Coronavirus Update: Moderna Ready For Interim Analysis, Brazil Resumes SinoVac Trial

Plus a plant-derived COVID-19 vaccine moves into Phase II/III

Moderna's vaccine has reached the requisite number of cases to trigger a Phase III interim analysis and Brazil allows SinoVac's trial to resume after a serious adverse event, but AstraZeneca's Calquence fails to show any benefit in hospitalized COVID-19 patients. Medicago and GSK also report vaccine progress and the RDIF strikes another production deal.  

Coronavirus
Trial Progress And New Production Deals • Source: Shutterstock

The Phase III study of Moderna, Inc.’s mRNA vaccine against SARS-CoV-2 has reached the threshold of cases needed to perform the first interim analysis.

In an 11 November statement, Moderna said it expected to submit data on more than 53 cases from the COVE study of the mRNA-1273 vaccine – the trigger point for an interim analysis – to the data safety monitoring board (DSMB), which will then analyze the data and issue a recommendation. The company remains blinded to whether the participants received the vaccine or placebo

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from COVID-19

Arcturus and CSL Take on Pfizer With Longer-Lasting COVID Vaccine

 
• By 

Kostaive is the first self-amplifying mRNA COVID-19 vaccine to receive approval from the European Commission and could provide serious competition to Pfizer/BioNTech's Comirnaty and Moderna's Spikevax.

Under-Pressure Moderna Banks $590m To Speed Up Bird Flu Vaccine

 
• By 

A week after a downbeat forecast at J.P. Morgan Healthcare Conference, the US mRNA specialist has pocketed another sizeable sum from the US Department of Health and Human Services to accelerate development of an H5N1 mRNA pandemic influenza vaccine.

Stock Watch: Q3, Bonfire Of The Vaccine Manufacturers

 
• By 

Pfizer’s and Moderna’s quarterly pandemic-related product sales could not mask other weaknesses while GSK’s quarter was marred by unimpressive non-pandemic vaccines sales.

Meiji Considers Legal Action Amid Japan Misinformation On Kostaive Vaccine

 
• By 

Japanese distributor Meiji Seika Pharma is considering possible legal action against what it views as online slander around COVID-19 vaccine Kostaive, which received its global-first approval in Japan last year and has now been launched for regular vaccination in the country.

More from Scrip

HHS Intensifies Pressure On Pharma With MFN Pricing Benchmark

 

The Trump administration released more details on “most favored nation” price targets drug companies are expected to apply to US drug prices.

Asia Deal Watch: Lilly Partners With Rznomics On Hearing Loss

 

Plus deals involving Minghui/Qilu, LENZ/Lotus, Amicus/Dimerix, Sanofi/Dr. Reddy’s, Henlius/Lotus, Apnimed/Desitin, Formosa/Saval, DAAN/GC Cell, VelaVigo/Ollin and Sol-Gel/Mayne.

Boehringer’s Next Generation IPF Drug Underwhelms

 

The company hoped its follow-up to blockbuster Ofev could clearly improve efficacy and safety benefits, but the full Phase III results from nerandomilast’s FIBRONEER-IPF fall short of a slam dunk.