The Chinese vaccines are rapidly making inroads into the Malaysian vaccine market place. After the 39 per cent Pfizer-BioNTech, 10 per cent AstraZeneca-Oxford and 10 per cent COVAX vaccine advance bookings, there is now reported, a 22 per cent booking of the Sinovac vaccine.
China’s Sinovac Lifesciences Co Ltd, manufactures the inactivated vaccine, CoronaVac which is administered intramuscularly, two doses, two weeks apart. And can be stored in a standard refrigerator at 2-8 degree Celsius, unlike the arctic temperatures required for the mRNA vaccines.
It is the only Chinese vaccine with published Phase 1/2 trials in the Lancet, on 743 volunteers, which found no severe adverse effects and produced an immune response.
In July 2020, whilst still in the Phase 1/2 trials, the Chinese government gave CoronaVac an emergency approval for early and limited use in high-risk persons.
Sinovac launched Phase 3 trials in three countries, Brazil, Indonesia and Turkey. In December 2020, researchers in Turkey announced Phase 3 trial efficacy of 91.2 per cent. Researchers in Brazil initially said it was 78 per cent effective in their clinical trials, but in January 2021 revised that figure to 50.4 per cent.
Bio Farma, an Indonesian state-owned pharmaceutical firm and the country’s only vaccine producer, partnered with the University of Padjajaran to conduct the Phase 3 trials in Indonesia which achieved an efficacy of 65.3 per cent. President Jokowi and his counterpart in Turkey, President Reccip Erdogan has since been vaccinated with the CoronaVac vaccine.
Officials of Sinovac said that there were no safety concerns with Adverse Effects Following Immunization (AEFI) rates of less than 5 per cent.
Indonesia’s vaccine manufacturing plant Bio Farma makes and supplies EPI (WHO Expanded Program on Immunization) vaccines for both local use and export. Its involvement in the Phase 3 trials, has given it a head-start with the acquisition of 1.2 million doses CoronaVac vaccines on December 6, 2020, and a second consignment of 1.8 million doses on 31 December 2020.
CoronaVac has been registered and approved for emergency use in China, Chile, Brazil, Indonesia and Turkey. The National Pharmaceutical Regulatory Agency (NPRA) has yet to approve the use of the vaccine.
Sinovac plans to roll out about 600 million doses in 2021. On January 12, Pharmaniaga signed a deal to purchase ready-to-fill Covid-19 vaccines, with the added option of being able to manufacture the vaccine domestically.
The other Chinese vaccine is Sinopharm, made by state owned company, Beijing Institute of Biological Products which created two inactivated coronavirus vaccine. It is injected into the deltoid muscles, two doses three weeks apart. Storage, like Sinovac is in an ordinary refrigerator at 2-8 degree Celsius.
Whilst still in Phase 1/2 trials, in June 2020, early and limited use was sanctioned by the Chinese government for HCW, embassy staff and other frontline and essential workers. In November 2020, the company claimed that one million volunteers had been immunised. In September 2020, the United Arab Emirates (UAE) gave licence for the early and limited use of Sinopharm in HCW.
Phase 3 trials were started in Morocco and Peru in July 2020. In December 2020, they announced 79.3 per cent efficacy by press release. Meanwhile, the United Arab Emirates, said the vaccine was 86 per cent effective, according to interim results of its phase three trial. The Sinopharm spokesman declined to explain the discrepancy in the efficacy rates. There have been no publications in peer-reviewed journals. Both UAE and Bahrain have since given full approval.
It is reported that, ACE Market-listed Kanger International Berhad which is known for its bamboo flooring manufacturing is partnering China National Pharmaceutical Group (Sinopharm) to distribute the vaccines to the private sector in Malaysia.
Two other Covid-19 vaccines are under development in China. CanSinoBio has a candidate vaccine called Convidecia. Like the AstraZeneca-University of Oxford vaccine, it is based on a viral vector vaccine technology (Adenovirus). It too was granted early and limited use by the Chinese government in June 2020.
Anhui Zhifei Longcom, the fifth Chinese vaccine uses a purified protein of the virus to trigger an immune response. In December 2020 it began Phase 3 trials. The company signed an MOU with MyEG.
We await the publication of the Phase 3 trials of the Chinese vaccines in peer-reviewed journals. Only then can the claims made by the vaccine manufacturers can be verified in terms of its efficacy and safety.
It is most unusual to allow vaccines in Phase 1/2 trials to be licenced for EUA. Thus western scientists are very concerned at the Chinese move to allow early and limited use in select populations and have remained sceptical and cautious with the claims of the Chinese vaccines manufacturers,
The NPRA must carefully analyse the research studies of the five Chinese vaccine manufacturers. It is very important to ensure that they are efficacious and safe as claimed in order to protect the community and to enhance vaccine confidence.
Singapore, Malaysia and the Philippines have signed deals with Sinovac, and Indonesia have already rolled out the Sinovac vaccines in its mass vaccination campaign.
China is leveraging the Covid-19 vaccine for both commercial gains and diplomatic ties. The countries least able to gain access to early vaccine supplies are looking at China to fill the void, namely among the developing countries in Asia, Africa, Latin America and the Caribbean.
It is still not clear how much the Chinese vaccines will cost. Bio Farma, a state-owned firm in Indonesia said it would cost around 200,000 rupiah ($13.60) locally. With the fill and finish being undertaken by Pharmaniaga at its plant in Puchong, the vaccine it is hoped would cost considerably less than the ones shipped from China.
By : Dr Musa Mohd Nordin – MALAY MAIL
*This is the personal opinion of the writer or publication and does not necessarily represent the views of The Stringer.