A major coronavirus vaccine clinical trial is on pause: research teams react to the results of the trial. Enrollment in ongoing international trials of a vaccine candidate are on pause following a “hypothetical” adverse event (AE) in a human who received the vaccine during the ongoing study in the United Kingdom.
In the vaccine, a group of viruses is engineered to produce a protein that prevents its replication. The vaccines were prepared using a DNA-based vaccine technology, but they have been shown to be safe and effective. For two years, the ongoing vaccine study was proceeding at full speed, until a few weeks ago, a potential side effect of the trial caught researchers’ attention.
Coronaviruses cause severe respiratory and heart disease, diarrhea, and vomiting. Their incubation period varies from two to 21 days. When the virus reaches a critical stage and affects the central nervous system, it can cause death within hours. Because the virus is so lethal, any side effects resulting from the vaccine must be very rare, or otherwise the trial would not have been allowed to proceed.
In this instance, the trial conducted a small percentage of the vaccine, so it did not provide enough data for the company to be confident it could adequately protect the public from this threat. Because the side effects are so rare, there is no need to stop the study. This is a risk management decision by the company.
Medical device trials often contain a number of safety assessments that are designed to detect problems with the process before they occur. This type of trial allows for thorough review of all data related to the product, ensuring there will not be unforeseen problems that could have resulted from the use of the product in the future.
Safety is something that is routinely reviewed as part of the assessment of drugs and procedures for regulatory approval. When a company is performing an assessment for a new drug, it is important to conduct the clinical study in a manner that safeguards the public.
Safety assessments may include testing for interactions with other drugs, assessing the safety of the ingredients, and conducting the clinical study in an environment that does not expose people to potential health risks. While the results of these tests are important to the company, they are not conclusive.
Because there are so many studies that are conducted simultaneously, it is important for the company to continue to evaluate the clinical trial to make sure it continues to provide the information needed to support regulatory approval. Even when a company determines that there are no safety concerns, it is important to conduct follow up studies to ensure the product is meeting standards.
The first step in doing this type of follow-up study is to contact the company and obtain copies of all test results from the coronavirus vaccine clinical study. This will allow the company to determine whether or not changes were made during the trial that are necessary to ensure that the vaccine is safe for the intended population.
After the company determines that the product was tested correctly, it is important to provide them with copies of the clinical trial. for approval purposes.
There are several steps to completing these reviews and approval. Companies that perform a medical device trial, for example, usually require companies to submit documents detailing how the product was administered, how long the trial lasted, which patients received the product, who was involved in the clinical trial, and the results of the testing conducted to support regulatory approval.
There are also several organizations that review the documentation submitted by pharmaceutical companies for the safety and effectiveness of the products. If the company fails to complete the regulatory review properly, there may be delays before the final approval of the product. These organizations are required to determine whether the product was able to give the intended protection against the coronavirus.