Ixchiq, the first chikungunya vaccine, was approved by the US Food and Drug Administration today. For people who are 18 years of age or older and are more likely to contract the chikungunya virus, Ixchiq is approved.
The main way that the chikungunya virus spreads to humans is through mosquito bites. Over the past 15 years, at least 5 million instances of chikungunya virus infection have been reported worldwide, making it a growing health danger. In tropical and subtropical regions of Africa, Southeast Asia, and parts of the Americas where chikungunya virus-carrying mosquitos are endemic, there is the largest risk of infection. But the chikungunya virus has expanded to new regions, increasing the disease’s incidence all over the world.
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.
According to Peter Marks, M.D., Ph.D., director of the FDA’s Centre for Biologics Evaluation and Research, “infection with the chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions.” “Today’s approval is a significant step towards the prevention of a potentially crippling disease with limited treatment options and addresses an unmet medical need.”
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.
Two clinical studies, one including 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. The side effects that vaccination recipients most frequently reported experiencing were headache, weariness, joint and muscular soreness, fever, nausea, and injection site sensitivity.
Furthermore, 1.6% of Ixchiq recipients and none of the placebo receivers experienced severe chikungunya-like side events, which are uncommon but may have required medical intervention and prevented daily activity. Two individuals required hospitalisation due to significant adverse responses resembling chikungunya. 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.
The FDA is mandating that the business carry out a postmarketing investigation to evaluate the substantial risk of severe adverse events akin to chikungunya after Ixchiq is administered.
It has been documented that pregnant women with viremia (virus in the blood) at birth can pass the chikungunya virus to their unborn children, which can result in a serious and often deadly case of chikungunya virus sickness in the infant. In a research assessing whether the vaccine virus was found in the blood after immunisation, 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. The Prescribing Information has a warning stating that neither the vaccination virus’s ability to spread from pregnant women to unborn children nor its potential to have any negative effects on the unborn child are known.
Additionally, the warning states that healthcare providers should consider the individual’s risk of exposure to the chikungunya virus, gestational age, and risks to the foetus or neonate from disease caused by the chikungunya virus in the pregnant individual when considering administration to pregnant individuals.
Based on immune response data from a clinical study done in the US on people 18 years of age and older, Ixchiq’s efficacy is determined. The immunological responses of 96 people who received a placebo and 266 persons who received the vaccine were compared in this study. The degree of antibody assessed in research subjects was predicated on a level demonstrated to be protective in non-human primates that had received blood from immunised individuals. Participants in almost all vaccine studies reached this antibody level.
The Accelerated Approval method was used to approve Ixchiq. The FDA may approve some medications for serious or life-threatening illnesses via the expedited approval process if there is proof of the product’s efficacy that is a reasonable indicator of therapeutic benefit. The FDA is evaluating Ixchiq for expedited approval, and immune response data from clinical trial participants is used as proof of efficacy. The FDA is demanding confirmatory clinical studies to be carried out in order to demonstrate clinical benefit prior to approving Ixchiq.
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.
Valneva Austria GmbH received approval from the FDA to market Ixchiq.