A couple of hours after Foreign Minister Marcelo Ebrard announced the approval by the Federal Commission for the Protection against Sanitary Risks (Cofepris) of Phase 3 of the CanSino Pediatric vaccine against Covid-19. Hugo López-Gatell, undersecretary of Prevention and Health Promotion, affirmed that the Chinese pharmaceutical company has not presented the information to Cofepris.
Did Cofepris approve four phase 3 clinical trials this month: CanSino Pediatric?
This Tuesday, in a morning conference, the Secretary of Foreign Affairs revealed that four clinical trials of vaccines against the pandemic have been approved in September, including the CanSino Pediatric one. Therefore, phases 1 and 2 of this vaccine are already carried out in Mexico.
“Cofepris approved four new phase 3 clinical trials this month: CanSino Pediatric; Walvax, this is messenger RNA. Sanofi, from France; and the Chinese Academy of Medical Sciences, which is also testing, is going to do another clinical trial. With which Mexico would have eight clinical trials of the same number of vaccines underway, “said the foreign minister.
Hugo López-Gatell assured that Cofepris does not have the information on these tests
However, hours later in a meeting with the media at the National Palace, Hugo López-Gatell assured that Cofepris does not have the information about the clinical trial for CanSino Pediatric.
“We have no information. CanSino has not presented any document to Cofepris in this regard ”, he assured.
López-Gatell said that it is not a new clinical trial, but rather the one that CanSino has already approved.
“It is not a trial in itself, it is part of the original trial, and it has been conducting, it is the trial conducted by Dr. Ruiz Palacios at the Institute of Nutrition, but no results have yet been shown to the health authority”, he commented before retiring.
Sputnik V and CanSino vaccines are NOT validated for emergency use by WHO
Despite the multiple substances that have been created to combat the pandemic. DO NOT forget that World Health Organization (WHO), continues to not validate vaccines against COVID-19; Sputnik V and CanSinoBio for your emergency use.
Which yes?
The world body has endorsed a list of emergency uses, which includes: Pfizer, AstraZeneca, Janssen, Moderna and Sinopharm. However, the WHO has said that each country can decide what dose to apply.
What is the WHO Emergency Use list?
The WHO Emergency Use List (EUL) opens the door for countries to accelerate their own regulatory approval processes to import and administer the vaccine.
“These data are reviewed by independent experts and WHO teams, who consider the current body of evidence on the vaccine in question. The plans to monitor its use and the plans to carry out additional studies ”, it indicates.
In addition, it also allows UNICEF and the Pan American Health Organization to purchase the vaccine to distribute it to countries that need it.
About the procedure
The WHO Emergency Use Listing Procedure (EUL) is a risk-based procedure for evaluating and listing in vitro diagnostics (IVD). As well as drugs and vaccines that do not have a strict regulatory evaluation and that are intended to be used mainly during public health emergencies of international concern.
“The emergency use list procedure is used to assess the suitability of new medical devices during public health emergencies. The objective is that medicines, vaccines and diagnostic tests are available as quickly as possible to face the emergency, while respecting strict criteria of safety, efficacy and quality ”, explains the WHO.
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