Sinovac’s COVID-19 vaccine gets approval for pediatric use
MANILA, Philippines — Coronavac, Sinovac’s COVID-19 vaccine, may now be administered to children after the Food and Drug Administration (FDA) granted the vaccine an emergency use authorization (EUA) amendment, Health Secretary Francisco Duque III confirmed on Monday.
The FDA approved the vaccine’s use for children aged six and above.
“Yes [EUA] amendment granted by [FDA] for 6-17 y/o pediatric age group!,” Duque told INQUIRER.net in a message.
Pharmaceutical consortium IP Biotech Group chairman Enrique Gonzalez, in a statement last Friday, thanked the FDA for the approval.
“Making this vaccine available to the younger age segment is a game changer in protecting the country’s youth and preserving recent gains in controlling the pandemic. This will also ensure greater access and vaccine equity for the Filipino families,” he said in a statement.
The FDA said that based on evidence, “it is reasonable to believe” that Coronavac may be effective to prevent, diagnose or treat COVID-19.
Gonzalez said that the Coronavac for children has the same dosage and formulation as the one used for adults.
It is administered in two doses, 0.5 milliliters each, 28 days apart.
According to a study in Chile, with data obtained from 1.9 million minors aged six to 17, Sinovac’s efficacy is at about 74 percent.
Individuals in the said age group who have been infected with COVID-19 but have received a Sinovac vaccine, can avoid hospitalizations with an average batting rate of 90 percent.
Coronavac’s efficacy in preventing intensive care unit hospitalizations and deaths is at 100 percent.
“The data will show that Sinovac is indeed a very safe choice for children and teenagers. This supports the notion on the safety and reliability of inactivated virus vaccines, much like the flu vaccine,” Gonzalez pointed out.