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Interview with Gytis Andriulionis, Head of State Drug Control, on the news portal tv3.lt on these and other topics. Its service and experts are currently involved in vaccine evaluation at the European Medicines Agency.
Experts evaluate: what have been the clinical trials, what is the effectiveness, what are the side effects, what are the side effects and how to reduce them? When registering, consider what age group to assign.
“All of these things are appreciated now and there are many challenges here. What cannot be vaccinated, for certain age groups or for certain conditions? Vaccination of people with relapses raises many questions. Vaccination of vulnerable groups, such as the elderly, pregnant women and the like.
A vaccine from certain manufacturers may be recommended for certain age groups. These are expert matters and are currently the subject of a heated debate, which is being addressed during the drug registration.
For sick people, this is one of the busiest topics, because the person you want to vaccinate already has antibodies. This is a very serious scientific question: does it need to be vaccinated? The virus with which a person has become ill can be later and already mutated than the one on which the vaccine was based, ”says G. Andriulionis.
All of these things are now valued by EVA and it is recognized that there are many challenges.
You mentioned that what is not vaccinated is valued. Could it be that some people cannot get vaccinated?
Gali. A vaccine from certain manufacturers may be recommended for certain age groups.
These are expert matters and are currently the subject of a heated debate, which is being addressed during drug registration.
Can children be vaccinated with one manufacturer and adults with another?
The option cannot be ruled out, as the subjects studied and the data obtained in clinical trials are evaluated. As with any drug, indications and contraindications are evaluated.
To date, there are an absolute number of indicators. If there are significant deviations or if the experts have questions, these matters are discussed and included or excluded from the terms of appointment.
That process is already underway, and we will see what the final will be on December 29. There is an unprecedented amount of work and challenge: our experts and service are involved in vaccine evaluation at the European Medicines Agency. At the same time, a number of preparatory work is being carried out: we participate in the composition of the logistics process. Receive information on incoming vaccine brands, security codes, serial numbers.
The vaccines in development are not in Lithuanian, but in English, with QR codes with a link to the leaflets, which would normally be unacceptable, but for the sake of speed we must ensure that the vaccine arrives as soon as possible. We are currently negotiating with registrants to print the packet brochures so that each patient receives information they can understand: what has been vaccinated, what are the possible side effects, where to report and request registration. Mass vaccination and vaccines from various manufacturers raise many questions.
What are the questions about vaccinating people who have been sick?
This is one of the most burning problems because the person you want to vaccinate already has antibodies. This is a very serious scientific question: does it need to be vaccinated? The virus that a person has contracted may be later and already mutated than the one on which the vaccine was based.
The goal is to ensure maximum safety, not to impose yourself on people who would do more harm than good. This is one of the registry items that is only recorded for those age groups where the benefits clearly outweigh the risks.
The final data from laboratory and clinical studies are now being evaluated. It examines whether the benefits far outweigh the risks and what the conditions are for such an exemption: what is appropriate and what is not, what is more effective and what is less. If such things stand out, they are formalized immediately.
President Gitanas Nausėda speculates that the Covid-19 vaccine in Lithuania is even before the New Year. When do you think we can get vaccinated in Lithuania?
The vaccines are currently being evaluated by the European Medicines Agency, as are our experts. The logistics of the vaccine will only begin after the drug has been registered. If the experts do not have additional questions, if the data is reliable and additional evidence from pharmaceutical campaigns is not needed, it is likely that the EEA will submit its proposal to the European Commission for the registration of vaccines on December 29 or not. Then the EC is registered.
Immediately after registration, the logistics process will begin, starting immediately after registration and for all EU countries at the same time. Most likely early next year (we can have the vaccine – aut. Past).
Last week, Health Minister Arūnas Dulkys said that he had received the first information about vaccination and that she was not happy about it. I had questions about the logistics in Lithuania and how much actual content from the campaigns will be sent to the countries?
The Ministry of Health provided information to Minister A. Dulkis. I do not know all the details of what was provided. I can only say that we are preparing and really prepared for this as much as possible, because two low temperature freezers have already been received and installed in the emergency center.
