By: Tony S. Bergonia – INQUIRER.net / December 07, 2020
MANILA, Philippines—A checkered past dug up by a leading US newspaper is hounding a Chinese pharmaceutical company producing one of several coronavirus vaccines being lined up for use in the Philippines.
In a Dec. 4 report, Washington Post said Sinovac Biotech had been found to have a record of bribing Chinese drug regulators to secure vaccine approvals, which had raised serious questions about its products’ safety.
Sinovac Biotech is one of several pharmaceutical firms being considered as coronavirus vaccine supplier in the Philippines. It has already started delivering vaccines to Indonesia, according to several reports online on Dec. 6.
Philippine government officials involved in procuring and distributing coronavirus vaccines, according to an INQUIRER.NET report last Nov. 25, were hoping to get up to 50 million doses of vaccines from Sinovac Biotech.
The Sinovac vaccine, which is carrying the brand name Coronavac, is being sold in China for $29.75, or nearly $30, per dose, according to a Reuters report last Oct. 15. Other reports said Coronavac was likely to cost $59 per dose. To acquire 50 million doses at the lower end of Sinovac’s price range or nearly $30 per dose, the Philippines would need at least $1.5 billion or about P75 billion.
The officials said the Philippines was also negotiating with other countries, like the United Kingdom, India and Australia, for vaccine supplies.
In a report last Dec. 2, CNN Philippines quoted government officials as saying the country may receive vaccines from Sinovac and Gamaleya, a Russian company, by the first quarter of 2021 due to “advanced” stages of negotiations.
Global implications
Washington Post, a Pulitzer Prize-winning newspaper, said Sinovac’s “history of bribery had raised concern among investors,” but it has only recently “taken on such global implications.”
The Post said it reviewed public records and court testimonies in China relating to bribery cases involving Sinovac and these showed that the company’s rise in China’s vaccine sector “took place with the help of priority projects from Beijing and kickbacks to officials who assisted in regulatory reviews and sales deals.”
Sinovac, the Post said, “has acknowledged the bribery case involving its CEO, saying in regulatory filings that he cooperated with prosecutors and was not charged.”
“The CEO said in testimony he could not refuse demands for money from a regulatory official,” Washington Post said in its report.
Sinovac’s coronavirus vaccine, Coronavac, is one of two frontrunners in China, the other being under development by Sinopharm, a state-owned company.
Sinovac, however, “has not yet released efficacy data, making it unclear whether its vaccine can protect recipients as successfully” as those of two bigger pharmaceutical firms, Moderna and Pfizer, which had reported 90 to 95 percent efficacy, the Post said.
According to the Post report, the bribery scandal appeared to have no impact on the safety or effectiveness of vaccines produced by Sinovac.
It said that there had been no evidence that “any of the vaccines approved in cases involving bribery were faulty.” “But some medical experts say that extra scrutiny of Sinovac’s drug claims is justified, given its record of moral flexibility,” the Post said.
Censorship
Washington Post said details of the bribery cases involving Sinovac in China had been kept under wraps because of media censorship.
In 2016, the Post said, Sinovac CEO and founder Yin Weidong admitted in a Chinese court that he gave more than $83,000 in bribes between 2002 to 2011 to a regulatory official in charge of vaccine reviews identified as Yin Hongzhang and his wife, Guo. “Yin Hongzhang confessed to expediting Sinovac’s vaccine certifications in return,” the Post said.
“Those years corresponded to Sinovac’s breakout period when the biotech startup founded in 2001 was handpicked by Beijing officials to lead the development of vaccines for SARS, avian flu and swine flu,” Washington Post said.
The Post said that Yin Hongzhang was found guilty of taking bribes from Sinovac and seven other companies and sentenced to 10 years in prison.
The Sinovac CEO, Yin Weidong, was not charged and still supervises its coronavirus vaccine production this year, the Post said.
But the case was just one of several, Washington Post added. “At least 20 government officials and hospital administrators across five provinces admitted in court to taking bribes from Sinovac between 2008 and 2016,” it said.
In a Beijing court in 2016, Yin Hongzhang, former deputy director of China’s drug-testing center, testified that Sinovac “gave him cash bribes over nine years” for approval of the company’s vaccines for hepatitis A, SARS, avian flu, foot-and-mouth disease and influenza A, according to the Washington Post report.
“When SARS hit, Sinovac’s Yin Weidong had already been bribing regulator Yin Hongzhang for a year,” the Post said, referring to Severe Acute Respiratory Syndrome, which is said to be related to SARS Cov2, the virus that is now causing COVID-19.
Sinovac reply
Airing the side of Sinovac, the Post said the firm in 2017 launched an “internal investigation in response to the bribery case.” “It has yet to announce the investigation result,” said the Post.
