Pharmaniaga awaiting go-ahead to test, administer Sinovac on children

 

Pharmaniaga Berhad says it is awaiting necessary approvals before it can administer Sinovac Covid-19 vaccines to children aged between three and 17 years old.

It hopes to be allowed to conduct clinical trials on children in Malaysia.

The listed firm is also seeking a greenlight to allow it to double its production ability and supply up to four million doses per month.

Pharmaniaga group managing director Zulkarnain Md Eusope said today that approvals were needed from China’s Food and Drug Administration (FDA) and Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) for these plans.

“We are awaiting approval by the China FDA for the Sinovac Covid-19 vaccine for children aged three to 17 years and (to allow) manufacturing of two doses per vial before submitting it to the NPRA for the variation process.

“The production capacity is expected to increase by four million per month once the two-dose vial is approved,” he said at an online press conference.

Such vaccines are presently approved for those aged 18 and above only.

Asked for a timeline, Zulkarnain could only offer estimates.

“If everything is fine then hopefully by the third or fourth quarter, the vaccine can be used for the children aged three to 17. It is a long process but hopefully it can be done by this year

“As for the exact timeline, I’m sorry I cannot tell you (as this is) subject to approval from the China FDA,” he said.

Testing on children

Zulkarnain also disclosed that Pharmaniaga was in talks with Sinovac to conduct clinical trials of the Covid-19 vaccine on children in Malaysia.

“We are working together with Sinovac to do the clinical trials for the children here as well. We are looking into that,” he said.

“We are studying and looking. We are also discussing with the Clinical Research Centre (CRC) on this matter.

“We have to lay down all the safety precautions because when you want to do clinical trials, it involves humans and (there) must be very thorough studies,” Zulkarnian added.

The CRC, now renamed as the Institute for Clinical Research (ICR), is a body under the Health Ministry’s National Institute of Health.

8.6 million doses

Pharmaniaga is the sole product registration holder of Sinovac’s CoronaVac vaccines in Malaysia.

Aside from importing completed vaccines from China, it also packages them domestically through a “fill and finish” procedure.

The Sinovac vaccine is presently approved for a one-dose vial. This means only one dose of the vaccine is allowed to be filled into one vial.

Pharmaniaga’s current production capacity is two million doses per month. It expects to double its capacity once it can produce two-dose vials.

The government-linked company is under contract from the federal government to supply a total of 8.6 million Sinovac doses by June 30, 2021.

(L-R) Pharmaniaga Group managing director Zulkarnain Md Eusope, Pharmaniaga Group deputy managing director Mohamed Iqbal Abdul Rahman

By the end of May, Zulkarnain said the firm was on track to supply just over 3.6 million doses - 2.6 million manufactured “fill and finish” doses plus one million completed imported doses.

Five million doses are expected in June - two million manufactured doses plus three million doses from China.

“Looking at the current critical Covid-19 situation in Malaysia, we will propose to the government that we supply both finished vaccines as well as fill-and-finished vaccines to help the government expedite the completion of the National Covid-19 Immunisation Programme,” he said.

Meanwhile, he also announced that Pharmaniaga has lodged police reports against “baseless and malicious allegations” online and on text messaging platforms about the firm and its fill and finish manufacturing procedures.

“We at Pharmaniaga are not intimidated and (we) have lodged police reports so that official investigations can be conducted and bring the unscrupulous parties who spread these hateful messages to justice,” he said. - Mkini