Chinese vaccine cleared for Philippines clinical trials
Undated photo shows coronavirus vaccine candidate developed by Sinovac Biotech Ltd.
Sinovac
Chinese vaccine cleared for Philippines clinical trials
Christina Mendez, Mayen Jaymalin, Edith Regalado (The Philippine Star) - October 16, 2020 - 12:00am

MANILA, Philippines China’s candidate vaccine for COVID-19 has been cleared by a panel of experts for phase 3 clinical trial in the Philippines possibly by November, according to the Food and Drug Administration.

FDA director general Eric Domingo said the vaccine expert panel or VEP of the Department of Science and Technology (DOST) on Monday gave the required clearance for pharmaceutical company Sinovac Biotech Ltd.

“We have been advised by the VEP that the (Sinovac vaccine) has passed their evaluation,” Domingo said during a virtual forum yesterday.

With the clearance from VEP, Domingo said Sinovac needs only to secure approval from the Single Joint Research Ethics Board (SJREB) of the Department of Health (DOH) before applying for clearance from the FDA.

He said the VEP reviews Phase 1 and 2 clinical trials of the candidate vaccine, while the ethics board evaluates the selection for trial participants.

“The clearance from the ethics board is still in progress. Though they (Sinovac) said they would be meeting the ethics board this week. We will be waiting for the result, because the FDA cannot start any study without Ethics Board approval,” Domingo noted.

“We have not seen the application yet so we don’t know the details and it’s really a matter of when the submission is given to the FDA. It is possible that they will submit their application next week or two weeks from now,” he said.

The start of the clinical trial depends on when all the requirements are complied with, although Domingo said it is possible that the Sinovic clinical trial may begin by November.

Domingo said that FDA evaluation on Sinovac for clinical trials upon approval of the ethics board should take 14 to 21 days.

As of yesterday, the DOH reported that confirmed cases of COVID nationwide rose to 348,698 with the addition of 2,261 cases.

By April

President Duterte is confident that the vaccine against the coronavirus disease will be available by April next year even as he stressed the need to tap financial resources to provide immunization for over 100 million Filipinos.

In a taped message on Wednesday, Duterte banked on the report of Health Secretary Francisco Duque III, who discussed how around 340,000 Filipino COVID survivors have developed natural immunity from the virus.

“First is on COVID. According to Secretary Duque if we go by the rules, all things considered, it will be in April,” the President said.

Duterte earlier said the vaccine would be available by December. He even volunteered to undergo clinical trials.

He said that Russia would like to establish a pharmaceutical firm in the Philippines to facilitate distribution of the vaccine.

Russia has said that it has developed a vaccine named Sputnik V against COVID-19.

“I just had a talk with the ambassador of Russia, the outgoing, and we had a serious one-on-one talk and they said that Russia is coming in,” he said.

“They are just wrapping up… and they would want to establish here. They will construct a plant, pharmaceutical, and they will bring in the vaccine,” Duetrte said.

Duterte met with outgoing Russian ambassador Igor Khovaev during a farewell call at Malacañang before his meeting with the Inter-Agency Task Force for the Management of Emerging Infectious Diseases the other night.

Duterte, who has charted an independent foreign policy, said he prefers the vaccines being developed by China and Russia instead of Western pharmaceutical groups.

“For me, it’s either China or Russia, I’ll be OK. … They say Pfizer, Moderna, those (from) western, US. It’s OK I guess since there are processes. They are using the same protocol in arriving at a certain finding for COVID using the same germ, so there is no difference,” he said.

Duterte assured the public that he has been looking at resources to fund the procurement of vaccines for everyone.

“But this I can assure you again I am looking for funds. I have the money already for the vaccine but I will look for more because you know there are now 113 million Filipinos,” he said.

Priority will be given to the less fortunate Filipinos and frontline workers, particularly the police and military, Duterte said, but he wants every Filipino to get the vaccine.

While vaccines can be given for free under the Universal Health Care Law, presidential spokesman Harry Roque Jr. said the less fortunate and frontliners will remain the government’s top priority.

Natural immunity

During the same conference, Duque reported that the 340,000 people who recovered from the disease have developed their immunity.

“They are endowed with protective antibodies against COVID-19 virus,” Duque said.

“That is what is known as natural immunity. They get the infection – pretty much the vaccines work the same way. Now they develop the antibodies, which act as ‘soldiers’ inside our bodies. Once the virus strikes again, there will be antibodies to fight the virus,” Duque explained.

“So, whether you are immunized in the natural way by infection or by vaccination, the principle is the same, Mr. President, you will have anti-bodies,” the DOH secretary told the President.

Duque said experts are still looking at how long antibodies will remain effective in the case of COVID-19 survivors.

“Hopefully, theoretically, it can provide lifetime protection. But there is no evidence to show that this is a matter of fact,” he said.

Since the disease is new, Duque said, the medical community is still conducting studies about it. “It’s still evolving, Mr. President. So we just have to watch out and learn as it evolves,” he said.

COVID-19 VACCINE SINOVAC
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