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Sinopharm volunteers in the country want to be told if they received placebo and ask to be vaccinated before the second wave

2021-03-28T18:19:30.403Z


There are more than 3,000 people who signed up for phase 3 trials. They want to know if they received the vaccine or not. And in case it has not happened, they ask to be immunized as soon as possible.


Paula galinsky

03/28/2021 2:11 PM

  • Clarín.com

  • Society

Updated 03/28/2021 2:42 PM

The Phase III clinical trials of the Sinopharm vaccine against coronavirus continue in Argentina and some of its participants - there are more than 3,000 - are asking for the double blind to be opened, that is, to confirm if, within the framework of the study , They were

immunized or given placebo.

This is key to knowing if they are protected and, in case of being part of the second group,

receiving the vaccine before the second wave

.

Although the papers state that they must wait a year, they say they were promised "by word of mouth" that the terms would be shorter.

Melany De Negri is one of them.

She is 23 years old but is considered "at risk" for suffering from cardiovascular disease.

She lives in Merlo with her parents and grandmother, who also have comorbidities, and she says that her life continues in Phase I. “I am a Veterinary student, I like Medicine and I signed up for the trial for that, with an altruistic objective.

But the reality is that it would help me a lot if they open the double blind, ”Melany shares.

The Chinese Sinopharm vaccine has already been enabled in the country for people over 60.

She took the antibody study and confirmed that she is not immunized so she understands that she got a placebo.

“The contract says that the trial lasts one year, but when the Sinopharm vaccines began to arrive in the country, they told us that it was going to open earlier and that it was shortly away.

We were excited: at one point they told us that they were going to do it in two weeks, then that changed and, for now, there are no news ”, he details.

In her faculty, the practices have already begun,

but Melany does not go for fear of catching coronavirus.

For this reason, he assures that, personally, receiving the vaccine would greatly improve his day-to-day life.

Although he says that he also thinks about "the collective".

“I am in contact with other volunteers.

Some, due to their age or because they were a risk group, had the possibility of being vaccinated and did not, they were waiting for the opening of the double blind.

That seems to me not to be good ”, he assures.

In General Rodríguez, Paula Páez got a turn to get vaccinated.

She is 53 years old,

suffers from kidney disease and arrhythmias

.

The Province offered to immunize him precisely with the trial vaccine: the Sinopharm vaccine, which, at that time, was not yet approved for people over 60. “I consulted with the reference he had for the study and he told me to give it to me.

I had done the antibody analysis on my own and had given me that I did not have it ”, adds Páez.

She says that she hesitated, not because of a safety issue, but because she would have liked to

leave her doses to someone else,

taking into account that she was guaranteed those of the clinical trial.

"The issue is that they did not give me certainty about when they were going to open the double blind, I am at risk and my husband too, so I got vaccinated at the beginning of March," says Páez who, despite this, adds to the request for the opening "thinking of the rest of the volunteers."

Julio Osvaldo González is another of those waiting.

He is 66 years old, lives in the Capital and has not yet had an antibody study, so he does not know whether or not he was immunized.

"They told me that they calculated to open the double blind for last December, then it was January and the date kept passing," he says.

He claims that in February the local authorities of the trial let him know that they had sent a letter to China to authorize the release of the data.

Last Friday they told me that they were only going to open for those who already had a turn to get vaccinated.

It is not my case ”, warns González.

His 36-year-old son Matías is in the same situation.

At home the only one who has already been immunized is his wife, who participated in the Pfizer trial.

In dialogue with this newspaper, Paula Resnik,

also a volunteer,

joined the request.

“I understand that I received a placebo because it came out that I have no antibodies.

The second wave is coming and I would be much calmer with the vaccine.

Although I signed up with an altruistic purpose, being immunized was a plus that I hoped to achieve at this point, ”acknowledges the 56-year-old woman who lives in the City of Buenos Aires.

According to Arnaldo Casiró, head of Infectious Diseases at Hospital Álvarez, the way to prove the efficacy and safety of the vaccines is from clinical trials in which the volunteers are divided in two.

"One group is given the vaccine, in this case Sinopharm, and the other becomes a control group

because they receive a placebo," says Casiró.

It is called "double blind" because neither party, neither the volunteers nor the study investigators, knows what was administered to each patient.

"When the study ends, the volunteers find out what was applied to them and those who received placebo have the right to receive the vaccine," adds the expert.


Although the Sinopharm vaccine has already been approved, based on Phase III studies that were carried out in other parts of the world, such as the United Arab Emirates, in Argentina the trials, with which they seek to add data, continue.

They are in front of the Fundación Hupedes, Vacunar and the Elea Laboratory.

From Fundación Hupedes they explained to

Clarín

that “the opening of the blind, as stated in the informed consent signed by the volunteers, is scheduled for when the study ends.

That is on day 369, for September, October or November, depending on when the patient has been admitted, although it is true that it may end earlier for various reasons ”.

That, as detailed, depends on the laboratory based in China.

“We are constantly talking with Sinopharm so that volunteers who have a vaccination shift are informed if they received vaccine or placebo.

We understand the claim in these cases and we hope that the situation can be resolved as soon as possible ”, they replied.

GS

Look also

Coronavirus in Argentina: why the Government also deferred the second dose of Sputnik V if they cannot be exchanged

Coronavirus in Argentina: the first batch of the Covax fund arrived with 218 thousand AstraZeneca vaccines

Source: clarin

All life articles on 2021-03-28

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