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EMA grants Bavarian Nordic access to PRIME scheme for RSV vaccine candidate

It is estimated that infections caused by this respiratory virus lead to over 175,000 hospitalisations and 14,0000 deaths in older people in the US each year


Bavarian Nordic has announced that the European Medicines Agency (EMA) has granted access to its priority (PRIME) scheme for the company's vaccine candidate for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults ages 60 and over.

The EMA launched its PRIME scheme to enhance support and enable accelerated assessment for the development of medicines that target an unmet medical need. Only one in four requests for PRIME eligibility are granted, according to the EMA.

There is currently no approved vaccine for RSV and access to the scheme has been granted upon an assessment that the available clinical data overall shows the potential of MVA-BN-RSV, Bavarian Nordic’s vaccine candidate, to address the unmet medical need in the proposed target population.

RSV is a common and pervasive seasonal respiratory illness that is highly contagious. Infections occur in people of all ages and feels like a common cold for most young adults, but it can be life-threatening for infants, the immunocompromised and older adults.

MVA-BN RSV has five distinct RSV antigens to induce a broad immune response against both RSV subtypes (A and B). This is similar to the immune response that occurs naturally in response to an RSV infection. The incorporation of five antigens sets MVA-BN RSV apart from other RSV vaccine candidates currently in development.

Results from Bavarian Nordic’s phase 2 trial, which enrolled healthy adult volunteers aged 18-50 years, showed a significant reduction in viral load in MVA-BN RSV vaccinated subjects compared to placebo. The vaccinated subjects also showed a significant reduction in clinical symptoms typically associated with RSV infections.

Strong results were also previously reported from a phase 2 trial of 421 elderly subjects aged 55 years and older. The study showed that the vaccine was well tolerated and induced both broad and durable antibody and T-cell responses against RSV.

In February 2022, the US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for MVA-BN RSV, for active immunisation for prevention of LRTD caused by RSV in adults aged 60 years and over.

Bavarian Nordic’s president and CEO Paul Chaplin, said: “…We are proud to receive eligibility for PRIME access for our RSV vaccine candidate, enabling us to pursue accelerated development and review processes with the regulatory authorities in both the US and Europe.

"These grants highlight the potential of our vaccine to fulfil the significant unmet need for a preventative therapy, particularly for the elderly who may be at risk of serious complications from RSV.”

Article by
Emily Kimber

30th June 2022

From: Regulatory, Healthcare



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