A doctors’ group urged agencies to hold off from giving the Sinopharm vaccine against Covid-19 to children, as it has not yet gained emergency approval for people under 18 from the Thai Food and Drug Administration (FDA). Opposition MPs also voiced concern.
“Children are not lab rats,” the Health Personnel Association (ภาคีบุคลากรสาธารณสุข) wrote on its Facebook page Monday, saying it “objects to the research that looks to provide Sinopharm to children.” The statement recommended Pfizer instead for children.
The Chulabhorn Royal Academy (CRA) this week started to give Sinopharm shots to 2,000 students age 10-17 as part of their latest trial with a target of 108,000 students. The trial was approved by its research ethics committee.
But the FDA last week rejected the latest request for the approval to give the inactivated vaccine to children as young as three.
The request was made by Biogenetech, an importer of the Sinopharm vaccine. Right now, the vaccine is only approved for people age 18 and above.
The FDA said they will wait for the results from Biogenetech’s third phase of its local study on the safety of giving the vaccine to children before they decide on the company’s request again.
The CRA defended its research, saying inactivated vaccines have been widely used to protect children from various diseases such as influenza, hepatitis and rabies as they are highly safe with fewer side effects when compared to other types of vaccines.
The Health Personnel Association questioned the criteria by the CRA’s research ethics committee to approve its latest Sinopharm trial, saying the decision was made on a pre-trial of just 720 samples.
“Is this an attempt to clear out the leftover [Sinopharm] stock to provide the space for Moderna vaccines that just have been ordered?” they wrote.
The CRA was the first entity to import Sinopharm after being the first non-government agency that received an emergency decree to allow them to import Covid vaccines. They announced last week they are bringing in 8 million doses of Moderna for booster shots.
Apart from questioning the CRA’s Institutional Review Board process, the association also said that “a group of people” is campaigning against the use of Pfizer on children in Thailand.
It pointed out that in the United States, the FDA and Center for Disease Control and Prevention have approved Pfizer for children aged 12 and above.
Many doctors, including Dr Yong Poovorawan, the Head of the Center of Excellence in Clinical Virology at Chulalongkorn University’s Faculty of Medicine, have come out over the past weeks to express their concern about the adverse effects of mRNA vaccines on children.
Dr Yong on Monday recommended that only one shot of Pfizer vaccine should be given to children age 12-17 to lower the risk of heart inflammation in children which has been associated with mRNA vaccines.
The Health Personnel Association said Pfizer has already announced on Monday that its vaccine works on children age 5 to 11 years old and the safety profile was similar to of the older age group of 16 to 25.
Tassanee Buranupakorn, an MP for the Pheu Thai Party in Chiang Mai, said she is concerned that Sinopharm vaccines are being given to children age 10 to 17 in a large trial even though the Thai FDA has yet to approve it.
She asked for the government to bring in more Pfizer to give to students instead.
Wiroj Lakkhanaadisorn, a party-list MP for the Move Forward Party, said parents who are giving their consent to allow their children to be vaccinated with the Sinopharm vaccine must understand that the sole entity responsible for any adverse effects is the CRA, and that the academy’s campaign “VACC 2 School” is a trial.
He said the only vaccine that has been approved by the Thai FDA to be given to children age 12 and above so far is Pfizer.
The government’s initial plan is to vaccinate 4.5 million students age 12-18 with Pfizer vaccine to support the reopening of schools in 29 locked-down provinces.
Apart from Pfizer and Sinopharm, the Government Pharmaceutical Organisation is also asking for the FDA’s approval to provide Sinovac to children age three and above, based on a study in South Africa.