FDA Approves First Vaccine for Chikungunya Virus

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Highlights:

• The U.S Food and Drug Administration approved the first chikungunya vaccine- Ixchiq
• Ixchiq is administered as a single dose intra-muscularly for individuals over 18 years of age and older who are more likely to be exposed to chikungunya virus
• The vaccine's capacity to transmit from mother to fetus during pregnancy, as well as any potential adverse effects in newborns, remains elusive

Tropical illnesses like chikungunya are caused by a virus that is carried by mosquito bites. With at least 5 million cases of chikungunya virus infection documented during the last 15 years, it is a growing threat to global health.

As a result of climate change pushing the mosquitoes that spread chikungunya into new areas, public health experts are concerned that the disease could pose a pandemic threat in the future. Up until now, the only method to guard against infection in the absence of preventative medication was to avoid getting bitten.

‘The US FDA's approval of Ixchiq should expedite the future chikungunya vaccine's release. #chikungunya #vaccine #ixchiq #globalhealthcare #medindia’

This unfulfilled medical need has been addressed by the recently FDA-approved Ixchiq chikungunya vaccine, which represents a significant development in the prevention of a potentially crippling illness with few available treatments (1^✔).

All About Chikungunya and Why There is Dire Need for Vaccine?

People typically contract the chikungunya virus through the bite of an infected Aedes Aegypti mosquito. In tropical and subtropical areas of Africa, Southeast Asia, and portions of the Americas where chikungunya virus-carrying mosquitos are endemic, there is the highest risk of infection. However, the chikungunya virus has expanded to new regions, increasing the disease's incidence across the globe.

Fever and joint pain are two of chikungunya's most typical symptoms. Muscle soreness, headaches, and rashes are possible additional symptoms. Debilitating joint pain can last for months or even years for certain people. Rest, drinks, and over-the-counter pain and fever drugs are all part of the treatment.

Chikungunya virus infection can cause serious illness and persistent health issues, especially in older persons and those with underlying medical disorders.

Although the virus is rarely lethal, symptoms can occasionally linger for months or even years. Apart from standard drugs for pain and fever treatment, there isn't a specific medication available to treat chikungunya at the moment.

Ixchiq- FDA Licenced First Chikungunya Vaccine

The vaccine, which will be sold under the brand name Ixchiq and was created by Valneva Austria GmbH in Europe, has been licensed for use in those 18 years of age and older who are more likely to be exposed. An injection into the muscle is used to deliver Ixchiq as a single dosage. It may give the vaccination recipient symptoms that are similar to those of chikungunya disease since it contains a live, weakened strain of the chikungunya virus.

In the research assessing whether the vaccine virus was found in the blood after immunization, the majority of participants had the virus found in their blood within the first week after vaccination; 14 days later, the virus was not found.

Two clinical studies, one involving about 1,000 people who got a placebo, and the other involving about 3,500 participants who were 18 years of age or older, were conducted in North America to assess the safety of Ixchiq.

Although uncommon, 1.6% of Ixchiq recipients and none of the placebo receivers experienced severe chikungunya-like adverse events that interfered with daily activities or necessitated medical attention. Two participants required hospitalization due to significant adverse responses resembling chikungunya.

The phase 3 clinical research of Valneva found a 98.9% sero-response rate observed at 28 days that continued to sustain at 96.3% 6 months following vaccination.

Side-Effects of Ixchiq

Headache, weariness, joint and muscular discomfort, fever, nausea, and injection site sensitivity were the most frequently reported adverse effects by vaccine recipients.

Furthermore, a few recipients experienced adverse responses resembling chikungunya that persisted for a minimum of 30 days. The vaccine may result in severe or protracted adverse responses similar to chikungunya, according to the Prescribing Information.

Chikungunya Vaccine's Impact on Maternal and Fetal Health

It has been documented that pregnant women can pass the chikungunya virus to their neonates during childbirth, which can result in a serious and often deadly case of chikungunya virus sickness in the infant. In its statement, the FDA stated that neither the vaccine's potential for side effects in neonates nor its ability to spread from mother to child in utero was known.

The warning also states that healthcare providers should consider the individual's risk of exposure to the chikungunya virus, gestational age, and risks to the fetus or neonate from disease caused by the chikungunya virus in the pregnant individual when considering administration to pregnant individuals.

Ixchiq's Approval Methods

Fast Track and Breakthrough Therapy designations were given to Ixchiq, and the application was given Priority Review. A tropical disease priority review voucher was also granted by the FDA to the Ixchiq producer in accordance with a clause in the Food and Drug Administration Amendments Act of 2007.

The purpose of this clause is to promote the creation of novel pharmaceuticals and biological products for the treatment and prevention of specific tropical illnesses.
In summary, the FDA's approval for the Ixchiq chikungunya vaccine could serve as a potential forerunner for chikungunya vaccinations, influencing the development of later, far more sophisticated vaccines.

Reference:

1. FDA Approves First Vaccine to Prevent Disease Caused by Chikungunya Virus - (https:www.fda.gov/news-events/press-announcements/fda-approves-first-vaccine-prevent-disease-caused-chikungunya-virus)

Source: Medindia

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