But in a recent annual report, released last April, Sinovac cleared its CEO, Yin Weidong, saying he was not charged with any offense “or improper conduct” and cooperated as a witness, the Post reported. “To our knowledge, the Chinese authorities have not commenced any legal proceedings or government inquiries against Mr. Yin,” Washington Post quoted the Sinovac report.
The Sinovac report was cited as saying the company “maintained strict anticorruption policies,” but these “may not be completely effective.”
Washington Post cited a statement sent directly to it by Sinovac, which said the company had already “entrusted the legal system to handle the past bribery cases appropriately.”
In the Philippines, Sinovac had applied last November for a permit from the Food and Drug Administration (FDA) for phase 3 trials of Coronavac, according to INQUIRER.NET.
INQUIRER.NET also reported last Nov. 30 that Sinovac and another Chinese pharmaceutical company, Clover Biopharmaceuticals, were the first vaccine producers to pass an evaluation by a panel of Philippine vaccine experts.
China’s Sinovac, Clover may start COVID-19 vax trials in PH
Philippine President Rodrigo Duterte had announced that funds would be made available to purchase vaccines once these have been developed. Still, he said there could not be enough for all Filipinos initially. He had said he wanted the poor and health workers to be a priority in immunization.
Fund lack
The Philippines’ Department of Health (DOH), according to an INQUIRER.NET report last Oct. 19, said although there was a P2.5 billion allocation in the proposed 2021 national budget for vaccines, it was short by P10 billion to administer the vaccines to at least 20 percent of the Philippines’ population, the department’s initial target.
Health Undersecretary Maria Rosario Vergeire said the DOH estimated that at least P12.1 billion was needed to make the vaccines available to the segment of the population that Duterte wants to be a priority in coronavirus vaccination—health workers and indigent Filipinos, the INQUIRER.NET report said.
She said that legislators had committed to increase vaccine funding.
Several online reports on Dec. 5 quoted Philippine Budget Secretary Wendell Avisado as saying the country may need up to P72 billion for coronavirus vaccines, a figure close to P75 billion, the amount needed if the Philippines were to acquire 50 million doses of Coronavac.
Multiple reports said up to 60 million Filipinos needed to be vaccinated to achieve herd immunity or having a significant segment of the population protected from coronavirus that would stop its transmission.
As of Dec. 5, the DOH had listed 438,069 COVID-19 cases in the Philippines with 1,733 new cases. It said at least 91.2 percent had recovered while 1.95 percent, or 8,526, had died. Cases are declining, according to Octa Research, a group of experts keeping track of COVID-19 data in the Philippines.
The Washington Post report said, “graft and weak transparency have long plagued China’s pharmaceutical industry,” but at no other time has the reliability of a vaccine maker from China “mattered this much to the rest of the world.”
Sinovac, the Post said, is now considered as a frontrunner in coronavirus vaccine development along with Moderna and Pfizer-BioNTech.
Key role
While tainted by its bribery cases, Sinovac’s role in ending the COVID-19 pandemic could still turn out to be crucial, according to the Post.
An expert interviewed for the Post report, however, said caution should be exercised.
“The fact that the company has a history of bribery casts a long shadow of doubt over its unpublished, non-peer-reviewed data claims about its vaccine,” the Post quoted Arthur Caplan, medical ethics division director of New York University Langone Medical Center.
In a report last Nov. 18, Reuters said Sinovac findings were published in a peer-reviewed medical journal, The Lancet Infectious Diseases, based on phases 1 and 2 of clinical trials for Coronavac in China involving more than 700 subjects.
“Even in a plague, a company with a morally dubious track record has to be treated with great caution concerning its claims,” Caplan said in the Post report.
Sinovac’s history of bribery, the Post quoted Caplan as saying, could “alienate some potential customers.”
Vaccines are considered dangerous if produced haphazardly since these carry amounts of viruses injected into the human bloodstream to wake antibodies that were expected to fight and lead to immunity. Vaccines’ viral loads should be enough to trigger antibody reaction without unleashing the disease against which the vaccine was designed.
In the case of SARS Cov2, as in other deadly viruses, experts said a vaccine that was carelessly produced and carried too much of the virus could kill, instead of immunizing, the vaccine recipient. Approval without tight scrutiny could lead to these kinds of vaccines.
However, some countries may still choose Sinovac vaccines because these “can be stored closer to room temperature” than those from Pfizer-BioNTech and Moderna, the Post report said, quoting Caplan.
The vaccine developed by Pfizer-BioNTech has to be stored at a temperature of minus 70 degrees Celsius. That of Moderna required a storage temperature of minus 20 degrees Celsius. Sinovac’s vaccine required storage of minus 2 to 8 degrees Celsius.
In the race to acquire vaccines, some countries, the Post report quoting Caplan said, “may lack other options.”
“When there are no options and you’re in a plague, you tend to take what you can get,” the Post quoted Caplan as saying. “Sketchy history or not,” it said. [ac]