This webpage was published on 18 August 2022.
The Valneva vaccine is a purified, inactivated, and adjuvanted whole virus SARS-CoV-2 vaccine.
The WHO Strategic Advisory Group of Experts on Immunization (SAGE) has issued interim policy recommendations for the use of the Valneva (VLA2001) vaccine. This article provides a summary of those interim recommendations.
For the purposes of this article, the vaccine will be referred to as Valneva or the Valneva vaccine.
The background documents are also available here.
Who can take the vaccine?
The vaccine is safe and effective for all individuals aged 18 to 50 years. In line with the WHO Prioritization Roadmap and the WHO Values Framework, older adults, health workers and immunocompromised persons should be prioritized.
Should pregnant and breastfeeding women be vaccinated?
Given the adverse consequences of COVID-19 disease during pregnancy and the favorable safety profile of Valneva, WHO recommends the use of Valneva in pregnant individuals. WHO does not recommend pregnancy testing prior to vaccination. WHO does not recommend delaying pregnancy or terminating pregnancy because of vaccination.
Vaccine effectiveness is expected to be similar in breastfeeding women as in other adults. WHO recommends the use of the vaccine in breastfeeding women as in other adults. WHO does not recommend discontinuing breastfeeding because of vaccination.
Who is the vaccine not recommended for?
Due to limited data on the immunogenicity of this vaccine in persons aged 50 years and above, the Valneva vaccine is not recommended for this age group. Similarly, there is no data on efficacy or safety for persons below the age of 18 years for this vaccine. Vaccination of individuals below 18 years of age with this vaccine is therefore currently not recommended.
People who have an anaphylactic reaction following the first dose of the VLA2001 vaccine should not receive any further doses of the same vaccine.
Anyone with an acute febrile illness (i.e. with a body temperature >38.5 ºC) should postpone vaccination until they are afebrile.
Is it safe?
SAGE has thoroughly assessed the data on quality, safety and efficacy of the vaccine and has recommended its use for people aged 18 to 50. Safety data is limited for persons over 50 years of age.
How efficacious is the vaccine?
It is no longer considered ethical to ask a group of people to remain unvaccinated for participation in efficacy trials. To counter this, WHO, national and international regulators, as well as manufacturers have agreed to evaluate new vaccines on the basis of immunogenicity data.
In the pivotal clinical immunogenicity study, people 30 years and older who received Valneva produced more neutralizing antibodies and had about the same seroconversion as people who received the Oxford/AstraZeneca COVID-19 vaccine (ChAdOx1-S [recombinant] vaccine), following two doses of the vaccine. People 18 to 29 years who received Valneva produced even more neutralizing antibodies, following two doses of the vaccine. There were only 3 people over the age of 50 and therefore data are limited for people above 50 years. These results indicate that it likely provides sufficient protection against COVID-19 for people 18 to 50 years of age.
What is the recommended dosage?
The recommended primary vaccine series is 2 doses (0.5 ml each dose) given intramuscularly. The second dose is recommended to be administered at least 28 days after the first dose.
Is a booster dose recommended for this vaccine?
In accordance with the WHO Prioritization Roadmap, a booster dose is recommended for the highest and high priority-use groups (i.e. older adults, health workers, persons with comorbidities), administered 4–6 months after completion of the primary series. If more than 6 months have elapsed since completion of the primary series, the booster dose should be given at the earliest opportunity.
Can this vaccine be ‘mixed and matched’ with other vaccines?
The Valneva vaccine cannot be used as a heterologous booster post primary vaccination with a mRNA vaccine.
The Valneva vaccine can be considered as a heterologous booster post primary vaccination with ChAdOx1-S.
There are no data for the use of the Valneva vaccine as a heterologous booster after primary vaccination series with inactivated and protein-based vaccines; until such data become available its use as a heterologous booster post primary vaccination with inactivated or protein-based vaccines are currently not recommended.
Does it prevent infection and transmission?
There is currently no data available related to the impact of the Valneva vaccine on the transmission of the virus that causes COVID-19 disease.
In the meantime, we must maintain and strengthen public health measures that work: masking, physical distancing, handwashing, respiratory and cough hygiene, avoiding crowds, and ensuring good ventilation.
Does it work against new variants of SARS-CoV-2 virus?
Studies are ongoing to evaluate the ability of Valneva to neutralize variants of the SARS-CoV-2 virus. Initial results are available and indicate that the Valneva vaccine produces fewer neutralizing antibodies against the Delta and Omicron variants, indicating it provides less protection against these variants.
How does this vaccine compare to other COVID-19 vaccines already in use?
It is impossible to compare vaccines head-to-head due to the different approaches taken in designing the respective studies, but overall, all of the vaccines that have been recommended by SAGE are highly effective in preventing severe disease and hospitalization due to COVID-19.
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