COVID-19 Update

Evonik has increased its global supply of plant-derived cholesterol used for mRNA vaccines and gene therapies.

Continuous improvements in technologies and services will help cold chain operators meet future industry demand.

Although the bio/pharma supply chain has vulnerabilities that still need to be addressed, the COVID-19 pandemic has left lasting effects—some of them for the better.

FDA has revised the Emergency Use Authorization for sotrovimab.

EMA has recommended approval of Spikevax for children aged 6 to 11.

Pfizer and BioNTech receive positive opinion for COVID-19 vaccine booster in adolescents 12 through 17 years of age in the EU.

TFF Pharmaceuticals announces findings that inhaled niclosamide significantly inhibits viral replication of the Omicron variant of SARS-CoV-2.

Medicago and GSK have announced that Health Canada has approved COVIFENZ, an adjuvanted plant-based COVID-19 vaccine.

Alvea has begun preclinical testing of a scalable, shelf-stable DNA vaccine against SARS-CoV-2 variants.

Moderna and Thermo Fisher Scientific have formed a collaboration to leverage dedicated commercial fill/finish manufacturing capacity in the US for mRNA vaccines and therapies.

Sanofi and GSK announce they are seeking regulatory authorization for COVID-19 vaccine.

Novavax announces the first doses of Nuvaxovid COVID-19 vaccine have begun shipping to European Union member states.

The turnkey facilities will promote scalable vaccine production for an end-to-end manufacturing network for mRNA-based vaccines in Africa.

Health Canada authorizes Novavax COVID-19 vaccine for individuals 18 years of age and older.

The company has announced plans to establish a commercial presence in six European countries.

FDA has granted Eli Lilly and Company’s bebtelovimab, a monoclonal antibody designed for treatment of COVID-19, an Emergency Use Authorization (EUA).

Guidance published during the pandemic has been updated to include content requirements for summary safety reports.

The agency’s safety committee is assessing reported cases of period irregularities associated with Comirnaty and Spikevax mRNA vaccines.

EMA has started its evaluation of an application for the use of a booster dose of Comirnaty in adolescents aged 12–15 years.

Although mRNA and viral vector vaccines have been top of mind for COVID-19 treatments, other technologies and treatments are emerging—along with new variants.

The global nature of the COVID-19 pandemic emphasizes the critical importance of expanded vaccination.

As company revenues are gaining a boost from COVID-19, the issue of pricing is being debated once more.

Both Pfizer and Moderna have started clinical trials for their respective Omicron COVID-19 variant vaccine.

A report by international regulators reviews the effectiveness of current COVID-19 vaccines against the omicron variant.

The agency’s COVID-19 task force says latest data shows use of COVID-19 mRNA vaccines during pregnancy is safe.

Protective external packaging ensures COVID-19 vaccines arrive safely.

FDA amended it’s Emergency Use Authorization to shorten Moderna’s vaccine booster dose interval from six to five months.

Intravacc is partnering with Leiden University Medical Center for the development and evaluation of a new intranasal coronavirus vaccine candidate in a clinical Phase I/II study.

The agency is expanding the use of a single booster of the Pfizer-BioNTech vaccine to children ages 12–15 and is shortening the time between primary vaccination and booster to at least five months.

FDA authorized emergency use of Pfizer’s oral antiviral drug to make the drug available as quickly as possible.