Pfizer vaccine could be authorized as of next week in Chile

For the authorization of special use that requires the vaccine from the pharmaceutical company Pfizer and BioNTech, the Institute of Public Health (ISP) called an expert committee to advise this regulatory agency in this decision.

The same will happen in the United States. The company wants its vaccine prototype to begin to be used in the prevention of Covid-19 before ending the clinical studies, after the excellent preliminary results obtained to date (95% effectiveness), it presented the documents for an emergency approval , decision for which the Food and Drug Administration agency (FDA, its acronym in English) , also requested the formation of a group of experts.

This Thursday, December 10, will be the day chosen for the US decision and seven days later, the same experts will decide on the vaccine from the Moderna company, the other pharmaceutical company that presented its documents for an authorization of this type.

In Chile, the meeting between the experts of the advisory council and the specialists of the ISP that will decide whether or not to authorize its use in the country, will take place between December 10 and 18, as announced by the director (s) of this institution Heriberto García Escorza.

For now, García explained, there is no exact date, because they must coordinate schedules between 22 people, but he believes that the resolution will be quick and that one session will be sufficient.

If approved, the ISP’s job doesn’t end there. It should be considered that vaccines for Covid-19They will also have a prior control, through Series Control, a process by which the production protocol and quality control, as well as their release certificates and transport conditions, will be reviewed, batch by batch, through a documentary review.

“All drugs and vaccines are subject to control and surveillance,” says Garcia. The granting of the sanitary registration, he adds, imposes obligations on the holder regarding the surveillance of the product (detection and reporting of adverse reactions), while the ISP, within its functions of drug control, includes the control (that the entire process of hospitalization, distribution and use of the vaccine is being carried out in accordance with the authorization granted) and monitoring of adverse effects.