The International Coordinating Group (ICG) on Vaccine Provision reported this week that it has added Merck & Co. Inc.’s single-dose Ebola vaccine to its global vaccine stockpile in Switzerland. An initial 6,890 doses are available, with more doses expected to be delivered to the stockpile this month and throughout the next few years. Depending on the demand for the vaccine, which will be used to protect people at the highest risk of contracting Ebola during an outbreak, it could take two to three years to reach the recommended level of 500,000 doses for the emergency stockpile, according to the ICG. Having the doses in the stockpile will ensure timely access for emergency use, the group said. Merck, of Kenilworth, N.J., developed the vaccine with financial support from the U.S. government. Licensed by the EMA, FDA and eight African countries, the vaccine also has been prequalified by the World Health Organization.
The U.S. Department of Justice (DoJ) cleared the way for Baxalta US Inc., Emergent Biosolutions Inc., Grifols Therapeutics LLC and CSL Plasma Inc. to work with the Biomedical Advanced Research and Development Authority to design quality standards for collecting COVID-19 convalescent plasma at blood banks for direct transfusion. In a Jan. 12 business review letter, DoJ said it had no intention of challenging the public-private collaboration, even though the companies planned to repurpose the standards for use in the development and manufacture of their own hyperimmune globulin therapies. DoJ found the collaboration to be procompetitive, saying it will facilitate the development of critical therapies for COVID-19.
An ongoing investigation of last year’s cyberattack on the EMA revealed that some of the unlawfully accessed documents related to COVID-19 drugs and vaccines have been leaked on the internet, according to the agency’s Jan. 12 update on the attack. Law enforcement authorities are taking action, the EMA said. The agency reported the cyberattack last month, saying that it primarily targeted data from companies related to COVID-19 products. It has since found that the data breach was limited to one IT application.
Australia’s Therapeutic Goods Administration (TGA) is seeking comments on a proposal to streamline how information about certain drug formulations is entered into the TGA electronic systems when a sponsor is seeking market approval. The proposal would discontinue the current process in which certain types of formulations are entered into the subordinate Proprietary Ingredients Table before they’re selected into drug applications for inclusion in the Australian Register of Therapeutic Goods (ARTG). The proposal wouldn’t affect how a drug is evaluated. It also wouldn’t change how the ingredient information is displayed on labels or in the ARTG public summaries. Comments should be submitted by Feb. 24.
The U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) updated a 2015 guidance Jan. 12 on applying for a parallel import license, which lets a drug authorized in a European Economic Area (EEA) member state be marketed in the U.K., as long as the imported product has no therapeutic difference from the cross-referenced U.K. product. The guidance discusses pharmacovigilance requirements and the how-tos of submitting an application. The MHRA also updated a guidance first issued a few weeks ago on exporting active substances manufactured in Great Britain for use in the EEA or Northern Ireland. The guidance explains how MHRA’s written confirmation process operates for such substances.