Canada's Health Canada is planning to expedite medication reviews by leveraging decisions made by foreign regulators, including the U.S. Food and Drug Administration (FDA). This strategy aims to streamline the approval process for pharmaceuticals in Canada. The specific foreign drug authorities and drug classes subject to this change remain undisclosed, as outlined in a draft ministerial order. However, Health Minister Marjorie Michel's office and Health Canada have not ruled out the possibility of including the FDA in this initiative. This move is part of Prime Minister Mark Carney's efforts to reduce red tape within the federal government.
Valneva has decided to withdraw its chikungunya vaccine, Ixchiq, from the U.S. market following the FDA's decision to investigate the vaccine further. The FDA's recent clinical hold on the investigational new drug application was prompted by a serious adverse event reported in a vaccine recipient abroad. Valneva acknowledged that the event involved a younger adult who received three concomitant vaccines, including Ixchiq. The FDA had previously suspended the biologics license for the vaccine in August 2025 due to serious safety concerns, citing over 20 cases of chikungunya-like illnesses and one death from encephalitis linked to the vaccine.
