What are the six questions to delve into the promising new corona vaccine test results?

In November 2020, Pfizer, which develops a vaccine for the new coronavirus, announced the provisional results of a clinical trial that 'has a preventive effect of over 90%.' Following this, Moderna also announced that the new coronavirus vaccine under development 'achieved over 94.5% efficacy in clinical trials.' In a series of promising announcements, Simon Kolstoe , Senior Healthcare Lecturer at the University of Portsmouth , summarizes 'six questions that dig deeper into the results' of vaccine development for the new coronavirus.

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Pfizer's newly developed vaccine, BNT162b2, is reported to have been tentatively reported to have 'more than 90% protective effect' in a phase III clinical trial announced on November 9, 2020. .. Moderna also reported the preliminary results of a phase III clinical trial on November 16 stating that the vaccine 'mRNA-1273' achieved a '94.5% protective effect'.

Moderna announces that the new corona vaccine under development has achieved '94.5% preventive effect' in clinical trials --GIGAZINE

These announcements are 'breaking news' about the vaccine for the new coronavirus, and details have not been disclosed, leaving the possibility of different results if the vaccine is used in the real world. In order to deepen our understanding of the vaccine development of such a new coronavirus, Kolstoe has 'six questions to dig into' as follows.

◆ 1: Does the result of the clinical trial mean that the vaccine is safe?
The vaccine is almost safe if it successfully passes a phase III clinical trial involving thousands of subjects, Kolstoe said. Since there is a system that allows not only pharmaceutical companies but also external scientists to confirm the results of clinical trials, the results of clinical trials are quite reliable. On the other hand, Kolstoe said that if, like Pfizer and Moderna, only provisional results are published rather than final results of clinical trials, caution is still needed.

Also, while some people are concerned that the new coronavirus vaccine is being developed at an unprecedented rate, most vaccine development is based on technology with a good safety profile. Although some new technologies are also used, the clinical trials and regulatory process are so rigorous that serious complications are detected early in development, Kolstoe claims. It is still difficult to detect long-term side effects from vaccination, but long-term side effects are unlikely to occur with vaccines, and the benefits of vaccination generally outweigh the disadvantages of not vaccination. ..

◆ 2: Do the published figures accurately reflect the purpose of the clinical trial?
In clinical trials, it is common to measure the results of multiple items, not just one item, but among them, 'what you want to know most in clinical trials' is set. The research team can also extract and publish only 'promising results' from a variety of measurement items, so when considering the results of clinical trials, is the first set objective achieved? It is important to check if it is. Kolstoe points out that Pfizer and Moderna announcements are based on interim results and may differ from the final results.

◆ 3: Did clinical trials correctly measure the efficacy of the vaccine?
When testing a drug for the purpose of treating a disease or alleviating symptoms, it can be complicated to judge that the drug worked. However, in the case of vaccines, it is relatively simple, and the question is 'whether the vaccinated person got sick', so it is necessary to pay attention to this point when looking at the results.

◆ 4: What kind of people are the subjects of the vaccine?
Whether the results of clinical trials can be applied to the real world is also an important issue to consider. In clinical trials, the effects of vaccines and other substances are carefully measured by dividing them into 'groups that actually receive drugs and vaccines' and 'groups that receive placebos.' However, if the population of subjects participating in a clinical trial is biased, the test results may not be directly applicable to the real world.

For example, in Phase I clinical trials, subjects are often made up of young, healthy people, which is different from the real-world population. As the clinical trial phase progresses, the subjects approach the real-world population, and in the final phase of the phase III clinical trial, almost the same real-world population will be secured.

In many cases, clinical trial research teams publish a breakdown of subjects such as race, age, and gender, and report whether the results differed by group, such as age and gender. As a result, the final result may raise issues such as 'vaccine efficacy is low in the elderly,' and Kolstoe says the results should be viewed carefully until the efficacy of each group is known. Mr. says.

◆ 5: Will the vaccine be available?
Whether or not a vaccine is available depends on several factors, including the cost and scale of production of the vaccine, the method of transportation and storage, and the availability of equipment for vaccination. Therefore, just because a vaccine has passed the clinical trial does not mean that the vaccine will be available immediately, and it is possible that the vaccine may be impaired in terms other than safety and efficacy.

◆ 6: Can you trust the reported content?
Distinguishing between trusted and untrusted sources is an important skill when thinking about academic news. Since there is a high tendency for superficial or incorrect information to spread on SNS, it is necessary to consider the source of the information, rather than just giving a brief explanation with a limited number of characters.

For articles that explain the content in an easy-to-understand manner, it is important to weigh multiple articles and scrutinize the content, and to find out about the papers and official announcements that the article referred to. Also, articles published in peer-reviewed journals are more reliable than unpeer-reviewed articles. It should be noted that the results of clinical trials published by Pfizer and Moderna were not published as papers at the time of writing the article.