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On November 9, Pfizer announced that its COVID-19 vaccine candidate demonstrated efficacy of over 90% based on the mix of 94 cases between the placebo and vaccine groups in its Phase 3 clinical trial...Some of us had wondered about the timing of the announcement, given that the results far exceeded the primary efficacy endpoint of only 50% (with appropriate statistical confidence intervals) set by the FDA for a successful vaccine, and Dr. Fauci's concurrence that 50% would be acceptable...READ MORE

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

Indian Prime Minister Narendra Modi has urged states that are witnessing a surge in coronavirus cases to establish cold storage facilities for COVID-19 vaccines...India is home to some of the world’s biggest vaccine makers and there are five vaccine candidates under different phases of trial here. But the state-run cold chain facilities used to keep some vaccines consistently refrigerated would be inadequate for the enormous challenge of rolling out a COVID-19 vaccine...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

AstraZeneca is the latest player to unveil early COVID-19 vaccine data, and results seem to show an efficacy gap between at least one of its vaccine regimens and those of its two mRNA-based peers. But while investors may be less than enthused with the data, the vaccine does sport a major advantage in logistics given its much warmer storage needs...AstraZeneca's COVID-19 vaccine candidate, dubbed AZD1222, can be stored and transported at normal refrigerated temps of 2 degrees to 8 degrees Celsius (36 degrees to 46 degrees Fahrenheit) for at least six months and can be administered in "existing healthcare settings," giving the shot a major logistics leg up over a leading mRNA-based competitor that requires ultra-cold storage...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