Mexico City. Given the new provisions established by the United States government, according to which, starting in November, only travelers who have a complete schedule of any of the SARS-CoV-2 vaccines, approved by the World Organization, will be able to enter that country. of Health (WHO), CanSino Biologics (CanSino BIO) announced that "for months it has delivered to the WHO all the information required to obtain the approval of the international organization."
In this document it can be seen that CanSino BIO added that "it is awaiting the final opinion, whose times are subject to the WHO".
He stressed that so far “no observations, requests for corrections or requests to expand the information presented have been received. In addition, in recent days, the inspection of our facilities by WHO representatives was carried out satisfactorily.
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It specified that the file or dossier submitted for consideration by the intentional agency contains manufacturing quality data, non-clinical data, and clinical data, a plan to monitor quality, safety, and efficacy in the field, and a commitment to submit new data to the WHO, as soon as this new information is available, as well as labeling details.
For this reason, "CanSino BIO is fully confident that this procedure will be concluded in the first weeks of November in a favorable manner, but, above all, for the benefit of the millions of people in Mexico and other countries that have received this vaccine, whose scheme A single dose has been shown to be safe and effective.”