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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

...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

FDA officials have released an alert for clinical laboratory staff and health care providers regarding information on viral mutations of coronavirus disease 2019...Amid reports of a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant from the United Kingdom, known as B117, the FDA announced that it is acting to ensure the accuracy of molecular diagnostic tests authorized by the agency...the FDA has identified 3 authorized molecular tests that may be negatively affected by genetic variants: MesaBiotech Accula, TaqPath COVID-19 Combo Kit, and Linea COVID-19 Assay Kit. However, “the impact does not appear to be significant,”...READ MORE

A Nevada man has been charged with fraudulently obtaining about $2 million in federal coronavirus relief aid, meant for small businesses, to buy luxury vehicles and condominiums in Las Vegas...The U.S. attorney’s office in Nevada accused Jorge Abramovs with bank fraud after he allegedly applied for funding to at least seven banks between April and June 2020...The complaint said Abramovs used a variety of company names — National Investment Group Corporation, National Legal Advisors In Care Of and National Investment Group — that “misrepresented the number of employees and the amount of revenue and payroll his companies had” to the banks...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

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

Washoe County Health District received doses from the same lot of Moderna’s coronavirus vaccine that California health officials have recommended providers stop administering after several people in the state experienced apparent severe allergic reactions...The health district administered doses from the same lot Moderna’s COVID-19 vaccine, 041L20A, to about 770 people at its drive-thru point of dispensing vaccination site...None of those individuals have reported severe allergic reactions, and there were no issues reported from patients who used the 15- and 30-minute waiting lots, which are set up to ensure that patients don’t experience any allergic reactions before driving off, after receiving the vaccine...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

President Donald Trump's Operation Warp Speed promised 20 million COVID-19 vaccines administered to Americans by the end of 2020. Halfway into January, the rollout is still lagging behind those expectations...But President-elect Joe Biden's team is planning to shake up how doses are delivered after he takes office next week. Rather than holding back supply to ensure people can get their second doses, the Biden administration plans to release all available doses...It’s a departure from the Trump team’s approach at a time when the coronavirus vaccine rollout is failing to meet the pace needed to stem the pandemic...READ MORE