Chinese companies are at the forefront of global efforts aimed at creating a vaccine against coronavirus, with more than half a dozen candidates in clinical development. Last week, the Tianjin-based Cancino biologics published results1 in early stage clinical trials have shown that the vaccine is safe and can induce an immune response.
However, companies can face difficulties as they try to push vaccines in the framework of the phase III studies, a critical stage of the testing required to prove the effectiveness and ensure approval by regulatory authorities. These trials typically require tens of thousands of participants, and with the outbreak in China largely under the control of the company to test its vaccine in other countries. But researchers say they are still struggling to record so many participants and recruit enough health professionals in data collection.
“Chinese companies should step outside of China,” says Jerome Kim, Director General of the International vaccine Institute in Seoul. “The race is on,” he says, “and it’s really about who can establish high risk most quickly.”
Chinese vaccine manufacturers will be faced with other problems. The vaccine, likely to face additional scrutiny, given the opaque regulatory system in the country and the previous scandals vaccine, scientists say. In 2018, it is reported that hundreds of thousands of children received the defective diptheria, tetanus and pertussis vaccine.
In a country where an outbreak of coronavirus began, China was quickly out of goal on the development of vaccines. Offering Cancino performed from the common cold, altered to mimic the syndrome. Sinopharm, the state pharmaceutical company in Beijing, is developing two vaccines made using particles of the coronavirus, which was have been inactivated so they cannot cause disease. The company said in a press release in June, both vaccines have produced antibodies to all the participants of the preliminary phase I and II clinical trials. Company and the Beijing Sinovac announced similarly promising results for their own inactivated viral vaccines.
This month, Sinovac initiated a phase III study of the vaccine in Brazil. Sinopharm will experience its inactivated vaccines, in the United Arab Emirates (UAE). Only three syndrome vaccine entered in phase III studies: developed by the biotech company Moderna in Cambridge, Massachusetts, one of Oxford University and drug manufacturer AstraZeneca, based in Cambridge, UK, and one by the biotechnology company BioNTech in Mainz, Germany, in cooperation with the new York drug company Pfizer.
Cancino also is preparing to launch phase III trials. But the Chinese government has said that the vaccine can be used in military design Cancino first company to have a vaccine for COVID-19 companies approved for use in humans. China is working hard“ to find an effective vaccine as soon as possible and to be transparent” when doing so, says Stefan, Paul, a vaccine researcher at the University of Lyon in France.
The speed with which Chinese vaccine manufacturers move has raised hopes around the world. Sinopharm and even promised that the vaccine ready to distribute before the end of the year.
Inactivated vaccines are widely used types of vaccines, so it makes sense for Chinese companies to focus on them, says Paul. “As a first-line vaccines, it is immunogenic to rapidly build and inexpensive,” he says.
But some viruses become more powerful when they infect organisms previously treated with inactivated vaccines, in a poorly studied phenomenon, known as antibody-dependent enhancement (ade). This was announced2 last year the monkeys were given a vaccine against the coronavirus-the causative agent of severe acute respiratory syndrome (SARS). Sinovac says it COVID-19 vaccine will not cause ADE in monkeys, but the risk will be closely monitored in all inactivated-vaccine phase III trials, says Paul.
Challenges for the future
Some observers wonder whether the company will be able to work at the promised speed and with accuracy that such tests require. The fact that China was ready to approve the vaccine Cancino for use in military research phase III was completed raised his eyebrows. “The solution is political, not scientific in nature. It does not show anything about the potential effectiveness of the vaccines,” says Marie-Paule Kieny, a vaccine researcher at INSERM, the French National medical research Institute in Paris.
Phase III clinical trials pose problems for vaccine manufacturers around the world, as, for example, need to recruit a sufficient number of participants and qualified medical staff. Demonstrating that the vaccine to induce an immune response and to protect people from the virus requires information about 20,000–40,000 people, which were divided into control and experimental groups, and then closely monitored for several months or even years, the researchers say. To achieve the required numbers, the test may need to combine the results of dozens of hospitals, each delivering information from hundreds of patients. “All of these things need to be done, and done right,” says Kim. “The number of sites that can do it and handle the volume is limited,” he adds. “Even the best sites have difficulties”.
Many Chinese companies are at a disadvantage because they have not created a network of hospitals around the world, Kim said. “AstraZeneca,” which was published3 promising early results of the study vaccine, based on cold virus, the chimpanzee is the same day Cancino, conducts research phase III, in the United Kingdom, Brazil and South Africa. Art Nouveau began testing his vaccine that causes the development of the immune response with synthetic RNA that mimics the RNA of the coronavirus uses to replicate, to 30,000 people in the United States, a country with a lot of experienced clinical researchers to conduct research and a large outbreak of coronavirus.
The US President Donald trump said last week that he was ready to work with any country that can deliver an effective vaccine, but Chinese companies were excluded previously receiving funding from the US government actions warp, which aims to accelerate vaccine development. Also the possibility of U.S.–Chinese cooperation was damaged on July 21, when the U.S. Department of justice released allegations that the Chinese hackers tried to steal COVID 19 samples of the vaccine from American companies.
Still, Kini, indicates that Sinopharm has cooperated with the government and a group of UAE 42 health local artificial intelligence the company, its phase III clinical trials, and Sinovac collaborates with the Institute of Butantan in Sao Paulo, Brazil. “Until now, Chinese companies seem to have succeeded in finding partners,” she says.
But some researchers question whether there is litigation in the UAE and Brazil will gather enough data to convince regulators that the effect of the vaccine. In the UAE, where Sinopharm plans to cover 15 000 study participants two vaccines, a relatively small number of people infected with COVID-19.
And although Brazil has a large outbreak of coronavirus, Institute Butantan test plans Sinovac vaccine among healthcare professionals, as expected, they will face more exposure to the virus than the non-doctor. Because of this, the trial will only enroll 9000 people to test if it works, says Ricardo Palacios, clinical research fellow at the Institute, who is leading the trial. “We have developed a trial in order to get answers in a more efficient way,” says Palacios.
Kim notes that in countries where health care workers wear appropriate protective equipment, they may not face greater exposure to the virus, which would undermine the rationale for a smaller trial.
The most important thing is that the data collection processes, which meets the international standards it is expected that the regulatory authorities of the drug and international organizations such as the world health organization, Kim said. “If you can’t do that, you’re in trouble,” he says.
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