Health Secretary Francisco Duque III has ordered the Department of Health (DOH) to file an emergency use authorization (EUA) application with the Food and Drug Administration for Sinopharm’s COVID-19 vaccine.

Duque said this in response to questions in a press conference on Saturday, May 8, when asked if the Philippines will return donated Sinopharm vaccines – as ordered by President Rodrigo Duterte – after the World Health Organization (WHO) gave emergency approval for the vaccine.

“I had already instructed the Public Health Services Office in the DOH to file with the FDA for issuance of emergency use authorization for the Sinopharm donated vaccines so that there will be no need to return them once the FDA issues out the emergency use authorization of the Sinopharm vaccine,” he said.

Health Undersecretary Maria Rosario Vergeire said in a press briefing on Monday, May 10, that the agency was currently processing Sinopharm’s application and was waiting for pending documents, including a dossier on the vaccine, before it could file an application for emergency approval with the FDA. 

While Duque ordered the filing of the EUA for donated Sinopharm doses, Vergeire said the application is also expected to facilitate anticipated deals with the vaccine firm and Chinese government.

The DOH’s move to seek emergency approval for the shot would likewise be more “advantageous” to government, she added, as negations were ongoing involving access to the vaccine. 

“We are not going to represent any manufacturer for that matter. The reason why we are doing this is merong posibilidad maging government to government ang transaction (there is a possibility of a government to government transaction) for Sinopharm,” she said.

Vergeire continued in Filipino: “We need to prepare since they have already been given [World Health Organization] EUL (emergency use listing) and we have preliminary negotiations and discussions with Sinopharm manufactures and the Chinese government regarding this vaccine. It’s better that we have an EUA so we are prepared.” 

Why this matters

Duque’s directive ordering the DOH to facilitate Sinopharm’s EUA application comes after President Rodirgo Duterte earlier drew criticism after he got administered with the Sinopharm vaccine, his preferred jab, even when it has yet to be granted an EUA in the Philippines.

Duque himself had administered the Sinopharm jab for Duterte. 

The President then said he would return China’s donation of 1,000 Sinopharm jabs. Malacañang later clarified that all but one dose would be returned, to complete Duterte’s second dose.

Sinopharm’s vaccine had likewise supposedly been used by members of Duterte’s close-in security, lawmakers, and Cabinet officials in 2020, prompting the FDA to launch a probe into the illegal use of vaccines in the country. 

The FDA earlier said it has not even began a formal review of applications for an EUA for Sinopharm as the applicants have yet to provide all the requirements. 

So far, the FDA had only issued a compassionate special permit for Sinopharm vaccines donated to the Presidential Security Group. FDA Director General Eric Domingo said Duterte’s vaccination had been covered by the limited permit. 

Health experts

While the DOH facilitates the application for Sinopharm’s shot, some of the country’s top health experts underscored the necessity of abiding by proper processes to use a COVID-19 vaccine, including the timely filing of an EUA. 

In a statement signed by 39 experts, including members of the country’s vaccine expert groups and government medical advisors, health professionals emphasized this was crucial to combat rising vaccine hesitancy in the Philippines. 

“Our challenge is to convince most of our people to get vaccinated for their own as well as for our society’s protection. Inoculating a vaccine without the EUA further erodes the trust and confidence of the people in the vaccination process,” they said. 

Following this, the group called on the government to rescind existing CSPs for COVID-19 vaccines without EUAs and that such vaccines, including Sinopharm’s, instead properly apply for an EUA. 

“We believe in “Tamang Bakuna, Tamang Proseso ” (The right vaccine under the right process).  The collective efforts of government agencies, supported by independent scientists and medical experts, are worthy of the people’s trust in vaccines and in the vaccination process. This trust will play a key role in winning the fight against COVID-19,” they said. – Rappler.com