Dr Noor Hisham: Malaysia awaiting Covid-19 vaccine trials data, cannot decide based on news reports alone

Health director-general Tan Sri Dr Noor Hisham Abdullah speaks during a press conference in Putrajaya on November 21, 2020. — Picture by Miera Zulyana
Health director-general Tan Sri Dr Noor Hisham Abdullah speaks during a press conference in Putrajaya on November 21, 2020. — Picture by Miera Zulyana

PUTRAJAYA, Nov 21 — Malaysia has not yet received official data on the latest stages of Covid-19 vaccine trials, Health director-general Tan Sri Dr Noor Hisham Abdullah said today.

He acknowledged the heavy press coverage of pharmaceutical firms reporting high rates of effectiveness for their vaccine candidates, but said the ministry would need data from the firms as well as health agencies before deciding on Malaysia’s Covid-19 vaccine policy.

“Now we are only hearing from the media about the effectiveness of the vaccine, but we cannot register the vaccine by relying on media reports,” Dr Noor Hisham said in a press conference today.

Dr Noor Hisham said no pharmaceutical firm has yet to publish their phase three clinical trial data despite the news reports of their candidates’ high effectiveness.

“We look at data. We don’t look at company,” he said, when asked if Malaysia is looking at any specific pharmaceutical companies to secure the vaccines from.

Health deputy director-general (research and technical support) Dr Hishamshah Mohd Ibrahim told Malay Mail later that the Vaccine Selection and Vaccination Policy Committee has about 20 experts from the public and private sectors to evaluate and select the Covid-19 vaccine for Malaysia.

The committee was under the Vaccine Supplies Access Guarantee Special Committee formed jointly between MOH along with the Science, Technology and Innovation Ministry (MOSTI).

“At the moment, some have completed their phase three, but they have got to submit their whole dossier, the data and everything. It’s so voluminous. Thousands of pages.

“But the one that they sent to the Food Development Authority (FDA) last Friday was only the interim analysis. This is Pfizer and Moderna is not there yet, and Pfizer decided to do the interim analysis after having like 194 events.

“Then from that analysis, you see whether it is effective or not. It’s just the way of the interim analysis, but in the interim analysis, it’s not just one aspect they look into. They need to look into a lot of other details,” he said.

Dr Hishamshah added Malaysia previously looked to benchmark foreign agencies, such as the FDA and the European Medicine Agency (EMA), when seeking vaccines.

“But of course, independently, the NPRA is going to look at assessing all of the documents and results, themselves, and they would refer to the expert panel,” he added, referring to the National Pharmaceutical Regulatory Agency.

Dr Hishamshah said that MOH has also been trying to get the Covid-19 vaccine trials conducted here “since the early days.”

“The problem with Malaysia is during the first and second wave, the attack rate was so low because the incidences of Covid-19 dropped down, so they were not interested at all,” he said, referring to pharmaceutical companies working on developing the said vaccine.

CNN reported that a final analysis of the Pfizer’s phase three coronavirus vaccine trial showed that it was 95 per cent effective in preventing infections, even in older adults, and caused no serious safety concerns.

Citing the company, the report said that Pfizer had counted 170 cases of coronavirus infection among volunteers who took part in its trial, adding that 162 infections were in people who got placebo, or plain saline shots, while eight cases were in participants who received its vaccine, which Pfizer claimed, worked out to 95 per cent efficacy rate.

Pfizer reportedly said that it will seek the US FDA to authorise for an emergency use of its vaccine “within days”, and that it would also be submitted its data to other regulatory agencies around the world.

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