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CureVac to ‘plow ahead’ with Covid vaccine regardless of trial outcomes     

An employee of the German biopharmaceutical company CureVac will demonstrate research on a vaccine against the coronavirus (COVID-19) disease in a laboratory in Tübingen on March 12, 2020.

Andreas Gebert | REUTERS

LONDON – CureVac plans to continue work on its Covid-19 vaccine despite disappointing results from clinical studies showing the vaccine is only 48% effective.

The German biotech company released its final analysis of the clinical trials of its coronavirus vaccine – known as CVnCoV – on Wednesday, confirming that the vaccine was 48% effective against Covid of all degrees of severity in all ages and 15 variants.

Pierre Kemula, CFO of CureVac, however, defended the vaccine on CNBC Thursday, saying the clinical trials were conducted at a time when several new strains of the virus were spreading around the world.

“We have to speak to the EMA now [European Medicines Agency] and want to make sure we have an open dialogue and share any data we have to assess the way forward, “he told CNBC’s Squawk Box Europe on Thursday.

When asked if it is worth developing the vaccine further when other successful vaccines are already in use in Europe and elsewhere, Kemula said the company had contractual obligations to meet.

“We have a contract with the European Commission to supply 225 million doses of the drug, so I think we need to move forward on that,” he said.

“There are a lot of vaccinations, there are a lot of people under 60 who haven’t had access to the vaccine before. So if we can contribute to the fight – in the short term in the pandemic, but also in the medium term with these other ways of [multivalents] … we are continuing to work on that. “Multivalent or polyvalent vaccines should immunize against more than one virus strain.

The results of the CureVac study, which enrolled 40,000 participants in ten countries in Latin America and Europe, showed that the vaccine was more effective in younger participants. The effectiveness rate among 18 to 60 year olds was 53% for diseases of any severity and increased to 77% for moderate and severe diseases in the same age group.

However, given that Covid-19 carries a higher risk for the elderly, the study results are disappointing, not least because two other vaccines made with messenger RNA (mRNA) – those from Pfizer-BioNTech and Moderna – have an efficacy greater than 90 % of have been shown to prevent Covid-19 infection. CureVac’s shares fell as much as 13% in Thursday’s pre-trading session.

Dr. Franz-Werner Haas, CEO of CureVac, defended the results in a statement on Wednesday, saying the vaccine “shows strong public health value” for those aged 18 to 60 and will be an “important contributor to tackling Covid.” -19 pandemic and the dynamic distribution of variants. “

He also cited “the current context of an increasingly diverse environment of Covid-19 variants”.

Several variants have emerged over the course of the pandemic, some of which are more virulent than others – like the alpha variant first discovered in the UK and the delta variant first identified in India – and Kemula said he believed mutations would continue to occur.

“As more and more people become infected with coronavirus, we are prepared for the disease to continue to develop as it progresses and has more and more variants,” said Kemula. The industry must think ahead, “how we can cope better with the current vaccines, but also possibly with various boosters (booster vaccinations),” he added.

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Health

Covid vaccine maker CureVac hopes shot will get EU approval in June

Coronavirus vaccine maker CureVac is hoping its Covid shot will get European approval in the second quarter.

Franz-Werner Haas, CEO of CureVac, told CNBC on Thursday that the vaccine maker was close to finalizing recruitment for the vaccine’s Phase 3 clinical trial. In view of the urgent need for additional effective coronavirus vaccines and the accelerated regulatory approval process, approval cannot take place long afterwards.

“According to our calculations, we expect to have the data by late April or early May,” Haas told CNBC’s Squawk Box Europe.

“We therefore assume that, depending on the dates, we will receive the approval in early June.”

As soon as the study is running, the German biotechnology company CureVac will wait for safety data and then carry out an interim analysis of the results of the late study. It is also crucial that a certain number of study participants have to wait for Covid-19 to develop to determine how effective the vaccine is in preventing the virus.

The data is then sent to regulatory authorities such as the European Medicines Agency for so-called “ongoing review”. This is where the data is analyzed by regulators to expedite the evaluation of new, potentially life-saving vaccines or drugs in public health emergencies.

The UK and EU have pre-ordered up to 455 million doses of CureVac’s mRNA vaccine, pending regulatory approval. The company is already making its vaccine, even though it hasn’t been approved, pending approval of the shot.

Haas, CEO of CureVac, said the company is trying to avoid manufacturing pitfalls that have been hit by other vaccine manufacturers. This issue was perhaps most noticeable at AstraZeneca, and has significantly relieved the vulnerability of global supply chains.

“Manufacturing is certainly a struggle right now,” he said.

“It’s not just that we manufacture ourselves, we have a whole network in Europe, with other companies that also support us in manufacturing, but it is sometimes very difficult to get the equipment to set up the plants, however also the material for the production of the mRNA. “

“But we are doing everything we can to produce as many cans as possible,” added Haas.