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Stephaun Wallace, head of global external relations at the COVID-19 Prevention Network at the Fred Hutchinson Cancer Research Center, receives his second injection in the Novavax Covid-19 vaccine phase III trial at the UW Virology Research Clinic, Seattle.(Source:Getty Images)

As it prepares a potential filing for emergency authorization of its COVID-19 vaccine in the UK and US, Novavax also has one eye on next-generation shots to take on new variants of the virus.

Its protein-based vaccine candidate NVX-CoV2373 is boosted by Matrix-M, a nanoparticle adjuvant and has shown efficacy against the original ‘Wuhan’ strain, as well as the ‘UK’ and ‘South Africa’ variants in late-stage studies.

It looks likely to be the next major COVID-19 vaccine to gain US Food and Drug Administration approval: this could come in May if the US Food and Drug Administration decides it can file the existing UK Phase III trial data as the basis of its filing for an emergency use authorization (EUA).

However this might take until June if the US regulator indicates that it wants to see the results from a larger US and Mexico-based study.

The latter strategy may also result in its first approval coming in the UK, where Novavax has worked closely with the Medicines and Healthcare products Regulatory Agency (MHRA).

Stan Erck

The company’s shares dipped on 1 March when CEO Stan Erck touched on this point on its Q4 call, but did not spell out precisely how he expected the filing would proceed. Investors see an early-as-possible US FDA emergency use authorization (EUA) as material to helping it maximize its revenues.

Erck said: "We are in ongoing discussions with the FDA to align on the data required for initiation of the EUA and continue to provide information to our opening IND application. At this time, we expect to complete our EUA filing in the second quarter."

Despite this authorization timing uncertainty, the company’s imminent transformation from a perennial also-ran to successful vaccines company looks locked in.

The company has already secured agreements for 300 million doses of NVX-CoV2373, including 100 million with the US government via the former Operation Warp Speed.

It is also working with India’s Serum Institute to jointly supply 1.1 billion doses of NVX-CoV2373 to Gavi through the COVAX Facility.

But if the company can also meet the challenge of the variants of concern, it will also secure many more future orders around the world in 2022 and possibly beyond, competing with frontrunners such as Pfizer/BioNTech and Moderna.

Lower Efficacy Against South Africa Variant

In January, the company announced encouraging results from a UK Phase III trial, recording a 95.6% efficacy against the original strain of COVID-19 and 85.6% against the UK variant strain.

A parallel Phase II trial in South Africa produced a 60% efficacy for the HIV-negative portion of the study population (ie, 94% of study participants) This lower efficacy level was attributable to the high prevalence of the South African variant in the study. It produced a much lower 49.5%% efficacy result when patients with HIV were added in to the results.

Despite this drop in efficacy, the results arguably put the company in a strong position as few others have data from a full clinical trial against the South Africa variant, where all are known to have diminished efficacy.

In early February, the company submitted that data to major regulators for rolling review, including the European Medicines Agency, US Food and Drug Administration, MHRA and Health Canada.

Now the company is weighing up its filing options: while the US FDA has indicated that it could accept the UK trial as its registrational study, the company might decide to await the first interim results from the US and Mexican PREVENT 19 Phase III trial, which is now fully enrolled with an ethnically diverse cohort of 30,000 subjects.

The timing of this readout will depend partly on the ‘attack rate’ of the virus in the US and Mexico, where the numbers of COVID-19 cases are now falling sharply in most regions.

Variant Trials To Start Soon

The company expects to start clinical trial of variant strain vaccines as standalone and bivalent candidates in mid-2021.

Regulators like the FDA and EMA have already spelled out in guidance that studies for variant strain vaccines do not need to have outright efficacy as their endpoint, but rather show non-inferiority to the original strain vaccine, and demonstrate safety.

Novavax’s chief medical officer Filip Dubovsky said the company was investigating two vaccine types, those that look at individual variants, and those that target both the original strain and the variant using a bivalent vaccine.

 “We think the latter is really where we want to be,” he commented. “We think that the difference between the protype strain, and the current strains are circulating in South Africa and Brazil represent a very broad range of [viral] spread.”

Creating a bivalent vaccine creates a number of technical and safety demands, including the requirement for a higher dose, but Novavax is confident about this challenge.

“We know we can do bivalent and easily. We know from our Phase I and Phase II studies, we went up to 25μg without having problems with that, so we think we have a solution here to the problem.”

Novavax is following in the wake of now three US FDA-approved vaccines from Pfizer/BioNTech, Moderna and Johnson & Johnson, plus the EU- and UK-approved product from AstraZeneca/Oxford.

All of these are pursuing strategies for tweaking their vaccines against the new variants, with Pfizer pursuing a simple booster approach (using a third dose of its existing vaccine), while Moderna is developing a variant-specific update, plus a bivalent approach.

Like the newly approved J&J vaccine, NVX-CoV2373 has the advantage of greater stability than than the mRNA vaccines. It can be stored at standard refrigeration temperatures of 2-8°C, and is presented in 10-dose liquid vials requiring no dilution, which should make it easy to distribute and administer. 

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