Sputnik V, other potential COVID-19 vaccines have no FDA approval yet – DOH

Published August 27, 2020, 10:04 AM

by Analou de Vera

The Department of Health (DOH) said that clinical trials for candidate vaccines for coronavirus disease (COVID-19) has yet to begin as the Philippines is still in negotiations with other countries.

Health Assistant Secretary Maria Rosario S. Vergeire
Health Assistant Secretary Maria Rosario S. Vergeire

DOH Undersecretary Maria Rosario Vergeire said the country’s vaccine experts panel is still in talks with different COVID-19 vaccine manufacturers.

“Ito pong ating mga ginagawa palang ay mga [We are still in] negotiations with the different manufacturers and also with the other governments who have committed to help the Philippines,” Said Vergeire.

Vergeire said that the Philippines’ experts panel is still reviewing the results of the initial clinical trial phase of the Sputnik V vaccine from Russia.

“Last week we have requested already the Phase I and Phase II details coming from Gamaleya Institute–yung Russian na vaccine para lang mapag-aralan ng vaccine experts panel [Last week we have already requested the Phase I and Phase II details coming from Gamaleya Institute – the Russian vaccine —in order for the vaccine experts panel to study it],” she said.

“Magbibigay po kami ng impormasyon pag meron na tayong mas na advance na negotiation o kung meron mag-umpisa na o nakapasa na sa FDA (Food and Drug Administration) [We will provide information when we have a more advanced negotiation, or if we will a start (a trial), or (if the conduct of the trial) has already been approved by FDA],” she added.

Gene sequencing

In a related development, Vergeire said the public should exercise caution in interpreting the recent findings of the Research Institute for Tropical Medicine (RITM) on the identified lineages of COVID-19 strain in the country.

“Yung pag aaral ng RITM kailangan cautious din ang interpretation natin dyan. Yung napag-aralan ng RITM maliit na proportion pa lang ng population and it was done in hindi ganun kadaming places [We need to be cautious in our interpretation in the RITM’s study. The coverage of the RITM study was just a small proportion of the population],” said Vergeire.

In the study, the RITM has identified five lineages of the SARS-CoV-2 virus in the Philippines. These lineages are named as A, B, B.1, B.1.1, and B.6.

The RITM said that lineages A and B were the original strains from China. Lineages B.1 and B.1.1 are associated with the outbreaks in Italy and other European countries. Meanwhile, Lineage B.6 was detected in India, United Kingdom, North America, Australia, and Singapore.

The RITM noted that the first three confirmed COVID-19 cases in the Philippines belong to the Lineage A and B. The three individuals are travelers from Wuhan, China, where the outbreak first emerged.

Meanwhile, the samples collected in the National Capital Region (NCR), Ilocos Sur, Rizal and Laguna in March, including samples from the first two reported cases of local transmission, belong to Lineage B.6. Moreover, the samples collected last June in NCR and Laguna belong to Lineage B1 and B.1.1.

The RITM noted that the “viral genomes that have been sequenced,” together with the Philippine Genome Center “represent a very small picture of SARS-CoV-2 transmission in the country.”

“The sequencing results, however, suggest that from January to July 2020, there were multiple introductions of different SARS-CoV-2 lineages and strains in the country,” it said.

Vergeire said that further study is needed to determine the origin of the COVID-19 spread in the country.

“We need more details, we need more data, we need to further the study so that we can accurately say na talagang hindi yung mga Chinese ang nagspread at nagkaroon tayo ng iba pang pinanggalingan nung mga sources of infection natin [that it was really not the Chinese [travelers] who spread [the infection] and that we had other sources of infection],” said Vergeire.