FDA grants EUA to Sinovac, vaccine delivery expected in three days

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The Food and Drug Administration (FDA) has granted an emergency use authorization (EUA) for the Sinovac Covid-19 vaccine from China but due to its low efficacy rate of only 50.4 percent, the agency withheld the recommendation to use the jab for health-care workers (HCWs).

However, FDA Director General Eric Domingo said that Sinovac can be used among clinically healthy individuals aged 18 to 59 years.

“The interim data from the ongoing Phase 3 [clinical] trials showed that when the vaccine is used on clinically healthy members of the community aged 18 to 59 it has an efficacy rate of 65.3 percent to 91.2 percent,” Domingo said during the Laging Handa news briefing.

The 65.3 percent was based on a clinical trial in Indonesia, while the 91.2 percent efficacy was the result of the trial in Turkey.

“However, it has a lower efficacy rate of 50.4 percent for health-care workers exposed to Covid-19. Therefore, it is not recommended for use in this group,” Domingo stressed.

China’s Sinovac has applied for EUA for its Covid-19 vaccine on January 13, 2021.

Other that were granted with EUA are Pfizer-BioNTech and AstraZeneca Pharmaceuticals vaccines.

Domingo reiterated that the granting of the EUA is not a marketing authorization or a Certificate of Product Registration, “therefore it cannot be sold to market commercially.”

Domingo assured that FDA is committed to continue its job to ensure that Filipinos can have access to vaccines that hold greater benefits and outweighs the risk and possible adverse effects during this time of pandemic.

For DND officials, families

A part of China’s donation Covid-19 vaccines will be used to inoculate officials and staff of the Department of National Defense and its bureaus, Defense Secretary Delfin Lorenzana said on Monday.

Lorenzana’s statement followed the FDA’s granting of Chinese product Sinovac an EUA for the government’s Covid vaccination program.

The grant of the EUA was followed later by a statement from Malacanang that the 600, 000 doses of vaccines that were donated by the Chinese government will be arriving in three days.

According to Lorenzana, 100,000 of the donated doses will go to the defense department which will be used to inoculate its officials and personnel, including those from its bureaus.

The military, through its spokesman Major Gen. Edgard Arevalo, said a bigger portion of the 100,000 doses will be used to inoculate soldiers and members of the Armed Forces of the Philippines.

“The 100,000 vaccines will be for the DND [Department of National Defense] and its bureaus. It will be administered by the Veterans Medical Center and V Luna Medical Center,” he said.

The defense secretary said the military is not included yet in the inoculation.

“Not yet. It is in two doses that is why the 100,000 can only cover for 50,000. It’s only enough for DND personnel and their families,” Lorenzana said.

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