Category:

The COVID-19 pandemic has raised the profile of mRNA vaccines in a dramatic way in about a year. Looking forward, the technology holds more promise and could displace traditional shots in some diseases, experts said, but it's not time to give up on well-known vaccine platforms, either...researchers at Moderna...reached human testing for their mRNA vaccine in record time. And separately, in under a year of development, testing and manufacturing, Pfizer and its mRNA partner BioNTech were able to score an FDA emergency use authorization last December...In addition to being able to rapidly advance new vaccines in response to emerging threats, the “beauty” of the platform is that the production process is “universal,"...Still, it’s not time to go all-in on mRNA... While experts are clearly enthusiastic about the platform, that “doesn’t guarantee that mRNA will immediately work against all pathogens,"...READ MORE

President-elect Joe Biden’s new $1.9 trillion COVID-19 relief plan includes money for boosting subsidies to help pay down the costs of Affordable Care Act exchange plans, bolstering supplies and for vaccine distribution...The American Relief Plan...includes new investments in supplies for strapped hospitals, money for vaccines and testing and seeks to give front-line healthcare workers new federal protections...A key pillar of the plan is $20 billion for a national vaccine program that partners with state and local governments. The plan will launch community vaccination centers around the country and mobile units for any hard-to-reach areas...READ MORE

FDA veteran Janet Woodcock will take over as commissioner, at least temporarily, according to media reports, and former deputy FDA chief Joshua Sharfstein is at the top of the list for the permanent job...President-elect Joseph Biden has tapped Woodcock as interim FDA commissioner while his team searches for a permanent replacement...Woodcock now oversees COVID-19 therapy development as part of Operation Warp Speed and has headed up the Center for Drug Evaluation and Research since 2008...READ MORE

After AstraZeneca pledged not to profit off its COVID-19 shot during the pandemic, a report emerged that the drugmaker might be ready to declare the pandemic over as soon as July. But according to EVP and biopharma president Ruud Dobber, it’s still “too speculative” to predict when the vaccine may start earning money...The company is building a capacity of 3 billion doses for countries around the world, and it won’t be until after AZ delivers on its government supply deals that it might “feel open" to selling the vaccine commercially...READ MORE

Unlike his predecessor, President Biden is embracing a more centralized strategy for managing the COVID-19 pandemic. He signed a flurry of executive orders and presidential directives on January 21, including one that institutes new mask mandates for interstate travel, one that creates a national board to expand access to testing, and another that requires international visitors to quarantine upon arrival in the United States. Biden pitched his National Strategy for the COVID-19 Response and Pandemic Preparedness as a "wartime effort" and did not soft-pedal the grim details...READ MORE

A report on the FDA PREPP initiative’s work in 2020 aims to strengthen the Agency’s response to future public health emergencies...FDA announced on Jan. 13, 2021 that it had published a report summarizing the work to date of the COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) initiative, which was launched in August 2020 to strengthen the Agency’s response to the current pandemic and to future public health emergencies...FDA asked an independent, non-government organization to review its pandemic response, record its accomplishments and activities, and pinpoint future opportunities for consideration, an FDA press release said. The organization interviewed FDA leaders, organized listening sessions with external stakeholder groups, and partnered with subject matter experts on the FDA staff to generate a summary report...READ MORE

A Mississippi owner of pharmacies and pharmacy distributors has been sentenced to 18 years in prison and ordered to repay the government nearly $287.7 million for his part in what prosecutors described as a $510 million health care fraud involving high-priced pain cream...Wade Ashley Walters...of Hattiesburg, also was ordered...to forfeit nearly $56.6 million that he gained personally from the scheme...Walters had been charged in a 37-count indictment. He pleaded guilty in July to one count each of conspiracy to commit health care fraud and conspiracy to commit money laundering...Between 2012 and 2016, Walters orchestrated a scheme to defraud Tricare, the insurance program for U.S. military, veterans, and their families, and private health insurers by distributing compounded medications that were not needed...READ MORE

...during a once-in-a-century pandemic, incoming President Joe Biden has promised to provide 100 million COVID-19 vaccinations in his first 100 days in office...“This team will help get …at least 100 million COVID vaccine shots into the arms of the American people in the first 100 days,” Biden said...When first asked about his pledge, the Biden team said the president-elect meant 50 million people would get their two-dose regimen. The incoming administration has since updated this plan, saying it will release vaccine doses as soon as they’re available instead of holding back some of that supply for second doses...Either way, Biden may run into difficulty meeting that 100 million mark...READ MORE

Although there was much analysis and anticipation over the past year about the difficulties and challenges in distributing millions of doses of new vaccines across the nation, the process so far has been much less effective than anticipated...30 million doses have been distributed, but only 4 million people were vaccinated in December 2020, and just 13 million have received shots so far...A main problem was the administration’s delay in authorizing the Centers for Disease Control and Prevention to provide states with clear guidelines for updating existing local procedures for distributing vaccines that critical “last mile” to clinics and health centers... Uncertainty about vaccine shipments and supplies, at a time when hospitals were dealing with surges in COVID-19 infections and deaths, prompted medical centers to cancel in-house vaccination activities. And there still is confusion about whether clinics should hold back supplies for second doses or administer all on hand...READ MORE

Yvelice Villaman Bencosme of Miami, Florida, has entered a guilty plea in US District Court for the Southern District of Florida, in response to one count of conspiracy to commit wire fraud...Bencosme (who served as primary investigator for clinical purportedly conducted at the medical clinic Unlimited Medical Research in Miami) admitted that from approximately 2013 to 2016, she participated in a scheme to defraud an unnamed pharmaceutical company by fabricating the data and participation of subjects in a clinical trial at UM Research...READ MORE