There are also backup options – a list of institutions that today have freezers with such a temperature regime in Lithuania has been compiled. They communicate with them so that the technique can be used if necessary. Due to technical measures, the problems are really solved. The creation and transport of groups of lists of people to be vaccinated is pending.
I can say that the first doses that will arrive in Lithuania will be in extremely minimal quantities. This is so unless it is an ethical question and the new leadership of the ministry will have to decide who and what groups in society will receive the first vaccine.
What is that minimum amount? At least roughly, could you tell me, for example, if there would be enough staff from a hospital or from several medical centers who would like to get vaccinated?
We have that data, but the contracts and their terms do not allow us to speak. The first step is to decide who that priority group will be. Every day there is more and more data that doctors occupy a second place. The first number are residents of long-term care homes.
More and more countries are reporting on these established priorities. In particular, the new ministry leadership will have to decide which group will be vaccinated. The second thing is that initially we will obtain quantities that are significantly smaller than the whole group, it will be necessary to decide how to distribute them, either by age criteria, by regions or in some different way.
If you decide to vaccinate people 85 and older first, then those first few doses might be enough for everyone. But the fact that we are talking about target groups – physicians, nursing home residents over 65, and people with comorbidities – will certainly not be enough for such large groups.
Which field vaccines can reach Lithuania first: Moderna, BioNTech with Pfizer or others?
It will depend on the logistics processes. Moderna is an American manufacturer that extends the process of good manufacturing, compliance validation and the like. But I would suggest talking about who will be the first to register, because from the moment of registration, negotiations on logistics start with campaigns. We already know the order of registration that BioNTech will be decided with Pfizer on December 29 and Moderna on January 12.
Next, we have two ongoing reviews from two vaccine manufacturers at the EVA: AstraZeneca with Oxford University and Johnson & Johnson Vaccines. The evaluation process for these four producers is already formalized, ongoing, and all the others are far behind.
The manufacturer has provided clear instructions, but they will be updated before the last registration day. There are several times that the packages can be moved, recharged and removed by changing the dry ice. This is a fairly complex logistics process.
If those instructions are violated, can those vaccines be given?
It is at the time of registration that these cold circuits, the stability chains, will be approved. Here, as with any medicine, its efficacy may be partially or totally lost due to improper storage or transportation conditions. We should follow that exactly.
President G. Nausėda believes that the majority of the population could be vaccinated against the coronavirus in mid-summer. Would you agree with that?
If all manufacturers successfully register and start logistics, larger quantities are also expected to be delivered to Lithuania in the second quarter. To be massive enough for everyone, you could say that this will be the third quarter of next year.
The groups of people to be vaccinated are configured by the Ministry of Health and the logistics will be in charge of the Health Emergencies Center.
Do you think the population is not afraid to get vaccinated against the coronavirus?
I think 70 percent. vaccination of the population is a goal. Reaching this percentage would mean a great advance in the management of the coronavirus pandemic.
Of course, a lot of work awaits us to convince the public and invite them to get vaccinated, because the vaccine is new, a lot of mistrust. But more information needs to be disseminated, although it developed very quickly, but absolutely all the safety requirements are maintained and the evaluation of the European Medicines Agency is in the same aspects and standards as for conventional medicines. That is, every effort is made to make it as safe as possible and to allow it to be marketed only if the benefits outweigh the risks.
All skeptics have been and will continue to be; I just hope there is public awareness that there will be no hostile public attitude, otherwise the fight against the pandemic will continue for a long time.
Who should compensate the population if side effects of the vaccine occur, the manufacturer or our country?
Today, there are general provisions that the registrant, manufacturer, owner of a drug, it is he who is responsible for the quality of the drug. And accordingly for all the side effects, if any. There are no medications without side effects. Although they are minimal, in some cases they are common.
Currently, the Ministry of Health is discussing the possible application of the no-fault compensation model, but the general provisions are that it is the registrant who is responsible for registering a medicine. If a decision were made, as in the UK or Canada, to the best of my knowledge and belief, it would allow an unregistered vaccine to be marketed, in which case national governments are responsible for any adverse reactions or harm.
See how Covid-19 is tested:
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