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This is the safety mechanism in vaccine trials


Dr. Elmer Huerta explains what is the safety mechanism for volunteers in the trials of vaccines against covid-19.

Trials continue after vaccine volunteer death 2:00

(CNN in Spanish) ––

The National Health Surveillance Agency of Brazil (Anvisa) reported this Wednesday that a volunteer died - it is not known if he is a man or a woman - from the phase 3 study of the AstraZeneca coronavirus vaccine that is being developed in Brazil.

Dr. Elmer Huerta clarifies what the safety mechanism is for volunteers in clinical trials.

In addition, it explains why the Data and Safety Monitoring Board allowed the trial to continue despite the death of the participant.

You can listen to this episode on Spotify or your favorite podcast platform or read the transcript below.

Hello, I am Dr. Elmer Huerta and this is your daily dose of information about the new coronavirus.

Information that we hope will be useful to take care of your health and that of your family.

Today we will see what is known about the death of the volunteer of the phase 3 study of the AstraZeneca vaccine and the University of Oxford in Brazil.


AztraZeneca coronavirus vaccine study volunteer dies

This Wednesday, October 21, the National Sanitary Surveillance Agency of Brazil (Anvisa) - the equivalent of the US FDA - reported that a volunteer - it is not known if he is a man or a woman - of the phase 3 study of the AstraZeneca vaccine that is develops in Brazil died on Monday, October 19.

With the news immediately known, many people related the event to the suspension of the same study due to a case of transverse myelitis - or inflammation of the spinal cord - that we described in the episode of September 9.

It has not emerged with certainty if the volunteer who died received the vaccine or the placebo.

Anvisa reported that the International Safety and Evaluation Committee was immediately notified of the death, and decided to continue with the study.

We think this is an excellent opportunity to recall how the safety mechanism works for participants in phase 3 studies of vaccine candidates that are being tested around the world.

Safety Mechanism for Participants in Vaccine Clinical Trials

All drug and vaccine trials have an independent group of researchers called the Safety and Data Monitoring Board.

The Board is constantly monitoring the side effects of the vaccine or placebo.

Ultimately, they are the ones who decide according to the severity of these side reactions, whether the studies should continue or should be stopped.

This Board acts as a true safety valve to protect participants, and its independent nature allows confidence in its decisions.

Let's also remember that in large trials, participants can suffer from multiple health problems.

Problems that are not at all related to the placebo or vaccine candidate injections they received in the study.

Personally, as a participant in the study of Moderna's vaccine candidate in the United States - whose details you can hear in the episodes of August 19 and 20 - I could suffer any type of problem related or not to the trial.

If that happens, the first thing to do is notify those responsible for the study.

So they can verify if I received the placebo or the vaccine candidate.

If it is found that I received the placebo, which may have happened to me, it would have nothing to do with the study and Moderna's vaccine candidate.

But if I had received the vaccine candidate, the research would have to continue to see if there is a relationship between my health problem and the medication.

The commitment of several manufacturers of vaccines against covid-19

It is also important to remember that AstraZeneca, along with eight other vaccine manufacturers, have signed a document, pledging not to seek premature government approval of their vaccines until they have data to demonstrate that their candidates work safely to prevent infection.

In summary, from the Board's swift decision to proceed with the trial, it seems clear that the unfortunate death of the volunteer has not been related to the clinical trial and that the trial will continue.

We can conclude then that participants in phase 3 studies of vaccine candidates are protected by the Data and Safety Monitoring Board and, therefore, when a vaccine candidate is licensed - to become a vaccine. - we can all get vaccinated with confidence.

Do you have questions about the coronavirus?

Send me your questions on Twitter, we will try to answer them in our next episodes.

You can find me at @Drhuerta.

If you think this podcast is helpful, help others find it by rating and reviewing it on your favorite podcast app.

We will be back tomorrow so be sure to subscribe to get the latest episode on your account.

And for the most up-to-date information, you can always head to

Thanks for your attention.

If you have any questions you can send them to Dr. Elmer Huerta via Twitter.

You can also head over to for all episodes of our “Coronavirus: Reality vs. Reality” podcast.


AstraZenecaBrazilcovid-19University of Oxford

Source: cnnespanol

All news articles on 2020-10-22

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