MANILA (UPDATED) — The Food and Drug Administration (FDA) approved on Wednesday the use of Sinovac’s COVID-19 vaccines for those 60 years and older, as Philippines faces vaccine shortage.
“After considering the recommendation of the experts and the current situation of high COVID-19 transmission and limited available vaccines, the FDA is allowing the use of Sinovac on senior citizens,” FDA Director General Eric Domingo said in a text message to ABS-CBN News.
Domingo said that before vaccination, the senior citizen’s health status and exposure risk should be evaluated to ensure that the “benefits of vaccination outweigh risks.”
Initially, Sinovac’s vaccine was only approved for use for those 18 to 59 years old because of the lack of data on elderly use.
Dr. Rontgene Solante, a member of the vaccine expert panel, said that the Brazil clinical trial of Sinovac only included 360 elderly people out of a total of 8,000 participants. He said the number wasn’t enough to make a conclusion that the vaccine was effective.
However, with the Philippines running out of AstraZeneca vaccines, the vaccine expert panel had to review Sinovac’s data again. The panel recommended to the FDA this week that the China-made vaccine be used for the elderly.
Only AstraZeneca had been allowed for senior citizen use. Of the 2.5 million vaccines that arrived in the Philippines, only 525,600 are from AstraZeneca while the rest are from Sinovac.
In a separate statement, the Department of Health said that while there is Phase I and Phase II data trial data for senior citizens taking Sinovac, the “efficacy data is not yet sufficient to establish vaccine efficacy.”
The DOH and the FDA further said that “while current efficacy data for Senior Citizens from Phase III trials is insufficient, the benefits of using the vaccine for this particular group outweigh its risks, and more scientific data on use for senior citizens may soon become available,” the DOH said.
The Philippines has been seeing record-high COVID-19 cases since March due to more transmissible variants and the non-compliance to health standards.
The country is facing a vaccine shortage, with the delivery delay in the next batch of AstraZeneca’s COVID-19 vaccines due to a global supply shortage.
World Health Organization (WHO) Country Representative Rabindra Abeyasinghe earlier said the agreed quantity of 920,000 vaccine doses for the next delivery might be reduced because of the shortage in vaccines worldwide.