The Chinese vaccine ‘Sinopharm · Sinobaek’ is in phase 3, but they lined up in Latin America and Southeast Asia.

On the 8th (local time), everyone’s eyes focused on the United Kingdom. This is because the world’s first COVID-19 vaccination began. The UK government urgently approved a vaccine developed jointly by US pharmaceutical company Pfizer and German Bioentech on day 2, and began vaccination for priority targets such as medical staff and the elderly.

China accelerates vaccine development [AFP=연합뉴스]

The minds of other countries also became urgent.

After Bahrain approved the use of the Pfizer vaccine on the 4th, the Canadian government also approved the Pfizer vaccine on the 9th. Canada will begin vaccinating starting next week. The US government has also issued an “ executive order for Americans to receive corona 19 vaccine first ” and is speeding up the approval process.

So what kind of situation is in China, which was the first to venture into vaccine development and engaged in “vaccine diplomacy”?

Chinese Synovac vaccine in clinical trials in Brazil [AFP=연합뉴스]

China’s vaccine development is led by ‘Sinobac’ and ‘Canino Biologics’, with ‘Sinpharm (Chinese Medicine Group)’ leading the way. Currently, there are 14 vaccines in clinical trials, but five have entered phase 3 clinical trials.

Sinopharm, China’s largest state-owned pharmaceutical company, has entered phase 3 clinical trials in 10 countries, including the United Arab Emirates, Morocco and Peru since July. What Sinoparm developed is a method of inoculation twice with ‘inactivated vaccine (a vaccine that uses inactivated viruses)’. Sinoparm said: “There have been more than 1 million people who have been vaccinated so far and there have been no side effects,” and announced a plan to provide 1 billion doses by next year.

The vaccine released by the private pharmaceutical company Sinovac is also an inactivated vaccine. Like Sinopharm, phase 3 clinical trials have been conducted in Brazil, Indonesia and Turkey since last July, with final results of the clinical trials to be announced this year. It is known that it can produce around 300 million doses a year.

Kansino Biologics, which started the world’s first clinical trial in Wuhan, China in March, is also currently in phase 3 clinical trials in Saudi Arabia and Pakistan.

Indonesia imports the Chinese Synovac vaccine [AP=연합뉴스]

Synofarm and Synovac state that “traditional inactivated vaccines are more stable than Pfizer or Modena vaccines that use new technology (mRNA).”

“The advantage of Chinese vaccines is that they can be stored in a general refrigerator with an image of 2 to 8 degrees” (BBC). Compared to Pfizer and modders and vaccines, which must be stored at -70 ° C and -20 ° C, respectively, it is more likely to be preferred by underdeveloped countries because it is easier to store and transport.

The cost is also inexpensive. Synovac vaccines are more expensive than AstraZeneca products at about 400 yuan (about 67,000 won), but cheaper than modders or vaccines.

Chinese Sinofam vaccine in clinical trials in Peru [AFP=연합뉴스]

The problem is that none of the Chinese products have fully completed phase 3 clinical trials.

Vaccine clinical trials are generally conducted in three stages after going through a “non-clinical trial” (a test used in animals to discover side effects and effects). Phase 1 clinical trials are conducted in a small number of healthy volunteers (20 to 100 people) and determine if the drug is really effective and has no side effects.

Phase 2 clinical trials are conducted in a larger number of people (100-300) and the appropriate dose will be determined. The phase 3 clinical trial is the final step in obtaining marketing authorization, and safety and efficacy are finally confirmed. To obtain statistically significant data, it is performed on a large scale patient (1000-5000 people).

Corona 19 vaccine from the American pharmaceutical company Pfizer [AFP=연합뉴스]

However, even though the results of the ‘phase 3 test’, which is the most critical step, did not come out, the Chinese government issued an emergency use approval in July, which generated controversy. There was no result of phase 3, because there are few cases of urgent approval.

The BBC reported that “state Sinoparm and Sinobac only have the results of phase 1 and phase 2 clinical trials.” The Washington Post (WP) said that “Sinobaek suffered from the problem of bribing regulators a few years ago” and raised questions about its reliability.

In early October, Synovac stopped the clinical trial due to the death of a volunteer during a phase 3 trial in Brazil. However, the vaccine was later found to be non-causal and clinical trials were resumed.

Vaccine protests in Sao Paulo, Brazil [로이터=연합뉴스]

Although the results of phase 3 clinical trials have not yet been published, the demand for vaccines in China is increasing.

On the 9th, the United Arab Emirates (UAE) granted the world’s first official license for the use of the Chinese Synofam vaccine. Also added an announcement that “86% effective”. Indonesia, which had conducted clinical trials with the Synovac vaccine, announced that “the efficacy of the Synovac vaccine is approximately 97%” and 1.2 million doses have already been imported into Jakarta. Synovac plans to supply 40 million doses of vaccine to the country.

Brazil also chose Sinobag. Sao Paulo has already signed a contract for the purchase of 46 million doses, and vaccination will begin at the end of January next year. Turkey also signed a contract to supply 50 million lots with Sinobaek.

Chinese pharmaceutical companies are expected to publish the results of the phase 3 trials in a few days. Can China Really Achieve Its Dream of “Vaccine Diplomacy”?

Reporter Lim Ju-ri [email protected]