Clinical Moderna RSV Vaccine passes Phase 2 Safety Review

Moderna RSV Vaccine passes Phase 2 Safety Review

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Big Pharma heavyweight: Moderna has developed a vaccine for RSV, which recently cleared a safety review and is advancing to phase 3 of clinical trials.

After successfully passing the phase 2 trial called ConquerRSV, the data shows that the vaccine is safe and tolerable at the recommended dose, according to a statement by Moderna.

Moderna plans to enroll 34,000 people in the next phase, all within the age bracket of 60 and older from countries worldwide.

Currently, no vaccine for RSV is available for the general public, but many Big Pharma companies are running clinical trials on different patient populations. It has been challenging to develop a vaccine against Respiratory Syncytial Virus that sometimes causes serious illness in the elderly and young children.

GlaxoSmithKline vs. Pfizer

GlaxoSmithKline was running late-stage trials for maternal RSV, but the U.K pharma company had to stop temporarily as a safety review uncovered some concerning information. This delay benefitted GSK’s competitor Pfizer who is also developing a maternal RSV vaccine.

RSVpreF is another respiratory syncytial virus vaccine developed by Pfizer, entering into a phase 3 trial called RENOIR this September. The trial is expected to enroll 30,000 adults aged 60 or above. Pfizer plans to prove through the study that the vaccine can save patients from lower respiratory tract illness in the first RSV season after immunization. We can expect a readout in early March or April of this year. 

Moderna’s Future Plans 

Moderna’s RSV vaccine is named mRNA-1345, built on the same principles as Moderna’s COVID vaccine. The FDA has granted the shot an accelerated approval pathway in candidates above the age of 60. Phase 3 of clinical trials will evaluate the safety and efficacy of the vaccine.

Moderna is combining COVID 19 and flu booster shots. An individual seasonal flu shot named mRNA-1010 is also in the works. It might be possible to combine the COVID-19, RSV, and season flu boosters into a single vaccine, according to Moderna. 

Johnson & Johnson is also developing its own RSV candidate. Sanofi and AstraZeneca have joined forces for an RSV vaccine of their own.

According to the CDC, the Respiratory Syncytial Virus hospitalizes over 58,000 children younger than five years in the U.S. It also causes the death of 14,000 adults aged 65 years or older.

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