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Dr. Lidia Oostvogels feels the pressure.
After nearly two decades of vaccine development, seeing the subject of her paintings, coronavirus, in the news every day is a novelty for her.
“It’s very exciting and very motivating, but a lot of pressure,” he said.
Dr. Oostvogels leads human trials of a coronavirus vaccine for the German biopharmaceutical company CureVac, where she leads her infectious diseases program and directs her progression of vaccines and therapies.
In January, after returning from the Christmas holidays, CureVac’s infectious disease team began discussing the outbreak in Wuhan and whether they could simply paint a vaccine.
“We had to convince our control that this was an assignment whose value I was beginning to paint,” Dr. Oostvogels said, adding that they knew no other case of MERS or SARS in which other people started presenting vaccines and then the viruses disappeared. “Of course it would have been much better if it had happened this time too, but it wasn’t. “
Once the SARS-CoV-2 genome series was published in early January, CureVac scientists began to look at the most productive way to make a vaccine to take to clinical trials, which verify new vaccines and medicines in humans.
They had to expand and manufacture the candidate vaccine, called CVnCoV, verify it in animals and obtain green approval from the regulatory government and ethics committees to start injecting into humans, which began in mid-June.
This is where Dr. Oostvogels’ clinical progression team comes in. Its task is to “establish and run clinical trials”. This means designing human trials, interpreting the entire “content” of the trial, including what to verify in subjects, who to verify and who to exclude and interpret the results, and making decisions about them. These.
Mrna
The CureVac vaccine is based on messenger RNA technology, or mRNA, which is new, only about 20 years ago. Lately there are six such vaccines for Covid-19 in human trials worldwide.
The DNA of MSR, the genetic code of living structures, in protein, the cornerstone of maximum living structures, explains Dr. Oostvogels. An mNR vaccine opposite Covid-19 works by ordering the cells in the framework to produce an express coronavirus protein (not the virus itself). ), triggering an immune formula reaction that the box can repeat if it finds the genuine virus.
No vaccine using this generation has yet been shown to be effective for human use.
The essays are attached to what Dr. Oostvogels calls the “bible”: the examination protocol developed through his team that describes everything similar to the essay, from his procedures to how knowledge will be analyzed. CureVac also produced the researcher’s brochure that lists detailed data on the vaccine, adding the production process, the effects of past controls and prospective risks. This guides researchers who conduct the trials, but also allows ethics committees and the regulatory government to compare the vaccine and whether or not to authorize the test.
CureVac is conducting its Phase 1 test, which tests side effects and discovers the most productive dose to anticipate, in the German cities of Tubingen, where the company is headquartered, Munich and Hanover, and in Ghent, Belgium. The ages of 18 and 40, because the burden of the disease affects the elderly, its participants pass up to 60 years.
When CureVac first announced his essays, they were inundated with emails from others who did not want to participate, says Dr. Oostvogels. “It was unbelievable. “
Researchers at 4 university hospitals with identified immunization centers are conducting trials to compare the CureVac vaccine, have their own volunteer databases, and are the only ones who can come with subjects in the clinical trial. possibly comes with personal medical practices.
The other people involved had to be in very good physical shape and tested for underlying conditions. For this trial, smokers or others with a safe history of smoking were excluded due to Covid-19 lung complications. Pregnant women too. In total, more than two hundred people won 2 doses of the candidate vaccine one month apart, with increasing doses staggered over time.
Once vaccinated at a center, the recruits stayed 4 hours of observation, returned the next day and then won a phone call the next day. “This is just the beginning. It’s intense,” Dr. Oostvogels said.
Participants are contacted 14 times, at least 10 visits, and tracked for approximately one year after the time of injection.
“People are dying as we speak because of this disease, so if it’s slow or spoils things because it doesn’t work well enough, it’s . . . immediate impact. “
Dr. Lidia Oostvogels, Head of Infectious Diseases, CureVac
dose
One of the most important questions is what the dose will be.
Dr. Oostvogels says it is not imaginable to compare the dose with other types of vaccines, such as a subunit vaccine such as the flu vaccine, which uses a component of a pathogen, or a attenuated vaccine such as chickenpox (for chickenpox) that uses a weakened virus because it looks different. It is also difficult to compare with other mNR applicants as none have been allowed.
The initial dose explained through Dr. Oostvogels’ team is based on CureVac’s past paints on a rabies vaccine, where two mRN injections at 1 or 2 micrograms induced neutralizing antibodies safely. “We knew from the rabies test that we could just start with little money because our platform, the way we created messenger RNA, is very powerful. “
Researchers start with low doses (2 micrograms) and then build them by gathering knowledge and building a knowledge base. They will want to inject a number of subjects into other dosage grades to compare them for statistical purposes. reasons that neutralize antibodies in a sufficient number or percentage of subjects to move on to the next phase of clinical development, explains Dr. Oostvogels.
His opinion on the Phase 1 trial is: “So far, so good”, it will not reveal express effects. “I am excited and looking for the future to move forward,” she said. The first effects will be published later this year.
In the near future, based on an internal and external evaluation of the first Phase 1 results, CureVac will initiate Phase 2a testing to verify protection and verify dosing in Panama and Peru with approximately 700 participants. 60 years of age and the development of racial diversity by using the review to determine whether there are differences between European and Latin American populations.
“Regulators will be interested to see that you have tested in a population,” Dr. Oostvogels said.
By November, CureVac aims to launch the Combined Phase 2b/3 exam for protection and efficacy, the first component involving vaccination of several thousand people in Europe, as well as in several Latin American countries.
” (We want to) collect instances (to assess the effectiveness of vaccines) and for that you have to be in countries where there are enoughArray instances . . . and it is in some Latin American countries right now,” he said.
If all goes well, they will move on to the full recruitment of 30,000 subjects.
To
Recently, trials of a separate vaccine from Oxford University resumed after it was discontinued after a player became ill. While researchers call for greater transparency in trials and experts say the rupture was also a sign of rigor of protection, says Dr. Oostvogels. that stops take place all the time but they’re not news. “[Now) everyone is after us,” he said.
She thinks it’s vital to keep other people informed about trials because she says belief and complaint are that studies are moving too fast and that protection isn’t being taken into account.
“I think what it really is is that the public sees that if something like this happens, the test stops, the evaluation is done decently,” he said.
CureVac CEO Franz-Werner Haas said his vaccine could be available until mid-2021 at a cost of 10 to 15 euros according to the dose. The CureVac vaccine candidate lately wants to be frozen for storage and transport, but the company is aiming to obtain a definitive vaccine that can be stored at the popular temperature, consistent with a temperature of 2 to 8 degrees Celsius. Oostvogels says it is less bulky because freezers cannot be obtained and are more expensive, and the vaccine would not need to thaw before injection.
She says the paintings are exciting but stressful given the volume of paints and high expectations. There is little room for errors or delays. ” People are dying as we speak because of this disease, so if it’s slow or spoils things because it doesn’t work well enough, it’s . . . an immediate impact, ” he said.
It also means that holidays are rare due to the threat of quarantine. “With the existing workload, I can’t not go to the office. “
For her, the optimal result is a vaccine that can protect anyone who needs it; in particular, she thinks of vulnerable members of our societies, like her mother, who is 80 years old and lives alone.
“Other fragile people who currently have no choice, because they don’t have the vaccine, will now have to stay home, far from everyone else, because the global exterior is too harmful to them. “
In July 2020, the European Investment Bank and the European Commission CureVac with EUR 75 million in investment for large-scale vaccine progression and production, adding the CureVac candidate vaccine for SARS-CoV-2.
CureVac
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