MANILA, Philippines — A team from the Food and Drug Administration (FDA) is flying to Russia to look into the vaccine manufacturing plant of Gamaleya Research Institute’s Sputnik V vaccine against COVID-19.
“Two or three inspectors are scheduled to go to Russia next week to inspect the manufacturing site for conformance to good manufacturing practice (GMP) standards,” FDA director general Eric Domingo said yesterday.
Domingo said checking the manufacturing plant is necessary in determining whether or not the FDA will approve Gamelaya’s application for emergency use authority (EUA) for its vaccine, which the Philippine government considers purchasing.
“That is their (Gamaleya’s) major deficiency. There are other deficiencies but are just minor ones,” Domingo noted of the missing requirement in the application for EUA.
However, no member of the Task Group on Vaccine Evaluation and Screening (TG-VES) will take part in the inspection of the Russian plant.
Department of Science and Technology (DOST) Undersecretary Rowena Cristina Guevara, who chairs the TG-VES, told The STAR that the inspection focusing on GMP is the FDA’s responsibility.
“It is for EUA application, so it is the FDA. The VEP is for clinical trials,” Guevara said, referring to the Vaccine Expert Panel spearheaded by the DOST.
Meanwhile, Domingo reported that China’s Sinopharm has yet to officially file an application for EUA with the FDA.
He said Sinopharm just sent a letter of intent to apply for EUA, but has not submitted the necessary requirements.
Phl eyeing Covaxin
On talks between the Philippine government and Indian drug maker Bharat Biotech, India’s Ambassador to the Philippines Shambhu Kumaran said an initial 8 million doses of its Covaxin may be supplied to Manila as soon as next month.
“From Bharat, I think the conversation that the local partner for Bharat has been having is anything of eight million doses over a year and a half, go up to 20 million doses,” Kumaran said at a press briefing.
“The advantage of Bharat is that they could potentially start supplies in late April or in May itself. So that will be, I think, a useful supplement to some of the other vaccine supplies that are coming into the Philippines,” he added.
Kumaran said Bharat has shown 81-percent efficacy against COVID-19 based on interim data.
In the interview on Kumaran by CNN Philippines, he said Covaxin also reportedly neutralizes the UK variant of the virus.
Bharat’s clinical trials on 26,000 Indian subjects showed its vaccine was both safe and effective, prompting the government to approve its administration on millions in India since January.
“Emergency use authorization is with the FDA and we are hoping that now that we are entering phase 3 efficacy – data has been shared – we have an early EUA and that we can pick up the commercial negotiations,” the envoy said.
Covavax, a done deal?
Kumaran also described as “pretty much a done deal” the Philippines’ procurement of 30 million doses of Covavax vaccine, which was developed through a partnership between American firm Novavax and the Serum Institute of India (SII).
Philippine vaccine czar Carlito Galvez Jr. and other officials are now in India to discuss the deal, which aims to augment Manila’s pandemic vaccine stock.
“We’re very hopeful that this vaccine can reach early in the third quarter or the late second quarter of this year. So it will provide the backbone for the Philippines vaccination effort in the second half of 2021,” Kumaran said.
Kumaran said AstraZeneca shots may also be sourced from the SII but some licensing issues have to be addressed.
“Potentially, I believe that even AstraZeneca in the second half of the year. But those licensing arrangements, I’m not really confident as to where they’re positioned. But that discussion is something that I am told also Secretary Galvez will initiate,” he added.
As this developed, local experts are not disregarding the possibility that the Brazilian variant of concern is already here, but yet to be detected.
“As of right now or today, as sequencing of samples continues, there’s none; there’s no Brazil P.1 variant yet. But we’re not disregarding the possibility (that it’s here),” Philippine Genome Center (PGC) Health Program director Eva dela Paz said.
Speaking at the Laging Handa public briefing yesterday, Dela Paz warned the public against complacency and negligence in observing the minimum public health protocols.
“The virus is getting better; it wants to be a better virus so it’s mutating. What’s important now is to bring down the number of cases for it to lose the opportunity to mutate,” she explained.
“If only we would abide by minimum public health protocols, we could minimize additional cases of COVID-19,” she added.
The Department of Health (DOH) clarified Wednesday that the Brazilian variant detected here was of Brazilian origin (B.1.1.28) but not the “variant of concern.”
The new UK and South African variants that were detected in the country might have contributed to the surge in cases of COVID-19 in the country, it added.
As of yesterday, the DOH logged a high of 3,749 additional cases which brought the nationwide COVID-19 caseload to 607,048.
It said 90.1 percent or 546,671 of the total cases have already recovered from the infection, including 406 newly reported recoveries.
Active cases rose to a total of 47,769 or 7.9 percent of the total, with 96 percent of them being mild and asymptomatic.
An additional 63 deaths pushed to 12,608 the total number of COVID-related fatalities. The figure accounts for 2.08 percent of the total cases.
‘Tourism workers to be prioritized’
In another development, the National Task Force against COVID-19 (NTF) vowed to include tourism workers among those who would be prioritized for vaccination.
Department of Tourism (DOT) secretary Bernadette Romulo-Puyat said Galvez “promised” that tourism workers would be included in the priority list of vaccine recipients.
These would include personnel of hotels serving as quarantine centers and other tourism workers, she said. “That was what Sec. Galvez promised me,” she said.
During her visit at a resort in Antipolo City last Wednesday, Puyat also said the DOT would help the Rizal provincial government in reopening its tourist sites to local travelers. – Rainier Allan Ronda, Rudy Santos, Ghio Ong, Alexis Romero