Dagdag COVID 19 vaccine okay sa FDA

By Jan Escosio June 27, 2023 - 07:58 AM

Binigyan ng Food and Drug Administration (FDA) ng Certificate of Product Registration (CPR) ang Cominarty, isang COVID 19 vaccine.

Ayon sa FDA malaking tulong sa paglaban sa 2019 coronavairus ang naturang bakuna, na nagtataglay ng tozinameran, na mRNA molecule na mahalaga sa paglikha ng protein na mula sa orihinal na COVID 19 strain.

“On 21 February 2023, Pfizer, Inc. submitted CPR application under Monitored Release (MR) for their Covid-19 vaccine. The application was processed in line with FDA Circular No. 2022-004, Implementing Guidelines on the Abridged and Verification Review Pathways for New Drug Registration Applications in accordance with Administrative Order No. 2020-0045 ‘Establishing Facilitated Registration Pathways for Drug Products including Veccines and Biologicals,'” ayon sa FDA.

Nabatid na ang CPR ay may limang taon na validity at ibinigay ito matapos ang masusing pag-aaral, clinical trials at pagsusuri sa mga datos.

TAGS: approval, COVID-19, Food and Drug Administration, news, Radyo Inquirer, vaccine, approval, COVID-19, Food and Drug Administration, news, Radyo Inquirer, vaccine

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