Active ingredient

Purified, inactivated whole virus particles of wild-type SARS-CoV-2. The virus particles are grown in cultured Vero cells with high S-protein density and combined with two adjuvants: alum and CpG 1018. Adjuvants are entities that are added to the agent of interest (in this case inactivated SARS-CoV2 virus particles) to make it more immunogenic. (Lazarus et al. 2022)

Delivery vehicle

Not needed

Method of administration

Deltoid IM injection

Recommended schedule

Primary series: 2 injections, at least 28 days apart (European Medicines Agency 2022)

Booster: A booster dose of 0.5 ml may be given to individuals who completed the primary vaccination course with COVID-19 Vaccine (inactivated, adjuvanted) Valneva or an adenoviral vector-based COVID-19 vaccine (see sections 4.8 and 5.1). The booster dose should be administered at least 8 months after completing the primary vaccination course. (European Medicines Agency 2023)

Dosage per shot

Adult: 0.5 mL (European Medicines Agency 2023)

Ages

18-50 years (European Medicines Agency 2023)

Efficacy

Phase 1/2 and Phase 3 clinical trials have demonstrated that two doses of VLA2001 produces a rise in neutralizing antibodies against SARS-CoV2 at least as good as the ChAdOx1-S (AstraZeneca) vaccine. Antibody levels rise is dose-dependent, with higher vaccine doses producing higher antibody levels. The trials also have demonstrated that recipients of the VLA2001 vaccine produce T-cells reactive against the S, M and N proteins. (Lazarus, Taucher, Brown et al. 2022; Lazarus, Querton, Corbic Ramljak et al., 2022).

PREGNANCY & LACTATION

As with all approved COVID-19 vaccines, guidelines recommend use of Valneva in pregnancy, only “when the potential benefits outweigh potential risks for the mother and fetus.” Currently, the benefits of COVID-19 vaccination do outweigh potential risks both in pregnancy and lactation, other than in rare cases of people who previously have suffered allergic reactions to ingredients in the vaccine.

Relation to Pregnancy and Lactation

Pregnancy is considered to cause an elevated risk of developing symptomatic and severe COVID-19. This risk increases with the presence of additional health conditions such as elevated BMI, hypertension, diabetes, chronic pulmonary disease, and an immunocompromised state.

The European Medicines Agency warns that there is “no experience with use of COVID-19 Vaccine (inactivated, adjuvanted) Valneva in pregnant women.” However, the Agency also notes that studies in laboratory animals do not suggest that there should be any harmful effects particular to pregnancy, fetal or embryological development, labor, or postnatal life. As for lactation, it is unknown whether COVID-19 Vaccine (inactivated, adjuvanted, adsorbed) Valneva is excreted in human milk. (European Medicines Agency 2022)

There is no plausible mechanism supporting the idea that this vaccine might present a particular danger during pregnancy or lactation. Maternal vaccination against COVID-19 could help protect newborns and nursing infants. (COVID-19 Vaccines While Pregnant or Breastfeeding (cdc.gov)

Adverse effects

Injection site : pain, erythema, tenderness, swelling, itching

Systemic: fatigue, malaise, headache, muscle pain, fever, nausea/vomiting

No safety signal of concern was identified, meaning that there were no indications of life-threatening adverse effects (Lazarus, Taucher, Brown et al. 2022; Lazarus, Querton, Corbic Ramljak et al., 2022)

Pregnancy and Lactation Positions by Country for the VALNEVA Vaccine (VLA2001)

World Health Organization (WHO). The Valneva VLA2001 COVID-19 vaccine: What you need to know

Sources

Lazarus R, Taucher C, Brown C et al.; Valneva Phase 1 Trial Group. Safety and immunogenicity of the inactivated whole-virus adjuvanted COVID-19 vaccine VLA2001: A randomized, dose escalation, double-blind phase 1/2 clinical trial in healthy adults. J Infect. 2022 Sep;85(3):306-317. doi: 10.1016/j.jinf.2022.06.009. Epub 2022 Jun 16. PMID: 35718205; PMCID: PMC9212764.

Lazarus R, Querton B, Corbic Ramljak I et al.; Valneva phase 3 trial group. Immunogenicity and safety of an inactivated whole-virus COVID-19 vaccine (VLA2001) compared with the adenoviral vector vaccine ChAdOx1-S in adults in the UK (COV-COMPARE): interim analysis of a randomized, controlled, phase 3, immunobridging trial. Lancet Infect Dis. 2022 Sep 5: S1473-3099(22)00502-3. doi: 10.1016/S1473-3099(22)00502-3. EPUB ahead of print. PMID: 36075233; PMCID: PMC9444237.

European Medicine Agency. Summary of Product Characteristics COVID-19 Vacine (inactivated, adjuvanted) Valneva. Accessed May 15, 2023. https://www.ema.europa.eu/en/documents/product-information/covid-19-vaccine-inactivated-adjuvanted-valneva-epar-product-information_en.pdf

WHO SAGE Roadmap for prioritizing uses of COVID-19 vaccines. Accessed November 15, 2022

Centers for Disease Control and Prevention. COVID-19 Vaccines While Pregnant or Breastfeeding (Updated Oct. 20, 2022).