Another step backwards for Valneva

 Valneva has had a tricky time developing its Covid vaccine VLA2001, with the UK rejecting the jab and the EU insisting on more data. Yesterday the EMA put the boot in once more, stating that authorisation of VLA2001 would be delayed, and was unlikely to occur before mid-April. 

The vaccine under development by Sanofi and Glaxosmithkline, now known as Vidprevtyn, is also a casualty of delays at the EMA. But better news came for Novavax in the shape of UK authorisation for its Nuvaxovid jab – underlining the disappointment for Valneva, whose jab the UK rejected. 

When asked why the rolling review of the Valneva vaccine would take more time than expected, an EMA spokesperson appeared to suggest that the ball was in the developer’s court. 

Marco Cavaleri, the organisation’s head of vaccines strategy, said during a press briefing yesterday that the EMA needed to look at in-depth clinical data on VLA2001, saying it was “difficult for us to see that we will be in the position to conclude before Eastertime”. 

Mr Cavaleri’s statements about the Sanofi/Glaxo shot were along similar lines, namely that the agency would need full clinical results on Vidprevtyn before it could make a decision. In its fourth-quarter results presentation today Sanofi said the safety and efficacy trial of its primary Covid vaccine was due to be reported towards the end of the first quarter. 

Super Nova

Meanwhile Novavax’s Nuvaxovid, which in December became the fifth EU-approved vaccine, yesterday became the fifth in the UK. Like Valneva’s shot, this product has had a tricky time of it; its pivotal trial readout was a long time coming, and then last summer Novavax admitted that its application for US emergency authorisation would be delayed by three months.

In the event the timelines were even worse: the US application was only made this week.

UK approval is something, at least. The country has ordered up to 60 million doses of Nuvaxovid, which has shown respectable efficacy and acceptable cross-reactivity against Omicron.

Analysts from Jefferies, writing in November, forecast a punchy $5bn for the jab, and to be fair the World Health Organisation’s Covax initiative has ordered more than a billion doses.

In terms of sales expectations for the coming year Valneva’s candidate is languishing at the bottom of the pile. The group guided to worldwide revenues of €350-500m ($400-572m) for VLA2001 in 2022, and that was before the EMA’s announcement.

Selected vaccines in the EU
Company	Vaccine	Type	Date authorised in EU	WW sales 2022e ($bn)
Pfizer/Biontech	Comirnaty	mRNA	Dec 21, 2020	33.6
Moderna	Spikevax	mRNA	Jan 6, 2021	20.3
Astrazeneca	Vaxzevria	Chimp adenovirus vaccine	Jan 29, 2021	1.3
Johnson & Johnson	Ad26.COV2.S/ JNJ-78436735	Adenovirus	Mar 11, 2021	3.0
Novavax	Nuvaxovid	Recombinant spike protein	Dec 20, 2021	5.0
Sanofi/ Glaxosmithkline	Vidprevtyn/ SP0253	Recombinant spike protein	Review began Jul 20, 2021	1.5
Valneva	VLA2001	Inactivated virus	Review began Dec 2, 2021	0.49
Gamaleya Institute	Sputnik V	Adenovirus	Review began Mar 4, 2021	-
Sinovac Life Sciences	Vero Cell Inactivated	Inactivated virus	Review began May 4, 2021	-
Curevac	CVnCoV	mRNA	Application withdrawn Oct 11, 2021	-
Source: Evaluate Pharma, company statements and sellside analysts. https://www.evaluate.com/vantage/articles/news/policy-and-regulation/another-step-backwards-valneva