Multiple Vaccine Manufacturers Plan to Jointly Promise Not to Submit the New Coronavirus Vaccine to the U.S. FDA for Advanced Approval

On September 5, foreign media reported that several new coronavirus vaccine research and development companies around the world are planning to jointly pledge that they will not send any new coronavirus vaccines to the U.S. Food and Drug Administration (FDA) for approval, until extensive safety and efficacy test data are obtained. This move is seen as an attempt to avoid political pressure on the FDA before the U.S. election. U.S. President Trump has repeatedly stated that he hopes that the vaccine will be 'ready' before the election day.

According to a report by 'Bloomberg' on September 5, people familiar with the matter said that several new coronavirus vaccine research and development companies around the world are planning to issue public joint commitments that they will not send any new coronavirus vaccines to the U.S. FDA for approval if they do not get extensive safety and effectiveness test data. The plan may appear in a joint statement of multiple companies next week.

The companies participating in the discussion included Pfizer, Moderna, Johnson & Johnson in the United States, GlaxoSmithKline in the United Kingdom, Sanofi in France, etc. The analysis pointed out that the statements of these pharmaceutical companies are considered to avoid political pressure for the FDA to approve vaccines as soon as possible.

The U.S. pharmaceutical industry has always used FDA approval as the gold standard for safety and efficacy. However, in the recent period, the FDA has made several controversial decisions, such as allowing emergency use of some new coronavirus therapies before the efficacy is determined. Analysis believes that this is due to political pressure.

Trump has stated many times that he hopes that the new coronavirus vaccine will be 'ready' before the November 3 general election. He recently said that the new coronavirus vaccine may be put into use on November 1, instructing states to prepare for distribution. The outside world is worried that Trump will use political means to pressure vaccine research and development in order to save the election. A recent poll showed that most Americans interviewed believe that the approval of the new coronavirus vaccine will be politicized.