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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

One hundred and forty-three day since World Health Organization member-states passed a resolution calling for the WHO to work with other agencies to identify how the coronavirus that emerged in Wuhan was able to jump from animals to humans, China has yet to agree upon an international team of experts to visit China to carry out that crucial work...Resolution WHA73.1, passed at a WHO World Health Assembly on May 19, calls on WHO, the World Organization for Animal Health, and the Food and Agricultural Organization to work jointly to “identify the zoonotic source of the virus and the route of introduction to the human population,” and refers specifically to “scientific and collaborative field missions” as part of that effort...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

...Gilead will supply the EC with up to half a million treatment courses of Veklury to treat COVID-19 patients...The European Commission has signed a joint procurement contract from the EC’s Emergency Support Instrument, worth a total of EUR 70 million with pharma giant Gilead, with the opportunity to extend the supply beyond the initial 500,000-treatment level if necessary. Participating countries now can place orders to procure the drug directly with the company...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?

Just days after Eli Lilly sent an COVID-19 antibody ahead for FDA scrutiny, the drugmaker's immediate chances were halted by a damaging trial stop for the therapy. Now, the FDA has knocked Lilly for its manufacturing controls at a New Jersey site producing the antibody...The FDA cited Lilly's Branchburg, New Jersey, facility on two counts of inadequate "control of computer systems," Lilly confirmed in an email. Those two findings included deleted data on the company's manufacturing processes and failed quality control over audit paper trails...FDA investigators flagged the quality control deficiencies in a notice...The investigators' findings qualified as official action indicated (OAI) in the notice, the highest enforcement priority level from the FDA for its observations...READ MORE