FDA: Sinovac seeks to expand use of its COVID-19 vaccine on children ages 3 to 17

Published July 7, 2021, 1:40 AM

by Analou de Vera

Sinovac’s COVID-19 vaccine (AFP/MANILA BULLETIN)

Chinese drug firm Sinovac Biotech has applied for an amendment to the emergency use authorization (EUA) of its coronavirus disease (COVID-19) vaccine in order for it to be used on children aged three to 17, the Food and Drug Administration (FDA) said.

“The Sinovac, just this afternoon (July 6), they already applied for an amendment of their EUA to include children. In this case, children from three to 17 years old,” said FDA Director-General Rolando Enrique Domingo during the Cabinet briefing aired early Wednesday, July 7.

“This is another potential vaccine that can be used for the pediatric age group,” he said. Under its current EUA in the Philippines, Sinovac vaccine can only be used for individuals aged 18 and above.

So far, the COVID-19 vaccine developed by Pfizer-BioNtech has been allowed by the FDA to be used for 12 years old and older.

Currently, the country’s Vaccine Experts Panel under the Department of Science and Technology (DOST) is studying this amendment application of Sinovac, said Domingo.

“Our vaccine experts are now taking a look at the data and of course asking questions to the proponents and getting more information,” he said.

“So ito ay inaaral natin within the month (So we are studying this within the month) —-to see if we will be able to allow the use of Sinovac in children,” he added.

Sputnik

In a related development, the Philippines’ Vaccine Experts Panel has allowed to extend the interval between the two doses of Sputnik V vaccine from 21 days to 42 days, said Domingo.

The Sputnik V vaccine was developed by Russia’s Gamaleya Research Institute.

“The manufacturer of Sputnik applied for an amendment to their EUA to increase the time between the first and second dose from 21 days to 90 days. However, nung inaral ng mga experts natin, ang nirerekomend ng experts natin is a maximum dose interval of 42 days (when our experts studied it, they recommended that the maximum interval should be 42 days),” said Domingo.

“Walang problema kung ma-delay po ang second dose (There is no problem if the second dose will be delayed) but if we give it within 42 days, we have enough reason to believe that the results are going to be very good,” he added.

Domingo, meanwhile, encouraged the public to get their second dose.

“Huwag po kayong matakot dahil kahit madelay kayo ng isang linggo, dalawang linggo, or tatlong linggo (Don’t be afraid because even if you are delayed for a week or three weeks), it is still worth it to get the second dose because it will still improve and increase your resistance to the COVID-19,” he said.

Novavax

The FDA is still waiting for American biotechnology firm Novavax to apply for an EUA in the Philippines for its COVID-19 vaccine.

Domingo said that Novavax has already sent a letter of intent to apply for an EUA. Novavax also already published the preliminary data of its COVID-19, he added.

“Hinihintay lang natin na ma-complete nila yung documents (We are just waiting for them to complete the documents). We will be going to process that as quickly as we can so that we will have another possible source of vaccines,” said Domingo.

 
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