Active ingredient

The vaccine is a recombinant, adjuvanted vaccine sold under the name VidPrevtyn Beta and manufactured by Sanofi in partnership with GlaxoSmithKline. VidPrevtyn Beta is indicated as a booster for active immunization to prevent COVID-19 in adults and is approved by the European Medicines Agency (EMA) and by Medicines and Healthcare products Regulatory Agency (MHRA) in the UK, as of the preparation of this fact sheet in June 2023.

There is no virus in the vaccine, nor does it contain genetic instructions in the form of RNA or DNA. Instead, the active portion of the vaccine is a genetically engineered portion of a protein that is present in the disease-causing agent, in this case a portion of the spike protein of SARS-CoV2 (the virus that causes COVID-19). Once produced with genetic engineering, the protein subunit is attached to another molecule, called an adjuvant, that enhances the protein subunit’s ability to trigger an immune response.

Delivery vehicle

Not needed

Method of administration

IM injection (preferred site: deltoid muscle)

Recommended schedule

Booster: at least 4 months following the prior vaccination series with either mRNA or adenoviral vector COVID-19 vaccines.

Dosage per shot

Booster: 5µg of B.1.351 antigen

Ages

18 years and older

Efficacy

Efficacy of VidPrevtyn Beta has been inferred by immunobridging of immune responses to an authorized COVID-19 vaccine, for which vaccine efficacy has been established.

The clinical immunogenicity of VidPrevtyn Beta given as a first booster injection was evaluated in two clinical studies: VAT00013 in COVID-19 mRNA vaccine-primed participants and VAT00002 Cohort 2, Beta arm that included participants primed with various types of COVID-19 vaccines.

PREGNANCY & LACTATION

With all approved COVID-19 vaccines, guidelines recommend their use in pregnancy, only “when the potential benefits outweigh potential risks for the mother and fetus.”

Animal studies do not show any harmful effects in pregnancy; however, data on the use of VidPrevtyn Beta during pregnancy are very limited.

The decision on whether to use the vaccine in pregnant women should be made in close consultation with a healthcare professional after considering the benefits and risks.

Although there are no studies on breast-feeding, no risk for breast-feeding is expected.

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 body mass index (BMI), hypertension, diabetes, chronic pulmonary disease, and an immunocompromised state.

Maternal vaccination against COVID-19 can help protect newborns and nursing infants. While COVID-19 vaccination during pregnancy and boosting of COVID-19 vaccination during pregnancy have been expected to protect the fetus and neonate by way of IgG antibodies and IgA antibodies, recent research has confirmed the former. Pregnant women and lactating women have elevated concentrations of anti-SARS-CoV2 IgG antibodies in their plasma.

IgG is the type of antibody that crosses the placenta, thus entering the plasma of the fetus. In maternal plasma, IgG levels rise within a few weeks of the woman receiving the first shot of the primary series of a vaccine and rise to higher levels after the second shot. Over the course of several months, IgG levels fall gradually, but within a few weeks of a booster dose, they rise again. Consequently, if a woman receives the booster, or the primary series, during the beginning to middle of the third trimester of her pregnancy, the fetus will receive passive immunity in the form of IgG antibodies. Since these antibodies persist for many months in the blood, the newborn will benefit from protection for many months.

IgA is the type of antibody typically present in secretions, including breast milk. While research suggests that anti-SARS-CoV2 IgA levels drop quickly in breast milk in women who have been immunized against SARS-CoV2, the same research shows that high levels of anti-SARS-CoV2 IgG are present in breast milk and persist. Considering all the above, COVID-19 vaccines, including the Sanofi-GSK vaccine, should benefit the newborn, if the mother receives them during pregnancy, especially during the third trimester (but at least a few weeks prior to delivery).

Adverse effects

The most common side effects with VidPrevtyn Beta (which may affect more than 1 in 10 people) are pain at the injection site, headache, muscle or joint pain, feeling generally unwell and chills. Nausea (feeling sick), diarrhoea, fever, tiredness, reddening or swelling at the injection site may affect less than 1 in 10 people. Lymphadenopathy (enlarged lymph nodes), and itching, bruising or a warm sensation at the injection site may affect less than 1 in 100 people.

Allergic reactions may occur with VidPrevtyn Beta. As for all vaccines, VidPrevtyn Beta should be given under close supervision with appropriate medical treatment available.

Sources

Heidary M, Kaviar VH, Shirani M, Ghanavati R, Motahar M, Sholeh M, Ghahramanpour H, Khoshnood S. A Comprehen-sive Review of the Protein Subunit Vaccines Against COVID-19. Front Microbiol. 2022 Jul 14;13:927306. doi: 10.3389/fmicb.2022.927306. PMID: 35910658; PMCID: PMC9329957.

Sanofi Pasteur. VAT00008 CoV2 preS dTM-AS03 Protocol Version 3.0. Accessed January 24, 2023

VidPrevtyn Beta COVID-19 booster vaccine, developed by Sanofi and GSK, approved for use in Great Britain. Accessed January 24, 2023

Press release: Sanofi and GSK’s next-generation COVID-19 booster vaccine VidPrevtyn® Beta approved by the European Commission. Accessed January 24, 2023

Sanofi: Positive preliminary booster data for their COVID-19 vaccine candidate and continuation of Phase 3 trial. Accessed January 24, 2023

Scramming F, Campisciano G, Comar M, Ragazzon C, Davanzo R, Quadrifoglio M, Giangreco M, Stabile G, Ricci G. IgG and IgA Antibodies Post SARS-CoV-2 Vaccine in the Breast Milk and Sera of Breastfeeding Women. Vaccines (Basel). 2022 Jan 16;10(1):125. doi: 10.3390/vaccines10010125. PMID: 35062786; PMCID: PMC8778843.

Summary of manufactured Products Characteristics (SmPC): https://www.ema.europa.eu/en/documents/product-information/vidprevtyn-beta-epar-product-information_en.pdf. Accessed May 26, 2023

VidPrevtyn Beta | European Medicines Agency (europa.eu): https://www.ema.europa.eu/en/medicines/human/EPAR/vidprevtyn-beta#overview-section. Accessed May 26, 2023