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Covid-19: What next for the Valneva vaccine?

BMJ 2021; 375 doi: https://doi.org/10.1136/bmj.n2839 (Published 23 November 2021) Cite this as: BMJ 2021;375:n2839

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Rapid Response:

UK government's disturbing treatment of Valneva and its COVID-19 vaccine still under assessment by MHRA

Dear Editors

The UK government's treatment of matter relating to Valneva COVID-19 vaccine is shocking.

In Sept 2021, the health secretary Sajid Javid was quoted to have said of Valneva "it was also clear to us that the vaccine in question that the company was developing would not get approval by the Medicines and healthcare Products Regulatory Agency here in the UK" to the House of Commons.

Then on Hansard, the UK parliament's official record, this was amended to "the vaccine in question that the company was developing has not yet gained approval by the Medicines and healthcare Products Regulatory Agency here in the UK and may not".

Just a few days ago, Boris Johnson was quoted to have said "I was personally very disappointed when we couldn't get approval for the Valneva vaccine in the way we had hoped".

All these things being said negatively of the vaccine is even more surprising given that the MHRA is still actively assessing Valneva's submission (which started only in August 2021) in the same rolling submission process for other COVID-19 vaccines previously approved and that the company only incorporated the positive phase III results (announced in October 2021) into the MHRA submission in November 2021.

This significantly raises the question of political interference into MHRA's processes, and predetermined bias considering the Health Secretary made damaging comments before adequate results are made available.

As discussed in the article, the Valneva product is the "only whole virus, inactivated vaccine candidate in clinical trials against covid-19 in Europe".

One of the reasons for COVID-19 vaccine hesitancy worldwide is the concern about the relatively "new" technology involved in mRNA vaccine which account for the majority of vaccine rollout in the US, UK and the EU. The Valneva vaccine is developed from tried and tested technique, and although the product itself is still new, there is potentially less concern with unforeseen long term side effects, regarded by some as more predictable than the mRNA vaccine. Hence Valneva (whole inactivated) and Novavax (recombinant nanoparticle spike protein) both of "conventional" technology and relatively good efficacy, may be more acceptable to some who are hesitant with current vaccine products against COVID-19 (as opposed to those who are largely against most vaccines of communicable diseases).

Furthermore Valneva may be helpful as suggested in the article in the booster vaccination rollout with heterologous products of different technology. The cancellation of the Valneva contract may very well be a premature decision that will haunt the Johnson govenrment

Lastly as a whole virus vaccine, it may be to be effective over a period of time (as more COVID-19 variants emerge) than the designer vaccines mostly targeting the protein spikes that give SARS-CoV-2 its "corona" status

Competing interests: No competing interests

28 November 2021
Shyan Goh
Orthopaedic Surgeon
Sydney, Australia