Category:

Japanese drugmaker Takeda has quickly emerged as one of the leading forces in the fight against COVID-19 as a vaccine manufacturing partner and R&D lead on a convalescent plasma-based therapy. Now, Takeda will help another biotech distribute its potential COVID-19 vaccine in the drugmaker's home country...Moderna has tapped Takeda to bring 50 million doses of its mRNA-based COVID-19 shots to Japanese shores as part of a government-backed vaccine distribution effort...Takeda will import and distribute Moderna's shot, dubbed mRNA-1273, starting in the first half of next year, as well as handle local regulatory approvals...READ MORE

As the leading COVID-19 vaccines move closer to potential emergency use, the research and regulatory processes have been intensely scrutinized. But there’s one area that hasn’t seen as much attention so far—manufacturing facility inspections...COVID-19 vaccine developers seeking FDA emergency use authorizations won’t have to undergo pre-approval site inspections...The FDA conducts thousands of facility inspections per year, and some find flaws that drug or vaccine companies must remedy before launching new products...READ MORE

Fast progress has spurred hopes that several vaccines could succeed, spurring jockeying among governments to secure supplies...Scientists, drugmakers and governments are moving with unprecedented haste to develop a vaccine against the new coronavirus...The fastest of them have already delivered promising data from initial human studies, and further results from larger tests should come quickly over the next three to six months...The goal...is to have a vaccine ready for use in some fashion by the end of the year, or early next. Doing so would be a scientific feat with few parallels. No vaccine has ever been developed so quickly, never mind manufactured for the world...READ MORE

Americans living or working in long-term care facilities, including nursing homes and assisted care living centers, will receive COVID-19 vaccinations for free if and when they become available, the Trump administration said...The administration announced a partnership with the nation's two largest drug store chains, CVS and Walgreens, "to provide and administer" the vaccines with "no out-of-pocket costs" for the recipients...READ MORE

Washington, Oregon and Nevada will join California to independently review any coronavirus vaccine before distributing it to the public...Gov. Gavin Newsom said Tuesday that the three states would identify their own public health experts to participate in the scientific review committee he announced last week, which was charged with ensuring that any vaccine approved by the U.S. Food and Drug Administration is safe and effective...California has also formed a second committee to develop guidelines for the ethical distribution of vaccines, Newsom said, addressing questions about who should receive the first doses and how to allocate potentially limited supplies...READ MORE

Following a rapid course of development and testing, Gilead Sciences Inc. has secured the first and only FDA approval for a COVID-19 treatment, the antiviral Veklury (remdesivir). Previously authorized only for emergency use (EUA) in the U.S., the drug can now be prescribed to adults and children 12 and older weighing at least 40 kg for the treatment of COVID-19 requiring hospitalization...READ MORE

A California panel of experts will independently review the safety of new coronavirus vaccines and initial plans for distribution, Governor Gavin Newsom said...The 11-person panel specializing in topics such as epidemiology, biostatistics, and infectious disease will review any vaccine approved by the Food and Drug Administration before it is distributed to state residents, Newsom told a news conference...The U.S. government’s efforts to speed development of a COVID-19 vaccine - and promises by U.S. President Donald Trump that one could be available prior to the Nov. 3 presidential election - has led to concerns of political interference in the regulatory process at the expense of safety. The FDA has vowed to ensure the safety of COVID-19 vaccines before approving them...READ MORE

The Trump administration announced it will cover a vaccine for COVID-19 at no cost to Medicare beneficiaries...The Centers for Medicare & Medicaid Services released an interim rule on Wednesday that aims to remove regulatory barriers for seniors to get the vaccine, which is expected to be approved by early next year...READ MORE

CVS Health is pushing for pharmacy technicians to be allowed to administer COVID-19 vaccines...The healthcare giant is hiring more than 10,000 full- and part-time pharmacy technicians in Q4 in anticipation of flu season, and urging for them to have an expanded scope of practice that would allow them to vaccinate patients for the novel coronavirus under supervision from an immunization-certified pharmacist...CVS said that allowing technicians to administer vaccines would "help fill the urgent need to safely and quickly scale distribution of a vaccine and extend the capacity of the health care workforce to address the pandemic."...READ MORE

Food and Drug Administration advisory committee meetings tend to be staid, albeit important, events typically watched by a few dozen company representatives, scientists, investors and patient advocates...But next week's hearing on coronavirus vaccine studies will be set against the backdrop of a presidential election 12 days later that could turn on the White House's response to the pandemic, likely making it a closely-watched affair of historic proportions...In the meantime, here are five important questions that could feature at next week's meeting...READ MORE

• How will vaccine safety be monitored following an emergency clearance? After a full approval?
• How long will immunity last and how would it be measured?
• How will vaccine-induced enhanced respiratory disease be monitored?
• Has enough data been collected on vulnerable groups?
• Will future vaccine trials need to measure COVID-19 cases, or will immune response data be enough?