Pfizer to apply for U.S. authorization on COVID vaccine "within days"
Pharmaceutical giant Pfizer Inc. said Wednesday that it plans to apply for emergency use authorization in the United States for a potential COVID-19 vaccine "within days," as it has shown the vaccine to be effective in clinical study.The two-dose vaccine, jointly developed with German firm BioNTech SE, met "all of the study's primary efficacy endpoints," the companies said in their press release, noting that an analysis indicated the vaccine was 95 percent effective in preventing the disease caused by the novel coronavirus.Last week, the companies released an interim analysis from the phase-th...
US hoping for two Covid-19 vaccines by end of November
Washington (AFP) - Two American companies expect to apply for emergency approval for their Covid-19 vaccines by late November, welcome news as the US crossed eight million confirmed cases amid a third surge of its coronavirus epidemic.Pfizer said Friday it hopes to move ahead with its vaccine after safety data is available in the third week of November, weeks after the November 3 presidential election.The announcement means the United States could have two vaccines ready by the end of the year, with Massachusetts biotech firm Moderna aiming for November 25 to seek authorization. "So let me be ...
FDA: Reno brand needs authorization to allow return to PH market
A popular liver spread brand must first secure the “required authorization” from the Food and Drug Administration (FDA) before it can be allowed again in the Philippine market, the agency said Thursday.This comes after the FDA issued an advisory informing the public that the several food products and supplements, including Reno Brand liver spread, were not registered with the agency as such products failed to secure any Certificate of Product Registration (CPR).In the advisory released Wednesday, the FDA also noted that it cannot assure that the products are safe for human consumption, and ord...
Philippines Daily Inquirer