Covid-19 vaccines move into pivotal development

The start this week of pivotal studies for Moderna and Biontech/Pfizer’s respective mRNA projects will remind investors of the huge numbers of volunteers that companies plan to enrol into Covid-19 vaccine studies. No fewer than 180,000 participants are expected to take part in six such trials by the end of this year. Funding is also in the spotlight: with Moderna’s study of mRNA-1273 beginning yesterday the company also said it secured an additional $472m of Barda funding – in addition to the earlier $483m from US Project Warp Speed – to bridge a “gap” left because of an increased enrolment target. Followers of Biontech/Pfizer’s BNT162 project will note that it is BNT162b2 that has gone into phase III, not BNT162b1, which had generated promising clinical data last week. The b2 variant codes for the full S-protein rather than the receptor-binding domain, which is the case for b1. Biontech says b2 has shown better tolerability than b1 while generating similar neutralising antibody titres. The group yesterday closed a $512m US secondary equity offering, but it will not go unnoticed that its project has received no US taxpayer funding.

Selected Covid-19 vaccines
Project Company Ph3 protocol open? Ph3 enrolment Detail Barda/Warp Speed funding ($m)
mRNA-1273 Moderna Yes 30,000 mRNA vaccine 955
BNT162b2 Biontech/Pfizer Yes 30,000 mRNA vaccine 1,950*
AZD1222 Astrazeneca 14 Aug 2020 30,000 Chimp adenovirus vaccine in ph1 1,200
Ad26.COV2-S Johnson & Johnson 23 Sep 2020 30,000 Adenovirus type 26 vaccine in ph1 465
NVX‑CoV2373 Novavax 15 Oct 2020 30,000 Nanoparticle vaccine; ph1 data early Aug 1,600
Not disclosed Sanofi 25 Nov 2020 30,000 Several projects in preclinical development 0
*Dose order rather than development funding. Source: International Society for Vaccines meeting & company announcements.

This snippet has been updated to include the Warp Speed order of 100 million doses of Biontech/Pfizer's vaccine projects.

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