Vaccine Development and Manufacturing

The companies have entered into an advance purchase agreement with COVAX to provide up to 40 million doses of the Pfizer-BioNTech COVID-19 vaccine, BNT162b2, to lower-middle-income countries.

The drug offers immediate post-exposure protection against the virus and will serve as a counterpart to the vaccine during its early phases.

Since FDA authorization of two innovative mRNA vaccines to combat COVID-19 in late 2020, 30 million doses have been distributed, but only 4 million people were vaccinated in December 2020, and just 13 million have received shots so far.

Baxter will provide commercial-scale manufacturing services at its Halle/Westfalen, Germany facility to prepare Novavax’s COVID-19 vaccine candidate for distribution in the United Kingdom and European markets.

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

The company plans to deliver initial doses by mid-2021, and Australia will have the option to purchase up to 10 million additional doses through the agreement.

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.

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

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.

After a hectic 2020, biopharma looks to deliver on COVID-19 vaccines and move other promising therapies forward.

Packaging and transporting large quantities of COVID-19 vaccines pose challenges for the cold chain.

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.

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

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.

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.

Freezers, shipping containers, and tracking systems aid distribution of COVID-19 vaccines.

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.

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