62 M’sians in Phase 3 trials


SUNGAI PETANI: Malaysia has taken another step forward in the fight against the pandemic with the first batch of 62 Malaysians being given the Covid-19 vaccine developed by China’s Institute of Medical Biology Chinese Academy of Medical Sciences (IMBCAMS).

Held at Hospital Sultan Abdul Halim’s Clinical Research Centre (CRC) here yesterday, half of the volunteers received the SARS-CoV-2 inactivated virus particles while the rest were given placebo doses.

Online trader Adam (real name not revealed as advised by the Health Ministry), 33, was the first in Malaysia to get the vaccine, which is undergoing Phase 3 of its clinical trials.

Adam said he hoped his participation in the trial could help in proving the effectiveness of the vaccine.

“We badly need the vaccine as the cases are constantly rising. Some of my friends have also been infected.

“So many countries are putting their priority on vaccination because the only way to overcome Covid-19 is through vaccination, ” he said.

College student Fitri, 19, said he signed up for the trial for the same reason as Adam.

Voicing hope that he had received the real dose, he said: “Since the vaccine is approved by the Medical Review and Ethics Committee, I have full confidence in it.”

Another college student, Pooja, 19, drove all the way from Butterworth to get the jab.

“I’m just doing my small part for my country. My father is a former army man who taught us never to hesitate if we get called up to serve the country.

“I signed up for the trial after knowing about the availability of the slots, ” she said.

Hospital Sultan Abdul Halim’s CRC head Dr SL Vijaya Kumar said the centre was the first of nine hospitals under the Health Ministry to undertake the clinical study because it was the first to complete the groundwork and recruitment screening.

“We are fortunate that all 62 applicants who registered are from various backgrounds and passed the medical test three days ago.

“In this double-blind study, none of them will know what they received.

“They will get the next dose in two weeks’ time and will return for follow-up checks within six weeks.

“After that, there will be follow-up interviews by phone for a year, ” he said.

Another 60 volunteers will get their jabs at the hospital today, followed by more volunteers in the weeks to come.

Dr Vijaya said they hoped to recruit some 375 volunteers for the trial by the end of February.

The hospital’s acting director, Dr Mohamed Ali Mohamed Nadhar Khan, said they were happy to be selected as collaborators for the trial.

“We would like to thank all the volunteers for taking part, ” he said.

Malaysia is the first country outside China to conduct the trial for the inactivated Covid-19 vaccine.

Before this, the IMBCAMS had carried out Phase 1 and 2 trials in China.

The same Phase 3 trials will also be carried out in Brazil.

According to the Health Ministry, Phases 1 and 2 of the clinical trials of the vaccine showed significant immune reactions against antigen SARS-CoV-2 without any serious side effects.

The Health Ministry said the collaboration initiative between the Malaysian and Chinese governments through IMBCAMS would help to generate scientific evidence in the development of the SARS-CoV-2 vaccine, which uses an inactive platform made from viruses that are killed through physical or chemical processes and does not have potential to cause diseases.

The other eight hospitals selected to conduct the Phase 3 trial are Hospital Sungai Buloh, Hospital Ampang, Hospital Raja Permaisuri Bainun, Hospital Taiping, Hospital Pulau Pinang, Hospital Seberang Jaya, Hospital Sultanah Bahiyah and Kuching General Hospital.

More than 7,000 members of the public had expressed interest in participating in the trial, the Health Ministry said.

Of these, 3,000 were selected, half of whom would receive two doses of the inactive vaccine while the other half would receive two placebo doses.

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