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GSK, Sanofi Seek Approval of COVID-19 Vaccine for Adults
In other COVID news, Novavax announces the first shipments of COVID-19 vaccine to EU member states and Australia grants provisional registration to Moderna’s vaccine.
GSK and Sanofi recently announced that they will submit data from their Phase 3 efficacy and booster trials for regulatory approval of their COVID-19 vaccine.
The Phase 3 VAT08 efficacy study evaluated a 10- microgram antigen formulation of the COVID-19 vaccine for efficacy, immunogenicity, and safety compared to placebo in over 10,000 participants 18 years of age and older.
In the study, researchers found that two doses of the Sanofi-GSK vaccine were 57.9 percent effective against symptomatic COVID-19, 100 percent effective against severe disease and hospitalizations, and 75 percent effective against moderate-to-severe disease in the seronegative population.
Neutralizing antibodies increased 84- to 153-fold compared to pre-boost levels when the vaccine was used as a two-dose primary series followed by a booster. Specifically, the vaccine elicited GMTs reaching 3711 units.
Additionally, a booster dose induced a notable increase in neutralizing antibodies of 18- to 30-fold across in participants who previously received a primary series of an FDA-authorized mRNA vaccine.
These results come at the heels of the company’s Phase 2 trial, VAT02, which found strong rates of neutralizing antibody response with 95 percent to 100 percent seroconversion following a second injection in all age groups and across all doses.
“We’re very pleased with these data, which confirm our strong science and the benefits of our COVID-19 vaccine. The Sanofi-GSK vaccine demonstrates a universal ability to boost all platforms and across all ages,” Thomas Triomphe, executive vice president of Sanofi, said in the announcement.
“We also observed robust efficacy of the vaccine as a primary series in today’stoday’s challenging epidemiological environment. No other global Phase 3 efficacy study has been undertaken during this period with so many variants of concern, including Omicron, and these efficacy data are similar to the recent clinical data from authorized vaccines,” Triomphe continued.
Novavax Announces First Shipments of COVID-19 Vaccine to EU
Novavax recently announced that the first doses of its COVID-19 vaccine, Nuvaxovid, have been shipped to European Union (EU) member states.
The first wave of shipments includes several countries, including Germany, France, and Austria.
“Today's announcement paves the way for vaccination with Nuvaxovid to begin in Europe within the coming days. The Novavax COVID-19 vaccine provides a differentiated option to bolster vaccination rates across Europe,” Stanley C. Erck, president and CEO of Novavax, said in the announcement.
“Nuvaxovid has demonstrated efficacy, a reassuring safety and tolerability profile, and is built on a well-understood protein-based vaccine platform used for other vaccines for decades,” Erck continued.
In December 2021, The European Commission (EC) granted conditional marketing authorization for Nuvaxovid to prevent COVID-19 in individuals 18 years of age and older. The authorization followed the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommendation to authorize the vaccine in all 27 EU member states.
Novavax and the EC have an advanced purchase agreement for up to 100 million doses of Nuvaxovid with the option for an additional 100 million doses.
Australia Grants Provisional Registration to Moderna’sModerna’s COVID-19 Vaccine
The Therapeutic Goods Administration (TGA) in Australia recently granted provisional registration to Moderna’s mRNA COVID-19 vaccine, mRNA-1273, for children aged six to 11 years of age.
Moderna submitted data from the ongoing KidCOVE study to the TGA. The study is currently evaluating the safety, tolerability, reactogenicity, and effectiveness of two 50 microgram doses of mRNA-1273 in healthy children.
Researchers divided the study population into three age groups, six to under 12 years of age, two to under six years of age, and six months to under two.
In October 2021, two doses of mRNA-1273 demonstrated a robust non-inferior neutralizing antibody response in children six to under 12 years of age compared to individuals 18 to 25 years of age.
The geometric mean ratio (GMR) comparing the response in children to the response in young adults was 1.5, with a seroresponse rate of 99.3 percent. Overall, two 50 microgram doses of mRNA-1273 were generally well tolerated.
“The TGA authorization for the use of our COVID-19 vaccine in children 6-11 years old in Australia is an important milestone for Moderna as it is the first regulatory authorization for the use of our vaccine in this age group,” Stéphane Bancel, CEO of Moderna, said in the announcement.
