Introduction
Interim analysis data showed that the vaccine's protection rate for the British mutant strain was 85.6%, while in the South African trial, when 92.6% of confirmed cases were infected with the mutant strain, the protection rate of the vaccine was 49.4%
On January 28, local time, the American company Novavax announced the first interim analysis results of its Phase III clinical trial of its new crown vaccine NVX-CoV2373. Data shows that the comprehensive protection rate of the vaccine is 89.3%. Photo/People's Vision
Text丨Reporter Wang Lijun Intern Reporter Wang Zhuoqing
A recombinant protein novel coronavirus vaccine has disclosed the interim analysis data of the phase III clinical analysis of the new crown vaccine, and its protection rate is 89.3%. This is the first time that the COVID-19 vaccine with this technology route has disclosed phase III clinical data worldwide. There are two similar vaccines in China under development, but there is still a distance between the phase III clinical blindness.
On January 28, local time, the American company Novavax (Nasdaq:NVAX) announced the first interim analysis results of its phase III clinical trial of its new crown vaccine NVX-CoV2373. Data shows that the comprehensive protection rate of the vaccine is 89.3%. Novavax said the vaccine can be stored at 2 to 8 degrees Celsius and can be distributed with the help of existing vaccine supply chains.
This time, the results of the Phase III clinical trial conducted in the UK and the Phase IIb clinical trial conducted in South Africa. In response to the British and South African mutant strains that have attracted recent attention, the vaccine has a protection rate of 85.6% for the British mutant strains; while in the South African trial, the vaccine has a protection rate of 49.4% when 92.6% of confirmed cases are infected with mutant strains.
affected by this news, Novavax's stock price rose sharply. As of press time, Novavax's after-hours price reached US$169.50, up 26.48%.
Novavax was founded in 1987 and was listed on Nasdaq in 1995. In addition to the new crown vaccine, Novavax also has multiple vaccine pipelines such as influenza, respiratory fusion virus (RSV), Ebola, Middle East respiratory syndrome (MERS), but there are currently no products on the market. In 2013, Novavax spent $30 million to acquire Swedish company Isconova and obtained Matrix-M adjuvant technology. In 2019, the second phase III clinical trial of the RSV vaccine developed by Novavax failed, with nearly 70% of its market value evaporated, and it was on the verge of delisting. However, during the 2020 COVID-19 pandemic, its stock price has been rising, reaching a high of $170 in August 2020.
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Antidote | Ding Sheng talks about the new crown vaccine: data disclosure is the prerequisite for exploring the protection rate [2021-01-23]
Countries are stepping up the vaccination of the new crown vaccine, and issues such as the effects of different vaccines and the guarantee of vaccination are still receiving great attention.
"Our own clinical data needs to be further disclosed." Ding Sheng, dean of the School of Pharmacy at Tsinghua University and director of the Global Health Drug Research and Development Center, pointed out in an interview with Caixin reporters that the disclosure of the original data of China's new crown vaccine clinical trials will help the academic community better evaluate its effectiveness and will also help dispel domestic and foreign doubts. He also believes that as vaccination gradually begins in various countries, we should consider in advance the international recognition of different vaccines and how to treat vaccinated people in daily epidemic prevention work.
At present, two domestically produced inactivated COVID-19 vaccines have been approved by regulatory authorities in different countries and regions. On December 31, 2020, the new crown vaccine developed by Sinopharm Group's Beijing Institute of Biological Products was conditionally approved for marketing. The new crown vaccine developed by Sinovac has been approved for emergency use in Türkiye, Indonesia and Brazil. The inactivated vaccine contains the new coronavirus that has lost its pathogenic ability but is still antigenic, which can stimulate the human immune system to produce antibodies against the new coronavirus.
antidote | The new crown vaccine is here, how to understand their protection rate? [2021-01-08]
Brazil disclosed some data on the new crown vaccine CoronaVac Phase III developed by Sinovac Co., Ltd. (hereinafter referred to as Sinovac).On January 7, Dimas Covas, head of the Butantan Institute, a Brazilian national research institution, said at a press conference that the protection rate of CoronaVac for mild cases is 78%, and the protection rate for moderate and severe cases is 100%. CoronaVac reduced the treatment rate related to COVID-19 by 78%, and the hospitalization rate decreased by 100%. However, information such as infections in different age groups in clinical trials and the number of asymptomatic infections has not been disclosed.
Butantan Institute is the only partner of Sinovac conducting clinical trials in Brazil. The trial recruited approximately 12,476 subjects. Dimas Covas said that 218 subjects were infected with the new coronavirus during clinical period and developed mild symptoms. But he did not give exact numbers of infections in the vaccination and placebo groups, saying only about 160 of them were given placebo and fewer than 60 were given the vaccine. The number of patients each included in the vaccine and placebo groups was not announced on the same day.
's so-called protection rate (Efficacy) measures the degree to which vaccines reduce the incidence of the new crown. Protection rate is defined as the percentage of the decrease in the diagnosis rate of vaccinated people compared with placebo people in clinical trials. The new crown vaccine ADZ1222 developed by AstraZeneca uses this method to calculate the protection rate.
The Drug Administration accepted the first application for the launch of the new crown vaccine. Both Sinopharm and Sinovac vaccines have made progress [2020-12-24]
On November 24, the official website of the State Drug Administration showed that the application for the launch of the new crown inactivated vaccine developed by Sinopharm Group's China Biologics Institute (hereinafter referred to as Sinopharm Beijing Institute) has been accepted. This is the first inactivated new crown vaccine in China to be accepted for the launch.
At present, no complete clinical trial data of the vaccine has been released. Earlier, the UAE Ministry of Health and Prevention announced that the vaccine is 86%. People close to regulators told Caixin reporters that China's vaccine approval will adopt strict standards.
Affected by this news, Sinopharm Co., Ltd. (600511.SH) stock rose sharply. As of the close, Sinopharm Co., Ltd. was 50.2 yuan per share, up 6.9%.
Editor | Ren Bo
Page | Liu Denghui Deng Yiyun
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