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ACTS Post opinions with a wide range of perspectives to encourage constructive discussion.
Vaccines against COVID-19 will be provided. Suspicions about them increase because the subject is not communicated properly. That’s what he said before Frog news Prof. Asena Serbezova, President of the Union of Pharmacists of Bulgaria. This is what he added:
Ms. Serbezova, the COVID-19 vaccines are not yet approved for use. However, the government presented a plan for its implementation. Does this mean that the EC has given a signal that they will be approved?
I think he gave that signal. We know that the negotiations took place with the EC. The liability clause still seems strange to me: the contract with Astra Zeneca transfers responsibility, if there is any adverse medical reaction, from the manufacturer to the country where the vaccine will be used. As you noted, there is no authorization for the use of vaccines yet, but such applications have been submitted and several additional meetings are scheduled to complete the evaluation. I see that for the Jansen vaccine, it has been observed that a review procedure was started on December 1. “At Pfizer, it was launched on October 6. For them, however, it will be conditional.
What does this mean?
Under normal conditions, the European Medicines Agency (EMA), if all goes well, first grants a marketing authorization within 5 years. Once it is renewed, it becomes undefined. Conditional leaves are for one year and this is done when there is an immediate medical need, as is the case, and there are not many results. This is the case in cases where you need to hurry. So the Pfizer vaccine will be conditional. The approval procedure has reached the second stage: the documentation is being reviewed. This procedure can generally take 7 months, including quality and safety. Companies are now submitting documents as they currently have them. For Astra Zeneca vaccines, the procedure is in its first part. But we can summarize that at this moment all vaccines are being reviewed, which are 4 in number from “Jansen”, “Pfizer”, “Astra Zeneca” and “Modern”, but none of them have been completed. The procedure for the Pfizer vaccine is at an advanced stage.
Are there more steps that need to be taken?
A report is then issued by the Medicines Committee and they propose to the EC to issue a marketing authorization. Most likely, all vaccines will be provided once a CE permit has been issued. This means that the vaccines are starting to be valid in all European countries, including Bulgaria.
Many people are skeptical of vaccines because they are free.
If the vaccine had to be paid for, it was necessary to go through another stage: the price registration. This would complicate things a lot for the sake of truth, because to be included in the positive drug list, there are conditions for you to be reimbursed in several countries. It would be really difficult. Here they have made the right decision: distribute the vaccine for free, because they will actually skip another 6 months of delay. People are suspicious because problems related to vaccines are not communicated properly. Here is the role of the relevant institutions, which can suggest how to present vaccines and their application. There are things that can be criticized on this subject, but there are also things that are good. It’s just that you can’t say things. True, the Bulgarian, when you give him something for free, immediately becomes suspicious. However, the state has decided that this case is in the public interest. And secondly, all price and registration levels are skipped. In fact, a green corridor is given for the administration of this vaccine. I assume that the prices of the vaccines have been agreed with the EC. This is good for companies because they will sell at the same price throughout the EU.
The companies were ready with a vaccine very quickly. Do you suspect that your trials began much earlier, even before the pandemic was declared?
Of course. I teach my students that a vaccine testing process takes 10-15 years. And the production process may take up to 1 year. The companies claim to have worked on earlier versions of the virus. But I can’t say how they knew there would be a pandemic.
Doesn’t this further reinforce conspiracy theories?
The very fact that 35 companies were rushing to develop vaccines and getting so much money is also strange to me. How many companies produce a flu vaccine is few. Traditionally, there are well established companies in the field of vaccines, while the “lame and crippled” rushed here, perhaps to absorb some funds.
And should the Bulgarian vaccine also go through the EMA procedure?
It is absolutely mandatory and a large amount of documentation must be prepared. The situation is unusual. And when it doesn’t communicate properly, suspicions increase. I have no doubt that the EMA will make a balanced assessment. They will not compromise on quality and efficiency. But when I teach students, I say that the product is allowed because the risk-quality ratio was favorable, according to the data at the time of approval.
Interview with Katya Ilieva
Bulgaria
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