While the Duterte government’s use of smuggled coronavirus vaccines remains unresolved, Philippine health officials once again found themselves on the defense against accusations of negligence.
The latest allegation on Friday, January 1, sees the Department of Health (DOH) and Food and Drug Administration (FDA) denying it stalled documents needed for late stage trials of a COVID-19 vaccine being developed by Chinese state-owned firm Sinopharm.
The DOH and FDA branded as “baseless” reports that it failed to act on documents needed for the Philippines’ participation in trials for the vaccine, pointing instead to Sinopharm’s lack of a reply to a letter the Philippine government sent on its proposals for collaboration.
The issue is the latest in a wave of rumors facing the DOH and FDA as the Philippines lags in a global race to secure supplies of a COVID-19 vaccine either through access to doses in Phase 3 trials or through purchase agreements.
Before the issue raised involving Sinopharm, officials from the two agencies leading the Philippines pandemic response were forced to address allegations it bungled a deal assuring Filipinos early access to Pfizer and BioNTech’s vaccine.
And only days ago were health officials again bewildered by early vaccination efforts done by top government officials and members of President Rodrigo Duterte’s close-in security.
The unregulated immunization activities had involved the use of smuggled COVID-19 vaccines, violating a number of laws including the FDA Act. It remains unresolved as the Duterte government has not answered questions hounding the searing issue.
What Sinopharm trials?
In an official statement on Friday, the DOH and FDA responded to reports “purporting that the DOH did not act on documents for the participation of the Philippines in the clinical trials of COVID-19 vaccine manufacturer Sinopharm.”
The DOH denied this, citing an inter-agency task force (IATF) resolution issued last May 2020, where it had approved Sinopharm’s participation in trials in the Philippines.
While the IATF approved the Department of Science and Technology’s (DOST) recommendation to collaborate with Sinopharm for trials, part of this included securing the FDA’s approval for trials.
The DOST also belied accusations the Philippine government did not take necessary steps to push trials forward, saying it responded to Sinopharm’s proposals for collaboration.
The DOST said Sinopharm proposed cooperation could take place in two ways. First, through trials that the Philippines would fund or through the Philippine government recognizing of authorization for Sinopharm’s vaccine granted by China’s regulatory authorities.
On the first proposal, the DOST said the Philippines “only funds trials under the WHO (World Health Organization) Solidarity Trial.” The DOST, meanwhile, did not mention if it commented on Sinopharm’s second proposal. But by practice and FDA guidelines on granting emergency authorizations for COVID-19 vaccines, China’s FDA is not among worldwide regulatory authorities the Philippines included for “reliance or recognition” pathways when granting approval for vaccines.
The use of “reliance and recognition pathways” help to speed approval of medical goods by allowing the FDA to cooperate with trusted authorities – like their counterparts in the United States, Japan, Australia, European Union, Singapore, South Korea, United Kingdom, and the World Health Organization, among others.
The DOST said “Sinopharm never responded to this letter” where it replied to its proposals.
In October 2020, the Chinese firm informed the Philippines it was no longer interested in conducting trials, saying it opted to supply doses of the vaccine to the country.
The FDA added that as of January 1, 2021, Sinopharm has not submitted any application for clinical trials nor emergency use authorization (EUA) of their vaccine in the Philippines. Only Pfizer has applied for an EUA in the Philippines.
Why it matters
As rest of the world moves forward to secure more doses, the Philippines has so far only closed a solid purchase agreement with AstraZeneca.
A tripartite agreement involving the pharmaceutical firm, the Philippine government, and private sector secured 2.6 million doses, while a second batch is in negotiations.
Other than this, Phase 3 clinical trials for Janssen Pharmaceutica’s vaccine are expected to begin this month after its application was approved before the end of 2020.
Meanwhile, the Duterte government is banking on the arrival of Chinese vaccines by March so it could start to tame the pandemic within the first few months of 2021 but so far, no vaccine made in China has applied for the necessary emergency authority to be granted by the FDA.
Obstacles facing the Philippines procurement of vaccines come against the backdrop of increasing COVID-19 cases. The National Economic Development Authority earlier said a return to strict lockdowns was not an option in 2021 as the country’s economic losses have been “huge.” – Rappler.com
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