Biopharma Update on the Novel Coronavirus: December 1

CV Update_December 1

News information is not all-inclusive and updates are published once a week on Tuesdays. 

 

FDA Actions

The FDA scheduled a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on December 17 to discuss the EUA request for Moderna’s COVID-19 vaccine.

Diagnostics Update: To-date the FDA has authorized 291 individual EUAs, which include 225 molecular tests, 59 antibody tests and 7 antigen tests.

 

Testing Therapies, Antivirals and Vaccines

Moderna announced that it plans to submit its request to the U.S. Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) for its COVID-19 vaccine, mRNA-1273. The company completed its primary efficacy analysis of the Phase III trial on 196 confirmed cases, which confirmed the high efficacy seen in the first interim analysis. At that analysis, the company reported 94.5% efficacy. The new analysis suggests 94.1% efficacy.

As concerns continue to grow over the efficacy of AstraZeneca’s experimental COVID-19 vaccine, the pharma giant could be heading toward conducting additional studies. Another clinical study could confirm the 90% efficacy data that stemmed from accidental use of a half-dose in an arm of its Phase III trial.

Convalescent plasma as a treatment for COVID-19 infections has demonstrated mixed results at best in terms of efficacy, and a recent trial in Argentina provides additional fuel to that conversation. The study showed the use of convalescent plasma provided no clinical benefit nor improved mortality in COVID-19 patients with pneumonia.

Last week, Gaithersburg, Maryland-based Altimmune submitted an Investigational New Drug (IND) application to the FDA to launch a Phase I trial of its AdCOVID single-dose intranasal COVID-19 vaccine candidate. They hope to begin the clinical trial in December.

BioVaxys announced titer analysis from its completed murine mouse model study demonstrated that two doses of its COVID-19 vaccine, BVX-0320, induced high levels of antibodies against the S1 fragment of the SARS-CoV-2 spike protein.

Novavax reported two of its three planned late-stage trials of its COVID-19 vaccine, NVX-CoV2373, are fully enrolled, with more than 20,000 participants having been dosed. The Phase III UK trial has completed enrolments of 15,000 participants. The South Africa Phase IIb trial is now fully enrolled with a total of 4,422 volunteers. The U.S./Mexico pivotal Phase III trial is expected to begin soon.

 

Organizational Actions/Announcements 

Pfizer and BioNTech announced they have submitted a formal Application for Conditional Marketing Authorization (CMA) to the European Medicines Agency (EMA for their COVID-19 vaccine, BNT162b2.

 

Other Industry News

With both the Pfizer-BioNTech and Moderna's COVID-19 vaccines at the U.S. Food and Drug Administration (FDA) for potential Emergency Use Authorization (EUA), airlines are preparing their cargo operations to ship the vaccines.

Every week there are numerous scientific studies published. Here’s a look at some of the more interesting ones including how COVID-19 hijacks the host cell. 

As the U.S. government’s Operation Warp Speed works to coordinate distribution of vaccines, top officials indicated they had allocated 6.4 million doses of vaccines to states based on their total populations. Specifically, based on the total number of adults in the state.

As the Pfizer-BioNTech COVID-19 vaccine is being evaluated by the U.S. Food and Drug Administration (FDA) and the Moderna vaccine is soon to follow, here’s a look at several of the top COVID-19 vaccine candidates and where they stand as of last week. 

India’s Dr. Reddy's Laboratories, Inc. partnered with the Russian Direct Investment Fund (RDIF) to begin a Phase II/III study for Russia’s Sputnik V vaccine. The study will be a multicenter and randomized controlled study. Recently, RDIF announced the second interim analysis of clinical trial data, which showed 91.4% efficacy for the vaccine on day 28 after the first dose; vaccine efficacy over 95% 42 days after the first dose.

GlaxoSmithKline made a $1 million donation to Direct Relief on behalf of consumers who have purchased its consumer healthcare products since the onset of the COVID-19 pandemic. The donation will be used to purchase personal protective equipment and essential medical items for U.S. health workers on the front line dealing with the pandemic. Since January, Direct Relief has delivered more than 46 million N95 and surgical masks, more than 8 million gloves, and tens of thousands of protective suits and other items to help safeguard health workers.

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