Despite US FDA approval Bhutan cannot use its Pfizer stock to vaccinate children of 5 to 11

Although the US Food and Drug Administration (FDA) has authorized the emergency use of the Pfizer-BioNTech COVID-19 vaccine, for the prevention of COVID-19, in children aged 5 through 11 years, however, Bhutan is waiting for the WHO’s recommendation on the matter.

The National Immunization Technical Advisory Group (NI-TAG) member, Dr Sonam Wangchuk, said the health ministry is trying to explore the vaccine for children, and its availability and supply chain.

The Pfizer vaccine that was kept in stock for 5-11 years, will not work since that is for adult doses, and it is not recommended for children 5-11 years. There are technical issues so the manufacturer is not recommending it, said Dr Sonam Wangchuk.

He said it is just in the US that they have approved and started vaccinating children from 5 to 11 years, and they have different doses for the children.

“We have to look for vaccines first. For now the NI-TAG team and government is exploring to look for vaccines, and discuss vaccinating children. We have to order from the Pfizer Company and also have to look at whether the government can procure vaccines from them before we decide, and until and unless, we have some assurance, we will wait till the vaccine is available,” said Dr Sonam Wangchuk.

Earlier the health ministry thought that approximately 150,000 Pfizer vaccine can be saved for children from 5 years to 11 years of age, if there is an approval to vaccinate. The current stock of Pfizer vaccine will expire towards the end of January 2022, so the NI-TAG team will plan how to go about using these Pfizer vaccines, and will think of booster doses for the elderly cohort. There is still time for booster dose though, said Dr Sonam Wangchuk.

Currently, the health ministry is trying to reach out to some experts and suppliers. Bhutan may require around 180,000 doses, and will wait for the vaccine availability.

“If we get vaccines sooner, we will roll out vaccines because there are no other vaccines. However, if the current Pfizer vaccine used on adults works, then we will roll out immediately,” Dr Sonam Wangchuk further said.

Bhutan can attain above 90 percent of vaccine coverage if there is an approval of vaccination of 5 years to 11 years of age, and by then Bhutan will be left with 5 cohorts, which is about 60,000 unvaccinated individuals, said Dr Sonam Wangchuk.

As per the FDA, the Pfizer-BioNTech COVID-19 vaccine for emergency use in children 5 through 11 years of age for the prevention of COVID-19, is found to be 90.7 percent effective.

The vaccine’s safety was studied in approximately 3,100 children age 5 through 11 years who received the vaccine. The safety data from the trials found the most common reactions were pain at the injection site, fatigue and headache, muscle and/or joint pain, chills, fever, swollen lymph nodes, nausea and decreased appetite.

More children reported side effects after the second dose than after the first dose. Reactions were mostly mild or moderate. There were no serious adverse events related to the vaccine, including anaphylaxis or myocarditis, although the latter likely was too rare for detection in a trial of that size. Side effects were generally mild to moderate in severity and occurred within two days after vaccination, and most went away within one to two days.

The Pfizer-BioNTech COVID-19 vaccine for children 5 through 11 years of age is administered as a two-dose primary series, 3 weeks apart, but is a lower dose (10 micrograms) than that used for individuals 12 years of age and older (30 micrograms). 

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