The Department of Health on Wednesday said the country’s vaccine panels will look into reports that Chinese vaccine manufacturer Sinovac bribed Chinese drug regulators before. A Washington Post report said court records show that Sinovac, which is also applying to run COVID-19 vaccine clinical trials in the Philippines, acknowledged the bribery.
The CEO of the company reportedly told the court that he could not refuse the regulatory official who demanded for money.
Sinovac, which is looking to supply the Philippines with COVID-19 vaccine, already secured the approval of the Vaccine Expert Panel under the Department of Science and Technology.
The same US newspaper report also said that at least 20 government officials and hospital administrators admitted to taking bribes from Sinovac employees between 2008 and 2016 in their testimonies in court.
Health Secretary Francisco Duque III said the agency is aware of the media report.
“This will also form part of the work of the vaccine expert panel. They will assess the veracity first and foremost of such a report. Kung meron mang katotohanan ito (If there is some truth to this),” he said during a virtual briefing.
Duque said there is also a possibility that the source of the media report was questionable.
“The prudent thing to do is to investigate and to validate. If true, it’s up to the vaccine expert panel to include this in the report and also FDA,” he said.
The health chief explained that such issues are the reason why there is an ethics review board as well. He said the board should ensure that the country does not enter into questionable transactions in case the corruption claim against Sinovac is true.
“We are aware of what is happening. Part of the work is for the VEP to assess the veracity of such report, kung merong katotohahan nito,” Duque said in an online forum.
“Hindi naman natin masabi kung questionable ba ang pinanggalingan ng ganitong balita (We cannot say if the source of the story is questionable), but we will investigate, validate, if this is true. If true, it is up for the VEP to include this in their report,” Duque added.
Duque said that aside from the VEP, the Ethics Board and the Food and Drug Administration will also look on the reports alleging irregularity on Sinovac’s operations.
A COVID-19 vaccine manufacturer would need to secure the approval of the VEP, Ethics Board and FDA before their vaccines can be administered in the Philippines.
“That is why they (regulatory agencies) are there in order to make sure that we will not be victimized by questionable transactions of Sinovac, and if this really happened,” Duque added.
According to the Washington Post report, Sinovac was about to run clinical trials of a SARS vaccine and a swine flu vaccine in 2003 and 2009, respectively, when the bribery charges were made.
The company’s CEO admitted to giving more than $83,000 to a regulatory official from 2002 to 2011. In return, Sinovac’s vaccine certifications were reportedly expedited.
While no safety concerns have yet been raised against Sinovac, experts interviewed by the Washington Post said such corruption charges may cast a “shadow of doubt” on the company’s vaccine claims.
Sinovac is one of the dozen or so companies that have already reached Phase 3 clinical trials. It’s application for clinical trials in the Philippines has already been approved by the vaccine expert panel.
It is still awaiting clearance by the ethics review board before it can be officially evaluated by the Food and Drug Administration.
Vaccine czar Carlito Galvez earlier said that the government is eyeing to give COVID-19 vaccines to 25 million Filipinos in 2021.
Also, Galvez said that the first COVID-19 vaccines that the country is likely to get are from Sinovac since this has already been approved for emergency use authorization in China.
Meanwhile, FDA director general Dr. Eric Domingo said that only the drug manufacturer or distributor and the government can request the FDA for an emergency useauthorization to use a vaccine still in development.
In a television interview, Domingo said the EUA does not mean the vaccine is ready for commercial use.
“Ang puwede lang [mag-request ng EUA ay] ang manufacturer, ‘yung lisensiyadong mag-import, o ang gobyerno, kasi hindi naman marketing authorization ang ibibigay ng FDA, hindi lisensya para magbenta ng bakuna dahil under development pa po yung vaccine (The only one who could request an EUA is the manufacturer, the licensed importer, or the government, since it is not a marketing authorization that the FDA will give, not a license to sell vaccines because it is still under development),” he said.
“Wala pa pong makakapagbigay ng permiso para magbenta ng bakuna dahil under development pa po mga bakuna (No one yet can give a permit to sell vaccines because it is still under development),” he added, referring to potential COVID-19 vaccines still undergoing trials.
Domingo also said the DOH could apply for an EUA on behalf of a drugmaker.
“Maaaring ang Department of Health ang mag-apply ng emergency use authorization sa FDA. Bilang isang gagamit at mag-aangkat, maaari po
siya mismo ang mag-apply, hindi kinakailangan yung mismong kumpanya (The Department of Health could apply for an emergency use authorization in FDA. Since it could use or import, it could apply [for an EAU], not necessarily the company),” he said.
Through Executive Order 121 he signed last week, President Rodrigo Duterte allowed the FDA to issue an EUA for COVID-19 drugs and vaccines.
An EUA will reduce the processing time for the approval of the vaccines for local use from six months to 21 days.
Domingo said COVID-19 vaccines that were granted EUA in richer nations have a good chance of getting an EUA from the Philippine FDA.
Domingo said the process from the submission of documents by the applicant to the granting of EUA by the FDA may last three to four weeks.
Meanwhile, Senator Risa Hontiveros said local government units should work closely with barangay health workers of indigent communities to create strategies to improve public confidence in vaccination.
She issued the statement after reports said that 31% of Filipinos were unwilling to get the COVID-19 vaccine.
Meanwhile, Senator Bong Go said that aside from DOH Secretary Duque and Galvez, Jr., Duterte is also willing to be injected with COVID-19 vaccine first to allay fears of the people and build confidence on its safety and efficacy.
Go said that the poor and vulnerable sectors as well as frontliners, including medical workers, uniformed personnel and teachers will be prioritized once the vaccine is proven safe and effective.
Go said the budget allotted for the procurement of the vaccine is being finalized and the government will ensure that it would be sufficient.
He also assured that the government may explore several ways in order to secure sufficient funding for the vaccine.
Go also commended the private sector particularly big businesses for expressing willingness to contribute to the bayanihan efforts and ensuring sufficient supply of Covid-19 vaccines.
Hontiveros said LGUs should begin mobilizing BHWs of COVID-19 vaccine prioritized communities to start surveying so that the DOH can tailor-fit education programs that could directly respond to the vaccine anxieties of people in the area.
She added that the BHWs play “a crucial role in addressing vaccine misinformation and miscommunication”.
“Many people have become distrustful of vaccines, despite scientific evidence that it can save their lives. It is imperative that we educate people, not only through the media,” said Hontiveros.
“We need to bring the positive conversation around vaccines to their immediate social circles, down to individual households. Our BHWs can be the starting point for that,” she added.
Hontiveros also urged the DOH, LGUs, and the National Telecommunications Commission to mount a ‘mega’ vaccine confidence project in 2021, to broadcast vaccine education programs suited to different regions.
“We should explore all media, from television, radio and hopefully even text mesaages. ‘Vaccine confidence’ should be our serious 2021 national public health project. Not just for the COVID-19 vaccine, but for all other vaccines, existing and future. It is one of the most important ways to secure the health of the public,” she added.
Hontiveros cited the measles and polio outbreak earlier in the year that had seen a resurgence despite existing vaccines.
“Trust and information is so important in a public health crisis. The best way to start the new year is to slowly earn the public’s trust again and to use that to pave the way to health for all,” Hontiveros added.