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20-M Sinovac shots coming

The Sinovac is now in the advanced stage. It got clearance from the vaccine expert panel and passed the ethics review board.

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At least 5 million vaccines from China’s pharmaceutical firm Sinovac will be available in the first quarter of next year as part of the government’s campaign against the coronavirus disease 2019 (COVID-19).

Vaccine czar Secretary Carlito Galvez Jr. said the target is to secure a total of 20 million vaccines from Sinovac for the entire of next year which will be delivered quarterly.

“The Sinovac is now in the advanced stage. It got clearance from the vaccine expert panel and passed the ethics review board. It is now awaiting the FDA (Food and Drug Administration) emergency use utilization after securing the same from China,” he said.

Galvez added the government is eyeing at least 20 million vaccines for each pharmaceutical firm.

“What we are doing is (to secure) 20 million per brand since this is not (a) one time (purchase). If we will order 20 million, five million will be delivered in the first quarter, five million in the second quarter, five million in the third quarter and five million in the fourth quarter,” Galvez noted.

“We have indexing on when the vaccines will arrive. Since there are different vaccines, they have different timelines, they have different dosages and they have different effects,” he added.

At the same time, Galvez stressed the vaccine will still undergo local clinical trial.

“For Sinovac, more than 100,000 trials were done in China as it was already allowed for emergency use in China and all the Chinese tourists were already vaccinated,” Galvez said as he added that health workers will get priority in the vaccination program.

“They are the frontliners and should be protected. Next in line will be the poor and the vulnerable communities, and then the essential workers, like the social workers, medical workers, soldiers and uniformed servicemen,” he said.

Galvez added aside from Sinovac, the government will also obtain vaccines from at least five to six companies, including Pfizer and Moderna.

He assured that all Filipinos will be inoculated.

“As what President said, we will vaccinate everybody with no exception and it’s for free,” he said.

Department of Health Undersecretary Mario Rosario Vergeire explained that AstraZeneca will be required to pass the stringent tests of the local panel of experts despite a tripartite agreement signed by the government, the manufacturer and the private sector.

In a daily government briefing, Vergeire noted the agreement signed with AstraZeneca was only one of many negotiations the government is holding with vaccine manufacturers.

“These are only part of the negotiations. If the private sector placed (an order), it only meant they have initial agreements with these companies,” Vergeire said.

Vergeire was referring to the tripartite agreement with British vaccine firm AstraZeneca where at least 2.6 million doses of COVID-19 vaccine will be acquired by the government.

“It will not happen until the vaccine passes our regulatory process. It’s just like they are having this advance commitment to ensure we have an allocation with the private sector. But we will not approve it unless it passes the regulatory process,” Vergeire added.

The World Health Organization (WHO), nonetheless, has questioned the safety of the AstraZeneca drug. Vergeire explained that the government has its own regulatory process.

“All the technology which enter the country should undergo this regulatory process. We have a vaccine expert panel and then it goes through the Food and Drug Administration,” she added.

 

More data needed

According to WHO, more data will be needed from AstraZeneca to ensure the safety and efficacy of the vaccine following concerns from the scientists at the University of Oxford.

“The government has regulatory oversight.

We will not allow a vaccine to enter the market if it is not registered with the FDA since we have no assurance if it’s safe or effective,” Vergeire added.

For his part, Vaccine czar Secretary Carlito Galvez Jr. said that the approval of the World Bank (WB) and Asian Development (ADB) will be needed for the acquisition of AstraZeneca since the funding will come from the two financial institutions.

“We will source our funds from the ADB and World Bank. In the ADB, they have what the call redundant measure, they will not buy vaccine if it is being questioned by the WHO. At the same time, they need to have regulatory clearance from three stringent countries and the originating country, in this case from the British government. They still have to secure FDA clearance,” Galvez noted.

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