The Sinovac-CoronaVac has been granted the emergency use authorization (EUA) by the Food and Drug Administration (FDA) for pediatric Covid-19 inoculation in the Philippines.
In an eight-page document signed by Dr. Oscar Gutierrez, Jr., officer-in-charge (OIC) director-general, the FDA authorized Sinovac for use in the country's pediatric Covid-19 vaccination efforts, in particular, for those aged six and above. The approval has been done after careful consideration of the application, with all the supporting documents, and a review of local experts.
“It is reasonable to believe that the Covid-19 vaccine Sinovac may be effective to prevent, diagnose, or treat Covid-19,” cites FDA. The health regulatory agency under the Department of Health (DOH) points out the totality of evidence including data from adequate and well-known controlled trials, and explained 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.
Sinovac may now be utilized by emergency response stakeholders such as the DOH or the National Task Force (NTF) against Covid-19 and other authorized agencies in line with the government’s Covid-19 pediatric vaccination program, which could significantly help meet the government’s goal of 39 million vaccinated children and achieve herd immunity.
“We thank the FDA and our vaccine experts for approving Sinovac’s Coronavac for ages six 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,” says Enrique Gonzalez, chairman of the pharmaceutical consortium the IP Biotech Group. “This will also ensure greater access and vaccine equity for the Filipino families.”
The Philippine Medical Association and the Vaccine Solidarity Movement stressed the significance of having more inoculation options for kids to boost vaccine confidence.
The FDA added that in granting the EUA, they 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 six 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. More important, Sinovac’s efficacy in preventing intensive care unit (ICU) hospitalizations and deaths of Covid-19 stands at 100 percent.
Brazil, though their regulatory body Anvisa, and Thailand arrived at a similar decision this month when they greenlit EUA for Sinovac for the same age group who has no co morbidities.
Gonzalez said that medical communities and regulators in the different countries that have granted EUA to Sinovac have provided data that can assure parents of 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,” says Gonzalez.
Last year, the World Health Organization validated the Sinovac-CoronaVac Covid-19 vaccine for emergency use, giving countries, funders, procuring agencies, and communities the assurance that it meets international standards for safety, efficacy, and manufacturing.