Valneva undergoes non-inferiority trial against AZ - Potentially available by fall.


For those in the UK and Europe, there is a new vaccine that will hopefully be available to you by the end of the year. The French vaccine company Valneva has made an inactivated whole-virus vaccine with two adjuvants. One is the very old adjuvant alum, used in flu shots, and also may be familiar to you as something in your kitchen to add to eggs to make meringue, or to pickle brine for crispness. The other is CpG 1080, which is made of little bits of a particular DNA sequence that are known to highly stimulate the immune system, because the immune system takes them as evidence of a bacterial infection.

The hope is that the whole-virus approach will give a broader T-cell response, especially against the variants.

Because the trial is happening in the UK, where the AZ vaccine is widely available, they are doing a non-inferiority trial against AZ. That is, all of the trial participants are getting a vaccine. One-third of participants over 30 will get AZ, and two-thirds will get Valneva. All of the participants under 30 will get Valneva. A non-inferiority trial is one where you test a new treatment in hopes of showing that it is no worse than an already-approved treatment. Presumably the reason all the young people are getting the new vaccine is to look for side effects.

The primary outcomes that they are looking for are antibody levels and side effects. They are not looking for efficacy. Apparently whatever regulatory body they will apply to is only requiring that they show antibody levels are at least as good as those from AZ, and that it is reasonably safe. This means that the trial will happen quickly, and they are hoping to get approval in the UK and EU in the fall.

Given their study design, it doesn't sound like they plan to apply to the FDA any time soon, so I don't think that this one will be available in the US.

India is actually now using a vaccine that is very similar to the one made by Valneva. It's an inactivated form of the first SARS CoV-2 to make it to India. It has two adjuvants, alum and a newer one. It's not as good as the RNA vaccines, but still about the same as having antibodies from infection, which is pretty good.

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