Just as I had anticipated ThirdDuring this day, the Pfizer laboratory entered the antecedents to the Institute of Public Health (ISP) for the approval of emergency use of its vaccine against Covid-19 in children and adolescents between 12 and 15 years old. This, after the US Food and Drug Administration (FDA) gave the green light in the US to start inoculation in that age range.
Consulted by this newspaper, the director of the ISP, Heriberto García, specifies that, in addition to expanding the use in minors, the pharmacist entered another technical request, referring to the preservation temperature of the vials (or bottles) where the vaccine is contained.
“Pfizer submitted two requests: the first is about extending the minimum age of use to 12 years. And there the quality, safety and efficacy are being evaluated for that population. They present this and what we have to review is if the doses are adequate, if there were adverse effects other than those of the original clinical study and all that that implies. The good news is that having FDA approval, it is an approval that does not require a committee of experts, but rather a technical look. whether or not what was presented in the clinical study is met. We hope to have an answer next week, between Monday and Wednesday, ”García explains.
Regarding the storage of the doses, the Chilean regulator was also requested “That the storage temperature for 30 days is 2º to 8º degrees (celsius)”.
This last aspect would allow the doses in the vaccination centers to be kept for a longer time, refrigerated at a temperature standard and without losing the properties of the drug.
“Currently the vaccine arrives frozen, and when it is thawed, it lasts for five days in refrigerators with a temperature of 2º to 8º. If I defrost them on a Friday, for example, I lose Saturday and Sunday to just start vaccinating on Monday. If I now have a 30-day window, I can defrost any day of the week because it is a month that I will last in the refrigerators. And there what we are going to review are the new antecedents of the stability of the vaccine at this temperature. This has already been presented in Europe (to the EMA) where they have already approved it “, says the director of the ISP.
The approval would coincide with a shipment of Pfizer of greater volume than the previous ones, they have indicated from the Minsal, and that would serve to begin to inoculate minors of this age during June. This, also with a view to facilitating the normalization of face-to-face classes in the country.
Preliminarily, García points out that the ISP you have already received a history of the Indian Covaxin vaccine and also the Russian Sputnik V vaccine, who “have been providing background information as the weeks go by. But we want to do the complete evaluation of both when we already have all the antecedents, to approve or reject with all the antecedents on the table, but not with doubts ”.
In the case of the vaccine from the Janssen laboratory (from Johnson & Johnson), which initially had a pre-contract with Chile, the application has not been submitted. However, the precedent they have from the ISP is that this vaccine may possibly get its approval in the country, since in March it entered the WHO list and is part of the solidarity mechanism for the distribution of WHO vaccines, Covax. “On that, we would have to do an evaluation at least four weeks before this vaccine arrives in Chile. If it enters through Covax, it is a simpler evaluation because it is approved by the WHO, ”says García.
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