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March 14, 2022

Philippines FDA grants approval to Sinovac’s paediatric Covid-19 vaccine

The vaccine is intended for the immunisation of children aged six years and above against Covid-19.

The Food and Drug Administration (FDA) of the Philippines has granted emergency use authorization (EUA) to Chinese firm Sinovac’s Covid-19 vaccine, CoronaVac, for use in paediatric individuals, CNN Philippines reported.

According to the approval, the vaccine is intended for immunisation of children aged six years and above against Covid-19.

Pharmaceutical consortium IP Biotech Group aided in the initial delivery of the private sector-procured Sinovac vaccines.

Philippine News Agency (PNA) quoted IP Biotech Group chairman Enrique Gonzales as saying in a statement: “Making this vaccine available to the younger age segment is a game-changer protecting the country’s youth and preserving recent gains in controlling the pandemic. This will also ensure greater access and vaccine equity for the Philippines.”

According to a Chilean study, the vaccine demonstrated an efficacy of 74% in 1.9 million children of the age six to 17 years.

Furthermore, the vaccine showed to avert hospital admission of 90% of children who still had a breakthrough infection.

It also prevented intensive care unit hospitalisation and mortality in 100% of the subjects.

Gonzales added: “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.”

The Philippines’ neighbouring nations such as Indonesia, Malaysia and China are using the Sinovac vaccine for inoculating paediatric individuals.

Including the vaccine in the paediatric inoculation drive could aid the nation to vaccinate 39 million children.

Currently, the government is using the Covid-19 vaccine of Pfizer and Moderna to inoculate the paediatric population. 

In March last year, Sinovac reported initial data from Phase I and II trials where CoronaVac was demonstrated to be safe and could elicit immune responses in children and adolescents.

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