Thai FDA ready to grant Pfizer jab full approval 30 days after submission


BANGKOK (NNT) – Following full approval of the Pfizer COVID-19 vaccine in United Sates, Thailand’s Food and Drugs Administration today invited Pfizer to submit more data for a similar full authorization in Thailand. This would allow the private sector to freely purchase the vaccine directly from the drug company, the same as with approved vaccines for other diseases.

In a public announcement today, Thailand’s Food and Drugs Administration (FDA) invited Pfizer Thailand to submit additional data for full authorization of the Pfizer-BioNTech COVID-19 vaccine, marketed under the name Comirnaty.

The vaccine, which has become the first COVID-19 vaccine in the world to receive full approval status for use in people from 16 years old, is currently approved for emergency use by the Thai drug regulator.

Dr Paisarn Dunkum, Secretary General of the Thai FDA, said today that the regulatory approval process for full authorization of Pfizer-BioNTech vaccine in Thailand would take no more than 30 days, following the submission of further data from the company.

Once fully approved, the drugmaker will be able to sell its COVID-19 vaccine through Pfizer Thailand as the authorized importer to private entities, similar to approved vaccines for other diseases currently available in the market.

Meanwhile, the full approval of Pfizer-BioNTech vaccine in Thailand could potentially be extended to people from 12 years old, should the company decide to submit necessary data covering this younger age group. Currently, the administration of this vaccine in Thailand for adolescents from 12 years old is permitted under emergency authorization.

The Ministry of Public Health is expecting the trend of new COVID-19 infections in Thailand to start going down.

Dr Chawetsan Namwat, the Director for emergency health hazards and diseases at the Department of Disease Control said today some of the lockdown measures currently in place could be relaxed, should the number of daily new cases continue to decline until the end of this month.

However, with the number of fatalities still high, the general public is encouraged to continue practicing protective measures, as well as getting vaccinated.