Tags : vaccine

GSK Signs an Agreement with Vir Biotechnology to Develop Solutions

Shots: GSK will make equity investment to gain access to Vir’s technology of $250M, priced at $37.73 (a 10% premium to closing share price on March 27, 2020). The equity investment and collaboration will complete at the same time & are conditional upon customary conditions including regulatory review by appropriate regulatory agencies under Hart-Scott-Rodino Act […]Read More

BioNTech and Pfizer Initiates Rolling Submission to EMA for SARS-CoV-2

Shots: The Rolling Submission is based on the preliminary results from pre-clinical and early clinical studies in adults, which shows that BNT162b2 triggers the production of neutralizing antibodies and TH-1 dominant CD4+ and CD8+ T cells that target SARS-CoV-2. BioNTech and Pfizer plan to work with the EMA’s CHMP to complete the rolling review process […]Read More

Novavax Initiates P-III Study of its COVID-19 Vaccine in the

Shots: Novavax has initiated a P-III study assessing the efficacy, safety, and immunogenicity of NVX-CoV2373 vs PBO in Matrix-M in up to 10,000 individuals aged 18-84yrs. with/out relevant comorbidities, over the next 4-6wks. Half the participants will receive two IM injections of a vaccine comprising 5µg of protein antigen with 50µg Matrix‑M adjuvant, administered 21 […]Read More

J&J Initiates Global P-III Clinical Study of its COVID-19 Vaccine

Shots: The initiation of the ENSEMBLE trial follows positive interim results of P-I/IIa study demonstrating the safety and immunogenicity of JNJ-78436735 following a single vaccination. The results have been submitted to medRxiv and expected to be published imminently The P-III ENSEMBLE study is designed to assess the safety & efficacy of a single vaccine dose […]Read More

Pfizer and BioNTech Plan for Regulatory Review of its COVID-19

Shots: The companies have shared additional P-I safety and immunogenicity data from their ongoing US study of the BNT162b2 against SARS-CoV-2, which has advanced into P-II/III evaluation. Across all populations, BNT162b2 was well tolerated with mild to moderate fever in fewer than 20% of the participants In P-I study, BNT162b2 (@7days after the second dose […]Read More

EC Concludes Exploratory Talks with J&J to Supply 200M Doses

Shots: The EC has the contractual framework in place to purchase the initial 200M doses on behalf of all EU Member States once the vaccine has proven safe and effective. The agreement includes an option to purchase up to an additional 200M dose If approved, the EC expects to facilitate a process for the allocation […]Read More

AstraZeneca to Initiate Production of its COVID-19 Vaccine Early in

Shots: AstraZeneca collaborates with the Mexican and Argentinean governments to initially produce 150M doses of the vaccine and eventually make at least 400M for distribution throughout the region The price for the vaccine is not final but it is expected not to exceed $4/ dose. The vaccine will initially supply to all Latin American countries […]Read More

Johnson & Johnson Signs an Agreement with the US Government

Shots: The US government will pay over $1B for 100M doses of its potential COVID-19 vaccine, Ad26.COV2.S, for use in the US following the US FDA’s EUA The government may also purchase additional 200M doses of Ad26.COV2.S under a subsequent agreement. The company is evaluating one- and two-dose regimens, in its clinical program for the global […]Read More