[ad_1]
FILE PHOTO: Syringes are seen in front of the Biontech and Pfizer logos shown in this illustration taken on November 10, 2020. REUTERS / Dado Ruvic
MANILA, Philippines – The coronavirus disease (COVID-19) vaccine produced by Pfizer-BioNTech has a good chance of obtaining an emergency use authorization (USA) considering it has been approved by the United Kingdom, the Food Administration said. and Medications (FDA). Thursday.
FDA Director General Eric Domingo said the UK’s approval of the vaccine means that the agency’s counterpart in that country has scrutinized data on the vaccine.
However, the pharmaceutical company has yet to apply for USA in the Philippines and present its data and documents.
“She is beautiful [Pfizer BioNTech] chance to have USA here if applicable. “We consider the FDA counterpart in the UK to be a strict regulatory authority,” Domingo said in an online forum.
(They have a very good chance of getting an EUA, as the FDA counterpart in the UK is one of what we consider to be a strict regulatory authority.)
“We know they have thoroughly analyzed the data,” he added.
(We know they scrutinize the data.)
If Pfizer-BioNTech requests an EUA in the country, the Philippine government would need to collect information on the stability of the products, especially during delivery.
The Philippines would also ask for data on whether vaccine test subjects, during their clinical trial, had included Asians or even Filipinos.
The FDA can grant an EUA to a pharmaceutical company within 21 to 28 business days, provided the applicant submits a complete application, Domingo said.
Under Executive No. 121, President Rodrigo Duterte has allowed the FDA to grant USA to the COVID-19 vaccines expected to be available in the Philippines.
According to the EO, the conditions for US issuance of the COVID-19 drug or vaccine are as follows:
Based on the totality of the available evidence, including data from adequate and well-known controlled trials, it is reasonable to believe that the drug or vaccine may be effective in preventing, diagnosing, or treating COVID-19;
The known and potential benefits of the drug or vaccine when used to diagnose, prevent, or treat COVID-19 outweigh the known and potential risks of the drug or vaccine, if any; Y
There is no suitable, approved, and available alternative to the drug or vaccine to diagnose, prevent, or treat COVID-19.
/ MUF
Read next
Subscribe to INQUIRER PLUS to get access to The Philippine Daily Inquirer and more than 70 other titles, share up to 5 gadgets, listen to the news, download from 4am and share articles on social media. Call 896 6000.
For comments, complaints or inquiries, please contact us.
[ad_2]
