Vaccine developers look to FDA for help

Vaccine developers look to FDA for help

Trials sought for emergency jab use

Local Covid-19 vaccine developers say they need support from the Food and Drug Administration (FDA) to provide a special "fast lane" to test their jabs for emergency use.

Under the government's aim to reach self-reliance on Covid vaccine development, the government has granted a budget of over one billion baht since last year to potential developers.

Kiat Ruxrungtham, head of Chulalongkorn University's vaccine research centre who developed the mRNA-based ChulaCov19, said developers are now sharing concerns on how to use a completely developed vaccine when it is clear that at least 70% of the population will have full doses of vaccine before their products are ready to market.

Prof Kiat said the FDA should allow a dual process to conduct human trials for emergency use, together with booster vaccines. He said many countries had developed booster vaccines from the mRNA base and the results were satisfactory.

"We are going to consider the case with FDA to reach a conclusion. If yes, we might see a place to use it for the booster vaccine," he said.

Porntip Wiwatwong, chief developer of HXP-GPOVac, an inactivated Covid vaccine from the Government Pharmaceutical Organization (GPO), backed the idea, saying the current process under the FDA's regulations will further delay local vaccine development.

Ms Porntip said it would be useful for the local vaccine developers if the FDA could provide assistance to hasten the process.

ChulaCov19 and HXP-GPOVac are now in the second phase of human trials, followed by a tobacco-based vaccine from start-up company Baiya Phytopharm that is now starting the first phase of a human trial on a small scale.

Meanwhile, a nasal spray that Biotech is developing will have its first phase of human trials done by early next year.

In related news, AstraZeneca will supply Thailand with an additional 60 million doses in 2022. AstraZeneca has signed a new agreement with the government to support the Ministry of Public Health's mass vaccination programme. As part of the 2022 agreement, AstraZeneca has committed to complete next year's supply of the doses by the end of the third quarter.

An existing contract between AstraZeneca and the government for the delivery of 61 million doses by the end of 2021 remains in place. To date, 24.6 million doses have been delivered this year, including eight million this month.

More than 1.3 billion doses of AstraZeneca's vaccine have been released for supply to more than 170 countries globally, and more than two-thirds of these doses have been delivered to low- and lower-middle income countries.

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