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FDA asked to rush OK of vetted vaccines

HOUSE Assistant Majority Leader and Quezon City Rep. Precious Hipolito Castelo on Tuesday urged the Food and Drug Administration (FDA) to rush the approval of the use of coronavirus disease-19 (COVID-19) vaccines that have been vetted by their countries of origin.

“There should be no red tape in the approval or authorization process because this is a race to save lives,” Castelo said.

Castelo said there is no need for the FDA to study vaccines that have already been extensively evaluated and authorized to be used on their population by their countries of origin and manufacture such as the United States (US) and Germany.

She said the FDA should act swiftly on the application for “emergency use authorization” (EUA) of the vaccine developed by US pharmaceutical giant Pfizer and German biotech firm BioNTech, which has been rolled out in the US and many parts of Europe and the world, including Saudi Arabia and Singapore.

“COVID-19 vaccines should be spared from politics and bureaucratic delay, which will cost us more lives and livelihood,” she added.

The Pfizer/BioNTech vaccine reportedly has an efficacy of 95 percent.

The two companies are reportedly the only vaccine makers that have so far applied for EUA with the FDA. They filed their application last December 23.

FDA director general Eric Domingo has said it would take his agency three weeks to a month to assess the application.

Domingo said one thing they would like to find out was if the Pfizer/BioNTech jab would have the same 95-percent efficacy on Asians and if people belonging to the Malay race participated in the developers’ phase 3 trials.

Castelo said Singapore, the first Asian country to receive the Pfizer/BioNTech vaccine, would begin inoculating its population tomorrow (Dec. 30), giving top priority to its health workers, followed by the elderly.

“If it is good for Singaporeans, it must be good for us. What is the FDA waiting for?” She asked.

She said even if the regulator issues Pfizer/BioNTech its EUA today, it would still take months “before they could supply us.”

However, she said the EUA approval could prompt other vaccine makers like Moderna and AstraZeneca to submit their own applications.

Castelo said the US has also authorized the use of the Moderna vaccine, while the United Kingdom is about to issue EUA for its homegrown jab developed by AstraZeneca and Oxford University.

“The more vaccines with high efficacy we have, the better for our people,” Castelo stressed.

She pointed out that the issuance of an EUA for the AstraZeneca/Oxford vaccine could prompt private domestic companies to increase the initial 2.6 million doses they have contracted from the two partners.

The companies have committed to give half of the vaccine to their employees and donate the other half to the government.