- Fierce JPM Week: Will AZ’s coronavirus vaccine turn a profit this year? It’s ‘too speculative’ to predict, exec says (fiercepharma.com)
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 to provide COVID-19 vaccines free of charge: government official (reuters.com)
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
- Las Vegas becomes third U.S. city with federally supported clinic offering COVID-19 antibody treatment (thenevadaindependent.com)
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
- Becton Dickinson, ramping up syringe capacity, set to turn out 1B COVID-19 vaccine devices by year-end (fiercepharma.com)
With more than 1 billion BD injectors called for in the global fight against COVID-19, the company is looking at ways to support vaccination efforts up close and preparing for the future delivery of pandemic prophylactics...Becton Dickinson...last month surpassed 1 billion pandemic injection device orders globally...The company recently stumped up $1.2 billion to expand its pre-filled syringe capacity, sketching plans for a new plant in Europe, plus upgrades to six of the company’s existing sites in the U.S., Mexico, Europe and Japan. Those moves are expected to boost capacity by more than 50%...The company also teamed up with BARDA on a $70 million project to expand operations and dial up capacity for traditional needle and syringe devices at its Nebraska facilities. That upgrade, set to wrap in summer 2021, will provide the feds with priority access to “hundreds of millions” of injectors for COVID-19 vaccination efforts, plus supplies for future pandemics...READ MORE
- Biden aims to release all available COVID-19 shots in departure from Trump strategy (fiercepharma.com)
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
- Trump administration accelerating launch of COVID-19 vaccinations in pharmacies (pharmacist.com)
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
- Look out, pharma. A ‘tidal wave’ of side effect reports is coming amid COVID-19 vaccine rollouts (fiercepharma.com)
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
- FDA Reviewing Effects of COVID-19 Variants on Diagnostic Tests (drugtopics.com)FDA Issues Alert Regarding SARS-CoV-2 Viral Mutation to Health Care Providers and Clinical Laboratory Staff (fda.gov)
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’s revised COVID dashboard has better county-level details (reviewjournal.com)
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
- Not so fast: FDA warns of ‘premature’ changes to COVID-19 vaccine dosing in clash with Slaoui (fiercepharma.com)
The FDA warns against changing the dosing levels and schedules of COVID-19 vaccines by Moderna and Pfizer-BioNTech...Amid concerns over limited COVID-19 vaccine supplies, some have proposed tweaking the shots’ dosing to immunize more people. One suggestion came from none other than U.S. vaccine czar Moncef Slaoui, Ph.D...Any changes to currently authorized vaccine dosing regimens pose a “significant risk of placing public health at risk” and undermine “the historic vaccination efforts to protect the population from COVID-19,” FDA Commissioner Stephen Hahn, M.D., and Peter Marks, M.D., Ph.D., head of the agency’s biologics department, said in a statement...READ MORE