Covid-19 Update

The guidance provides recommendations for data and information needed to support an EUA for COVID-19 vaccines.

The study, entitled CV-NCOV-002, is being held in Peru and Panama and has enrolled 690 participants, including older adults ages 61 and above, and younger participants 18 to 60 years old.

The agency sent an open letter to European Ombudsman Emily O’Reilly affirming the agency’s intention to apply the same standards to the evaluation of COVID-19 treatments as it does to other medicines.

The European Medicines Agency has started a rolling review of AstraZeneca’s COVID-19 vaccine.

Fill/finish inspection for vaccine vials and syringes must remain GMP-compliant while aiming for fast, efficient methods.

Misleading messages contribute to eroding trust in public health agencies

The Serum Institute of India will receive upfront capital to expand manufacturing capacity, pending vaccine approval, to ensure distribution.

The 60,000-ft2 facility was built using CRB’s ONEsolution project delivery method and was designed to expand GRAM’s large-scale fill/finish capacity.

Par Sterile will produce the vaccine for use in Novavax's Phase III clinical trial in the United States, while also providing fill/finish services for commercial distribution in the US.

A clinical trial to enroll up to 10,000 volunteers across the UK will assess whether NVX-CoV2373 is effective in the prevention of COVID-19.

UK's Prime Minister visited the site of the country’s VMIC in Oxfordshire, and met the teams working at the forefront of the national COVID-19 response.

A Phase III trial to evaluate safety and efficacy of Janssen’s COVID-19 vaccine candidate, JNJ-78436735, also known as Ad26.COV2.S, is enrolling participants on three continents.

Thermo Fisher will handle the technical transfer of the lenzilumab bulk drug substance process, with commercial scale production potentially beginning before the end of 2020.

The Korean MFDS has given its approval for Celltrion to initiate a Phase II/III trial of its anti-COVID-19 monoclonal antibody treatment candidate, CT-P59.

The companies will receive upfront funding from the European Union for the scale-up of manufacturing capabilities at industrial sites in Belgium, Italy, Germany, and France.

Fears about overly accelerated development programs has heightened demands for wider access to information on study protocols, statistical analysis plans, and early results.

The collaboration will expand the manufacturing capacity for lenzilumab, a COVID-19 therapeutic candidate, in advance of a potential Emergency Use Authorization in 2020.

The agreement will Increase global manufacturing capacity for Novavax’s vaccine candidate, NVX-CoV2373, to more than two-billion annualized doses when at full capacity in 2021.

The agreement between the two companies will significantly increase global supply capacity for Lilly's potential COVID-19 treatments.

The Russian Direct Investment Fund has announced three deals with India, Brazil, and Mexico, for the supply of doses of Sputnik V, a potential COVID-19 vaccine.

The companies aim to scale up production of Eli Lilly’s potential COVID-19 antibody therapies, pending regulatory approval.

BioNTech plans to produce up to 250 million doses of its COVID-19 vaccine candidate, BNT162b2, in the first half of 2021.

Valneva will supply the UK government with an initial 60 million doses of the vaccine in the second half of 2021, if successful, and will provide more doses thereafter.

The funding will help advance the vaccine’s clinical evaluation, potential marketing authorization, development and manufacturing in Germany, and the number of participants in late-stage clinical trials.

In addition to increasing production, Thermo Fisher will create 1000 jobs across its global manufacturing sites to further automation capabilities and optimize warehouse and sterilization capacity.

The temporary guidance discusses the resumption of normal manufacturing during the COVID-19 pandemic.

Clinical trials for AZD1222 coronavirus vaccine resume in the UK as per guidance by MHRA.

In an opinion article, FDA leaders commit to applying “the best science” to approval decisions.