The CDC’s Advisory Committee on Immunization Practices (ACIP) has unanimously recommended the agency endorse administering Moderna Inc.'s COVID-19 vaccine, Spikevax (elasomeran), to adults. The vote was a strong echo of the FDA’s full approval of the vaccine for adults only a few days earlier, on Jan. 31. After hearing safety and efficacy data from Moderna and an internal analysis of that data from the CDC, ACIP recommended by a vote of 13-0 that the CDC endorse the vaccine’s use for people 18 years and older.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: AB Science, Antares, Biophytis, Catalyst, Eubiologics, Novavax, Pardes, Pharmazz, Syros, Timber.
Despite mandating earlier this year that private health insurance plans make over-the-counter COVID tests free to their subscribers, the U.S. CMS took until Feb. 3 to make the same benefit available to Medicare beneficiaries. The problem is that these tests will not be available to Medicare beneficiaries free of charge until “early spring,” the agency said, a point in time by which the latest surge of the pandemic is likely to have dissipated.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biontech, Jazz, Logicbio, Pfizer, Qsam, Samsung, Theseus.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amylyx, Glaxosmithkline, Johnson & Johnson, Merck, Mitsubishi Tanabe Pharma America, Pfizer, Qilu Regor, Regor, Ridgeback, Vir, Xbiotech.
Russia’s Ministry of Health is looking to extend its role on the global stage. Over the next few months, the ministry, along with other regulatory agencies in Russia, said it plans to start the accreditation process of coming into compliance with World Health Organization (WHO) standards.
HDT Bio Corp. looked at the world and saw health care inequity, so it built itself to help countries with developing economies help themselves. The company is bringing RNA technology for handling COVID-19 to underserved areas such as Brazil so they can develop, manufacture and distribute their own vaccine instead of relying on big pharma or developed-nation governments.
Since COVID-19 hit the U.S. in 2020, the pandemic has taken more than 800,000 American lives. In that same time, cancer has claimed 1.2 million lives, President Joe Biden said Feb. 2 as he “reignited” the cancer moonshot he first launched in 2016 when he was serving as vice president.
Amid pressure to get a COVID-19 vaccine authorized for infants and toddlers sooner than later, Pfizer Inc. and Biontech SE initiated a rolling submission seeking to amend the U.S. FDA’s emergency use authorization for their mRNA vaccine to include children 6 months through 4 years of age.
RSS
