Sinopharm EUA application can't proceed yet as papers lacking, says FDA

Kristine Sabillo, ABS-CBN News

Posted at Mar 05 2021 03:53 PM

MANILA — The Food and Drug Administration on Friday said it still hasn’t started evaluating Chinese firm Sinopharm’s application for emergency use authorization (EUA) for its COVID-19 vaccine as it has yet to file required documents.

FDA Director General Eric Domingo told ABS-CBN News that the local distributor of the China state-owned company said it would apply.

“Kaya lang 'yung kanilang ipinadalang online application ay wala pa masyadong lamang dokumento,” he said. “More of an intent to apply tapos meron naman talaga 'yung license to operate as an importer.”

(But the online application they sent does not contain many documents. It was more of an intent to apply letter and their license to operate as an importer.)

Domingo said they already sent the local distributor a list of required documents for the EUA. Because of the lack of documents, he said they did not even ask the company to pay for an application fee.

“Unless of course substantially makumpleto nila requirements hindi pa natin mapapaandar 'yung kanilang application,” he said.

(Unless of course they substantially complete the requirements then we can’t process their application yet.)

There has been confusion over Sinopharm’s application this week after conflicting reports from Malacañang and the Department of Health. Sinopharm's COVID-19 vaccine is President Rodrigo Duterte's preferred brand for his own inoculation. 

It was also the brand used by his security men in controversial unauthorized inoculations. They were later granted "compassionate" license for 10,000 jabs. 

Currently, only Pfizer, AstraZeneca and Sinovac have emergency use authorization for their COVID-19 vaccines in the Philippines. While an EUA does not allow the commercial sale of vaccines, it lets government use them for the national immunization program.

SPUTNIK V

On the other hand, the FDA might release their decision on the EUA application of Russia’s COVID-19 vaccine next.

“Sa ngayon 'yung medyo advance na ang evaluation 'yung sa Gamaleya (Institute). Ito 'yung Sputnik vaccine. Dahil meron na silang clinical trial phase 3 data na na-publish na rin naman sa isang peer reviewed journal,” Domingo said of the Russian government-funded research institution.

(Gamaleya is now in the advance stage of evaluation. This is the Sputnik vaccine. This is because they already have clinical trial Phase 3 data published in a peer-reviewed journal.)

Domingo said they are just waiting for documents on the manufacturing process of Gamaleya.

“Kailangan natin ng proof ng good manufacturing practice, 'yung consistency ng quality ng produkto tsaka 'yung stability niya pagdating dito sa atin,” he said.

(We need proof of good manufacturing practice, the consistency of the product’s quality and its stability when it’s delivered here.)

Domingo explained that they normally allow the vaccine developer to submit good manufacturing practice certification from accredited bodies abroad.

“Pero kung walang ganung papel o in the absence of a certification then we have to do inspection ourselves. So nag-assemble na rin kami ng team na mag-inspect doon at the Russian Embassy ay tutulungan din ma-expedite kung kailangan natin mag-inspeksyon,” the official said.

(But if there is no document or in the absence of a certification then we have to do the inspection ourselves. We also assembled a team to inspect the facility and the Russian Embassy will help us expedite the process if inspection is needed.)

Once this is done then the FDA can finish its evaluation of Sputnik V.

 BHARAT BIOTECH

Also awaiting the FDA’s decision is Bharat Biotech from India.

“Parang kahapon nag-announce sila patapos na ang kanilang report on the interim Phase 3 trial results. At ilalabas na daw nila soon. Ito ang inaantay natin na submit nila bago natin maumpisahan talaga yung evaluation dahil dito,” he said.

(Yesterday they announced that their report for the interim Phase 3 trial results is almost done. And they will release it soon. This is what we’re waiting for so we can start evaluation.

On Thursday, news came out that Bharat Biotech’s Covaxin, upon the second dose, had an 81% interim efficacy in “preventing COVID-19 in those without prior infection.” It is also said to be effective against the UK variant through the same trial. 

 MODERNA, NOVAVAX, JANSSEN

The FDA is also expecting three more vaccine developers to apply for EUA in the Philippines.

“Nakapag meeting na tayo and nanghingi ng information natin sa Moderna and sa Janssen and Novavax,” Domingo said.

(We already had a meeting with Moderna, Janssen and Novavax and they already asked for information.

Domingo said US-based Moderna is eligible for the expedited 21-day evaluation period since it already has an EUA from a Stringent Regulatory Authority in the United States and the United Kingdom.

Having an EUA from an SRA, which is recognized by the World Health Organization, can bolster a company’s application. Domingo has said the expedited 21-day processing of EUA applications is only for vaccines approved by an SRA.

“Itong si Novavax at si Janssen mukhang nag-apply sila sa US FDA,” Domingo said. 

(It looks like Novavax and Janssen have applied before the US FDA.)

He said if they are approved by the US then it will also expedite the evaluation in other countries, including the Philippines.

He said Johnson & Johnson’s pharmaceutical company Janssen will most likely apply for its one-dose regimen. The company is currently running clinical trials in the Philippines for a possible longer-lasting two-dose regimen.

Watch more in iWantTFC