Emergency Authorization for Coronavirus Vaccines: How It Happens in the USA

FDA Grants Emergency Use Authorization For Third Covid-19 Vaccine in U.S. | NBC Nightly News

Matt McCarthy: &# 171; I recommend vaccines to all my patients. But I understand the fears of people associated with the fact that they will be injected with an experimental vaccine.&# 187;

What is the peculiarity of the procedure for issuing an emergency permit for use in an emergency situation? Are there any risks to the population? Can such permission be revoked??

Matt McCarthy, professor at Cornell University College of Medicine and author of the book “Superbugs: Race to Epidemics” (Matt McCarthy, Weill Cornell), answered these questions from the Voice of America correspondent. McCarthy also works at New York-Presbyterian Hospital, where he treats patients with COVID-19..

Margot Gontard: What is special about the category of emergency authorization for the use of a drug in an emergency (EUA) and whether there have been similar precedents before?

Matt McCarthy: An Emergency Use Authorization (EUA) is different from traditional FDA approval. This procedure is intended for situations where it is necessary to use a medicine as soon as possible and has only been used in the United States once, in 2005, for the anthrax vaccine. The issuance of this authorization means that there is sufficient evidence that the use of a particular drug is beneficial, and there is no evidence that it can cause serious harm to the patient’s health..

There is also a liability issue that no one wants to talk about: vaccine manufacturers will only be held partially responsible if something goes wrong. Therefore, the recommendations are made by a group of independent vaccine experts, none of whom work for pharmaceutical companies. Their mission is to act as a bulwark against any misuse of a drug or violation of the authorization procedure for its use. This is the first time their discussion takes place so publicly..

M.G .: Does this mean that, in case of negative health consequences, people will not have the opportunity to go to court?

M. M .: At this point, we are not particularly well aware of what would happen if I was given an injection of a vaccine that received an emergency authorization for use, and I woke up the next morning and, for example, could not walk. I don’t expect this to happen, but if it does, can I sue the manufacturer? Nobody talked about who would take responsibility in such a situation. From the very wording “emergency” it can be concluded that the liability of the vaccine manufacturers will be limited. Therefore, we need a public discussion about this so that the population is informed and people can make an informed decision regarding vaccination..

M.G .: What factors do experts pay attention to??

M. M .: Safety is one of four parameters that must be met in order to obtain an emergency approval for use. It also includes efficiency, production and distribution. You need to understand what the manufacturers’ plans for all of this are in order to make sure they can get the vaccine from the place of production, say, Utah or any other state in the United States..

M.G .: Are you a proponent of universal vaccination with such drugs??

M. M .: I am a proponent of universal vaccination. I recommend vaccines to all my patients. But I understand the fears of people associated with the fact that they will be injected with an experimental vaccine. It is important to understand that even when these vaccines are approved for use in an emergency, they are still experimental, meaning they still have not gone through the formal approval and licensing process. It also means that clinical trials will continue..

M.G .: Consequently, even if the vaccine receives an emergency authorization for use, it can later be withdrawn.?

M. M .: The authorization may be revoked if there is reason to believe that the vaccine is harmful. He is not given out forever. Permissions like this can always be revised..

M.G .: Is there any reason for concern?

M. M .: Moderna and Pfizer vaccines are RNA vaccines. At this time, there is no evidence to indicate that they can be dangerous. But we continue to watch. RNA is genetic material. Could such a vaccine harm the human body? – We don’t know yet. They have never been used before..

Emergency Authorization for Coronavirus Vaccines: How It Happens in the USA

When they tell me that we will use something that has not been used before, and besides, they confront the fact that we will do it in a short time, having data on the effect of the vaccine for only two months, I start to get a little nervous. The good news is that we have compelling clinical trial results and there is currently no reason to believe that the use of such vaccines would cause any harm..

I would also like to make sure we understand how well the vaccine will protect against coronavirus in the long term. Whether you will need to vaccinate again in July or August for those who received the vaccine in December or January. We cannot know this now, but it is obvious that people are very interested in it..

The question also remains whether this virus can continue to mutate. We call this “antigenic drift”. Can this virus “drift” enough to become more resistant to the vaccine? There are two types of similar viruses with which the coronavirus can be compared: measles pathogens and influenza. The measles virus does not mutate much. You may be vaccinated once or twice, and this will last you a lifetime. And the influenza virus, on the other hand, mutates strongly, every year a new vaccine has to be created. We do not know which of these two viruses the coronavirus will look more like. Based on what we know so far, the coronavirus is not mutating very much..

M.G .: The Pfizer and BioNTech vaccine requires storage at minus 70 degrees Celsius, which can pose significant logistical and storage challenges. Is this a common situation?

M. M .: Most vaccines do not require freezing storage. By all appearances, areas near big cities and metropolitan areas will be able to cope with this. We do not yet know how this will happen in the outback. A number of other vaccines are in development, and some may be more suitable for a particular environment or region than others. For example, it is assumed that a vaccine manufactured by Johnson & Johnson will only need to be injected once and does not require a low temperature to store it. Perhaps this will be the best option for mass vaccination..

M.G .: One of the concerns that people have expressed about the RNA vaccine is that it could potentially affect a person’s genetic code. Are there any reasons for such concerns??

M. M .: At the moment, there is no evidence that they can change the genetic code of a person..

Emergency Authorization for Coronavirus Vaccines: How It Happens in the USA

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