Covid-19 vaccine leaders make hay while Novavax flounders

Instead of long-awaited phase 3 data Novavax’s first-quarter presentation reveals a Covid-19 vaccine manufacturing snafu.

Trial Results

Novavax’s fairytale journey from biotech basket case to serious Covid-19 vaccine contender has hit problems. Investors are still awaiting US phase 3 data that some had expected in March, and to this issue Novavax has now added a manufacturing delay.

The stock slid 9% yesterday and another 20% this morning as the group said production capacity for the recombinant nanoparticle Covid-19 vaccine NVX-CoV2373 would miss its earlier target by up to six months. It would be ironic if a vaccine seen as having huge scientific promise ended up missing its window of opportunity.

This is precisely the scenario with which Novavax is now coming to terms, at least in the west, where vaccines from Pfizer/Biontech, Moderna, Astrazeneca and Johnson & Johnson have made huge progress in tackling the Covid-19 pandemic, reducing deaths and incidence, and allowing lockdowns to start being eased.

Knock-on delays

Indeed, this is largely why Novavax’s long-awaited US/Mexico phase 3 trial, Prevent-19, has been set back. According to the original protocol interim readout of the 33,000-subject study would have been triggered by the first 72 Covid-19 cases, with final analysis at 144.

But things did not pan out this way. Not only did vaccine availability in the west make it unethical to give trial participants placebo, some patients in Prevent-19 were understood to have started using antibody tests to figure out whether they had received the vaccine or placebo, thus self-unblinding and threatening the whole study.

In April, by which time many had expected data, instead of carrying out an interim analysis Novavax implemented a blinded crossover in Prevent-19, giving all placebo recipients NVX-CoV2373.

The group will now only perform a final analysis, on events accrued before this crossover. On its first-quarter call yesterday Novavax said these data would come “in a few weeks”, though it is unclear how many cases they would comprise.

This, along with awaiting manufacturing clearance, has set back regulatory submissions, which had been due in June. Novavax now says US, Europe and UK filings will be delayed to the third quarter, arguing that despite the setbacks it can see “light at the end of the tunnel”.

Source: Novavax presentation.

But it gets worse. Not only will clinical data delays set back filing and approval, whenever NVX-CoV2373 is eventually launched its rollout will be slower than had been expected owing to a shortage of raw materials.

In January Novavax had told Reuters that it would be producing up to 150 million Covid-19 vaccine doses monthly by May or June. Yesterday it revealed that the end of the third quarter would see capacity of only 100 million doses a month reached, with 150 million a month not hit until the fourth quarter.

Novavax attempted to reassure investors that it would be manufacturing at full capacity “in 2022 and beyond”. But this will count for little if the pandemic is all but over in the west, seeing NVX-CoV2373’s role reduced to a booster or seasonal shot after the likes of Moderna and Pfizer/Biontech have already cleaned up.

Missing the boat?

This is unfortunate for a vaccine that had impressed in large UK and South Africa studies in March. But it is a recurring theme for Covid-19 vaccine players that missed the early boat.

Another of these, Inovio, effectively fell out of the race entirely yesterday with the release of phase 2 data for its contender INO-4800, showing antibody titres at just a fraction of that seen with convalescent plasma. Not only that, but the phase 3 portion of this trial remains on US hold.

Clearly for Novavax things are not this bad, and scientifically NVX-CoV2373 remains highly competitive. But Novavax is now touting its duty to supply the developing world, something it yesterday said was equitable and in line with recent suggestions of a temporary IP waiver.

This is all very well, but the west is where the money is, and the harsh reality of Covid-19 becoming a developing world problem would be a hit to the bottom line. At least Novavax has already pre-sold around 109 million NVX-CoV2373 doses to US Operation Warp Speed, and the $1.7bn for this is money in the bank.

How many of these 109 million doses actually end up being given to Americans is now an open question.

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