The European Commission approved Sanofi and GlaxoSmithKline’s COVID-19 booster vaccine VidPrevtyn Beta, the first next-generation, protein-based adjuvanted COVID-19 booster approved in Europe, for use in adults age 18 and older.
The vaccine includes the Beta variant antigen and GSK’s pandemic adjuvant and is indicated for adults who have previously received an mRNA or adenoviral vaccine.
“Today’s approval validates our research in developing a novel solution for the COVID-19 pandemic,” Thomas Triomphe, executive vice president, vaccines for Sanofi, said in a statement. “As we’re ready to start first shipments, VidPrevtyn Beta will be an important new option to protect propulations against multiple strains of COVID-19.”
Earlier this year, Sanofi and GSK announced positive results from two immunobridging trials of their booster–the VAT02 Immunogencity & Safety Study and the COVIBOOST (VAT013) study.
The studies showed that VidPrevtyn produced 15-fold antibodies against the D614 parent virus of COVID-19 and 30-fold against the Beta variant when used as a booster in adults with prior mRNA vaccinations.
Against the Omicron BA.1 variant, VidPrevtyn showed a 40-fold increase in antibody titers. Neutralizing antibodies were doubled compared to the booster vaccine based on the original parent COVID-19 virus against Omicron BA.1 and BA.2.
The COVIBOOST study was conducted by the Assistance Publique—Hôpitaux de Paris (AP-HP) included 247 adults aged 18 to 73.
The VAT02 showed that adverse events were mostly mild to moderate, transient and self-resolutive.
The VAT08 Stage 2 Efficacy & Safety Study found 64.7% efficacy against symptomatic SARS-CoV-2 infection, regardless of any prior infection and 75.1% efficacy among those who were previously infected with SARS-CoV-2.
“This EC approval is an important step in providing further vaccine solutions to Europe for the coming winter,” Philip Dormitzer, MD, PhD, global head of research and development, vaccines, at GSK, said in a statement. “Our protein-based, adjuvanted vaccine candidate has the potential to make an important contribution to public health as the pandemic evolves futhers.”
European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended authorization of the booster based on sufficiently robust data on the quality, safety and immunogenicity of the vaccine. The studies found the VidPrevtyn booster to be at least as effective as the Pfizer-BioNTech vaccine at restoring protection against COVID-19.
The most common adverse events were usually mild and cleared up after a couple of days, including pain at the injection site, headache, muscle or joint pain, feeling generally unwell and chills.
CHMP determined that a standard marketing authorization is appropriate for VidPrevtyn Beta after concluding that the benefits of the vaccine outweigh the potential risks.
VidPrevtyn Beta will continue to be monitored for safety and effectiveness.
U.S. federal funds from the Biomedical Advanced Research and Development Authority (BARDA), Administration for Strategic Preparedness and Response at the U.S. Department of Health and Human Services supported the studies of VidPrevtyn in collaboration with the U.S. Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and the National Institute of Allergy and Infectious Diseases (NIAID).
Other companies continue advancing development of COVID-19 boosters, including Vaxxinity’s UB-612, heterologous booster that recently began enrolment for phase 3 clinical trials and initiation of rolling submission to the Therapeeutic Goods Administration in Australia for provisional approval.