Sinovac clinical trial on elderly might start in May, says vaccine expert

MANILA — The Philippine government's vaccine expert said on Tuesday that following the start of 2 other COVID-19 vaccine clinical trials, Chinese company Sinovac might start its trial in May.

“This is really for the 60 years and above. Kasi yun yung parang naging questions before na kulang yung data nila (That was the issue before that they do not have enough data),” Dr. Nina Gloriani, vaccine expert panel head, said during a Department of Health virtual briefing. 

“Dapat ngayong April sana sila nagstart baka mga May,” she added.

(They should have started in April but they may start in May.)

Sinovac is only one of the two vaccine brands available in the Philippines. While its emergency use authorization states that it is not recommended for those 60 years old and above, the Food and Drug Administration recently decided to revise this to allow the vaccine to be given to the elderly. 

• FDA OKs Sinovac’s COVID-19 jabs for senior citizens amid vaccine shortage

Gloriani said the recent decision took into consideration new data from abroad and the the “totality of evidence.”

“So this clinical trial will add to that data,” she said.

Sinovac has long been slated to start its clinical trial in the Philippines but Gloriani said it was further delayed due to changes in protocol.

While not privy to the details, she said it has something to do with ethical concerns since the rollout of vaccines already started in the Philippines.

She pointed out that clinical trials are usually placebo-controlled, which means that a percentage of the participants will only be receiving a placebo vaccine that has no effect. This might raise concerns for participants who might want to really get vaccinated.

Gloriani said the Sinovac study in the Philippines involves around 1,000 to 2,000 participants. The study will last for a year.

She said vaccine developers Janssen of Johnson & Johnson and Clover Biopharmaceuticals have also started separate clinical trials that are one year in duration as well.

Both studies are for adults aged 18 years old and above.

Janssen’s clinical trial is for a two-dose regimen and will involve 700 participants. Gloriani said the recruitment of participants started in February and ended in the 1st week of March.

• Janssen to begin Phase 3 clinical trials in PH within the week

Janssen’s one-dose vaccine is already being used in other countries but the DOH previously said that the clinical trial in the Philippines is being done to check for long-term efficacy.

• Janssen COVID-19 vaccine clinical trials in PH to check for long-term efficacy — DOH

Meanwhile, Clover started its recruitment of participants in March.

“All over the world they are gathering data from other sites. Because they just started last March 25 ongoing pa rin yung kanilang recruitment,” she said, adding that she is not sure if the participant count in the Philippines has gone down from 8,000 to 2,000.