VALNEVA (VLA2001) - vaccine against COVID-19 (inactivated, with adjuvant)

Valneva was recommended by the EMA’s Committee for Medicinal Products for Human Use on 23 June 2022 for a standard EU-wide authorisation. The European Commission will issue a decision shortly.

COVID-19 vaccine (inactivated, with adjuvant) Valneva is a vaccine to protect people aged 18 to 50 years against coronavirus disease 2019 (COVID-19).  It is used for primary vaccination.

The vaccine contains whole particles of the original SARS-CoV-2 strain (the virus that causes COVID-19), which has been inactivated (killed) and cannot cause the disease.

How is the vaccine administered?

It is administered in two injections, usually into the muscle of the upper arm, 4 weeks apart.

How does the vaccine work?

Valneva works by preparing the body to protect itself from infection with SARS-CoV-2. It contains the original SARS-CoV-2 strain, which has been inactivated and cannot cause the disease. The vaccine also contains two adjuvants (aluminium and cytosine phospho-guanine), substances that help strengthen the immune response to the vaccine.

When a person is given the vaccine, their immune system identifies the inactivated virus as foreign and produces antibodies and T cells against it. If the vaccinated person later comes into contact with SARS-CoV-2, the immune system will recognize the virus and be ready to defend against it. Antibodies and immune cells can protect against COVID-19 by working together to kill the virus, prevent it from entering body cells, and destroy infected cells.

What benefits of the vaccine have been shown in studies?

The main study compared the immune response elicited by Valneva with that elicited by the approved COVID-19 Vaxzevria vaccine.

The results of the study, which involved nearly 3,000 people aged 30 years and older, showed that the COVID-19 (inactivated, adjuvanted) Valneva vaccine induced the production of higher levels of antibodies against the original SARS-CoV-2 strain compared to Vaxzevria. In addition, the proportion of individuals producing high levels of antibodies was similar for both vaccines. Additional data from this study also showed that the vaccine was as effective at triggering antibody production in people aged 18 to 29 years as it was in people aged 30 years and older.

Based on the data provided, it was not possible to draw a conclusion about the immunogenicity of Valneva’s vaccine (its ability to induce antibody production) in people over 50 years of age.

There are limited data on the immunogenicity of the vaccine against dangerous variants, including sub-variants of Omicron, which are the dominant strains in many EU countries at the time of authorisation.

Based on the available data, we can say that Valneva is well tolerated with relatively few adverse reactions as a primary course or as a booster dose. Therefore it is safe.

The vaccine is also effective, but probably not as effective as some other vaccines available, especially the iRNA vaccines.

As with other available COVID vaccines, there is likely to be some protection against infection with Omicron, although it will not be for long. Fortunately, protection against severe disease from Omicron should be more durable.

Most available vaccines against COVID-19 target the spike protein, the part of the virus that binds to the host cell, allowing the virus to infect the cell. While VLA2001 is based on the hereditary Wuhan coronavirus, the authors of a recent preprint argue that because whole-virus vaccines generate immunity to the entire virus, not just the spike protein, such vaccines may perform better against novel escape variants such as Omicron.

There is certainly some basis for this assumption, but we don’t yet know if it will prove to be the case.

Can children be vaccinated with Valneva?
Valneva is not currently approved for use in people under the age of 18. The EMA has agreed a plan with the company to test the vaccine in children at a later stage.

Can immunocompromised PEOPLE be vaccinated with Valneva?

There are no data on immunocompromised people (people with weakened immune systems). Although immunocompromised people may not respond well to the vaccine, there are no particular safety concerns. Immunocompromised people may still be vaccinated as they may be at higher risk from COVID-19.

Can pregnant or breastfeeding women be vaccinated with Valneva?

Animal studies have not shown any harmful effects during pregnancy; however, data on the use of Valneva during pregnancy are limited.

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

It is currently unknown whether the vaccine is present in breast milk. Breastfeeding women should consult their health care professional before being vaccinated.

Can people with allergies be vaccinated with Valneva?

People who already know they have an allergy to one of the vaccine components listed in the leaflet should not receive the vaccine. People who are allergic to yeast-derived components should also not receive the vaccine as yeast is used to produce one of the vaccine ingredients.
Cases of anaphylaxis (severe allergic reaction) have occurred in people receiving vaccines against COVID-19. Therefore, as with all vaccines, the COVID-19 vaccine (inactivated, adjuvanted) Valneva should be administered under strict medical supervision, with appropriate medical treatment. People who have a severe allergic reaction when given the first dose of vaccine should not receive the second dose.

How well does Valneva work for people of different ethnicities and genders?

The immune response elicited by the vaccine in the main study was sustained across genders. Participants in the main study were predominantly of European descent; however, there is no reason to assume that the immune response elicited by Valneva will vary across ethnicities.

What are the risks associated with the vaccine?

The most common side effects with Valneva are mild and improve within a few days after vaccination. These include headache, muscle pain, tenderness and pain at the injection site, fatigue and nausea. They may affect more than 1 in 10 people.

Itching, hardening, swelling and redness of the skin at the injection site, oropharyngeal pain (mouth and throat) and fever may occur in less than 1 in 10 people.

Lymphadenopathy (enlarged lymph nodes), dizziness, paresthesia (sensations such as tingling, tingling, pins and needles), dysgeusia (taste disturbance), syncope (fainting), hypoesthesia (decreased sensation of touch, pain and temperature), migraine, diarrhea, (abdominal) pain, hyperhidrosis (excessive sweating), rash, limb pain, muscle cramps, joint pain, and blood tests showing an increase in the sedimentation rate of red blood cells (which may indicate inflammation) are uncommon side effects (affect less than 1 in 100 people).

Thrombocytopenia (low blood platelet levels), photophobia (abnormal sensitivity of the eyes to light), urticaria (itchy rash), and thrombophlebitis (inflammation in a vein leading to a blood clot) are rare side effects (affect less than 1 in 1,000 people ).

Why is Valneva approved in the EU?

Based on data comparing the immune response elicited by Valneva with that elicited by an authorised vaccine against COVID-19, the EMA concluded that the vaccine is expected to be at least as effective as a comparative protection against the disease in people aged between 18 and 50 years.

However, based on the data provided, it was not possible to conclude on the immunogenicity of the vaccine in people over 50 years of age; therefore, the vaccine is currently recommended for use only in people between 18 and 50 years of age. In terms of safety, the most common adverse reactions to Valneva are mild and improve within a few days after vaccination.

The EMA has therefore decided that the benefits of Valneva outweigh the risks and that it can be authorised for use in the EU.