Germany’s CureVac announces phase 2b/3 COVID vaccine trial

CureVac begins phase 3 of experimental covid vaccine.



German biotech firm CureVac announced on Monday the start of Phase 2b/3 clinical trial of its COVID-19 vaccine candidate. The trial is expected to include more than 35,000 participants in Europe and Latin America.

The trial will assess the safety and efficacy of the coronavirus vaccine in adults in preventing COVID-19 of any severity as well as preventing moderate to severe confirmed cases of COVID-19 in participants who have never been infected with SARS-CoV-2, CureVac said.

“The clinical safety and immunogenicity data achieved to date look promising and we are hopeful that this trial will continue to demonstrate the impact of mRNA technology and our vaccine to prevent COVID-19, and to help defeat this pandemic,” Chief Executive Franz-Werner Haas said.

CureVac has taken a slightly different route to test mRNA than the BioNTech/Pfizer and Moderna approach. It is using the vaccine’s potency in a 12-µg dose, compared to the 100 µg used by Moderna. This will enable CureVac to make more doses of the vaccine. CureVac is also aiming to trigger balanced immune responses.

This phase of the trial will randomly select 4,000 subjects across two age groups—18 to 60 years and 61 years and older—who will be given two doses of CVnCoV or placebo four weeks apart. 61 years and older participants will number around 1000.

COVID-19 Vaccine CureVac Coronavirus Vaccine Phase 2b/3

CureVac will move into phase 3 if the data supports the larger study. In phase 3, 32,500 subjects will be recruited to receive the vaccine.

Data on reactogenicity and immunogenicity within this trial will determine start of the phase 3 of the trial. The trial regulators will observe at least 1000 of the receivers for a week after the first dose and make a decision on the phase 3.

CureVac will move into phase 3 if the data supports the larger study. In phase 3, 32,500 subjects will be recruited to receive the vaccine. CureVac plans to pool data from the phase 2b and 3 portions of the clinical trial.

The first review will take place after 56 people have developed COVID-19, with later reviews scheduled for 111 and 185 cases. CureVac estimates the first review will take place around five months after the first vaccination. If seven cases or fewer are in the CVnCoV arm at that point, CureVac will count that as a successful vaccination point and will likely start preparing for regulatory filings.

The German government is supporting three vaccine candidates with about 750 million euros (US$911 million) in total. The European Commission has already secured up to 405 million doses of the vaccine.

The other mRNA vaccines have had nearly 90 plus percent efficacy. CureVac will also need a similar 90 percent efficacy and a good safety profile to join the top tier of COVID-19 vaccines.

Based on the available data, the CureVac candidate’s immune responses compared to other vaccines is similar. A higher proportion of subjects who received 12 µg of CVnCoV had moderate to severe fever, headache and fatigue also seen in the BioNTech-Pfizer phase 3, although the CureVac results come from a small cohort.

The CureVac vaccine does not require very cold temperatures like the BioNTech vaccine, (which needs -70 degree temperature) and can stay stable for at least three months at standard fridge temperatures, the company said. The group will join 13 other drugmakers in proceeding to phase 3 trials, according to the World Health Organization.

The company says it will be able to produce up to 300m doses in 2021, and a further 600m doses in 2022. This is far less than the BioNTech/Pfizer capacity. They have promised nearly 1.3bn doses next year. 

Avatar
Christy Gren
Christy Gren is an Industry Specialist Reporter at Industry Leaders Magazine; she enjoys writing about Unicorns, Silicon Valley, Startups, Business Leaders and Innovators. Her articles provide an insight about the Power Players in the field of Technology, Auto, Manufacturing, and F&B.

Recent Posts

Apple car may upset auto industry manufacturing model

Apple car may upset auto industry manufacturing model

Since last December, the Apple car project called Titan has been generating much interest with speculations surrounding design manufacturing...
21 hours ago
Amazon opens two new logistics centers in Italy

Amazon opens two new logistics centers in Italy

Amazon will open two new logistics centers in Italy this year, investing over $278 million (230 million euros), the world’s largest online...
21 hours ago
Fitch Ratings invests in AI startup to improve bank misconduct detection

Fitch Ratings invests in AI startup to improve bank misconduct detection

Fitch Ratings, a global leader in credit ratings and research, has inked a partnership with a French artificial intelligence startup as it e...
21 hours ago
New Shepard Rocket launches Successful Test Liftoff

New Shepard Rocket launches Successful Test Liftoff

The New Shepard rocket by Blue Origin successfully conducted the test launch in the Texas testing site, successfully performing take-off and...
2 days ago
MIT unveils Modern Design for Hybrid-Electric Airliner

MIT unveils Modern Design for Hybrid-Electric Airliner

Engineers at MIT conceptualized a hybrid-electric plane that would reduce nitrogen oxide emission levels and harmful greenhouse gases signif...
2 days ago
Store Closures Cost European Retail Giant Primark $1.43 Billion in Sales

Store Closures Cost European Retail Giant Primark $1.43 Billion in Sales

The European retail giant Primark said the COVID-19 had caused a loss of over $1.43 billion (£1.05 billion) in sales from store closures. T...
3 days ago