On Dec. 30, Sinopharm—China’s state-owned drug company, also known as the China National Pharmaceutical Group—announced promising phase 3 clinical results for its coronavirus vaccine candidate. According to Sinopharm’s press release, its vaccine was 79.34% effective at preventing new cases of Covid-19.
According to the statistical analysis of Sinopharm China Biotech, the results of the interim analysis of the new coronavirus inactivated vaccine phase III clinical trial showed that the safety of the new coronavirus inactivated vaccine of Sinopharm China Bio Beijing Company is good after inoculation, and the vaccine group is vaccinated after two injections of the immunization program. All patients produced high-titer antibodies, the neutralizing antibody positive conversion rate was 99.52%, and the vaccine’s protective efficacy against the disease caused by the new coronavirus infection (Covid-19) was 79.34%. The data results reached the relevant technical standards of the World Health Organization and the country. The “Guiding Principles for Clinical Evaluation of New Coronavirus Preventive Vaccines (Trial)” issued by the Food and Drug Administration is required by relevant standards. At present, Sinopharm China Biotech Beijing has formally submitted a conditional listing application to the State Food and Drug Administration.
Like other press releases put forth by the companies developing vaccine candidates, Sinopharm’s doesn’t actually contain any peer-reviewed data. This is somewhat to be expected: Sinopharm, like other drug companies, is submitting its actual data to China’s drug regulatory authority directly. (In the US, drug companies shared data with the US Food and Drug Administration, and in the UK, they shared it with the country’s Medicines and Healthcare Products Regulatory Agency.)
But Sinopharm’s release is by far the briefest announcement of any published thus far. There is no mention of study size, participant demographics, or side effects.
This brevity could be because Sinopharm’s vaccine candidate has already reached roughly 1 million people in China, despite not having official clearance from any regulatory body. For months, the company has been nudging other state-owned companies to encourage their employees to get jabs as soon as possible. These vaccines were part of an emergency use program (which differs from the emergency use authorization granted to select Covid-19 treatments and vaccines in the US.) Individuals who have received the shots aren’t counted formally in Sinopharm’s clinical trial, but their data could shed more light on the vaccine’s safety and efficacy in the long run.
Sinopharm’s vaccine is one of four from Chinese entities that has reached late-stage clinical trials. It was the first to begin formal clinical testing in the United Arab Emirates in July. Currently, trials are ongoing in Bahrain, Jordan, Peru, and Argentina as well.
Unlike the other vaccines that have reached late-stage clinical trials around the globe, Sinopharm’s uses a killed version of the SARS-CoV-2 virus to prompt an immune response. It’s a tried and true method of developing vaccines, but a rarer approach for Covid-19 vaccines because it uses the actual virus itself. Also unlike vaccines from Pfizer/BioNTech and Moderna, Sinopharm’s needs to be chilled, around 2°C to 8°C (35.6°F to 46.4°F), but not frozen. At these temperatures, it has a shelf life of two years—making it much easier to transport and more accessible for areas that don’t have deep freezers.
All eyes will be on China as it gets closer to rolling out Sinopharm’s vaccine candidate en masse. The country has committed to supporting developing countries in its vaccine distribution, a vital step to curbing the pandemic. But in China, the vaccine costs $60 to $150 for both doses. That price point that may make it less accessible for lower-income individuals.