New Coronavirus Vaccine Clinical Warning, Nine Major U.S. Pharmaceutical Companies Promised Not to Apply for Listing Before Confirming Vaccine Safety

In the morning of September 10, the international pharmaceutical giant AstraZeneca is undergoing an accident in the global clinical trial of the new coronavirus vaccine. Some participants developed severe neurological symptoms after the injection of the drug. The incident triggered the model. Clinical trials of the vaccine have been suspended.

In the report, AstraZeneca CEO Pascal Soriot told investors on the 8th that a British woman showed symptoms consistent with transverse myelitis (a rare and severe myelitis) . The woman's condition is improving and will be discharged from the hospital as early as this Wednesday.

The commentary believes that although it is not uncommon in the international medical community to suspend drug trials to review safety data, the new coronary pneumonia vaccine being developed has received high attention and this adverse event has become the global focus.

AstraZeneca's New Coronavirus Vaccine Clinical Trial Accident Occurred

The chief scientific adviser to the British government said that, in addition to the vaccine jointly developed by AstraZeneca and Oxford University, after the decision to suspend research for safety reasons, other coronavirus vaccine trials may also be suspended in the next few months.

Dr. Francis Collins of the National Institutes of Health testified before a Senate Committee that U.S. health officials would not skimp on safety assessments when approving vaccines. Collins said that studying the safety and effectiveness of the new coronary pneumonia vaccine candidate is now the 'first task' of the National Institutes of Health. He told U.S. lawmakers that an independent data and safety monitoring committee is reviewing the integrity of clinical trials and continues to monitor the results to ensure the safety of participants.

Bloomberg News commented on September 9th, what is the most valuable asset of a pharmaceutical company? Compared with any research results, cutting-edge laboratories or trade secrets, the U.S. pharmaceutical industry benefits from one thing most importantly : its reputation.

To be clear, this is not to say that the pharmaceutical industry is popular. In fact, it ranked last in the 2019 public respect survey of major industries conducted by the public opinion polling agency Gallup. But every day, doctors and patients turn to products from this industry to save lives. This is like what Americans say about lawyers : unless you need a lawyer, no one likes a lawyer.

The public’s trust is largely due to the Food and Drug Administration (FDA). For decades, the FDA has been the world's gold standard for drug regulation. When the agency approves a drug, vaccine or medical product, their approval seal is more valuable than any pharmaceutical manufacturer’s advertising campaign.

This halo of reputation is also the reason why the industry agreed to pay the FDA millions of dollars for high-quality, fast reviews. The modern pharmaceutical industry cannot leave the FDA. Without it, it will suffer severe pain.

Protecting the FDA, and thus the industry, is the reason why the nine major U.S. drugmakers pledged this week not to send vaccines to FDA for review until the evidence is conclusive.

The industry knows that submitting an unqualified application and then watching it pass under the push of political forces will cause reputational damage far more than the outbreak of the epidemic. This is not just a shot to prevent the failure of new coronary pneumonia, but it will destroy the most valuable asset of the industry : trust.

During the current U.S. election, the pharmaceutical industry did not participate in anti-Trump activities, nor did it come close to supporting Trump campaigns. It is doing what it has always done, considering its own long-term interests. More important than political parties, corporate tax rates, drug pricing legislation or almost any other thing that pharmaceutical companies worry about, it requires the trust of doctors and prescriptions for products that include it, and patients need to take them. Similarly, the FDA is also taking steps to maintain its reputation by protecting itself from political interference.

All of this means that if it takes weeks or months to accumulate the required clinical trial data to obtain reliable evidence that the vaccine is effective and safe, drugmakers will wait. If the FDA needs more time to review the timing of vaccination, it may be postponed until after election day. Although President Trump hopes that the sooner the better.

But this also means that if the test data is faster and convincing and ready, American society will not have nearly a thousand Americans die of new coronary pneumonia every day. If you think that a vaccine is rushed to the market without conclusive evidence, it would be a scandal, imagine what a scandal would be if a pharmaceutical manufacturer or institution deliberately delayed the launch of the vaccine when people fell ill and died out of political considerations.