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Novavax plans a flurry of ex-US filings for its COVID-19 vaccine amid another delay in its EUA filing in the US(Source:Shutterstock)

 

Although Novavax, Inc. is late to the COVID-19 vaccine party, the company is expressing confidence in the potential role in the market for its NVX-CoV2373, potentially as a booster shot, with new data showing strong activity against variants of concern. It is also looking ahead as it tests combinations of NVX-CoV2373 with its flu vaccine.

The Gaithersburg, MD-based vaccine maker announced its second quarter earnings on 5 August, reporting revenues of $298m, compared with $35.5m in second quarter 2020. The quarter also saw a net loss of $352m, compared with an $18m net loss in the comparable period the year before.

While the messenger RNA vaccines, Pfizer Inc./BioNTech SE’s BNT162b2 and Moderna, Inc.’s mRNA-1273, inch toward full US Food and Drug Administration approval, a move that those companies believe would help mitigate vaccine hesitancy among the public, Novavax announced another delay. It had originally targeted filing for FDA emergency use authorization in the second quarter, but that was pushed back to the third quarter and now again to the fourth.

Cantor Fitzgerald analyst Charles Duncan expressed disappointment in the delays. “Novavax (again) pushed guidance for a US EUA submission into 4Q21, as it continues to work on the issue of qualification and validation of analytical methods that are needed to complete the demonstration of process consistency,” he said in a 6 August note, adding that he believed the company has the analytic assays at hand given that it has started regulatory filings already.

“However, its quixotic ‘partners,’ bureaucratic US government agencies that are funding a proportion of its studies (not the FDA), needs [sic] to approve them and therefore remains [sic] the gating factor for submission to the FDA,” Duncan said.

In a same-day call with analysts, CEO Stanley Erck pointed to continued global need for vaccines.

“[We] can note that through the development of vaccines and treatments to date, significant progress has been made to combat the COVID-19 pandemic,” Erck said. “However, we also note that with a continued circulation of variants, and with the inequitable access to vaccines that persist in many parts of the world, Novavax’s mission to bring NVX-CoV2373 to market as swiftly as possible has never been more important.”

Analysts agree the rapidly expanding number of Delta cases could also give Novavax an important role to play. “[The] NVX-CoV2373 EUL would fill an urgent need in countries where lagging vaccination rates have met surging Delta cases,” H.C. Wainwright analyst Vernon Bernardino said in a 6 August note.

Still, Novavax took a hit on the filing pushback. The stock closed at $189.89, down 19.6%.

Emphasis On Ex-US, Booster Shots

In conjunction with the earnings release, Novavax announced data from a Phase II study in the US and Australia showing that a single booster shot of NVX-CoV2373 produced a more than fourfold increase in neutralizing antibodies against wild-type SARS-CoV-2, along with a sixfold increase in cross-reactive functional antibodies to the Delta variant compared with the primary vaccination series. Moreover, an analysis of sera from the primary vaccination series showed cross-reactive functional antibodies against Delta, along with the Alpha and Beta variants, all showing a sixfold to tenfold boost.

Data from the final analysis of its Phase III PREVENT-19 trial of the primary vaccination series in the US and Mexico showed 90.4% overall efficacy, including 92.6% efficacy against variants of concern and 100% efficacy against non-variants of concern.

The company said it submitted filings for authorization of NVX-CoV2373, a nanoparticle protein-based vaccine, in the Philippines, Indonesia and India under a partnership with the Serum Institute of India Pvt. Ltd.. It also plans to file for an emergency use listing with the World Health Organization this month.

On 4 August, it announced an advanced purchase agreement with the European Commission for up to 200 million doses. The plan is to file with the UK’s Medicinal and Healthcare products Regulatory Agency during the third quarter, and “within weeks” file also with the EMA, Health Canada, New Zealand’s Medsafe and Australia’s Therapeutic Goods Administration.

“We continue to see significant opportunity in ex-US markets to provide supply for initial vaccinations,” Erck said on the call. “In high-income countries, we believe our technology well positions us to become the booster of choice.”

Novavax plans to have capacity to manufacture 100 million doses per month by the end of the third quarter and 150 million per month by the end of the fourth quarter.

With the spread of variants of concern, especially Delta, there is a growing view that booster shots will become necessary. While Pfizer has said it plans to seek authorization of a booster shot in the fall, the FDA and the US Centers for Disease Control and Prevention had suggested that authorizing boosters was not a priority. (To Boost Or Not To Boost Pfizer At Odds With US FDA) But on 6 August, The Washington Post, citing unnamed officials, reported that the FDA has fast-tracked its review of booster shots for people with weakened immune systems, with plans to authorize them within weeks or days.

Moderna has also been busy developing booster shots, using both its original vaccine as well as variant-specific and multivalent versions, reporting what it called “robust” efficacy when shots were administered at 50mcg. (Moderna Reports Robust Response From COVID-19 Booster Shots)

Novavax Joins Flu/COVID Vaccine Combo Bandwagon

Apart from booster shots, there is growing interest in giving COVID-19 vaccines with vaccines against other respiratory disease, particularly flu, either via co-administration or in combination. Novavax is exploring both, while Moderna is aiming for a pan-respiratory vaccine against COVID-19, influenza and respiratory syncytial virus.

The company posted preclinical data on bioRxiv.org showing that qNIV/CoV2373, a combination of NVX-CoV2373 with the influenza vaccine NanoFlu, induced protective hemagglutination inhibition (HAI) responses to seasonal influenza A and B while maintaining clinical and virologic protection against experimental challenge with SARS-CoV-2. Based on the results, the company plans to start a Phase I study of qNIV/CoV2373 in Australia later this year.

Novavax also announced data from a substudy in its Phase III trial in the UK on 431 participants receiving seasonal influenza vaccination together with NVX-CoV2373 or the flu vaccine alone. The company said there was an efficacy trend of 87.5% against COVID-19, while the co-administration did not adversely affect influenza response. Results posted on the preprint server medRxiv.org did show a reduction in antibody responses to the COVID-19 vaccine. Adverse events – including injection site tenderness or pain, fatigue and muscle pain – were more common in co-administered participants, though rates of serious adverse events were low and balanced against the participants who only got the influenza vaccine.

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