COVID-19 Update

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).

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

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

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

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

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.

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

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.

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.

Moderna’s vaccine is weaker against the Omicron variant, but boosters can increase neutralizing antibody levels by as much as 83-fold.

The agency recommended granting conditional marketing authorization for use of Nuvaxovid in people 18 years of age and older.

GlaxoSmithKline and Vir Biotechnology have received a conditional marketing authorization from MHRA for Xevudy (sotrovimab) in the treatment of COVID-19.

Moderna’s agreement with the UK government includes 29 million COVID-19 vaccine doses for delivery in 2022 and 31 million doses for delivery in 2023.

Partnerships formed during the COVID-19 pandemic have provided a platform for change in assay development and transfers that should continue in the future.

Samsung Biologics, GreenLight Biosciences, and Environmental Impact Acquisition Corp. have partnered to advance GreenLight’s mRNA COVID-19 vaccine candidate.

The companies are testing their existing vaccines against the new variant of concern and are pursuing variant-specific versions.

The Comirnaty vaccine received a positive opinion from the EMA’s CHMP for children five to under 12 years of age.

Samsung Biologics will manufacture GreenLight BioSciences' COVID-19 vaccine candidate for clinical trials and commercial sales.

FDA has amended its EUA for Pfizer-BioNTech’s and Moderna’s COVID-19 booster to include all individuals aged 18 or older.

EC has granted marketing authorization for Celltrion's Regkirona (regdanvimab, CT-P59) as a treatment for adults with COVID-19.

Novavax has announced that EMA has started its review of a conditional marketing authorization application for its COVID-19 vaccine, NVX-CoV2373.

The agency is recommending the authorization of Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab), two monoclonal antibody drugs, for treating COVID-19.

The agency is evaluating Moderna’s application for use of Spikevax in children aged 6 to 11.

The agreement will allow Birmingham Biotech to commercialize the University of Birmingham’s antiviral COVID-19 nasal spray.

The agency is reviewing data on the use of molnupiravir (MK 4482 or Lagevrio) for potential use to treat COVID-19 prior to authorization.