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The FDA said Thursday that it has developed a test for COVID-19 in fecal matter, in an attempt to prevent the disease from being inadvertently transmitted during fecal transplantation. Read More
Johnson & Johnson (J&J) has cut enrollment from 60,000 to 40,000 for its global phase 3 ENSEMBLE 1 trial evaluating COVID-19 vaccine candidate JNJ-78436735 as a single-dose regimen. Read More
Moderna has begun dosing adolescents in a phase 2/3 trial evaluating messenger RNA-based vaccine candidate mRNA-1273 and plans to enroll 3,000 U.S. participants aged 12 to 17. Read More
The FDA is very likely to grant Emergency Use Authorization (EUA) for Pfizer’s COVID-19 vaccine following a 17-4 advisory committee vote (with one abstention) Thursday in support of emergency clearance, meaning vaccinations of high-risk patients could start as soon as this weekend. Read More
Sinopharm, a state-owned Chinese drugmaker, has received full approval from the United Arab Emirates (UAE) for its inactivated COVID-19 vaccine, making the UAE the first nation outside China to grant such approval. Read More
The University of Oxford has attempted to clarify the dosing error it and AstraZeneca (AZ) made in a clinical trial assessing COVID-19 vaccine AZD1222, following divergent reports between the two of what exactly transpired. Read More
With FDA emergency authorization seeming very likely for Pfizer’s COVID-19 vaccine within days, all 50 states and U.S. territories have finalized their individual “microplans” for distribution and administration, according to an Operation Warp Speed official. Read More
Yesterday, Pfizer and BioNTech disclosed that information pertaining to their regulatory submission for emergency-use approval of COVID-19 vaccine BNT162b2 was hacked on a European Medicines Agency (EMA) server containing the data. Read More
Both the EU and Japan have forged larger initial supply deals for Pfizer’s COVID-19 vaccine than the U.S. government, which is in the hot seat for declining to order additional vaccine doses, and it appears Pfizer will have to honor its deals with other countries before it can provide more to the U.S., though the government disputes that. Read More
Distribution plans for the Pfizer-BioNTech COVID-19 vaccine in the U.S. remain an enormous question mark as an initial roll-out of mass vaccination gets under way in the UK. Read More
The COVID-19 pandemic does not appear to be slowing down the rate at which the FDA is approving novel drugs, although there is anecdotal evidence that it is causing the agency to miss some deadlines for approvals under the Prescription Drug User Fee Act (PDUFA). Read More