Deal's off if vaccine doesn’t pass muster, KJ assures amid doubts about Sinovac

 

Special Vaccine Supply Access Guarantee Committee co-chairperson Khairy Jamaluddin assured that Malaysia will not go through with its Covid-19 vaccine procurement deals if the vaccine in question does not meet standards.

He reiterated that the agreements are subject to approval by the National Pharmaceutical Regulatory Agency, which would assess the vaccine candidates for its safety and efficacy.

The reassurance comes amid questions regarding the efficacy of Sinovac’s CoronaVac vaccine candidate.

“If we are not satisfied with the safety and efficacy, we will not go through with the procurement. Sinovac’s clinical data is just being released. We will review the data and decide.

“This is why our strategy has been a portfolio of vaccines. (This is) to ensure we have enough supply and to mitigate against regulatory and manufacturing issues. Buy from more than one source,” he said in a series of posts on the microblogging service Twitter today.

The minister was responding to news reports that a Phase III clinical trial in Brazil found CoronaVac to be only 50.4 percent efficacious.

Malaysia is currently in final stages of negotiation to procure 14 million doses of the vaccine candidate, which would be enough to vaccinate seven million Malaysian (21.9 percent of the population) against Covid-19.

In addition, local pharmaceutical company Pharmaniaga Bhd has struck a deal with Sinovac to purchase CoronaVac in bulk, and fill-and-finish two million doses per month at its Puchong facility beginning in March.

For the record, CoronaVac is undergoing Phase III trials in China, Indonesia, Chile, Turkey, and Brazil.

Phase III trials are designed to assess a treatment’s efficacy and help spot rare side effects. It is the last round of testing before seeking regulatory approval to bring a vaccine or a new drug to market.

Sinovac itself has yet to make any efficacy claims regarding its vaccine candidate, but several research groups studying the vaccine have made varying claims on the matter without publishing the underlying data.

Turkish researchers claimed CoronaVac had an efficacy of 91.25 percent, while Indonesian regulators claimed interim results showed an efficacy of 65.3 percent.

Brazilian researchers initially claimed that CoronaVac had an efficacy of 78 percent, but later clarified the figure referred to the prevention of “mild-to-severe” cases.

Once data on “very mild” cases are included, the overall efficacy was 50.4 percent.

In comparison, the World Health Organisation had said a Covid-19 vaccine should be at least 50 percent efficacious and preferably comes in a single-dose format.

Several other pharmaceutical companies have already published data showing that their vaccines far exceeded the WHO benchmark, but required two doses. CoronaVac also calls for a two-dose regimen.

The vaccine produced by Pfizer and BioNTech was shown to have 95.0 percent efficacy, while Moderna’s vaccine has 94.1 percent efficacy.

The efficacy of the vaccine developed by AstraZeneca and the University of Oxford appeared to range from 62 percent to 90 percent depending on dosage, but irregularities in the trial meant questions still linger.

Malaysia had initially signed a deal to procure 12.8 million doses of the Pfizer-BioNTech vaccine and then negotiated an option to double its order in case some other vendors fail to deliver its orders.

Dr Adham Baba

On Monday, Health Minister Dr Adham Baba signed an agreement with Pfizer for additional 12.2 million doses of its vaccine. The total would be enough to immunise 39 percent of Malaysia’s population.

Apart from the Pfizer-BioNTech vaccine, Malaysia has also signed agreements to procure 12.8 million doses of the AstraZeneca-Oxford vaccine. Half would come directly from the manufacturer, while the other half would come through the Covid-19 Vaccines Global Access Facility (Covax).

Malaysia is in final negotiations with Sinovac, CanSino Biologics and the Gamaleya Centre to purchase their vaccine candidates.

If successful, this would see Malaysia purchase 14 million doses from Sinovac (21.9 percent population coverage), 3.5 million doses from CanSino Biologics (10.9 percent population coverage), and 6.4 million doses (10 percent population coverage) from the Gamaleya Centre.

All vaccines and vaccine candidates above require two doses to be effective, except the one being developed by CanSino Biologics.

So far, the Pfizer-BioNTech vaccine is the only one approved by the NPRA, and the first shipments of the vaccine are expected to arrive in late-February.

In response to criticisms, Sinovac chairperson Yin Weidong said the different trial sites had used vaccines from the same batch but utilised other testing protocols.

"These Phase III clinical trial results are sufficient to prove that CoronaVac vaccine's safety and effectiveness are good around the world," Reuters quoted him as saying. - Mkini