Valneva joins the phase 3 Covid-19 vaccine club

Meanwhile, Ocugen hopes that Covaxin's India data will be enough for US approval.

As the world awaits pivotal US data on Novavax’s Covid-19 jab, plenty of other players are still trying to get in on the second wave of vaccines.

One of the latest, Valneva, pushed VLA2001 into a pivotal UK study yesterday, while Ocugen hopes that its contender, Covaxin, could get the nod in the US on the back of data from a phase 3 trial in India. The latter’s share price climbed 18% yesterday.

Both vaccines are based on inactivated coronavirus, making them different from currently authorised shots. With concerns over unusual blood clots with adenoviral vector-based vaccines from Astrazeneca and Johnson & Johnson, perhaps it is not too late for some of the Covid-19 vaccine laggards to make a mark, especially if booster doses are eventually needed.  

An analysis by Evaluate Vantage shows that there are several more candidates set to go into phase 3 this quarter, including a delayed project from Sanofi and Glaxosmithkline.

The second-wave of Covid-19 vaccines
Project Description Developer(s) Update
Covaxin  Inactivated virus (2 doses) Bharat Biotech/ Ocugen Data from ph3 India trial reported Apr 2021
NVX-CoV2373 Recombinant nanoparticle (2 dose) Novavax Data reported from UK ph3 & S Africa ph2b trials; US/Mexico ph3 data due Q2 2021
CVnCoV mRNA (2 dose) Curevac Herald, Europe ph2/3 data due Q2 2021; Europe ph3 due 2021
Ad5-nCoV Adenovirus type 5 (1 dose) Cansino Biologics Ph3 recruiting in Russia & S America
ZyCoV-D DNA (3 doses) Zydus Cadila Ph3 ongoing in India
Coronavirus-like particle Covid-19 vaccine Coronavirus-like particle (2 dose) Medicago/ Glaxo Ph3 started Mar 2021 in Canada & US
COVID-19 S-Trimer Trimerised fusion protein (2 dose)  Clover/Dynavax Ph2/3 OUS Spectra trial started Mar 2021
VLA2001 Inactivated virus (2 doses) Valneva/ Dynavax Ph3 UK Cov-Compare study vs Astra's Vaxzevria started Apr 2021
Covid-19 vaccine project Recombinant protein (2 doses)  Sanofi/ Glaxo  Ph3 due to start Q2 2021, pending results from ph2 trial
INO-4800 DNA (2 doses) Inovio Ph3 due to start in Q2 2021, pending ph2 data & lifting of FDA hold
ARCT-021 Self-amplifying mRNA (1 dose) Arcturus Ph3 planned for Q2 2021 pending results from ph2 trial
Note: includes notable projects already progressed into phase 2/3 development or likely to do so imminently. List not exhaustive. Source: EvaluatePharma & company statements.

Valneva has beaten some more experienced players to phase 3. Its study will compare the immune response with VLA2001 versus that seen with Astrazeneca’s Vaxzevria in 4,000 UK participants.

One question is whether this trial will support approval outside the UK, but maybe this will not matter to Valneva for now. Only the UK has gone big on VLA2001 so far, ordering 100 million doses. The company recently ditched discussions with the European Commission, citing lack of progress, and hopes to sell its project to individual EU member states and countries outside the EU.

Outside India

Ocugen, meanwhile, has been up front about its desire to get Covaxin authorised by the FDA. The company gained US rights to the jab from Bharat Biotech in February, and the groups now have data from a second interim analysis of an Indian phase 3 trial in hand, in which Covaxin showed 78% efficacy, rising to 100% against severe disease.

The shot is already authorised in India, and Ocugen has said it hopes to gain a US nod in the second half of this year. There have been questions about the trial’s conduct, however; even notwithstanding these, approval on the strength of a trial conducted in India seems unlikely given the FDA’s stance so far.

A case in point is Novavax’s NVX-CoV2373, which performed well in a UK phase 3 trial. Enrolment into the project’s pivotal US trial was completed in February, and results have been due “any day” for a while now.

Novavax is facing concerns about its manufacturing capabilities, while there are also questions about dropouts in its US trial, given the availability of other Covid-19 vaccines. Hopefully, on the latter point, things will become clear soon with release of the results.

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