Sinovac has been granted the emergency use authorization (EUA) by the Food and Drug Administration (FDA) for pediatric COVID vaccination in the Philippines.
In an 8-page document signed by FDA officer-in-charge Director General Dr. Oscar Gutierrez Jr., the agency said it has decided to grant the authorization to Sinovac for use in the country’s pediatric COVID vaccination efforts, particularly for those 6 years old and above.
“It is reasonable to believe that the COVID-19 vaccine Sinovac may be effective to prevent, diagnose or treat COVID-19. In addition, the FDA said that the known and potential benefits of Sinovac, when used to diagnose, prevent or treat COVID-19, outweigh the known and potential risks of the said vaccine,” the FDA said, citing the totality of evidence, including data from adequate and well-known controlled trials.
With this development, Sinovac may now be used by emergency response stakeholders such as the Department of Health or the National Task Force Against COVID-19 and other authorized agencies in line with the government’s COVID-19 pediatric vaccination program.
This would significantly help to meet the government’s goal of vaccinating 39 million kids.
“We thank the FDA and our vaccine experts for approving Sinovac’s Coronavac for ages 6 and above. 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,” said Enrique Gonzalez, chairman of the pharmaceutical consortium IP Biotech Group.
Earlier, the Philippine Medical Association and the Vaccine Solidarity Movement stressed the importance of having more vaccine options for children to boost vaccine confidence.
The FDA said that in granting the EUA, it also considered the similar authorizations given to Sinovac by their counterpart National Regulatory Authorities (NRAs) such as China, Brazil and Indonesia.
The study in Chile, with data gleaned from 1.9 million children aged 6 to 17 years old, also showed that Sinovac’s efficacy is at about 74 percent.
Minors who have contracted COVID-19 but had been vaccinated with Sinovac avoided hospitalizations with an average batting rate of 90 percent.
Sinovac’s efficacy in preventing intensive care unit (ICU) hospitalizations and deaths of COVID-19 also stands at 100 percent.
Brazil, though its regulatory body, Anvisa, and Thailand arrived at a similar decision this month when they greenlit the EUA for Sinovac for the same age group with no comorbidities.
Gonzalez said medical communities and regulators in the different countries that have granted EUA to Sinovac have provided data that can assure parents on the safety and efficacy of vaccinating their children.
“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 said.