It is very interesting to hear another positive story about the results of the vaccine experiment. A good vaccine is the most likely way to end the epidemic.
Last week, Pfizer’s interim results showed that its vaccine reduced COVID-19 cases with 90% efficacy. Now Moderna is taking it a step further, and the interim results show nearly 95% efficacy against the vaccine, giving hints that it can protect against serious illness. Neither reported serious safety issues, and the vaccine was not tested on tens of thousands of participants.
Many COVID-19 vaccines are under development, so more results will come in the coming months. Their headline figures can be very impressive like this, but you’ll need to dig deeper to figure out exactly what the new results mean.
With this in mind, here are six questions to ask about the results of a new vaccine trial.
1. Does this mean the vaccine is safe?
It is almost certain if you have successfully passed the Phase 3 exam with thousands of participants. If you have serious questions about safety, the vaccine doesn’t get there.
Historically, pharmaceutical companies have been able to contain negative results, but now it is legally required to publish results in all experiments so that other scientists can review the results. As a result, this sector is generally much more reliable than it used to be, but you still need to be careful if only intermediate results are reported.
Some are concerned that the COVID-19 vaccine was produced at an unprecedented rate. However, the majority are based on platform technology with a good safety profile. While several new technologies are in use, the clinical trial and regulatory process is very rigorous and will capture most of the potential complications early in development.
Of course, it’s still difficult to know about the long-term side effects, but it’s rare for vaccines, and all the risks are usually much lower than those of the disease being vaccinated.
2. Do the headline numbers reflect what the test is designed to measure?
Tests often measure a lot, but there is always one basic study question or goal that the test is designed to answer.
There are several secondary research questions on the exam, but the answers to them are not considered as signs of success. If you test enough different goals, you will always achieve some goals due to blind opportunities. Distorting clinical trial data in this way is a form of research cheating called p-hacking. You can check the clinical trial registry to find the primary and secondary goals for any trial.
Again, it is important to consider whether this is an intermediate result. While these results may be promising (as Pfizer and Moderna have shown), we cannot guarantee that they will be final.
3. Did the trial measure what was right?
Determining what is considered a drug or drug “effective” can be very complicated in many diseases. But for vaccines, the question is very simple. Did people with active vaccines get sick? Measurements more complex than this (often referred to as surrogate results) should be handled with care.
4. Who has been tested for the vaccine?
Can test results be transferred to the real world? Here, it’s important to understand the difference between the population (anyone who could get COVID-19 in this case) and the sample of the population who participated in clinical trials.
In many cases, tests use two carefully matched (and comparable) samples under carefully controlled conditions. One is given a vaccine and the other is given a placebo (such as a saline injection or a vaccine that has already been developed for another disease) to control the effectiveness of the participant who believes they have been vaccinated. This works.
Safety issues in phase 1 trials mean that the sample is typically made up of young, healthy people with few health issues that do not represent the entire population. However, as the trial progresses to a later stage and grows in size, researchers are trying to get a more representative population sample.
This is why final stage (Phase 3) trials are so important because samples are selected to represent the population for which the vaccine is targeted. Official publications of test results usually provide a table describing who was included in the sample, often giving the different groups of efficacy ratios (separated by gender, age, etc.). Unfortunately, headline efficacy figures (e.g. 95%) may not apply equally across the population.
This is very important for COVID-19 because we know older people are much more vulnerable. So, you shouldn’t read too much of the results until you can see an age analysis of efficacy.
5. Can the vaccine be used?
Before we get so excited, we need to ask some practical questions. How much does the vaccine cost? Can you make it in bulk? Is it easy to transport and store? And how many boosters do you need? These logistical issues (e.g. the requirement to store and transport at very low temperatures) can easily prevent new vaccines from entering the hospital.
6. Can you trust what is reported?
Identifying trusted and untrusted sources is an increasingly important technique. Social media is often superficial and prone to disseminating misinformation. On the other hand, journal articles and clinical trial registrations can be difficult to interpret for anyone except experts.
Reliable journalism is the answer. Look for publications with editorial oversight and reliable scientific and medical reporting records. Reading more than one interpreter will give you a balanced view.
It is also important to ask where the reporter found the information they are reporting. Referencing the results published in peer-reviewed journals is a good sign. This shows that a rigorous fact check has been made. Be careful if the main source of your article appears to be a pre-print (a paper that has not yet been peer reviewed) or a so-called gray literature such as a press release or company report.
Likewise, be careful if your main source is interviews or quotes from people with a Ph. A citation from one scientist in an interview is not identical to a citation from the same scientist in a peer-reviewed academic paper.
Get the latest news on the coronavirus (COVID-19) outbreak
Provided by The Conversation
This article was republished by The Conversation under a Creative Commons license. Read the original article.
Summons: Moderna follows Pfizer with exciting vaccine news.
This document is protected by copyright. No part may be reproduced without written permission, except for private research or fair trade for research purposes. Content is provided for informational purposes only.