Vaccines

Bayer will support the development and supply of CureVac’s COVID-19 vaccine candidate, CVnCoV.

Intravacc and Cristal Therapeutics have entered into a strategic collaboration for the development of novel vaccine programs against human diseases.

Amid pressure to get more vaccines administered faster, FDA pushes back against changes in dosing regimens.

The companies have entered into an agreement to support the formulation and fill/finish of Moderna’s COVID-19 vaccine supply outside of the United States.

Part of Operation Warp Speed, the trial will enroll 30,000 people ages 18 to 64 and 65 and older at 115 sites.

Outsourcing increases as the industry balances development and manufacturing of both COVID-19 treatments and non-pandemic-related medicines.

Shutting down the COVID-19 pandemic requires a global, selfless effort.

Boreas from Telstar are -86 ºC ultra-low-temperature freezers developed to house COVID-19 vaccines.

Administration of the COVID-19 vaccination from Oxford University and AstraZeneca is expected to begin in the UK in early 2021.

A report in the New England Journal of Medicine states preliminary results from a Phase III clinical trial shows the vaccine is 94.1% effective.

The agency is organizing a second public meeting on January 8, 2021 to discuss the assessment, approval, and roll-out of new COVID-19 vaccines.

Moderna’s mRNA vaccine to prevent COVID-19 disease is granted FDA Emergency Use Authorization and CDC recommendation.

A decision by the European Commission on conditional marketing authorization for the European Union’s first COVID-19 vaccine is expected soon.

The agency is answering frequently asked questions about the Pfizer–BioNTech COVID-19 vaccine on its website.

FDA is expected to issue Emergency Use Authorization for Moderna’s vaccine, enabling immediate distribution.

A newly developed polymer, DynaShield, may have the capability to ensure global access for COVID-19 treatment and prevention.

The company has formed an agreement with the Ministry of Health of Singapore to supply mRNA-1273, Moderna’s COVID-19 vaccine candidate, to the people of Singapore.

The HERALD trial will involve participants 18 years and older who will receive a two-dose schedule of CVnCoV or placebo at multiple sites is Europe and Latin America.

EUA marks a milestone in COVID-19 vaccine development and is hailed as a turning point in pandemic fight.

Success in combatting the pandemic depends on the ability of manufacturers to quickly and efficiently produce and distribute the huge quantities of vaccines demanded by the United States government and public health organizations around the world.

Committee recommends Emergency Use Authorization of first mRNA-based COVID-19 vaccine; FDA approval is pending.

Evonik offers lipid nanoparticles for gene-based drug development and manufacturing.

The company has received $500 million in funding from Sino Biopharmaceutical for further development, capacity expansion, and manufacturing of CoronaVac, its COVID-19 vaccine candidate.

CDMO HALIX will manufacture the drug substance for AstraZeneca’s COVID-19 vaccine candidate, AZD1222, at commercial scale at its cGMP facility in the Netherlands.

Janssen announces rolling submissions for its COVID-19 vaccine with Health Canada and EMA.

The COVID-19 pandemic has accelerated the need for modular designs to rapidly expand vaccine production capacity.

The investment will expand and upgrade manufacturing capacity and technology for pre-fillable syringes and will also includes a new manufacturing facility in Europe.

Transparency and open-dialogue are vital to sway the vaccine-hesitant community.

Moderna has filed for authorization for its COVID-19 vaccine candidate, which has shown high efficacy and safety in a Phase III trial.

Wacker will support production of CureVac’s COVID-19 mRNA-based vaccine candidate at its biotech site in Amsterdam, with production scheduled to start in the first half of 2021.