Russia’s Gamaleya Research Institute has applied to the Philippine health regulator for emergency use authorization of its COVID-19 vaccine but needs to file further documentation, the regulator said late Friday.
Gamaleya’s emergency use application is the third the Food and Drug Administration (FDA) has received after Pfizer and AstraZeneca both made similar applications.
“The submission was preassessed and the applicant was instructed to comply with the lacking documents,” FDA Director General Rolando Enrique Domingo said in a statement.
The agency also approved on Friday the application of China’s Clover Biopharmaceuticals to conduct late-stage clinical trials, he added.
Clover is the second Chinese developer to apply for Phase III clinical trials in the Philippines following Sinovac Biotech.
In December, the FDA allowed a clinical trial for the COVID-19 vaccine of Johnson & Johnson’s unit Janssen.
The Philippines has the second-highest number of coronavirus cases and deaths in Southeast Asia, after Indonesia.
Travel from Austria
Meanwhile, the government has expanded its travel restrictions and prohibited foreign passengers from Austria from entering the country until Jan. 15 as part of efforts to prevent the spread of the new COVID-19 variant detected in South Africa.
Austria has reported cases of the new coronavirus mutations from South Africa and the United Kingdom.
The Philippine government earlier imposed travel restrictions on arrivals from 27 other countries until Jan. 15 to prevent the entry of the new strain from the United Kingdom.
Passengers from Austria who arrived in the Philippines before Jan. 10 are required to complete a 14-day quarantine even if they tested negative for COVID-19 in a reverse transcription-polymerase chain reaction (RT-PCR) test.
Filipinos arriving from Austria are allowed to enter the Philippines but must also complete a facility-based 14-day quarantine even if they have negative RT-PCR test results.
Passengers who merely transited through Austria and did not leave the airport, and had not been cleared for entry by immigration officials would not be considered to have come from the country.
Unaccompanied minor Filipino passengers coming from Austria would not be allowed entry except if they are returning through the government’s repatriation program.
The repatriated minors would be turned over to the Overseas Workers Welfare Administration, which would ensure their safety and observance of quarantine protocols.
Virus case update
The Department of Health (DOH) on Saturday said it logged 1,952 new cases, bringing the total count to 485,797.
Active COVID-19 cases numbered 26,784, the DOH said.
There were 291 more recoveries, bringing the total to 449,615, and 34 new deaths, bringing the total fatalities to 9,398.
—With reports from Reuters, Leila B. Salaverria and Patricia Denise M. Chiu