Too rapid the development of vaccines and anti-coronavirus medicines, according to a virologist at Fudan University in Shanghai, Shi-Xiang, can carry a number of risks. The expert wrote this in a commentary that published the magazine Nature on his website. According to the virologist, for example, there is a risk that new substances will start to be administered before their effects are properly demonstrated or possible negative impacts on human health are found.
“The world is committed to supporting rapid programs to develop COVID-19 vaccines and drugs. Companies in the United States and China are even planning to test vaccines on healthy human volunteers, ”said the virologist.
He also agrees that it is important that drugs against this disease be available globally as soon as possible, but at the same time, it is important not to rush and underestimate anything in their development.
Shi-Jiang, who has been involved in the development of anti-coronavirus agents for years, points out that measles, rubella, polio, or influenza vaccines have a long history of safe use. Compliance with regulatory authority requirements has been developed.
"In my opinion, standard protocols are necessary for health protection," says the virologist. "Before allowing the use of the COVID-19 vaccine in humans, regulators should first verify their safety," he added.
Regulators should also require pre-clinical testing results to demonstrate that the vaccine can prevent infection. "Even though this is likely to mean weeks to months of testing," Jiang said.
Target? Safe and effective vaccine
The death rate for COVID-19 is relatively low, according to Shi-Xiang, but the disease is spreading rapidly. A large number of people will therefore need the vaccine. Regulators should therefore, properly - first on animals - assess the potential health risks of these new substances before testing the vaccine on healthy volunteers.
Most of the COVID-19 drugs that are registered for clinical trials in China contain substances previously approved for the treatment of other diseases. This means that they are not directed against human coronaviruses and their effects on COVID-19 have not been tested in animals, which would otherwise be required by the Chinese regulatory authorities, notes the virologist.
In addition, how these substances react in combination with other drugs has often been ignored. Their potential toxicity must be evaluated before they can be used in the present disease.
"Measure twice, cut once"
Scientists should also consider that the coronavirus behind COVID-19 has the potential to mutate when developing vaccines, which could make the original vaccine inactive. Regulators should therefore ensure that substances they release for testing do not work exclusively for a particular coronavirus, but rather more generally.
In addition, testing of vaccines and medicines in humans without taking enough time to assess possible security risks could, according to the virologist, undermine citizens' confidence in their government. The public's willingness to adhere to anti-epidemic measures is related to this confidence. For the development of drugs and vaccines against coronavirus, therefore, the saying "twice measure, once cut".