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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

In order to deliver COVID-19 vaccine to more people more quickly, the Trump administration intends to expedite rollout of its immunization partnership with pharmacies. The logic behind the concept is that getting vaccinated at a local pharmacy will be more accessible and efficient for many Americans than going to a hospital...READ MORE

With COVID-19 vaccine launches gaining steam—and an unprecedented level of media coverage zeroed in—pharma companies of all stripes should brace not only for a wave of adverse event reports, experts say, but for lawsuits that could follow...With tens of millions of Americans set to be vaccinated, including many people at high risk of severe COVID-19, it's not just vaccine makers who need to actively look out for potential adverse events or drug interactions, lawyers with Sidley Austin said...All pharma companies—not just those involved in COVID-19 vaccine deliveries—can expect “a significant increase in volume of reports over the coming months,” Torrey Cope, a partner in the firm's Food, Drug and Medical Device Regulatory practice, said in an interview...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

Nevada launched an updated COVID-19 data dashboard...providing the public with more local data about the impact of the coronavirus...The dashboard contains county-level data about testing, cases, hospitalizations and deaths. For the first time, the data on the page can be downloaded...The Nevada Department of Health and Human Services compiles and updates the data daily. It can be accessed at nvhealthresponse.nv.gov...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

China will provide COVID-19 vaccines free of charge once they become available to general public, government authorities said...an official with China’s National Health Commission, told reporters that while manufacturing and transport of vaccines does have costs, the government will still be able to provide vaccines for free to individuals...“Our people don’t have to pay a single cent for the vaccine,”...READ MORE

A new temporary clinic in Southern Nevada began administering COVID-19 antibody treatment on Friday, bringing new hope to lessen the severity of the virus and reduce the strain on local hospitals...Sunrise Hospital and Medical Center opened a Monoclonal Antibody Clinic with the support of the National Disaster Medical System and the U.S. Department of Health and Human Services. The clinic is expected to operate for four to six weeks but can be extended to match the community’s need...This is the third antibody infusion clinic in the country, with others opened in El Centro, California and Tucson, Arizona within the past two weeks...READ MORE