Speed up the approval process for Covid-19 vaccine, Yii urges


By Emma Victoria

BANDAR Kuching MP Dr Kelvin Yii has urged the government to expedite the National Pharmaceutical Regulatory Agency (NPRA) approval for the Pfizer-BioNTech’s Covid-19 vaccine.

He said Health Minister Dr Adham Baba had submitted the vaccine’s dossier and data to the NPRA on Dec 12, for assessment and approval, with the process expected to take between 90 and 120 working days.

“Does it mean that the vaccine will be available (if approved) by April 26 and latest by June 14, after taking into account weekends and public holidays.”

“This is too late due to the urgent need for the vaccine, not just for the health sector but also to boost the economic sector,” he said in a statement.

“It is also important for opening borders and trade, including creating travel bubbles with neighbouring countries like Singapore.”

Yii questioned if Pfizer-BioNTech needs to postpone the delivery of the one million doses to Malaysia while pending for the NPRA’s approval.

“If the vaccines were to be delivered to Malaysia as scheduled by March, where would they be stored and how much it would cost? The vaccines must be kept at minus 70 degrees Celsius,” he said.

“If Pfizer is forced to postpone the March delivery pending NPRA’s decision, will this affect the amount of the promised 12.8 million doses, as the United States and many other countries are demanding for more doses urgently?” he asked.

The US-based Institute for Health Metrics and Evaluation (IHME) had projected a continuous rise of Covid-19 cases in Malaysia until mid-March next year, hitting over 5,000 infections daily from February 25 onwards.

“If there is no urgent intervention, we may see our health care system being overwhelmed again by April or June,” he said.

“While I am all for the Ministry’s efforts to verify and do the necessary evaluations to make sure that the vaccine is safe, the government needs to take extra and special steps to expedite the approval process so that the people can get the necessary inoculation as soon as possible.”