Covid-19 roundup: Novavax vaccine authorized in EU for teens; CEPI backs Codiak's efforts on betacoronavirus shot
Seven months after the European Commission granted conditional approval to Novavax’s Covid-19 vaccine Nuvaxovid in adults, the biotech is back with a new European authorization.
Novavax announced Tuesday that the EC approved expanding the vaccine’s conditional marketing authorization to include adolescents ages 12-17. The biotech got a positive CHMP opinion on using the vaccine in that age group almost two weeks ago.
The biotech reported that the authorization was based on data from the pediatric expansion of a Phase III trial, which achieved its primary “effectiveness endpoint” and reported 80% clinical efficacy.
Novavax added that preliminary safety data from the trial showed the vaccine to be “generally well-tolerated” with a few types of adverse reactions. Those included injection site tenderness/pain, headache, myalgia, fatigue, and malaise.
“With this authorization, we are extremely pleased to be able to offer our Nuvaxovid COVID-19 vaccine to adolescents in the EU,” Novavax CEO and president Stanley Erck said in a statement.
Investors sent the share price $NVAX up 7% after the market opened Tuesday.
While FDA approval of Nuvaxovid is pending, an adcomm thought it had potential, voting 21-0 with one abstention last month to recommend emergency authorization of the vaccine.
CEPI partners with Codiak on vaccine R&D against family of coronaviruses
CEPI (Coalition for Epidemic Preparedness Innovations) is now announcing the next recipient of seed funding amid its push for pandemic preparedness and investing in vaccine development.
The coalition and Codiak BioSciences announced a partnership Tuesday to “advance the development of vaccines that provide broad protection against SARS-CoV-2 (including its variants) and other Betacoronaviruses.” Betacoronaviruses are one of four types of coronaviruses, and include SARS-CoV-2, along with the viruses that cause SARS and MERS.
CEPI will provide seed funding of up to $2.5 million to Codiak, pushing vaccine candidates from its “pan-Betacoronavirus program” through preclinical research.
Codiak’s share price $CDAK went up slightly, just short of 4% after the market opened.
CEPI had previously laid out an ambitious five-year plan amidst international support to lay the groundwork against future pandemics. That plan included a goal to compress vaccine development timelines to 100 days, develop a universal vaccine against Covid-19 and other viruses and, according to CEPI, create a reservoir of vaccine candidates ready to test against pathogens.
While Codiak is still a smaller company, it has a bigger reach thanks to Lonza, which acquired Codiak’s manufacturing facility last year.
Codiak’s candidate so far, exoVACC, uses exosomes, a type of extracellular vesicle that can contain protein, DNA and RNA to stimulate an immune response involving multiple forms of immunity, such as antibody and T-cell-mediated immunity.
Codiak CSO Sriram Sathyanarayanan celebrated the partnership, saying the company expects it “will fund the completion of preclinical development and identification of a clinical candidate for our pan Betacoronavirus program.” Other details, such as timelines or financial specifics, remain undisclosed.