The need to clarify the safety and effectiveness of China’s vaccines is urgent, after Sinoform revealed that nearly one million people have been vaccinated before the completion of clinical trials. The campaign warned foreign scientists that it puts people at unnecessary risk. Chinese officials have repeatedly assured the public that the country’s corona virus vaccines are safe, while providing some details. Last month, Liu Jingzhen, head of Synopharm, said that none of the company’s vaccinators had experienced any adverse reactions. “Only a few had mild symptoms,” he said. Are all the technical terms used to describe how road vaccines work and are investigated for a corona virus vaccine to know about vaccines? Let us help: Adverse event: A health issue that raises volunteers in the clinical trial of a vaccine or a drug. An adverse event is not always caused by the treatment tested in the test. Antibody: A protein produced by the immune system that attaches to a pathogen such as the corona virus and prevents it from infecting cells. Approval, License and Emergency Use Authorization: Drugs, vaccines and medical devices may not be sold in the United States without the approval of the so-called Food and Drug Administration. After a company submits the results of clinical trials to the FDA for review, the company determines whether the product is safe and effective, which usually takes several months. If the country faces an emergency – like an epidemic – a company can apply for an emergency utility authorization, which can be issued considerably faster. Background rate: How many times a health problem called an adverse event arises in the general population. To determine if a vaccine or drug is safe, researchers compare the rate of adverse events in a trial to the background rate. Efficacy: The benefit of administering the vaccine compared to placebo, as measured in a drug test. To test a corona virus vaccine, for example, researchers compare how many people in the vaccine and placebo groups get Kovit-19. Efficacy, by contrast, is the benefit that a vaccine or drug provides in the real world. The effectiveness of a vaccine may vary more or less than its effectiveness. Phase 1, 2 and 3 trials: Clinical trials usually take place in three stages. Phase 1 trials typically involve a few dozen people and are designed to test whether a vaccine or drug is safe. Phase 2 trials, involving hundreds of people, allow researchers to try different doses and gather additional measurements regarding the effects of the vaccine on the immune system. Phase 3 trials, involving thousands or tens of thousands of volunteers, determine the safety and effectiveness of a vaccine or drug that is waiting to be seen to see how many people are protected from a disease designed to fight it. Placebo: A substance that has no therapeutic effect, often used in clinical trials. To see if one vaccine can prevent Covid-19, researchers can inject half of their volunteers with the vaccine, and the other half will get a saline solution. They can compare how many people are affected in each group. Post-market monitoring: Monitoring that takes place after a vaccine or drug is approved and is regularly recommended by physicians. This monitoring usually confirms that the treatment is safe. In rare cases, it detects side effects in some groups that were missed during clinical trials. Prognostic research: Studies that take place before the clinical trial begins, usually involving tests that test a treatment on cells or animals. Viral vector vaccines: A type of vaccine that uses a virus that is harmless to drive immune system-triggering substances in the human body. Viral vectors are used in several experimental Covid-19 vaccines, developed by Astrogenega and Johnson & Johnson. Both companies use a common cold virus called adenovirus as their vector. Adenovirus contains corona virus genes. Test protocol: Follow-up procedures to be performed during a clinical trial. In October, Zheng Zhangwei, a senior health official, said he had set up a “follow-up program” to monitor the population. Although he did not give any details, he was vaccinated. Sinovak Biotech, a Beijing-based private vaccine maker, has already started exporting its vaccines to countries such as Indonesia and Brazil. The state-run newspaper Science and Technology Daily reported that Sinoform, which has another vaccine for testing late, is preparing to deliver 500 million doses worldwide. It is unknown at this time what he will do after leaving the post. The government has already approved a vaccine for emergency use in September for leading workers at risk of contracting the Govt-19. In some countries where synoform tests have been performed, Chinese vaccines are helping to protect the population. Morocco says it is preparing to vaccinate 80 percent of its adults, initially relying on a synoform vaccine, but will wait until China approves the vaccine, according to the Moroccan news website Medias24. Chinese vaccines also attract developing countries because they are easier to distribute. Sinoform says its vaccines should only be refrigerated at 2 to 8 degrees Celsius (or 35 to 46 degrees Fahrenheit) and can be stable for up to three years. In contrast, the vaccines of Pfizer and Moderna, which are made from genetic material that falls off when dissolved, require an industrial freezer, making transportation and storage very challenging.
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