The FDA has a series of designations it grants to drugs or biologics intending to treat rare, serious, or life-threatening conditions. One of these is Breakthrough Therapy designation. According to MPR, VLA1553, an investigational vaccine to protect against Chikungunya virus (or Chikungunya disease), recently received Breakthrough Therapy designation from the FDA.
VLA1553
Over the past year, there have been over 3 million reported cases of chikungunya throughout the Americas alone, representing a growing burden. However, there are few protective measures in terms of vaccines. VLA1553 is a potential option to overcome this unmet need.
So what is VLA1553? This is the first vaccine against chikungunya being evaluated in Phase 3 clinical trials. This live-attenuated vaccine only requires a single dose to confer protection. Once administered, the vaccine deletes some of the chikungunya virus genome, inhibiting infection and symptoms. According to the drug developer Valneva:
In Phase 1 clinical trials, Valneva observed that VLA1553 led to the development of antibodies to chikungunya in 100% of the 120 healthy participants in this trial.
The vaccine received Breakthrough Therapy designation, which is granted to drugs, used to treat serious conditions, which demonstrate significant improvements (or potential improvements) over available therapies. Once a developer receives this designation, they are also eligible for drug development program guidance and features of Fast Track designation. Outside of Breakthrough Therapy status, VLA1553 has also received PRIME designation in the EU and Fast Track designation in America.
Chikungunya Virus
The Chikungunya virus is spread through bites from infected mosquitos, although it can also (in rare cases) be spread through blood or transmitted from mother to child. When the chikungunya virus (CHIKV) is transmitted, patients normally feel symptoms between 3-7 days following infection. The virus has been found on Caribbean islands but is much more prevalent in Europe, Asia, Africa, and the Indian and Pacific Oceans.
Generally, this infection is not fatal. However, symptoms may be severe, painful, and debilitating. Symptoms include:
- Fever
- Muscle pain
- Joint inflammation
- Fatigue
- Severe, and sometimes sustained, joint pain
- Rash
- Headache
Learn more about Chikungunya.
