Deal signed: Local firms to supply Sinovac, Gamaleya vaccines from March

 

The government has signed two new agreements today that would see two local firms supply 18.4 million doses of Covid-19 vaccines to the Health Ministry, which would be enough to cover 28.75 percent of Malaysia’s population.

According to a Health Ministry press release today, Pharmaniaga Lifescience Sdn Bhd would supply 12 million doses of Sinovac’s CoronaVac vaccine. The first shipments are expected in April.

Meanwhile, Duopharma Sdn Bhd would supply 6.4 million doses of Gamaleya Research Institute’s Sputnik V vaccine in stages beginning in March.

“The supply of both companies’ vaccines would begin after obtaining approval from the National Pharmaceutical Regulatory Agency and Drug Control Authority […]

“The procurement of these vaccines would be coordinated through the National Covid-19 Immunisation Programme that is currently still in final phases of obtaining government approval,” the ministry said.

The term sheets were signed by Health Minister Dr Adham Baba and directors from both companies.

Previously, the ministry had signed agreements with Pfizer for 24.28 million doses of its Covid-19 vaccine and AstraZeneca for 6.4 million doses.

All the vaccines above call for a two-dose regimen to be administered between two to four weeks apart, depending on the vaccine used.

Pfizer had previously published studies showing that its vaccine (also known as BNT162b2 or Comirnaty) has an efficacy of 95 percent after seven days following the second dose. However, storage of this vaccine requires ultra-cold refrigeration and may prove logistically challenging.

AstraZeneca has also published results from its efficacy trials showing an overall efficacy of 70.4 percent, but irregularities in the trial have prompted more questions regarding its true efficacy and the best dosing regimen.

Neither Sinovac nor the Gamaleya Institute has published data from their efficacy trials.

Nevertheless, different research groups have announced conflicting efficacy rates for the CoronaVac vaccine ranging from 50.4 percent to 91.25 percent. Different study designs used in each trial has been cited as the main reason for the different results.

The Russian Direct Investment Fund claims that the Sputnik V vaccine has an efficacy of 91.4 percent.

Meanwhile, in a separate statement, Pharmaniaga highlighted the higher 91.25 percent figure and said it means CoronaVac has comparable efficacy with other vaccines.

“Pharmaniaga, MOH as well as the Ministry of Science, Technology and Innovation have had several discussions with Sinovac on the Phase 3 clinical trial results in Indonesia and Brazil which were conducted using different study designs, yet in accordance with the strict standards and guidelines of the World Health Organisation.

“In Brazil, for instance, the clinical trial was done solely on healthcare professionals’ groups. Pharmaniaga is satisfied with the outcome especially when CoronoVac is the only vaccine in the market to have taken such a bold step to conduct the study in a highly infectious environment of that group.

“Therefore, we are very confident that CoronaVac is safe, efficacious and of high quality for the use of Malaysians,” said Pharmaniaga group managing director Zulkarnain Md Eusope.

It should be noted that the Brazilian arm of the CoronaVac efficacy trial is also the largest of the three arms that have announced results, with about 13,000 participants compared to over 7,000 in Turkey and 1,600 in Indonesia.

Experts have cautioned that Coronavac’s efficacy figures are difficult to interpret until the full dataset is released.

Meanwhile, Pharmaniaga said its end of the deal entails purchasing CoronaVac from Sinovac in bulk, filling and finishing the product at its small volume injectable plant. The first shipment from Sinovac is expected to arrive in February.

It assured that the plant has been certified by the European Union and has also been awarded Good Manufacturing Practice certification.

Its sister company, Pharmaniaga Logistics Sdn Bhd, will be responsible for distributing the vaccine to hospitals, clinics, and other facilities designated by the government.

For the record, the government plans to administer sufficient Covid-19 vaccines to achieve herd immunity in 18 months, hence allowing life to return to normal. - Mkini