Minister Clarifies Pharmaniaga, Duopharma Not Appointed For Covid-19 Vaccine ‘Fill-Finish’

Khairy Jamaluddin says out of five human vaccine projects in Malaysia, only one — for cholera — reached the preclinical stage.

KUALA LUMPUR, July 28 — Minister Khairy Jamaluddin clarified in Parliament today that the government has not selected local pharmaceutical companies — Pharmaniaga Bhd and Duopharma Biotech Bhd — to undertake fill-finish processing for any Covid-19 vaccine.

The minister of science, technology and innovation told the Dewan Rakyat that the two government-linked companies were simply identified as pharmaceutical corporations with the capacity to conduct fill-finish processing, which is a process where the active agent of the pharmaceutical product is formulated or mixed into its final form (like liquid or powder), and filling and sealing it within final containers (like prefilled syringes).

“The National Science Council, in a meeting on July 14, has discussed the public-private approach for the fill-and-finish stage. The decision in selecting the companies for fill-and-finish is not simply confined to Duopharma and Pharmaniaga,” Khairy told Parit MP Nizar Zakaria.

“They are among the choices of companies now with the capacity to conduct fill-and-finish.”

The Umno lawmaker had asked Khairy in Parliament if it was true that the government has decided to appoint Pharmaniaga and Duopharma for fill-finish processing of a Covid-19 vaccine in Malaysia, the criteria for selection of the two companies, and why they were not selected based on open tender.

“However, the selection of the companies must be done and be based on their capacity for local manufacturing of pharmaceutical products according to good manufacturing practice (GMP), as per the standards of the Pharmaceutical Inspection Cooperation Scheme (PIC/S),” Khairy said.

“And the appointment of a manufacturer that fulfills these standards is very important to ensure that the fill-and-finish aspect is conducted safely. The decision to appoint such companies must fulfill conditions that will be set later by the National Pharmaceutical Regulatory Authority (NPRA) under the Ministry of Health (MOH).

“This appointment will most certainly be done according to current government procedure.”

The Galen Centre for Health and Social Policy previously said it could take a long time for a pharmaceutical company, which successfully develops a Covid-19 vaccine, to proceed with a fill-finish agreement with a third party here, as Malaysia has yet to prove capacity in manufacturing human vaccines. Deputy Health Minister Dr Noor Azmi Ghazali also told Parliament recently that it could take years for the world to get a vaccine for the novel coronavirus.

Galen chief executive Azrul Mohd Khalib said sterile fill-finish operations were critical in pharmaceutical manufacturing, as it is the last step before the product is packaged and delivered to patients.

“They demand sterile environments, higher levels of specialised expertise, equipment and innovation. Risks include loss of valuable vaccine batches, compromised integrity, and potential health risks to patients due to microbial contamination or product degradation. Patient safety is paramount. It is not rebottling a soft drink,” Azrul said recently.

He added that if the fill-finish operation requires higher investments to bring existing Malaysian manufacturing infrastructure up to standard to pass regulatory scrutiny, it may be less cost-effective compared to purchasing the vaccine directly from the manufacturer that would have economies of scale.

Khairy said today that since 2006, the Ministry of Science, Technology and Innovation (MOSTI) and the Higher Education Ministry have funded 55 vaccine development projects involving 16 local institutions.

However, out of five human vaccine projects, only one — for cholera — reached the preclinical stage, whereas Malaysia has managed to develop 19 animal vaccines. Preclinical research assesses the features of a treatment or test (like the chemical makeup of a drug), after which the tests and treatments go through clinical trials to check if they are safe and effective for use in people.

“Currently, we have been more successful in the commercialisation of animal vaccines compared to human vaccines,” Khairy said.

He also revealed that the National Science Council’s July 14 meeting, chaired by Prime Minister Muhyiddin Yassin, has decided that MOSTI and MOH prepare a roadmap on vaccine development in the country so that Malaysia has the ability to produce human vaccines in the medium term.

“Then we will get vaccine security and reliance without having to totally rely on imports like what we’re doing now.”

Kulim Bandar Baharu MP Saifuddin Nasution Ismail questioned why the government was preparing a new roadmap on vaccine development, pointing out that Malaysia launched a National Biotech Policy 15 years ago, while various institutions, like the National Institute of Natural Products, Vaccines and Biologicals (9-BIO), were set up between 2003 and 2006.

“Based on our research, we have identified a few weaknesses in the previous vaccine development model, including the formation of 9-BIO that ultimately did not succeed under the Ministry of Health,” Khairy replied.

“Therefore, a new roadmap is being created so that we can look at vaccine development with a different approach, by simply focusing on a few viruses instead of trying to do too much research like what is happening now, and also to look at more systematic research and development funding that is more targeted towards the viruses that will be identified.

“We will review the entire ecosystem — from basic research, preclinical, clinical trials, until commercialisation — to ensure that we can correct and resolve whatever past mistakes.”

Khairy said Malaysia was currently discussing with China on Covid-19 vaccine development, as the country already has several companies and institutions working on a vaccine for the novel coronavirus.

He cited CanSino Biologics that has been given limited approval by the Chinese government on developing a Covid-19 vaccine, Sinopharm’s Phase 3 clinical trials in the UAE, and Sinovac’s Phase 3 clinical trials in Brazil.

“Tomorrow, I am scheduled for a video conference with my Chinese counterpart, Wang Zhigang, on this issue, including the possibility of Malaysia getting access to a vaccine from China if Malaysia’s Ministry of Health finds it suitable, safe, and effective,” Khairy said.

He explained that Malaysia has volunteered to countries like China for clinical trials for a Covid-19 vaccine, but several companies pulled out because of the reduction of coronavirus cases in Malaysia. Clinical trials for the vaccine, he said, require plenty of Covid-19 cases, such as UAE and Brazil with tens of thousands of cases. Malaysia currently has 179 active Covid-19 cases.

“However, we’re prepared and we have the capacity to conduct clinical trials through Clinical Research Malaysia that has driven the ecosystem of clinical research development in Malaysia. We also have facilities that can conduct Phase 1 clinical research, which is the Clinical Research Centre at Sarawak General Hospital.”

Phase 1 of a clinical trial aims to discover the best dose of a new medicine with the fewest side effects, where the drug will be tested in a group of 15 to 30 patients. Phase 3 trials aim to compare a new medicine to the standard-of-care drug, enrolling 100 or more patients in randomised trials where one group gets the new treatment, while the other gets the standard-of-care drug.

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