What is the difference between emergency use of the new crown vaccine and full approval?
Recently, the U.S. Food and Drug Administration (FDA) is stepping up the full approval process for Pfizer vaccine. What does it mean to be fully approved by the FDA for a new coronavirus vaccine, and what is the difference between emergency use authorization (EUA) and full approval?
According to a report from The Conversation website on August 12, local time, a new survey showed that 30% of American adults who have not been vaccinated said that they are waiting for the FDA to fully approve a new crown vaccine for use.
Pfizer vaccine was urgently authorized for use by the FDA at the end of 2020. Since the company submitted its application on May 7, 2021, the FDA has been under increasing public pressure to request full approval of the Pfizer vaccine. US President Biden previously stated that Pfizer's vaccine will be fully approved in the early fall of this year. The New York Times pointed out that at a time when cases of delta variant strains are increasing rapidly, the full approval of Pfizer vaccine will help increase the vaccination rate, eliminate misinformation about vaccine safety, and clarify the compulsory vaccination. Legal Issues.
According to the official FDA website, emergency use authorization is to promote the provision and use of medical countermeasures including vaccines during public health emergencies. Once submitted, the FDA will evaluate the emergency use authorization application, combined with scientific analysis, to determine whether it meets the relevant statutory standards.
Although the emergency use authorization of the vaccine simplifies the process and makes the vaccine available to the public more quickly, it still has to comply with the strict requirements of the FDA to ensure the safety and effectiveness of the vaccine; and when a vaccine manufacturer applies for full approval, all The time required is longer and the FDA has more data for evaluation.
Of course, for the new crown vaccine, whether it is emergency use authorization or full approval, the FDA first needs to conduct preliminary safety studies on a small number of volunteers to determine the potential adverse effects or side effects that the vaccine may cause, as well as the safest and most effective vaccine dose. .
Once it is determined that the vaccine is safe and the optimal dose is determined, the researchers will conduct a larger-scale placebo-controlled experiment to test how effective the vaccine is. It is worth noting that the number of volunteers participating in the initial safety experiment of the new crown vaccine is consistent with the participation of other commonly used vaccines, including tetanus, diphtheria, pertussis and meningitis vaccines.
However, the FDA has different clinical research requirements for emergency authorization and full approval of the new crown vaccine. Most of the side effects associated with the vaccine occur immediately after vaccination. Emergency authorization only requires follow-up and observation of volunteers for two months, while full approval requires follow-up and observation for six months. In addition, vaccine manufacturers must also provide more detailed production plans and processes, and accept higher-level supervision and inspections, which greatly increase the review time. Full approval may initially only apply to the same age group that was tested in the original emergency use authorization, such as approving Pfizer vaccines for people 16 years and older, and people 18 years and older in Modena, and as experimental data increases, The age limit will also be relaxed.
In addition to Pfizer, Modena also submitted an application for full approval of the Modena vaccine on June 1 this year, but the company is still submitting data and did not disclose when the application process can be completed. The third vaccine approved for emergency use in the United States, Johnson & Johnson’s vaccine also plans to apply for full approval from the FDA later this year.
但是，FDA对新冠疫苗的紧急授权和完全批准则有着不同的临床研究要求。大部分与疫苗相关的副作用都是在接种疫苗后立即发生，紧急授权只需要跟踪观察志愿者两个月，而完全批准则需要跟踪观察六个月。此外，疫苗制造商还必须提供更详细的生产计划和流程，接受更高级别的监督和检查，这些都大大增加了审核的时间。完全批准最初可能仅适用于在原来紧急使用授权中进行测试的相同年龄组，比如批准辉瑞疫苗给 16 岁及以上人群，以及莫德纳的18岁及以上人群，而随着实验数据的增加，年龄限制也会放宽。