The UK Medicines and Healthcare products Regulatory Agency (MHRA) have announced approval of the Valneva COVID-19 vaccine after meeting the required safety, quality and effectiveness standards.
Prof Eleanor Riley, Professor of Immunology and Infectious Disease, University of Edinburgh, said:
“One particular advantage of the Valneva vaccine is that it is made up of the whole SARS-CoV-2 virus, not just the spike protein. This means that it will induce antibodies and T cell cells against many different components of the virus, including components that are much less susceptible to variation than the spike protein. It is possible, therefore, that this vaccine may provide better protection against new variants as they arise.
“The fact that the vaccine can be stored in a regular refrigerator will make it much easier to deploy in remote areas and in areas lacking resilient cold chains. Whilst the initial vaccine roll out is more or less complete in Europe and North America, there are still large areas of Africa, Asia and South America where vaccination rates remain woefully low; anything that eases access to vaccine in these areas will be hugely valuable.
“Approval of this vaccine by the MHRA may not make an immediate difference to vaccination programmes in the UK, but may ease the path for approval of the vaccine in countries that are still in desperate need.”
(Please note this is not a third-party comment, see full declaration of interests below)
Dr Juan Carlos Jaramillo, Valneva’s Chief Medical Officer, said:
“VLA2001 is the first whole-virus, inactivated COVID-19 vaccine to gain regulatory approval in the UK. Inactivated vaccines are a well-established technology used over the last seventy years to vaccinate billions – including for seasonal flu, polio and rabies. Valneva receives messages every day from people who are keen to receive our inactivated COVID-19 vaccine, and we believe that it could help increase coverage – particularly with those who are hesitant about novel technologies.
“In an inactivated vaccine, the virus is killed but the whole virus envelope is preserved, so compared to those COVID-19 vaccines that target only the spike protein, VLA2001 has the potential to provide an added benefit by boosting T-cell responses against additional SARS-CoV-2 proteins. In a pivotal Phase 3 trial (https://valneva.com/press-release/valneva-reports-positive-phase-3-results-for-inactivated-adjuvanted-covid-19-vaccine-candidate-vla2001/), VLA2001 demonstrated superiority in terms of neutralizing antibody titer levels against a licensed COVID-19 vaccine (AZD1222), as well as non-inferiority in terms of seroconversion rates and a significantly better tolerability profile.
“In order to gradually expand the label and indications of VLA2001 to further age groups, Valneva is currently conducting additional clinical studies, including for potential use as a homologous and heterologous booster vaccine in the course of 2022. Additionally, VLA2001 has shown a positive homologous boosting effect 7 to 8 months after primo-vaccination (https://valneva.com/press-release/valneva-announces-positive-homologous-booster-data-for-inactivated-adjuvanted-covid-19-vaccine-candidate-vla2001/) and lab studies have confirmed its ability to neutralize the initial Wuhan strain as well as Omicron and Delta variants (https://valneva.com/press-release/valnevas-inactivated-covid-19-vaccine-candidate-shown-to-neutralize-omicron-variant/), highlighting its potential for broad-spectrum protection.”
Prof Paul Hunter, Professor in Medicine, UEA, said:
“Valneva (VLA2001) is a whole inactivated virus vaccine with adjuvant. Other examples of inactivated viral vaccines include the current poliovirus, hepatitis A, some influenza vaccines and Rabies vaccines. So this could make the vaccine more acceptable to those people who reticent about using one of the mRNA or DNA vector vaccines. In this regard it is similar to the Sinovac vaccine.
“There is very little peer-reviewed data that I can find on the vaccine, though a few company press releases, but it is said to be well tolerated and effective. The vaccine as full and half dose was included in the COV-BOOST study (Munro AP, Janani L, Cornelius V, Aley PK, Babbage G, Baxter D, Bula M, Cathie K, Chatterjee K, Dodd K, Enever Y. Safety and immunogenicity of seven COVID-19 vaccines as a third dose (booster) following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK (COV-BOOST): a blinded, multicentre, randomised, controlled, phase 2 trial. The Lancet. 2021 Dec 18;398(10318):2258-76” did look at both a half and full dose VLA2001 as a booster dose and found them to be well tolerated. Both doses should give some boost to anti spike IgG especially in people who previously had two doses of Oxford/AZ but somewhat less after Pfizer. Cellular immunity responses were not that impressive compared to the other vaccines.
