinical data indicate that our vaccine induces robust immune responses against Omicron variants, including BA.4/5.”

Nuvaxovid is also available for use as a booster in adults aged 18 years and older in the US, EU, Japan, Australia, New Zealand, Switzerland and Israel. A number of countries also have policy recommendations allowing use of the vaccine as a heterologous or homologous booster dose, Novavax said.