With President's Interference, How Can Scientists Review Vaccines Impartially？
United Daily News Editorial, June 9, 2021
With Taiwan mired in a serious shortage of coronavirus (COVID-19) vaccines, the administration of President Tsai Ing-wen is forcefully promoting domestically developed vaccines and even purposely halting the import of foreign vaccines. It came as a shock that Academician Chen Pei-jer, of Academia Sinica and a member of the vaccine review committee in the Food and Drug Administration (FDA), Ministry of Health and Welfare (MOHW), decided to resign from the committee late May due to external political interference. He claims that the domestic vaccines are unable to receive Emergency Use Authorization (EUA) before July and stated that the biggest obstacle for vaccine review is President Tsai. It is startling that the vaccine chaos in Taiwan involves a tussle between the president and a scientist.
The reason behind Dr. Chen’s resignation is straightforward because President Tsai has publicly announced that domestic vaccines will be available in July so there is no way for the FDA to resist this pressure but to approve the vaccines. Being a scientist and unable to examine the vaccine impartially, Chen chose to resign. We have respect for Dr. Chen’s demonstrated professionalism. But if his concern is correct, then the FDA could hastily approve the domestic vaccines under the President’s pressure. If the domestic vaccines are provided to the public without going through honest and proper review procedure, then is it possible that the general population will become guinea pigs for the domestic vaccines?
Dr. Chen’s criticism of the domestic vaccines cannot be regarded as “bad-mouthing.” It is an honest opinion from a scientist according to his professional knowledge. His main arguments are: (1) The domestic vaccines developed using the protein subunit is technologically most challenging and least effective in vaccine efficacy; for example, the U.S. Novavax vaccines using similar technology still have not received international authorization despite nearly finishing phase 3 clinical trials. (2) None of the two domestic vaccines has completed phase 2 clinical trials when the President made the promise to vaccinate in July and no democratic countries in the world have ever granted EUA to a vaccine which only completed phase 2 trials.
Some medical experts espouse different views towards Dr. Chen’s first argument. They agree that the protein subunit vaccines involve higher technological challenge yet disagree that it is definitely least effective. Its dosage is hard to estimate and may require 3 shots, yet its storage is simpler and doesn’t require special refrigeration. Novavax vaccines are about to complete phase 3 clinical trials with tens of thousands of participants and are expected to submit EUA applications to the U.S. and the EU in the next season. Once it is completed the vaccination may soon begin. In other words, technological difficulty is not the major issue. The main problem is that the government is trying to rush approving EUA for domestic vaccines without large-scale phase 3 clinical trials. This is genuinely troubling the scientists.
Under the current political climate in Taiwan, it takes a lot of courage for Dr. Chen to say that the biggest obstacle comes from President Tsai. Chen is immediately under the carpet-bombing from ruling Democratic Progressive Party (DPP) supporters, even his own brother was asked to join the attacks. Vaccine should be a science issue, but in Taiwan it has escalated into partisan political rivalry. If science is not respected in a society, there is no room for rational debate. Furthermore, the identity of members of the review committee should be kept confidential to protect them from undue lobbying. Why did the MOHW leak Dr. Chen’s name? Who is truly responsible for turning Taiwan into a place where cyber-warriors can dominate public opinion and blur the line between right and wrong?
Chen is worried that the vaccine review committee does not have much room for independence under the pressure of the president. The concern, in fact, is not unfounded. The most representative example is the national conference for judicial reform in 2017. President Tsai, who presided the meetings, reprimanded the judicial reform committee: "What are you doing?" when the selection of Supreme Court judges did not fit her wishes. She then modified the content of the proposed resolution by herself and observe votes until satisfied. In the end, she ridiculed everyone: "Isn't this the same as how I wanted you to vote the first time? You made a big circle!"
Just imagine, President Tsai is so overbearing in her treatment of members in the judicial reform committee. Can the vaccine review committee of the FDA be more hardline? We can hardly be optimistic. Academician Chen only honestly stated his personal opinion but was encircled and suppressed by DPP supporters. If other vaccine committee members dare not approve the domestic vaccine easily, then their fate would be unpredictable. The critical question to be asked is this: If the president has her hand stretched so long, how much room is there for the scientist to be honest and impartial to his profession?