J&J seeks to register single-shot vaccine
Firm has 30 days to file 'missing papers'
Johnson & Johnson is seeking to register its single-shot Covid-19 vaccine in Thailand, the Food and Drug Administration (FDA) revealed on Monday.
The American multinational corporation has applied to register their vaccine with the FDA but some documents were missing, said Dr Surachoke Tangwiwat, deputy secretary-general of the FDA.
The company is required to have the relevant papers and file them within 30 days, he said.
In the meantime, the FDA is examining the filed papers that have been submitted, Dr Surachoke said, adding that no other company has recently applied to register their coronavirus vaccine.
The FDA last week revealed that it approved the registration of AstraZeneca Co's vaccine after the firm submitted nearly 10,000 pages of documents in December.
As for the registration of China's Sinovac Covid-19 vaccine, Dr Surachoke said although it has yet to be registered for use in China, the jab could be allowed to be used in Thailand if the FDA determines it is safe and effective.
The plan to locally manufacture AstraZeneca's vaccine is pressing ahead despite uncertainty surrounding the timing of the delivery of the jab, according to Dr Sophon Mekthon, chairman of the government's sub-committee on Covid-19 vaccine management.
Siam Bioscience Co is contracted to manufacture the AstraZeneca vaccine in Thailand.
The kingdom will also import early doses of the AstraZeneca vaccine, which are due early this month.
However, the import has been rescheduled due to the European Union's bid to limit Covid-19 vaccine exports, Dr Sophon said.
"Once the vaccine arrives, the inoculation plan will immediately be implemented," he said.
He declined to say when the AstraZeneca jabs will reach Thailand, noting that the government has yet hear the firm's explanation about the European Commission's (EC) export limitations.
According to the EC, it needs to ensure timely access to vaccines for all EU citizens and tackle the current lack of transparency in vaccine exports outside of the EU.
The EC recently put in place a measure requiring that such exports be subject to authorisation by member states.
Dr Sophon said the government's committee tasked with securing supplies of Covid-19 vaccines, led by Dr Nakorn Premsri, director of the National Vaccine Institute, has assured him that AstraZeneca would not be the sole supplier of Covid-19 vaccines in Thailand.
US vaccine developer Novavax could also be a supplier if its jab is approved by the FDA, he said.