A surprising clinical advance may take place, in the coming months, in several hospitals in Spain. Among them, the Regional Hospital of Málaga. And it’s going to start co-administer the flu vaccine with the Spanish Covid-19 vaccine, Bimervax. The objective is to verify the effects of both vaccines administered at the same time in the human organism. One of the researchers to carry out the study in Malaga is the Regional physician, Maria Jesus Lopez. Study that he describes as “an innovative trial.”
The idea of this project comes from the interest in verifying if it would be feasible to administer two vaccines at the same time: that of the circulating flu -and well known- and the Spanish one of the Covid-19, Bimervax, from the recently created pharmaceutical company HIPRA.
Let’s say that, until now, a similar type of study has not been carried out. These types of trials are usually carried out when vaccines are going to be tested, but with the HIPRA vaccine and the flu vaccine that we are going to use, we can say that it is an innovative trial
López affirms that they seek to verify if the side effects of these vaccines, both locally and systemically, increase or remain the same as if they were administered independently. And the same with the immune response: corroborate if the user’s body responds in the same way with both doses as with only one.
«Let’s say that, until now, a similar type of study has not been carried out. These types of trials are usually carried out when vaccines are going to be tested, but with the HIPRA vaccine and the flu vaccine that we are going to use, we can say that it is an innovative trial”, admits López.
Phases of the study
López says that they already have authorization from the promoter of the study to carry it out. The study will last two months, being the first one they are in right now.
At the moment, in this first stage they are looking for 300 volunteers aged 65 or over nationwide. Additionally, these volunteers will need to have at least two doses of Pfizer or Moderna administered; Those of the messenger RNA.
The study, after the second month, will be carried out as follows: three groups will be created in the trial; the first one will receive the HIPRA vaccine along with the one from the flu campaign. The second group will be vaccinated with Bimervax and a placebo dose -without their knowing it-, and the third group will be vaccinated against the flu and another dose of placebo in the same way.
«Los groups will be formed randomly. On the first day, patients will have their blood drawn, immunizations given, and a log book provided. On the seventh day they are called back for consultation to see what adverse effects have been described in the notebook. And on the 28th of the month a blood sample will be taken again to analyze it with the initial samples”, explains the researcher.
And why the placebo doses? To check the immune action of each type of vaccination separately; that is, if the organism reacts differently with both vaccines than without them.
a positive response
If we meet the deadlines required by the Spanish Agency for Medicines and Health Products, in two months we could be administering the HIPRA vaccine with the flu vaccine for the following campaign
If it is an effective trial, López affirms that it could be launched soon at the national level. “If we meet the deadlines required by the Spanish Agency for Medicines and Health Products, in two months we could be administering the HIPRA vaccine with the flu vaccine for the following campaign,” he adds.
The World Health Organization (WHO) He assured in May of this year that the global pandemic situation had ended, although the coronavirus continues to exist. In a scenario in which skepticism towards vaccines has gained strength, López assures that, although there are volunteers that do not meet the inclusion criteria of the study, the response in Malaga is being positive.
López assures, on the other hand, that it is completely safe to give two vaccines at the same time, and there have even been occasions in which up to three or four have been administered.
“We only let that person rest for about 15 minutes after the injections because of the immediate effects that may occur. But, usually nothing happens“, Add.
Los Adverse effects of these vaccines are also well known. López explains that they have already been authorized by the competent bodies and marketed, to the point that anyone can buy an anti-flu in a pharmacy.
The object of the study, therefore, is to verify whether these adverse effects, beyond local pain in the area of the puncture, are similar to those already registered, are enhanced or, on the contrary, do not occur. «Among the effects that they may have, and that have already been studied, are the headache, and to a lesser extent, tiredness or fatigue»explains the researcher.
It remains to be seen if the trial is a success and when this practice can be extrapolated to the entire population, in what is a study in which there are great expectations.
2023-08-14 04:59:15
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