Modena is following Pfizer in exciting vaccine news – how to read these dramatic developments

Pfizer vaccines must be stored at -80 ° C, which makes deployment more difficult. credit: BlurryMe / Shutterstock

It’s very exciting to hear another positive story about vaccine test results. A good vaccine is the most likely way to end a pandemic.

Last week, Pfizer’s interim results suggested that the vaccine would reduce cases of COVID-19. 90% effectiveness..Now Moderna is one better and the interim results are almost 95% effectiveness For that vaccine — with hints that it may protect against severe illness. Neither has reported serious safety concerns and has not tested the vaccine with tens of thousands of participants.

So many COVID-19 vaccine under development, More results may follow in the coming months. The numbers in their headlines may be very impressive like these, but you need to dig deeper to know exactly what the new results mean.

With that in mind, there are six questions to ask about the results of the new vaccine trial.

1. Does this mean that the vaccine is safe?

If you’ve successfully passed a Phase 3 trial with thousands of participants, you’re almost certain. If there is a big question about safety, the vaccine will not reach this point.

Historically, pharmaceutical companies Suppress negative consequencesBut now Legally required For all exams to post results so that other scientists can review them. As a result, this sector is generally much more trusted than before, but you still need to be careful if only intermediate results are reported.

Some people are concerned that the COVID-19 vaccine is being produced at an unprecedented rate.However Majority Based on platform technology Excellent safety profile.. Although some new technologies are used, the clinical trial and regulatory process is very rigorous and addresses most of the potential complications very early in development.

Of course, it’s still hard to know about long-term side effects, but these are Unusual for vaccines, And the risk is usually significantly lower than the risk of getting vaccinated.

2. Do the numbers in the heading reflect what the test was designed to measure?

Trials often measure a lot, but there is always a single major research question or purpose designed for a trial to answer.

The trial also has some secondary research questions, but answering them is not considered a sign of success. If you test for a sufficiently different purpose, some will always be met for a blind chance. Misconducting test data in this way is a form of so-called research misconduct. p-hacking.. To see the main and secondary purposes of the trial Clinical trial registration..

Again, it’s important to consider whether these are intermediate results.Such results are promising, but Pfizer and modern Shows — Not necessarily the final result.

3. Did the trial measure the right thing?

For many illnesses, determining what is considered a drug or the “effect” of a drug can be very complex. But for vaccines, the question to ask is very simple. Did the person who received the effective vaccine get sick? More complex measures (often Surrogate result) Must be treated with care.

4. Who tested the vaccine?

Can the outcome of the trial be transferred to the real world? Here it is important to understand the difference between a sample of the population (in this case anyone who can catch COVID-19) and that population who participated in the study.

In many cases, tests use two carefully matched (and therefore comparable) samples under carefully controlled conditions. One is given a vaccine, the other is given a placebo (such as a saline injection or a vaccine already developed for another illness), and the effect that participants think they have been vaccinated. Control. Has an effect..

In Phase 1 trials, safety concerns mean that the sample is generally young, has few health concerns, and probably consists of healthy people who do not represent the entire population. However, as the trial progresses to later stages and grows, researchers seek to secure a more representative sample of the population.

This is the reason for the final stage (Phase 3) trial The sample is very important because it is selected to represent the population to be vaccinated. Formal publications of test results usually provide a table explaining who was included in the sample, and often provide efficacy rates (classified by gender, age, etc.) for different groups. Unfortunately, heading effectiveness numbers (for example, 95%) may not apply evenly across the population.

This is very important for COVID-19. Older people are known to be much more vulnerable. Therefore, you should not over-read the results until you have a breakdown of the age of effectiveness.

5. Can I use the vaccine?

Before we get too excited, we need to ask some practical questions. How much does a vaccine cost? Is it possible to make them all together? Is it easy to transport and store? And how many boosters do you need?These logistical issues (for example, needing to be stored and shipped at very low temperatures) can easily prevent new ones. vaccine Enter the clinic.

6. Can you trust what is being reported?

Distinguishing between trusted and untrusted sources is an increasingly important skill. Social media is often superficial and tends to disseminate false information. On the other hand, it can be difficult for non-professionals to interpret journal articles and clinical trial registries.

Reliable journalism is the answer. Look for publications with editorial oversight and a proven track record of scientific and medical reporting. Reading multiple interpretations can help you get a balanced view.

It is also important to ask where you found the information that the journalist is reporting. Referencing the results published in peer-reviewed journals is a good sign. This indicates that a strict fact check has been performed.Be careful if you think the main source of the article is a preprint (an unpeer-reviewed article) or other so-called one. Gray literature, Press releases, company reports, etc.

Similarly, be careful if your primary source seems to be interviews or citations from people with PhDs, or impressive positions. Citations from scientists in interviews are not equivalent to citations from the same scientist in peer-reviewed academic papers.

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