After Pfizer deal announced, Dr Noor Hisham says COVID-19 vaccines must first get MOH green light

Health director-general Tan Sri Dr Noor Hisham Abdullah yesterday said his ministry has to look into the safety and effectiveness of a COVID-19 vaccine before purchasing it, as none has yet to produce the full report of the third phase clinical trials.

After Prime Minister Tan Sri Muhyiddin Yassin announced a deal to buy 12.8 million doses of Pfizer Inc’s COVID-19 vaccine, Dr Noor Hisham said health authorities are still waiting for the final report on the efficacy of the vaccines.

“Even though initially discussions were held with 10 vaccine companies, which have entered the third phase clinical trials, to procure the vaccine, there is no full report on the trials yet.

“What we got so far is the success of the vaccines reported in news and social media. So, we are still waiting in terms of technicality,” he said in his daily COVID-19 briefing.

Dr Noor Hisham also said the vaccines have to be first registered with authorised bodies such as the United States Food and Drug Administration (FDA) or the European Medicines Agency.

“Even though we have made the deal with the vaccine producer, it should register with the FDA or the European Medicines Agency, which emphasises the effectiveness and safety of the vaccine,” he said.

“Once the registration is complete, then we can move to the second phase which is the supply. At the moment, we have ordered 12.8 million doses of vaccine.

“This could cover about 20 per cent of our population, which is 6.4 million people,” he added.

Dr Noor Hisham said this will be also followed by the distribution of the vaccine, where frontliners, especially health workers, and high-risk groups will be given the priority to receive the vaccine.

He also said that the vaccine will be given to people above 18 in the first phase as most of the research conducted by the vaccine companies, involves volunteers from that group.

“Once the vaccine is given to the people, we have to monitor whether it produces any side effects,” he said.

Lastly, Dr Noor Hisham also said that they have to evaluate the vaccine on its effectiveness rate in order to check whether the main objective has been met, which is to produce the immunity group.

Yesterday, Muhyiddin said the deal with Pfizer Malaysia and German company BioNTech SE, will be enough to vaccinate 6.4 million people, with the initial shipment of one million doses earmarked for 500,000 frontline health workers.

Pfizer Malaysia then said that the BNT162 mRNA-based vaccine that would work against the SARS-CoV-2 coronavirus will be subject to clinical success and regulatory approval here before it is supplied. ― Malay Mail

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