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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

Moderna, a biotech advancing one of the leading COVID-19 vaccine candidates, has faced questions for several months over its patents and intellectual property. Responding to investor questions, the company now says it won't enforce its vaccine patents against other companies during the pandemic...company President Stephen Hoge said Moderna is “quite studiously not asserting infringement.” Without naming names, the biotech says other COVID-19 vaccines in development might be using Moderna-patented technology...“We’re not interested in using that IP to decrease the number of vaccines available in a pandemic,”...Further, the company is open to licensing its technology after the pandemic. Moderna made the pledge in response to investor questions around its patents...READ MORE

Patients are asking to join clinical trials of antibody-based COVID-19 drugs after U.S. President Donald Trump was treated last week with an experimental therapy from Regeneron Pharmaceuticals Inc...Medical experts said more data is needed to assess the treatment’s efficacy before wider use should be allowed...The company said...that it has submitted a request to the U.S. Food and Drug Administration for an emergency use authorization for its antibody combination...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

Nevada health officials said they would resume the use of rapid “point of care” tests after federal health officials chided them for banning their use and accused them of violating federal law...Dr. Ihsan Azzam, Nevada’s chief medical officer, doubled down on his insistence that too many questions remained about the accuracy of rapid antigen tests. He said his team was “disappointed” in the U.S. Department of Health and Human Services...“We are not saying the tests have no use, we are just saying pause for further review and additional training,”... Admiral Brett Giroir, assistant secretary for health at the U.S. Department of Health and Human Services, told reporters that federal law prohibits states from imposing a ban like the one that Nevada health officials ordered Oct. 2. He said Nevada is the only state to do so...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

Sisolak, his staff, officials from various state agencies met with representatives of the Southern Nevada and Washoe County health districts...to address the concerns the local health officials had raised in a letter last week about being shut out of the governor’s decision making process for COVID-19 directives, according to a joint statement from Sisolak and the local health officials...In their original letter, health officials said they received less than a day’s notice that the governor would increase the state’s gathering limit from 50 to 250, and allow for even larger crowds for sporting events and other live entertainment, with approval from local authorities. The health districts added that their resources are already strained from responding to the pandemic, and expressed frustration with the state adding more responsibility to their plate without discussing the issue with them...READ MORE

The head of Centers for Medicare & Medicaid Services reiterated support for Medicaid work requirements as enrollment in the program swells this year...CMS Administrator Seema Verma spoke about work requirements...Her remarks come less than a month after a study in Health Affairs found that work requirements in Arkansas did not lead to more employment...“I am supportive of states making decisions about their programs and deciding what has worked best,” Verma said...She added that 20 states have been interested in the work requirements program...CMS has approved waivers for 10 states but currently no states are running a work requirement program. Arkansas, Indiana, Michigan and New Hampshire all started work requirement programs, but court rulings struck them down. Utah implemented its work requirement program in January, but it was suspended in April due to COVID-19...Verma said that the goal of the programs were to help improve the health of able-bodied Medicaid beneficiaries...READ MORE