Mix-and-match COVID-19 vaccine clinical trial underway —DOST exec

The clinical trial for the P240-million mix-and-match COVID-19 vaccines in the country has started, according to an official of the Department of Science and Technology (DOST). 

DOST Undersecretary Rowena Guevara on Saturday said the trial began in Marikina City on Friday and will start in Muntinlupa next week.

The other cities involved in the trials are Davao, Manila, and Dasmariñas in Cavite.

"Nasa 204 million pesos ang gagastusin para sa clinical trial ng COVID-19 vaccine mix-and-match... Ang pinakamalaking gastos ay 'yung mga test na gagawin sa mga participant," Guevara said in an interview on Dobol B TV.

(The cost of the clinical trial for the COVID-19 vaccine mix-and-match program is P204 million. The bulk of the expenses will be for the tests that will be done on the participants.)

On Friday, Guevara said the Food and Drug Administration (FDA) approved the clinical trial for mixing and matching of different COVID-19 vaccine brands on November 16.

The participants in the trial should be at least 18 years old above and have not yet been vaccinated against COVID-19.

"Bukod sa tinitignan ang indibidwal, binabantayan din ang epidemiological condition nu'ng barangay kung saan nanggaling ang mga participant," Guevara said on Saturday

(Aside from the individual, the epidemiological condition of the barangay where the participant resides will also be monitored.)

All COVID-19 vaccines in the country have only been given the Emergency Use Authorization (EUA) by the FDA, as Clinical Trial Phase 3 was not yet done.

"Kaya rin sila binigyan ng EUA dahil sa pandemic... Binalanse ang benefit at risk," the DOST official explained.

(That is why they were given the EUA because of the pandemic. The decision was based on balancing benefit and risk.)

She added that the benefit of the vaccines against COVID-19 is higher than the risk. However, there is still a risk because the studies on the vaccines are not yet finished.

The country has more supply of Sinovac vaccines than other brands so this is the primary dose used for the mix-and-match clinical trial.

Researchers will monitor the participants of the clinical trial for one year, monitoring their immune response.

"Kapag binigyan tayo ng bakuna, hindi naman agad ang response ng katawan sa bakuna... Nasa limang araw ang hihintayin bago kuhanan ng dugo ang participant at susukatin ang immune response," said Guevarra.

(If we administer the vaccine, the immune response is not seen immediately. We have to wait for five days before blood is drawn from the participants to measure his/her immune response.)

For each mix-and-match vaccine participant, a certain amount of time will be given in between the first, second and third doses.

"Kasama na ito sa protocol na pinaaprubahan natin sa FDA (This is part of the protocol that we asked the FDA to approve)," said Guevarra. —KG, GMA News