MANILA, Philippines — Covaxin, the COVID-19 vaccine of Indian pharmaceutical firm Bharat Biotech, can now be used in the Philippines, the Food and Drug Administration (FDA) confirmed yesterday.
At a public briefing, FDA director general Eric Domingo said the vaccine has been cleared for use after Bharat last week submitted all the required documents for its emergency use authorization (EUA). Bharat, which filed an application back in January, was issued a “conditional EUA” by the FDA last April because the documents submitted by the company were incomplete.
After submitting its certificate on having passed inspections for Good Manufacturing Practice, Bharat can now send its vaccines to the Philippines, Domingo said.
With Bharat’s addition, there are now eight vaccine brands that have secured EUA in the country, including Pfizer-BioNTech, AstraZeneca, Sinovac, Gamaleya-Sputnik V, Janssen, Sinopharm and Moderna.
Not for minors
On whether or not Sinovac and Moderna can be administered to minors, Domingo said neither of the two companies is ready to expand the indication of their COVID-19 vaccines for a younger age group.
“We asked vaccine manufacturers like Sinovac and Moderna if they will expand to include children, both of them are not yet ready to apply,” he said.
The FDA chief said the two companies could still be compiling data from their clinical trials involving children below 18 years old.
“When they are ready, they will apply for the expansion of their EUAs,” he said.
Health protocol
Meanwhile, Sen. Richard Gordon who chairs the Philippine Red Cross (PRC), emphasized the importance of practicing minimum public health standards even with the growing number of people being vaccinated against COVID-19.
“Our battle with the ongoing pandemic is still long and people need to take care of themselves as well as their family; and to do that, we need to practice proper wearing of masks, regular hand washing, and physical distancing,” Gordon said at the first anniversary of the PRC Subic Molecular Laboratory last Thursday.
The PRC Subic Molecular Laboratory, constructed in partnership with Subic Bay Metropolitan Authority, conducted a total of 86,507 COVID-19 tests in its first year of operation.
In celebrating its anniversary, Gordon stressed the importance of swab testing people exposed to COVID-19 patients and those who are experiencing symptoms to prevent further transmission of the virus. Nationwide, the PRC has conducted about 3,307,946 tests in its 13 molecular laboratories. The lab in Subic is capable of conducting 2,000 tests per day.
Lagundi trials
Meanwhile, Science and Technology Secretary Fortunato dela Peña said the preliminary findings of clinical trials on lagundi as an effective adjunct treatment for COVID-19 infection were promising.
Dela Peña, in his weekly virtual Bayanihan report, said that the study being conducted by the University of the Philippines-Manila has already wrapped up its Stages 1 and 2 screening and recruitment of a total 278 participants from seven COVID-19 quarantine facilities.
The preliminary results, he said, were promising as no participant-patient had progressed to moderate or severe COVID-19, much more succumbed to the illness, both from the lagundi and the placebo groups.
However, there was no significant difference noted in the time to recovery between the lagundi and placebo groups overall and for each systems monitored.
“In terms of safety, no serious adverse events were reported,” Dela Peña added.
He said that the study team was still in the middle of analyzing the data, particularly from the Stage 2 screening and enrollment. “Analysis for other outcomes such as RT-PCR and viral load are forthcoming,” he said. – Ric Sapnu, Rainier Allan Ronda