Sputnik V nears expert panel OK
Only a few more documents are needed from the manufacturer to back its early trial results
The Department of Science and Technology (DoST) on Saturday said Russia’s Sputnik V vaccine may have a “big chance” of getting approval in its initial assessment for conducting a clinical trial in the country.
Only a few more documents are needed from the manufacturer to back its early trial results, the DoST said.
“It (Sputnik V) has a big chance of passing the vaccine expert panel since they’re only asking for just a few more documents,” DoST Secretary Fortunato de la Peña said in a radio interview.
As explained, the vaccine expert panel will assess the findings from the initial three clinical phases if it is applicable to Filipino participants.
But in the case of the Sputnik V since it has only finished the first two phases, it’s third phase with thousands of participants will include those from selected countries such as the Philippines, Brazil, Russia and the United Arab Emirates.
Despite this, De la Peña assured that everything will be checked accordingly by the panel claiming that it will not pass their assessment if not all are investigated.
Sinopharm backs out
He reiterated that Sinopharm, which is another vaccine arm of China, has backed out from conducting a clinical trial in the country.
Initially, he said the group wanted to supply and push through with a trial in the Philippines but their decision may have changed due to the shouldered cost.
“In the end, I don’t know if the information we gave affected their decision that if the trial is outside the WHO (World Health Organization) then each manufacturer will shoulder their own cost in the clinical trial because after all that they said they’ll just provide the supply,” he said.
On Thursday, the Food and Drug Administration (FDA) disclosed that Sinovac — another Chinese firm — was the first to pass the panel after already submitting its complete application documents among the other eyed manufacturers.
The vaccine expert panel will assess the findings from the initial three clinical phases if it is applicable to Filipino participants.
Director-General Dr. Eric Domingo said Sinovac has already been endorsed to the ethics review board where they expect further submissions to be finished within the week.
Provided that everything goes as scheduled, he said an estimated length of 21 days is expected to finalize everything before the FDA can decide whether they will be given a green light for the local trials.
In general, experts said that the clinical trials will run for three to six months with an estimated possibility that a vaccine against COVID-19 may be out by the second quarter of 2021.
VCO trial results
Meanwhile, results for the clinical trial on the use of virgin coconut oil (VCO) among COVID-19 patients may be out by the second week of November, the DoST said.
De la Peña said that in the following days they are set to analyze all data gathered from the community hospital trial in Laguna which dealt with mild and probable COVID-19 patients.
There has been positive feedback based on the initial results with a majority from the 56 participants being sent home after recovering from the disease.
However, he noted that they have yet to find out whether these patients are those that have been given with virgin coconut oil as it was administered randomly as part of the blind trial.
“Hopefully those were the ones that were given with VCO because actually participants part of it will undergo a blind trial where the other set has VCO while the other doesn’t have,” he said.
He explained that the group was divided as such in order to test its effectiveness as a supplemental treatment against COVID-19.
Its other trial site in the Philippine General Hospital, meanwhile, is still in the recruitment stage of severe and critical COVID-19 patients who wish to volunteer for the trial.
He said the hospital is currently having a hard time due to a decrease in the number of admitted patients.
As of writing, no approved treatment against COVID-19 has yet been declared as trials both on medication and vaccines are still ongoing.