Valneva COVID vaccine

[camper2]

I have heard very little about this vaccine (manufactured in Scotland?) and wondered if anyone knew more about it and whether it would be useful for us immunosuppressed people on the likes of Acalabrutinib. Would it be better than Pfizer? Is it approved yet?

[bennevisplace]

Not yet approved but very likely to be, here in the UK (contrary to Sajid Javid, self appointed drug regulator) and also in Europe. This is based on strong phase 3 trial results just released. It looks like HM Gov prematurely canned the Valneva supply contract.bbc.co.uk/news/health-58952...

[kensim9]

Not to be too political, but Boris doesn't like France & Scotland. 😁, hopefully will be approved as more traditional way of making vaccine with less need for frozen storage. 😀

[bennevisplace in reply to kensim9]

Yes Valneva technology is like AZ's and it performed better in trials. Being a year or so late to market its market share will be price sensitive I guess.

Edit 1: Valneva needs a sales deal to be able to demonstrate real-world superiority of its vaccine, i.e. protection against variants of concern that is stronger and longer. To that end Pfizer, Moderna and Astrazeneca are (said to be) developing improved versions of their respective vaccines.

Edit 2: Valneva technology is not like AZ's. Rather than genetic code for spike protein, VLA2001 delivers inactivated whole virus plus an adjuvant. But like ChAdOx1 it can be stored at fridge temperatures.

[SERVrider]

Now the EMA has relocated to Amsterdam and covers only the hated EU, our esteemed Health Secretary won't pay any attention to any EMA approval. The MHRA will do its own approvals as and when.

[SeymourB]

camper2 -

Valneva is an inactivated virus vaccine, so should be safe for immunocompromised people for whom a live virus vaccine might lead to an actual infection. It's a 2 dose vaccine, and they want to also use it as a booster. All that depends on approvals.

precisionvaccinations.com/v...

This is the main Phase III trial - it compares VLA2001 Vaccine To AZD1222 (ChAdOx1) Vaccine, and is called COV-COMPARE:

clinicaltrials.gov/ct2/show...

There's also a trial in older people in New Zealand:

clinicaltrials.gov/ct2/show...

I don't see a preprint for them yet on biorxiv.org/ the main preprint server for biology.

As far as whether it would be significantly better for those in treatment on BTKs, I doubt it. It might be somewhat better when compared to ChAdOx1 based on press reports of progress in normal people, but I wouldn't expect it to be dramatically better, since both vaccines work similarly.

One difference, I think, is that Valneva's VLA2001 has adjuvants.

valneva.com/research-develo...

An adjuvant is an additive to a vaccine that irritates the innate immune system. Compared to a non-adjuvanted vaccine like ChAdOx1, and adjuvant causes more immune cells to come to the scene of the injection, and then take pieces of viral vaccine and damaged cells to show to the B-cells and T-cells. So it's an easy way to boost a vaccine's strength without adding more of the inactivated virus itself.

Valneva has a press report with preliminary trial results that tout higher titers and better tolerability compared to ChAdOx1:

valneva.com/press-release/v...

"VLA2001 was generally well tolerated. The tolerability profile of VLA2001 was significantly more favorable compared to the active comparator vaccine. Participants 30 years and older reported significantly fewer solicited adverse events up to seven days after vaccination, both with regards to injection site reactions (73.2% VLA2001 vs. 91.1% AZD1222 (ChAdOx1-S), p<0.0001) and systemic reactions (70.2% VLA2001 vs. 91.1% AZD1222 (ChAdOx1-S), p<0.0001)."

The expected performance against variants is theoretical, and remains to be proved. In the preliminary reports, there were no serious Delta infections in either arm of the trial. I'm curious to find out exactly which variant they inactivated.

=seymour=

[bennevisplace in reply to SeymourB]

Thanks Seymour.

Valneva also measured T cell responses to the S, N and M proteins. A broader cellular response can only help?

No comments yet from British medics bmj.com/content/375/bmj.n2551