Vaccine Manufacturers Boycott, U.S. FDA 'Gold Standard' Loses its Glamour

According to U.S. media reports on September 5, many global new coronavirus vaccine development companies including Pfizer, Modena, Johnson & Johnson in the United States, GlaxoSmithKline in the United Kingdom, Sanofi in France, etc. are planning to issue public joint commitments of no extensive safety and effectiveness test data of new coronavirus vaccine will be sent to the U.S. Food and Drug Administration (FDA) for approval.

For a long time, the pharmaceutical industry has always regarded FDA's approval as the 'gold standard' for safety and efficacy. However, the 'gold standard' has obviously lost its luster when the FDA itself is caught in a whirlpool of 'politicization'.

The primary reason why these pharmaceutical manufacturers that compete with each other in the development of vaccines are 'unanimously external' is that the FDA made a number of controversial decisions during the epidemic: On August 23, the FDA issued an emergency authorization to allow hospitals to resume use phase plasma treatment of patients with new coronary pneumonia, however, American public health experts believe that the treatment does not have enough data to prove its effectiveness and sustainability; on March 28, the FDA authorized the use of chloroquine and hydroxychloroquine for the treatment of new coronavirus pneumonia However, subsequent data show that these two drugs have no significant effect in treating patients, but will also produce some serious side effects.

However, these decisions of the FDA have been praised by Trump administration officials. Trump himself not only promoted hydroxychloroquine on many occasions, he himself also took hydroxychloroquine in May. The FDA has also made a delay in authorizing plasma treatment decision was criticized by Trump for 'political motivation'. It can be said that it was the series of decisions made by the FDA during the new coronary epidemic that did not fully meet scientific standards and were more like catering to the White House’s 'political agenda' that gave major pharmaceutical manufacturers doubt its ability to make scientific decisions.

Pharmaceutical manufacturers are 'unanimously external', which is also closely related to the current dilemma faced by pharmaceutical manufacturers, especially vaccine manufacturers. For many years, vaccines have never been a purely medical problem in European and American countries. There are serious social, political, religious and cultural conflicts behind it. CBS quoted a survey conducted by the polling agency YouGov on September 6, saying that if the new coronavirus vaccine is freely available in the United States, only 21% of Americans would say that they would be vaccinated as soon as possible. This data is actually down from July for 11 percentage points. And another 58% said they would consider it, but would wait and see others before making a decision. This situation is not uncommon in Europe: The German 'Star' weekly reported on August 22 that nearly 20% of Germans are unwilling to receive the new coronavirus vaccine. A July survey by the "Huffington Post" showed that 32% The French said they would not be vaccinated; the British 'Guardian' claimed that 1/6 of the British people would not be vaccinated.

With a profoundly 'anti-vaccine' Western cultural background, major pharmaceutical manufacturers will naturally be more cautious in launching the new coronavirus vaccine. Stefana Boncer, CEO of Moderna, publicly stated that the company is slowing down its trial registration to include more patients from high-risk groups. The company prefers to have more diverse participation and try, spend an extra week.'

The prudence of pharmaceutical companies in developing vaccines is also related to the current U.S. elections that are becoming increasingly fierce. According to U.S. media analysis, due to the continued lagging behind Biden in the polls, especially in the polls of several key battlefield states, Trump urgently needs to create political achievements to attract the support of swing voters.

For Trump, under the raging situation of the epidemic, it is undoubtedly an excellent benefit for pharmaceutical companies that have received large amounts of funding from the U.S. government to launch vaccines at 'critical time points'. However, pharmaceutical companies are obviously unwilling to 'endorse' them at the risk of losing the company's long-term interests. Therefore, although Trump and CDC officials have recently repeatedly declared that the United States can launch the new coronavirus vaccine at the end of October or early November, pharmaceutical companies have always been cautious about this statement and are reluctant to dance with the White House.

In the final analysis, the reluctance of pharmaceutical companies to submit vaccines to the FDA once again highlights the intractable contradiction between 'scientific anti-epidemic' and 'political anti-epidemic' in the United States under the epidemic. Since the outbreak, the U.S. government has always put political issues ahead of its response to the epidemic. Not only has it refused to follow the advice of epidemic prevention experts, it has also dismissed some officials who pointed out that the White House and health departments have not done enough to prevent the epidemic. The United States is known as the 'anti-epidemic captain' Anthony Fauci, Director of the Institute of Allergy and Infectious Diseases, turned out to be bizarre in April and May this year.

At the same time, under the pressure of the White House, the CDC, which is a key department in response to the epidemic, has been stunned. Recently, the CDC quietly revised the epidemic prevention guidelines, stating that close contacts of confirmed cases of new coronary pneumonia do not need to undergo mandatory testing if they are asymptomatic. After the news was exposed, there was an uproar in the United States. Many experts criticized the CDC for putting the lives of ordinary people in danger. They were even more worried that these changes meant that the CDC was being undermined by Trump and political officials appointed by him. .

It can be said that it is precisely because the White House politicians have always placed the seizure of political personal gains at the forefront of the work list that has prevented Americans from obtaining clear, credible and operational guidance on epidemic prevention, and ultimately made the United States, which has the highest medical level in the world, to lose in this 'war against the epidemic'.