CureVac preps its COVID-19 shot for deployment as J&J, AZ holdups slow Europe's rollout

The European Union is looking to shake up its COVID-19 vaccination game plan following a turbulent start to the rollout, presenting an opportune moment for mRNA vaccine developer CureVac to enter the scene. Eying a potential market debut in the coming months, the biotech has already started vaccine production.

CureVac, which has started a rolling review process for its two-dose vaccine with the European Medicines Agency, plans to release late-stage trial results in the coming weeks, CEO Franz-Werner Haas said on a call with analysts Thursday. Depending on the results, the company expects that EU authorization for its shot, CVnCoV, could come in the beginning of June, Haas told CNBC last week.

The company’s most critical phase 2/3 trials are now fully enrolled, Haas said Thursday. The data produced should be enough for the company to finalize its application with the EMA in the second quarter. 

The Tübingen, Germany-based biotech has several European partners helping produce its shot, including GlaxoSmithKline, Bayer and Novartis. The company is now predicting an output of 1 billion doses in 2022, up from its previous estimate of 600 million, Haas said.

For this year, meanwhile, CureVac plans on producing 300 million doses of CVnCoV. Europe has already claimed 225 million initial doses, with an option for an additional 180 million under a supply deal signed last year. 

“We are already producing CVnCoV doses at risk to readily supply CVnCoV at the time of a potential market authorization,” Haas said Thursday. 

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The timing of CureVac’s vaccine is critical for Europe, which has stumbled to administer jabs from AstraZeneca and J&J following reports of rare and serious blood clots. J&J halted its vaccine deliveries to the EU earlier this week following the recommendation from top U.S. health agencies to put its shot on hold while experts investigate the cases. 

The decision bewildered officials in Europe, who sought more clarification about the “completely unexpected” announcement, Reuters reported Tuesday. Italian newspaper La Stampa subsequently reported Wednesday that the commission has opted against renewing its vaccine contracts with AstraZeneca and J&J once they expire at the end of the year. 

The bloc will now likely lean more on mRNA vaccines, a source from the Italian health ministry told the newspaper. On Wednesday, EU Commission President Ursula von der Leyen said Pfizer will supply the bloc with an additional 50 million doses during the second quarter this year. More supply deals could be coming, von der Leyen said.

While CureVac’s two-dose shot is months behind those produced by Pfizer/BioNTech and Moderna, its storage requirements aren't as stringent as the authorized mRNA shots.

"There is much more vaccines needed than available, and certainly we are talking ... primarily with the governments but also international organizations," Haas said, referring to COVAX, the global vaccine distribution effort looking to deploy doses in low-income countries. 

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Since the vaccine’s late-stage clinical trials began in December as variants of Sars-CoV-2 began to emerge, it’s likely those mutations will affect the results, Ulrike Gnad-Vogt, CureVac’s interim chief development officer, said on the call. The company is also testing its shot alongside an influenza vaccine to determine if they’re compatible, Gnad-Vogt said.