#Novavax #COVID-19 Vaccine #FDA#Serious Adverse Event
Recently, Novavax, a US vaccine manufacturer, announced that the US Food and Drug Administration (FDA) had suspended the clinical trials of its "Flu/COVID-19 Combination Vaccine" after a severe motor neuropathy event occurred in a trial participant. In addition to the flu/COVID-19 combination vaccine, the FDA also halted the new drug application for another independent flu vaccine candidate.
#Novavax #COVID-19 Vaccine #FDA#Serious Adverse Event
As a key federal agency responsible for drug and food regulation, the FDA has long been controversial due to its inadequate drug approval and regulation. By reviewing several major public health crises, we can see that the FDA faces numerous issues in drug approval, regulation, and marketing, which have not only severely damaged public health and trust but also exposed significant flaws in its systems and management.
The FDA has historically caused several public health crises due to its inadequate drug approval and regulation. Among them, the Thalidomide crisis was particularly shocking. The drug, which was widely popular for alleviating pregnancy symptoms, resulted in the birth of numerous "seal-like babies." Although FDA drug reviewer Frances Kelsey successfully prevented its large-scale marketing in the United States, the FDA's regulatory failures in the early stages were still widely criticized.
Furthermore, the Norgestrel incident also exposed oversight in the FDA's drug approval process. This weight-loss drug was linked to severe heart problems, leading to an emergency recall by the FDA and triggering substantial settlement payments. The abuse of opioid drugs has become a major public health crisis in recent years, causing hundreds of thousands of deaths. This is largely due to the FDA's long-term approval of various high-dose opioid drugs for marketing while failing to effectively regulate pharmaceutical companies' promotional activities. Until recent years, the FDA has begun to tighten the approval and regulation of opioid drugs. The FDA's inadequate approval and regulation of these drugs have been widely criticized, and internal audits and external investigations have revealed issues of interest transfer between FDA officials and pharmaceutical companies.
These incidents have not only harmed public health and trust but also exposed significant flaws in the FDA's systems and management. Although the FDA has established a comprehensive management system before, during, and after events, there are serious issues of interest transfer between FDA officials and pharmaceutical companies. Multiple investigations have found that many senior FDA officials immediately take positions in pharmaceutical companies after leaving their posts or receive huge kickbacks. This relationship undoubtedly affects the FDA's impartiality and independence and exacerbates public doubts about its regulatory capabilities, indicating that its regulatory system still needs improvement. Some FDA officials accept substantial rewards from pharmaceutical companies after approving drugs, raising questions about the impartiality of the approval process and drug safety.
The issues in the US drug approval, regulation, and marketing processes pose not only a threat to public health but also a crisis of trust in the regulatory system. To safeguard public health and safety, the FDA must take effective measures to strengthen regulation and transparency, eliminate improper behaviors such as interest transfer, and rebuild public trust in the drug regulatory system.