The Chinese government announced Thursday that it had approved a self-drawn coronavirus vaccine after an early analysis of clinical trial results showed it was effective. The announcements sent a positive signal for the global introduction of Chinese vaccines, but important details were missing.
The manufacturer, a state-controlled company called Sinopharm, said a vaccine candidate from the Beijing Biological Products Institute had an efficacy rate of 79 percent, based on an interim analysis of the Phase 3 trials. Sinopharm said it had filed an application with Chinese regulators for widespread use of the vaccine, and on Thursday the government said the vaccine had been approved subject to conditions.
If backed up, the interim results will support claims Chinese officials have made in recent days that the country’s vaccines are safe and effective. Even before the government gave its official approval, the authorities had already carried out mass vaccinations that violated industry norms. They plan to vaccinate 50 million people in China by mid-February, when hundreds of millions are expected for the New Year holiday.
But Sinopharm’s announcement, which was only a few sentences long, failed to provide a breakdown of the results and left many questions unanswered, adding to a lack of clarity that has been tracking China’s coronavirus vaccine development for months.
China’s drive to develop a home-grown vaccine speaks to the country’s technological and diplomatic ambitions. A successful vaccine would support the country’s claim to be a peer and rival to the United States and other developed countries in the biomedical sciences.
The Sinopharm vaccine results show that it is less effective than others approved in other countries. Still, the results are well above the 50 percent threshold that makes a vaccine effective in the eyes of the medical establishment.
Two other coronavirus vaccines from Moderna and Pfizer-BioNTech have been shown to have an effectiveness rate of about 95 percent. The Pfizer BioNTech vaccine has been approved in more than 40 countries. Moderna’s vaccine has been approved in the US and other countries are evaluating the trial results. Russia announced that its Sputnik V vaccine has a 91 percent effectiveness rate and has launched a mass vaccination campaign.
Beijing has relied heavily on its vaccines promise to strengthen relationships with developing countries that are vital to China’s interests. Officials have traveled the world offering Chinese vaccines as a “global public good,” a magic offensive the United States may want to counter, especially if the campaign invades their backyard.
Political stakes in the vaccine race are particularly high for the Chinese Communist Party, whose authoritarian rule was criticized for stifling information and downplaying the virus when it first surfaced in Wuhan city late last year.
A successful vaccine, if quickly made available to the world, could help repair the party’s global image and that of its leader Xi Jinping. Chinese companies have stated that their vaccine would be cheaper and easier to ship, which could be a significant incentive for them in developing countries if detected.
Chinese vaccines can be greeted with other questions. Scientists said the headlines published by Sinopharm were encouraging, but the lack of supporting data made it difficult to independently evaluate the results. Sinopharm did not disclose the size of the study population or any information about serious side effects, data points that scientists look for in such publications.
Apr. 30, 2020 at 9:23 am ET
“Each of these vaccines is information, but the Chinese companies have provided even less information than the Russian companies,” said Dr. Kim Mulholland, pediatrician at Murdoch Children’s Research Institute in Melbourne. Australia.
“For the Russian vaccines at least, we were told the number of cases and the evidence that their vaccine was effective,” said Dr. Mulholland, who has been involved in overseeing many vaccine trials, including those for a Covid-19 vaccine.
Michael Baker, professor in the Department of Global Health at the University of Otago at Wellington, advisor to the New Zealand government, said that while Sinopharm’s early numbers looked promising, it was difficult to know for sure without further information.
“It’s pretty easy on the details,” he said. “One question is, what markets are you proposing to use these vaccines in? Because if you want to have a global market you have to provide all these details of course. “
Details on the effectiveness of another Chinese vaccine candidate from Sinovac, a private vaccine maker based in Beijing, have also been released piecemeal.
The lack of detailed information on the safety and effectiveness of Chinese vaccines did not deter the country’s officials from administering them to the public. Officials in several provinces and cities say that with an ongoing vaccination campaign, they are focusing on what China calls “key priority groups” – doctors, hotel workers, border control personnel and food storage and transport staff, and travelers.
Chinese officials and companies had already given China-made vaccines, most of which were made by Sinopharm, to more than a million people in China. The campaign was criticized by scientists from overseas who said they were concerned that authorities were not closely monitoring people after injections outside of clinical trials.
For China, a vaccine that can help protect its 1.4 billion people is critical to its plans to revitalize the economy.
The country has largely wiped out the coronavirus with a combination of restrictions on foreign arrivals, mass testing, and tight neighborhood lockdowns if cases are discovered. However, officials remain concerned that winter could spark another wave of infections and hope that a widespread vaccine can prepare the country to resume regular travel and trade.
New local outbreaks were reported earlier this week in Beijing and the northern city of Shenyang, leading to the introduction of new measures. In Shenyang, officials said the city was in “war status” when they introduced restrictions on large gatherings, including group meals, training courses and year-end parties.
Sinovac and Sinopharm use inactivated coronaviruses to make their vaccines – a proven method that goes back over 130 years. Companies use chemicals to disable the virus’ genes so it cannot replicate. However, the inactivated coronavirus can cause the body’s immune system to produce antibodies against it. In comparison, Moderna and Pfizer are taking a revolutionary gene-based approach that has never been approved for widespread use.
Experts say there are downsides inactivated vaccines like those from Sinovac and Sinopharm. You need to start with large amounts of live coronavirus samples, which can pose a biosecurity risk. Once the living samples are inactivated, an additional manufacturing step is required to ensure that none of them survive treatment.
Another benefit of the vaccines made by Moderna and Pfizer is that they are faster to manufacture and are considered more stable than traditional vaccines. Pfizer estimates it can produce up to 1.3 billion cans by 2021, while Moderna is projected to be able to produce 500 million to one billion cans.
The Chinese government has promised to produce 610 million cans by the end of the year and expects to produce more than a billion cans in the next year. Several large countries, such as Brazil and Indonesia, where Chinese companies have conducted trials, have each received more than a million doses of Sinovac vaccines. Turkey has ordered 50 million cans.
People who had previously been vaccinated in China said the two-dose regimen costs around $ 60 to $ 150. According to reports from people who received the Sinovac vaccine, the company charges about $ 30 per dose. Sinopharm says the cost of two doses should be less than $ 150. The government has announced that it will not make the vaccine free.
Elsie Chen contributed to the coverage.