Former EMA director: “The British agency only put a stamp on the vaccine, without a detailed examination”

Many Italians were surprised to hear that allergic reactions occurred in the UK immediately after administration of the vaccine.

“I must admit that I was a bit surprised and this is a serious criticism that I am sending to the British Licensing Agency. That is, they received information about the vaccine on December 1, and already on December 2 they authorized the vaccine. That means that they didn’t see the 40,000 cases. so they didn’t look at each one individually, the protocol, that is, the entire file that has thousands of pages, was not viewed correctly, so they just put a stamp on what the pharmaceutical industry gave them, which is completely contrary to the purpose of these agencies, that is, we have to be the guarantor, the third party who guarantees. Now they have stated that they do not advise vaccinating people who have had severe anaphylactic attacks.

But beware, we have to differentiate between allergies and anaphylactic crises because an allergy can be, for example, to the hay for which a test has been made, someone has a cold or mild asthma problem, allergy to dust, etc. So the people in question had anaphylactic shock and these are people who had to go everywhere with an adrenaline shot in their pocket, so the tests were not done as the protocol requires. If the English agency had read the protocol before putting an official seal, it would have said: you will receive the vaccine only in an emergency or you will have to wait.

And that surprised me, so what happened is not so dramatic because it is known that whoever has such reactions solves the problem with cortisone, as was the case with these two people, but the problem is that it did not happen here. precise audits of the Agency that regulates everything, ”Razi said in an interview with RTS.

Photo: Depositphotos-scukrov

Just the day before the introduction of the vaccine in the UK, a survey was conducted on the streets of London and most people said that the vaccine was found too early and that speed is something that scares the public. can you explain how the vaccine was found so fast compared to those? from the past that took much longer?

“In four months, we had 130,000 volunteers who were exposed to the virus, so it was easier for us on that side. It’s a pretty long phase, it usually takes about three years to reach this number and we already had it in so many years. little time time required number of people This is the most important factor when it comes to speed to find a vaccine.

Another important factor is the amount of human and financial resources that we had at our disposal. We have never seen so much money coming in to achieve this goal. I mean public money so that companies have very little risk and can invest.

The third was, and the EMA and the FDA did that, they created a task force, so instead of the committee having to analyze 30 products, to wait for the dossier to be ready, we can see who came first. We decided to form a team that would only deal with these things; In the EMA agency we have 70 people plus about 300 people throughout the European network who only deal with Kovid and that is something that obviously cannot be done for all medicines, we do not have all those people, but this time it was the right thing to do. So a lot of things were done in parallel rather than one after the other, and that led to the one year time, which we normally need, to be reduced to three months. ”

You said you were asked to skip the third phase, who asked you?

“All the consortia. They told us, if the second phase was already successful, why couldn’t we make a vaccine and continue the research at the same time, but we said no. We wanted to continue in the traditional way, I think it is better to wait.” two months, then make a vaccine and that’s what happened because we knew we would have no problems finding volunteers, so we took advantage of those two months because we saw all the quality problems, everything related to the administration was done, now the consortia know that if we approve the vaccine on December 29, production can begin. “

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After an agency like the EMA consents to a vaccine, of course. certify that the vaccine is safe if there is some kind of “vax monitoring” after that?

“This is very important. There is usually something called drug monitoring and it is quite a very developed system, especially in Europe. We will monitor it for at least one year, that is, whoever received the authorization must give us permanent and continuous feedback. and should continue with studies and research, for example in the field of pediatrics, when it comes to pregnant women, that is, in a specific part of the population.

So the condition is that they have to continue the research over the next year, and not only that, this time the EMA and the ECDC – the European Center for Infection Control in Stockholm have a specific observation protocol, that is. Vaccine monitoring because we will have more than one vaccine on the market, so it is important to understand the differences, which vaccine is better for immunosuppressed people after 2-3 months of vaccination, which one is better for the older population, which one for the younger and similar.

It is also very important to confirm the immunity of people who have received the vaccine and to understand how long immunity lasts because what we now know is that the first people who received the vaccine after six months are still immune to the virusIn two months we will know that they are immune at 8 months, but we still do not know, we hope so “.

We currently have several vaccines, we can mention the ones that are most talked about Pfizer, Moderna and Astrazenek. What are the differences between these vaccines, how does a pharmaceutical company develop one type of vaccine and another?

“I think it’s great luck because we didn’t have to bet on a single horse as they say, that would be a bit worrying. So the differences between the vaccines are very big, they use completely different technologies. Pfizer and Moderna are quite similar because they use carrier RNA. so it is quite safe and less invasive from a certain point of view, and it is a more modern type of vaccine that is produced faster. One uses a lipid component so you have to use very low temperatures, to be stored at -70 , -80 degrees.

Modern uses another type of vector that is more stable, but as efficiency they should be equal, we will see.

On the other hand, Astrazeneka uses a much more classic viral vector, a DNA vector that replicates, others use the oldest types of vaccines, the most primitive, but which are very effective, they are vaccines that have really served us in these 100 years. Therefore, they run less risk, but production is slower. me it’s good to have them all because later we will discover that there is a vaccine for everyone. “.

In a discussion between virologists here in Italy, some of them said that they have more confidence in those older protein vaccines, the classic ones because they know them better while these new ones are quite unknown, which one would you receive?

“I think it is the best vaccine is the one that comes first. You will most likely go for these modern ones … one of the problems, that is. Something that we saw as a problem, although there were no consequences, for example for these protein substances, is that they were more painful than these new ones, they contain mercury and the like. Actually, they are some small things, but if we can avoid them, why not? Now that we have the opportunity to stop having these problems, are we not satisfied again?

So I am open to all kinds of vaccines, I am an immunologist and the basic principle is the same for everyone, actually it is a kind of trick for the immune system, we give it information which is a kind of spy that tells us what “code” the enemy is using. It doesn’t matter much how you give this information to the immune system.

So the risk of the vaccine is that we can have a low temperature as happens when we receive the flu vaccine, does it depend on the organism?

Exactly. Somewhere between 5 and 10 percent of people have a low temperature, that feeling of not being very well, like you have a mini flu that lasts for a very short time. The good news is, at least that’s the latest information that has yet to be confirmed, yes. who has a stronger reaction later has a stronger immunity, as if he had a small gift if he suffered a little more“concludes Dr. Razi.