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German CureVac to register Covid-19 vaccine in EU soon

Author : 112.ua News Agency

Source : 112 Ukraine

The European Union, with constant delays in the delivery of various vaccines against coronavirus and the incident with AstraZeneca, needed a new hero. And now, it seems, he was found. A drug called CVnCoV from the German pharmaceutical company CureVac may appear on the market in late spring - early summer
21:51, 21 April 2021

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The company has recently filed an application for vaccine registration in Switzerland and expects to register in the European Union in the current quarter.

We talk about the effectiveness, stages of testing the drug, and what it has in common and different from the existing vaccines against Covid-19.

Related: EMA admits connection between use of Johnson & Johnson vaccine and blood clotting

How it works and how it differs from others

The vaccine was developed in collaboration with the German pharmaceutical giant Bayer and the Coalition for Epidemic Preparedness Innovation (CEPI).

This is the third RNA vaccine, but, according to Bloomberg, the pharmaceutical company has focused on the properties of the drug, and not on speed in the race. Tests are taking place more slowly than competitors BioNTech/Pfizer and Moderna, but the result is a vaccine that is stable at standard refrigerator temperatures for at least 3 months.

Thus, Pfizer BioNTech must be maintained at -70 degrees, Moderna at -20 degrees.

The vaccine can also be stored for 24 hours at room temperature.

Related: Healthcare Ministry increases gap between Covishield/AstraZeneca vaccine shots

The publication believes that this property could be a game changer for developing, poorer or warmer countries. It will also be easier for Western countries if the vaccine can be stored in a standard refrigerator in nursing homes or doctors' offices.

The drug is based on matrix ribonucleic acid (mRNA). According to CureVac CEO Franz-Werner Haas, the key difference between the CureVac vaccine is that it uses naturally occurring, unmodified mRNA to trigger an immune response "as close to natural as possible." The immune response is comparable to that of antibodies in recovered coronavirus patients.

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The CureVac product also requires a lower dosage - just 12 micrograms for two shots (compared to 30 micrograms for BioNTech and 100 for Moderna). This will speed up mass production.

Haas said he wants to replicate the 95 percent efficacy of the vaccine leaders: "We're pretty bold and say, this is also what we can achieve."

Related: Ukraine approves use of AstraZeneca vaccine produced in Korea, - minister

Clinical trials progress

- The first clinical trials began in June 2020 in Germany, Belgium, Peru, and Panama, reports Clinical Trials Arena. Phase I and IIa showed that the drug was well tolerated at all doses tested and elicited strong antibody responses in addition to T cell activation.

- In January, CureVac entered into an alliance with Bayer, which took over organizational issues, services in the third phase of clinical trials, during its registration and production, as well as when promoting in the EU and in selected markets outside the EU.

- In December 2020, CureVac initiated a key Phase IIb / III trial in Germany with 36,000 participants who received a 12 mcg dose of CVnCoV. An additional Phase III study at the University of Mainz involving more than 2,500 health workers is also underway. A phase III study is also underway in Mexico.

By the end of April, the results of the final phase are expected, during which the vaccine has been tested on humans on two continents.

- On February 12, CureVac filed an application for vaccine evaluation with the European Medicines Agency (EMA).

After the completion of the third stage of clinical trials and in the case of certification of the EMA drug, CureVac will remain the holder of the marketing authorization, Bayer received the option on its behalf to register the vaccine in other countries.

Vaccine registration is expected by June. But CureVac is not going to stop with this vaccine and will start developing the next one, with self-enhancing mRNA technology, so that it can fight multiple strains of the virus in one go.

Related: Johnson&Johnson to supply vaccine to EU with warning about side effects

Side effects

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At the first stage, it turned out that after the second administration of the drug to the volunteers at a dosage of 12 μg, some of the participants showed fatigue, headache and muscle pain, chills and an infrequent rise in temperature. But these effects were temporary and disappeared within 24-48 hours.

Who signed the first contracts

Germany has already relied on CureVac and Pfizer/BioNTech. Last June, the German government paid € 300 million for a 23 percent stake in CureVac, and then gave a € 252 million grant for coronavirus research.

In addition, the German Ministry of Education and Research (BMBF) will provide about 627 million euros in 2020-21 to the developers of BioNTech vaccines in Mainz and CureVac in Tübingen.

Production facilities have been created for the production of the drug. Rentschler Biopharma, based in Laupheim, is preparing to start large-scale production of the CureVac vaccine immediately after registration in the EU. It is also going to be produced by the Swiss company Celonic at its plant in Heidelberg, Germany, the Swiss Novartis in the Austrian Kundl and the German Wacker in Amsterdam. These capacities are capable of providing a fundamental change in the vaccination campaign in the second quarter and, at the latest, in the third quarter, provide vaccines to everyone in the EU, and then supply them to the whole world. And if necessary, I think, to quickly master the release of new variants of these vaccines in response to new mutations of the virus.

The European Union will buy 405 million doses of the vaccine from CureVac.

Related: Use of Pfizer doubles deaths after vaccination in UK compared to AstraZeneca

The Swiss government has already signed a contract with CureVac for the supply of 5 million doses of the vaccine, which is awaiting registration of the drug.

 

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