The need to clarify the safety and efficacy of Chinese vaccines became more urgent after Sinopharm found out that it had vaccinated roughly one million people before clinical trials were completed. The campaign has alarmed overseas scientists who say it exposes people to unreasonable risks.
Chinese officials have repeatedly assured the public that the country’s coronavirus vaccines are safe, yet provide little detail. Last month, Liu Jingzhen, a Sinopharm said none of the people receiving the company’s vaccine experienced any side effects. He said “only a few had mild symptoms”.
Are all the terms used to describe the function and testing of vaccines confused? Let’s help:
- Adverse event: A health problem that occurs in volunteers during a clinical trial of a vaccine or drug. An adverse event is not always caused by the treatment tested during the study.
- Antibody: A protein produced by the immune system that can attach to a pathogen, such as the coronavirus, and prevent cells from becoming infected.
- Approval, authorization and authorization for emergency use: Drugs, vaccines, and medical devices cannot be sold in the United States without obtaining approval from the Food and Drug Administration, also known as licensing. After a company submits the results of clinical trials to the FDA for consideration, the agency decides whether the product is safe and effective, which usually takes months. If the country is facing an emergency, such as an epidemic, a company can apply for emergency use permit, which can be entered much faster.
- Background ratio: How often a health problem, called an adverse event, occurs among the population. To determine if a vaccine or drug is safe, researchers compare the rate of adverse events that occurred during the study with the background.
- Efficiency: The benefit of vaccination over placebo was measured in a clinical trial. For example, to test for a coronavirus vaccine, researchers are comparing how many people in the vaccinated and placebo groups receive Covid-19. Efficacy, on the other hand, is the benefit that a vaccine or drug provides in the real world. The effectiveness of the vaccine may be lower or higher than its effectiveness.
- Phase 1, 2 and 3 experiments: Clinical trials are typically conducted in three phases. Phase I studies usually involve a few dozen people and are designed to monitor whether the vaccine or drug is safe. Phase 2 research involving hundreds of people will allow researchers to try out different doses and gather additional measurements of the effect of the vaccine on the immune system. Phase 3 studies, involving thousands or tens of thousands of volunteers, determine the safety and effectiveness of a vaccine or drug by looking at how many people are protected against the disease they are fighting.
- Placebo: A substance that has no therapeutic effect is often used in a clinical trial. To determine if a vaccine can prevent Covid-19, researchers can give the vaccine to half of their volunteers, while the other half receive placebo from salt water. They can then compare how many people from each group become infected.
- Post-market monitoring: Post-approval check of a vaccine or medication that is regularly prescribed by doctors. This observation usually confirms that the treatment is safe. In rare cases, you may experience side effects that have been missed in clinical trials in certain groups.
- Preclinical research: Pre-clinical trials, which usually involve experiments where the treatment is tested on cells or animals.
- Virus-vector vaccines: A vaccine that uses a harmless virus to drive the driver’s immune-boosting ingredients into the human body. The viral vector is used in a number of experimental Covid-19 vaccines, including those developed by AstraZeneca and Johnson & Johnson. Both companies use a common cold virus, called an adenovirus, as a vector. Adenovirus carries coronavirus genes.
- Trial protocol: A set of procedures to be performed during a clinical trial.
In October, senior health official Zheng Zhongwei said the government had set up a “follow-up program” to track vaccinated people, although no details were provided.
Beijing-based Sinovac Biotech, a manufacturer of vaccines, has already begun exporting its vaccines to countries such as Indonesia and Brazil. Sinopharm, which has another vaccine in its late-stage tests, said it is preparing to deliver 500 million doses worldwide, the state newspaper Science and Technology Daily writes.
It is unclear whether the Emirates will start using the Chinese vaccine – which is provided by Sinopharm developed by the Beijing Institute of Biological Products – for mass vaccinations. As early as September, the government approved the vaccine for emergency use for those working on the front at risk of Covid-19 infection.
In some other countries where Sinopharm is conducting experiments, Chinese vaccines are being counted to protect their populations. Morocco says it is preparing to vaccinate 80 percent of adults, initially relying on Sinopharm vaccination, although Moroccan news site Médias24 says China would wait for the vaccine to be approved.
Chinese vaccines are also attractive to developing countries because they are easier to distribute. According to Sinopharm, your vaccines should only be refrigerated at 2 to 8 degrees Celsius (or 35 to 46 degrees Fahrenheit) and may remain stable for up to three years. In contrast, vaccinations from Pfizer and Moderna, which are made with genetic material that disintegrates when thawed, require industrial freezers, making transportation and storage more difficult.