Valneva COVID shot shelf life extended; gets EMA nod for booster; shows efficacy in trials
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Valneva (NASDAQ:VALN) said the shelf life of its COVID-19 vaccine VLA2001 was extended by regulators to 21 months from 18 months previously, while providing clinical and regulatory updates for the vaccine.
The French company had previously noted that it will not invest in further development of the vaccine, due to lack of new partnership.
The company, however, is completing remaining clinical studies and filings as agreed with regulators.
Booster Nod by European Medicines Agency (EMA) panel:
On Feb. 23 the EMA's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for using VLA2001 as a booster in adults 18 years to 50 years of age, at least seven months after primary vaccination (the second dose) with VLA2001 (homologous booster dose) or with an adenoviral vector COVID-19 vaccine (heterologous booster dose).
Phase 3 Study - VLA2001-301:
In addition, the company said that data from a phase 3 trial, dubbed COV-Compare (VLA2001-301), showed neutralizing antibodies on Day 208 (six months after primary vaccination with VLA2001) were non-inferior to the active comparator AZD1222, an adenoviral vector vaccine.
AZD1222 vaccine is AstraZeneca's (AZN) COVID vaccine.
Valneva added that the fold decline of neutralizing antibodies over six months after a second VLA2001 shot was similar to the active comparator, and less pronounced than for other COVID-19 vaccines.
The T-cell response against the spike protein elicited upon VLA2001 vaccination was in the same range as for the active comparator, according to the company.
Phase 3 study - VLA2001-304:
Data from the trial â which enrolled older adults, 56 years of age and above â showed that VLA2001 was well tolerated by when given as a two-dose or three-dose immunization. This confirmed the previously reported favorable safety profile of the vaccine, the company noted.
However, in this age group, a two-dose VLA2001 was inferior in terms of geometric mean titers and seroconversion rates compared to younger adults aged 30 years and above.
Valneva added that after two doses, immunogenicity in older adults was at a level that could be correlated with 60-70% vaccine efficacy versus ancestral SARS-CoV-2.
Meanwhile, a third shot of VLA2001 increased immunogenicity in people aged 56 years and above to the titers linked with vaccine efficacy of >90% against ancestral novel coronavirus.
Shelf Life:
Valneva noted that it will continue to submit data to further extend the shelf life of VLA2001. The vaccine's shelf life was recently extended to 21 months compared to 18 months previously.