Could It Be This Fall? Concerns Over Vaccine Development Rush... Safety Verification and Side Effect Issues Raised

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Hyunwoo Lee] Expectations for the release of a COVID-19 vaccine are growing as U.S. President Donald Trump mentioned that the development of a novel coronavirus (COVID-19) vaccine could be possible within this year. Some speculate that if clinical trial results proceed even faster, the vaccine could be available for use starting this fall. This statement comes after the U.S. Food and Drug Administration (FDA) recently granted emergency approval for remdesivir, an Ebola treatment, as a COVID-19 therapy, drawing attention to whether there will be concrete progress. However, concerns have also been raised about whether the development speed is too fast, along with safety verification and potential side effects.

According to CNBC and others on the 3rd (local time), President Trump emphasized at a Fox News town hall meeting held at the Lincoln Memorial in Washington, "I am confident that a vaccine will be developed by the end of the year," adding, "We are pushing very hard." He specifically mentioned the pharmaceutical company Johnson & Johnson, saying, "In my opinion, many companies are getting close to developing a vaccine." Johnson & Johnson has previously stated hopes to have vaccine approval by early 2021.

Scott Gottlieb, former FDA commissioner, also stated in an interview with CBS on the same day, "The COVID-19 vaccine could be available as early as this fall," adding, "Several vaccine manufacturers have completed early-stage clinical trials." The positive signals for vaccine development are further highlighted as they came right after the emergency use authorization of remdesivir. On the same day, Daniel O’Day, chairman of Gilead Sciences, the maker of remdesivir, said in an interview with CBS, "We plan to deliver the drug to patients starting this week," and "We will donate all the drugs we currently have free of charge."

However, the global medical community is expressing concerns about the speed of COVID-19 vaccine development. It is generally known that vaccine development requires more than four years. If developed too quickly, there are worries about difficulties in verifying safety and side effects. U.S. pharmaceutical companies are promoting 'Human Challenge Trials (HCT)' to accelerate vaccine development. HCT involves deliberately infecting young and healthy volunteers with the COVID-19 virus to test the effectiveness of vaccine candidates, aiming to speed up clinical trials. However, this experiment has low safety and the risks are not properly disclosed, raising ethical issues.

In the U.S., volunteers for HCT are being recruited under the name "One Day Sooner," and it is reported that about 9,000 people from over 50 countries worldwide have applied for HCT. Shima Shah, a professor of medical ethics at Northwestern University, explained in an interview with The New York Times (NYT), "HCT will raise ethical issues before benefits," adding, "There will be controversies about how participants are selected, whether risks and information can be sufficiently provided to participants, and what compensation will be given for participation."

The World Health Organization (WHO) is reviewing guidelines in response to the HCT issue. According to Hong Kong’s South China Morning Post (SCMP), Margaret Harris, WHO spokesperson, stated, "We plan to announce HCT guidelines within the next few weeks," adding, "HCT volunteers must be able to fully understand the risks involved."

This content was produced with the assistance of AI translation services.