COVID-19 Update

Despite the COVID-19 pandemic disruptions, with continued support and industry resilience, the European bio/pharma outlook for 2021 is positive.

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.

President Trump signed the COVID-19 package, which appropriates $2.3 trillion to finance the federal government through September 2021 and provides support for individuals and entities suffering from the economic crisis wrought by the pandemic.

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.

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.

A report, launched by Takeda UK, has shown that despite the increase in media attention, COVID-19 has had little positive impact on the perception of pharmaceutical companies.

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.

The European Medicines Agency has launched a full investigation into a cyberattack.

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.

Pfizer-BioNTech details its case for Emergency Use Authorization for "highly effective" COVID-19 vaccine.

A longer-than-expected scale up of raw materials forces Pfizer to cut 2020 vaccine production in half.

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

Pharmaceutical laboratories must keep lab data integrity practices in mind in order to properly handle the effects of the COVID-19 pandemic.

After a difficult year, bio/pharma science delivers promising results.

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

MHRA has granted a temporary authorization for emergency use to Pfizer and BioNTech for the mRNA vaccine against COVID-19.

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

A holistic approach to validation and quality assurance is essential.

FDA granted fast track designation for AB201, a small recombinant protein that is a potent, selective inhibitor of tissue factor, for the potential treatment of COVID-19.

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.