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As a tide of late-stage data rolls in on COVID-19 vaccines from Pfizer, Moderna and AstraZeneca, the U.S. is gearing up for reviews that could see a vaccine authorized and deployed before the year is out. On Saturday, the chief of the White House's Operation Warp Speed effort laid out a definitive timeline, setting expectations for when the public could expect at least two shots to become available...Moderna will file for an emergency nod for its mRNA-based vaccine candidate before the month is out, Moncef Slaoui, Ph.D., head of "Warp Speed" and former vaccine chief at GlaxoSmithKline, said...That submission will segue straight into a Dec .17 data review, with the aim to ship vaccines to distributors within 24 hours of approval and potentially start vaccinations two days after the advisory panel makes its call, Slaoui said...READ MORE

To help pharmacists advise people on COVID-19 tests, FIP has...issued a guidance document produced by its SARS-CoV-2 Testing Working Group, which has evaluated the diagnostic testing methods and devices currently available...The document covers how different types of diagnostic tests work and the interpretation of results. It also addresses the question of whether or not the presence of antibodies confers immunity to SARS-CoV-2, and makes recommendations on information to give to patients who have tested positive or negative...READ MORE

...Pfizer and its German partner BioNTech said they plan to apply Friday to the Food and Drug Administration for an emergency use authorization for their Covid-19 vaccine, a watershed moment in the effort to curb the global pandemic...It is unclear how long the FDA will take to review the application, though the agency is expected to move swiftly. Agency officials have pledged to seek advice from an expert panel of outside experts, the Vaccines and Related Biological Products Advisory Committee...before ruling on the application. VRBPAC members have been asked to hold three days in December as potential meeting dates...READ MORE

...FDA issued an emergency use authorization to Eli Lilly for the investigational monoclonal antibody therapy bamlanivimab to treat mild to moderate COVID-19 in adult and pediatric patients...Bamlanivimab is authorized for patients ages 12 years and older who test positive for SARS-CoV-2 virus, weigh at least 40 kg, and are at high risk for progressing to severe COVID-19 and/or hospitalization. It is also authorized for adults ages 65 years or older or those who have certain chronic medical conditions...READ MORE

NHS England is preparing for the huge task of delivering COVID-19 vaccines, including through community pharmacies...Delivery of a COVID-19 vaccine to the public will require the participation of “as many of the workforce who are trained in vaccination as possible” from community pharmacy...Jill Loader, deputy director of pharmacy commissioning at NHS England and NHS Improvement, said there were “a number of different ways community pharmacy can get involved” in the COVID-19 vaccine delivery programme, with some community pharmacies expected to be commissioned as a vaccination site through a locally enhanced service...“We anticipate that we are going to need to use as many of the workforce who are trained in vaccination as possible,” she said...READ MORE

As planning for the distribution of a COVID-19 vaccine begins in earnest, experts say policymakers should include value-based pricing in those considerations...Pricing for value would ensure drug companies and other firms are able to continue to innovate new ways to address the virus without lining their pockets with billions in profits off of a critical vaccine...The researchers say COVID-19 vaccines and therapies will likely require a hybrid pricing approach that cribs from multiple strategies, but measuring value is key for policymakers to "consider the full costs and benefits of products and the wide-ranging ramifications of their actions."...READ MORE

U.S. regulators...allowed emergency use of the first rapid coronavirus test that can be performed entirely at home and delivers results in 30 minutes...The announcement by the Food and Drug Administration represents an important step in U.S. efforts to expand testing options for COVID-19 beyond health care facilities and testing sites. However, the test will require a prescription, likely limiting its initial use...The FDA granted emergency authorization to the single-use test kit from Lucira Health, a California manufacturer...The company’s test allows users to swab themselves to collect a nasal sample. The sample is then swirled in a vial of laboratory solution that plugs into a portable device. Results are displayed as lights labeled positive or negative...READ MORE

With Moderna and Pfizer both reporting sky-high response rates to their COVID-19 vaccines, the pressure is on federal health officials to ensure a rapid—but smooth—rollout. Wednesday, they unveiled a detailed timeline that provides some clues about when most Americans can expect to be vaccinated...High-priority populations such as healthcare workers and nursing home residents could obtain COVID-19 vaccines in December...The key to distributing the vaccines to older Americans quickly is a distribution deal the government struck with Walgreens and CVS last month. Last week, more agreements were formed with pharmacy chains and independent pharmacies...Warp Speed has been fostering the development of six additional COVID-19 vaccines...Moderna expects to ship 20 million doses for use in the U.S. by the end of this year and up to 1 billion worldwide next year. Pfizer is gearing up to ship 50 million doses this year...READ MORE

Moderna reported...that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has started a rolling review of mRNA-1273...CHMP’s decision to commence the rolling review of data on mRNA-1273 has been based on the preliminary results from non-clinical and early clinical studies, which have suggested the vaccine has an efficacy of 94.5%. The rolling review will be performed by the committee until there is sufficient data to support a formal marketing authorization application...READ MORE

More good news emerged from the COVID-19 vaccine front, with Moderna Inc. reporting that its candidate, mRNA-1273, has met the statistical criteria pre-specified in the study protocol for efficacy in an interim analysis, with efficacy of 94.5%. The product is an mRNA vaccine encoding for a prefusion stabilized form of the Spike protein...Moderna plans to submit for an emergency use authorization from the FDA in the weeks ahead, and expects the application will be based on the final analysis of 151 cases with a median follow-up of more than two months. The study enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the NIH and the Biomedical Advanced Research and Development Authority...READ MORE