FDA Ends Suspension of Chikungunya Vaccine, Adjusts Label

Contact Your Elected Officials

Regulators in May effectively stopped administration of the vaccine.

The Food and Drug Administration has lifted its hold on a vaccine against chikungunya, the agency announced on Aug. 6, as it adjusted the label for the shot.

The FDA is ending its recommended pause, which effectively stopped administration of Valnevaโ€™s vaccine Ixchiq, the agency said in a statement.

FDA officials in May advised adults aged 60 and up not to receive the vaccine, following reports that recipients who received it suffered severe symptoms usually experienced with infection of the chikungunya virus.

Several of the recipients died.

The FDA said on Wednesday that it finished an updated assessment of the risks and benefits of Ixchiq and that it is lifting the pause because the benefits outweigh the risks for some people.

The FDA cleared Ixchiq in 2023, and the Centers for Disease Control and Prevention recommended it in 2024 for adults traveling to certain countries.

The FDA also said in the new announcement that it has approved an updated label for the vaccine.

The label now says the vaccine is for adults โ€œwho are at high risk of exposure to CHIKV,โ€ or the chikungunya virus. The label used to say, โ€œat increased risk of exposure.โ€

The limitations section of the label now state: โ€œVaccination with Ixchiq is not advisable for most U.S. travelers. For most U.S. travelers, the risk of exposure to CHIKV is low. The Centers for Disease Control and Prevention provides resources for assessing likelihood of exposure to CHIKV among travelers and laboratory workers.โ€

The label now also says that administration of the vaccine should only be done after consideration of a personโ€™s risk of severe or chronic problems if infected with the virus, as well as the risks of โ€œserious, severe, or prolonged chikungunya-like illness caused by vaccination with Ixchiq.โ€

The warnings section highlights how some people have reported severe complications following receipt of the vaccine, including hospitalization and death. The vaccine โ€œmay cause serious, severe, or prolonged chikungunya-like illness,โ€ it states.

Byย Zachary Stieber

Read Full Article on TheEpochTimes.com

The Epoch Times
The Epoch Timeshttps://www.theepochtimes.com/
Tired of biased news? The Epoch Times is truthful, factual news that other media outlets don't report. No spin. No agenda. Just honest journalism like it used to be.

Hereโ€™s What the USโ€™ Security Guarantees For Ukraine Might Look Like

Western security guarantees for Ukraine are one of the main issues delaying a political resolution to the conflict. Russia launched its SMO primarily in response to NATO-emanating threats from Ukraine.

The Cost of Anger

I will not write much here. There are no words I can say. I only wish to remember those forgotten casualties, the unseen cost of the current antagonism in America.

Another Mass Trans Shooter Not to be Discussed

Robin (Robert) Westman was identified by police as the suspect behind a shooting at a Catholic school that left two children dead and 17 others injured.

AI Techno-Hell Roundup: The Birds and the Bees

In addition to total supplantation of human labor, AI is also doing a number on homo sapiensโ€™ psychological welfare โ€” seducing lonely techno-serfs.

Flagged for Burning

Trump ordered AG to enforce laws against flag desecration focusing on flag burning linked to violent crimes, property destruction or other illegal activities.

Child Who Shielded Friends During Minneapolis School Shooting Praised by Officials

Officials praised children at Annunciation Catholic School in MN who put themselves in harmโ€™s way to protect their friends during a mass shooting.

TransUnion Reports Data Breach Affecting 4 Million American Consumers

TransUnion LLC, Chicago-based credit-reporting firm, announced a data breach involving personal information of 4.4 million consumers throughout the US.

Trump Suggests Holding Republican National Convention in 2026

President Trump may call on the RNC to host a Convention midway through his presidential term, sometime before congressional elections in 2026.

US Economy Grew 3.3 Percent In Q2, Beating Prior Estimate

U.S. economy expanded at a 3.3% annualized pace in second quarter of 2025 with rate of growth exceeding earlier estimate and signaling economic strength.

Trump Says He Will Protect Social Security Amid Potential Congressional Cost-Cutting Proposals

Trump said his admin will protect Social Security and Medicaid, when asked which programs he would want to see cut in a congressional reconciliation bill.

Trump Admin Asks Military Base Near Chicago for Support on Immigration Operations

Naval Station Great Lakes was asked by DHS for โ€œlimited support in the form of facilities, infrastructure, and other logistical needs to support DHS operations.

DHS Proposes Revamp of Student and Exchange Visas, Citing Fraud and Abuse

The Dept of Homeland Security on Aug. 27 posted a draft version of proposed changes to temporary visas for overseas students and exchange visitors.

Trumpโ€™s 50 Percent Tariff on India Takes Effect

President Trumpโ€™s additional 25% tariff on India became effective at midnight on Aug. 27, bringing the total rate to 50% on many imports entering the US.
spot_img

Related Articles