“So it is difficult to know how effective the vaccine will be in use compared with the other vaccines, either as a primary course or as a booster especially with omicron. Personally I do not think it will find a lot of use in the UK as the vast majority of people in the UK have either been vaccinated with what appears to be more effective vaccines or had at least one covid infection and many have had both vaccine and an infection. It may find more use in low income countries because it is likely to be easier to store and transport than some of the other vaccines.”
(Please note this is not a third-party comment, see full declaration of interests below)
Prof Adam Finn, Professor of Paediatrics, University of Bristol, and Chief Investigator of the Valneva vaccine clinical development programme in the UK, said:
Is this good news?
“This is an important step forward in several ways. It is the first stringent regulatory authority (MHRA/EMA/MHRA) for this vaccine, thus a critical milestone towards WHO emergency use authorisation.
“It is also the first approval of a COVID19 vaccine based on immunogenicity (compared to an already-authorised vaccine), thus a pointer towards approval of future novel and reformulated vaccines.
What evidence was this authorisation based on; is the evidence robust?
“Phase 1-3 safety and immunogenicity data (compared to AZ vaccine).
“To get MHRA authorisation it’s safe to say data need to be robust.
How does the Valneva vaccine work; is it different to other approved vaccines?
“It’s an inactivated whole virus vaccine (analogous to inactivated polio vaccine for example). Other vaccines used in the UK and Europe only contain/express Spike (S) protein, not the whole virus. Valneva also contains a novel adjuvant called CpG which increases the size of immune responses including cell mediated immune responses (also known as T cell responses).
Does the data suggest Valneva is ‘as good as’ the other COVID-19 vaccines we already have?
“The data show viral-neutralising antibody responses that are, on average, higher than those to the licensed AZ vaccine. This vaccine also results in lower rates of common side effects than observed after mRNA and AdVactor vaccines.
Are there any factors that make the Valneva vaccine better/ more preferable than the other ones?
“The vaccine is less reactogenic (common short term side effects – sore arms, headaches, fevers) than mRNA and AdV vaccines. Antibody responses – at least post priming doses – are as good as or better than AZ. T cell responses to several viral antigens are observed – the importance of these for protection are not yet known. Evidence on effectiveness against infection and severe disease will only become available once the vaccine has been widely used.”
Is it important to still approve COVID-19 vaccines even though we already have multiple approved vaccines; why?
“It’s a good idea to have several types of vaccine and several vaccines of each type. This increases supplies, increases alternative supplies (so reducing unexpected shortages), increases the numbers of options in terms of effectiveness over time and safety as experience grows.
As it’s approved for only 1st and 2nd doses in 18-50 year-olds, who / how many people will be eligible to take this vaccine in the UK?
“Unlikely to be available in the UK in the near future at least as the government cancelled its contract to buy the vaccine last year.
Why is it this group / doses that are approved and not a wider age range or third/booster doses?
“Only data on this age group and priming doses have been seen and approved by MHRA, hence the approval.
Is there still more data to come from the Valneva trial?
“Yes data in the elderly and following boosters are in the pipeline and will reach regulators in the near future.”
All our previous output on this subject can be seen at this weblink:
Prof Eleanor Riley: “No COI.”
Dr Juan Carlos Jaramillo is the Chief Medical Officer of Valneva and a member of the Company’s Management Board.
Prof Adam Finn is Chief Investigator of the Valneva vaccine clinical development programme in the UK. He receives no remuneration for this work over and above his salary from the University of Bristol and has no personal or family financial or intellectual property assets related to this company or any other vaccine developer or manufacturer.
AF is an investigator in several COVID19 vaccine trials and studies including Oxford-AstraZeneca, Pfizer, Janssen and Valneva vaccines and several UK government-funded studies involving more than one vaccine. He is U.K. Chief Investigator Sanofi COVID19 booster vaccine trial. He is an advisor to the UK government as a member of JCVI. He chairs the WHO Euro Technical Advisory Group of Experts and is a member of the WHO Special Advisory Group of Experts Working Group on COVID19 vaccines. He undertakes consultancy work for several vaccine developers. He receives no personal remuneration for any of this work, owns no IP or stocks and shares and is paid only in his role as Professor of Paediatrics at the University of Bristol.
No others received