No let-up in Covid-19 vaccine trials

Whether immunogenicity data will be enough for regulators is still an open question. Both the FDA and the EMA currently ask for at least one phase 3 efficacy trial; however, nations that are struggling to get access to jabs might be less picky.

SK seems to be aiming at the developing market, saying it hopes to deliver its vaccine, if approved, via Covax, the scheme working on worldwide vaccine access.

Vantage has found two other late-stage studies looking at immunogenicity: Valneva’s UK trial of VLA2001, and Medigen Vaccine Biologics’ study in Paraguay of MVC-COV1901; the latter is already approved in Medigen’s home market of Taiwan, despite controversy over a lack of supporting data.

Outside US

The table below shows that other several countries could also soon have domestically developed shots, including Iran and Vietnam.  

Inovio appears to have given up on the US for now. The Innovate trial of the group’s DNA-based candidate INO-4800 has been on FDA hold for some time now; Inovio said during its second-quarter call that it did not plan to enrol any US patients into the phase 3 portion of the study, and would instead focus on Latin America, Asia and Africa.

The group plans to seek BLA approval in the US if Innovate succeeds – which seems a long shot given that the phase 2 portion of the study found unimpressive neutralising antibody levels, according to a preprint.

Meanwhile, the mRNA player Arcturus has been cagey about its plans, saying only that its candidate ARCT-021 had been “selected by a global entity for inclusion in a multinational phase 3 vaccine trial”.

While the list below is dominated by small names, two big pharma groups stand out: Sanofi and Glaxo, both of which famously missed the first wave of Covid-19 vaccines, finally took their project into phase 3 in May.

The companies said they would also evaluate the vaccine as a booster, “regardless of the initial vaccine platform received”. This seems like a sensible move, as most of the market for second-wave vaccines, at least in the US and Europe, looks likely to be for boosters.

Still, the incumbents are already getting in on the act here, too, with Moderna and Pfizer/Biontech recently submitting booster applications to the FDA for Spikevax and Comirnaty respectively.

The agency plans to hold an advisory committee meeting to discuss Pfizer and Biontech’s request on September 17, three days before the US government’s plan to start offering booster shots begins.