New Crown COVID-19 Vaccine Description
New Crown COVID-19 is an inactivated vaccine that is made of virus particles that are grown in culture and lack disease-producing capability. This vaccine candidate was developed by Sinopharm’s Wuhan Institute of Biological Products Co. and the Chinese Center for Disease Control and Prevention (CDC).
Sinopharm's SARS-CoV-2 strain (WIV04 strain and GenBank accession number MN996528) was isolated from a patient in the Jinyintan Hospital, Wuhan, China. The virus was cultivated in a qualified Vero cell line for propagation, and the supernatant of the infected cells was inactivated with β-propiolactone (1:4000 vol/vol at 2 to 8 °C) for 48 hours. Following clarification of cell debris and ultrafiltration, the second β-propiolactone inactivation was performed in the same conditions as the first inactivation.
The vaccine candidate was adsorbed to 0.5-mg alum and packed into prefilled syringes in 0.5-mL sterile phosphate-buffered saline without preservative.
On August 13, 2020, JAMA published a study that concluded saying 'In this interim report of phase 1 and phase 2 trials of an inactivated COVID-19 vaccine, patients had a low rate of adverse reactions and demonstrated immunogenicity; the study is ongoing. This inactivated COVID-19 vaccine reported a low rate of adverse reactions and demonstrated immunogenicity, but a longer-term assessment of safety and efficacy will require phase 3 trials.'
In the phase 1 trial, 96 participants were assigned to 1 of the 3 dose groups (2.5, 5, and 10 μg/dose) and aluminum hydroxide (alum) adjuvant–only group (n = 24 in each group), and received 3 intramuscular injections at days 0, 28, and 56. In the phase 2 trial, 224 adults were randomized to 5 μg/dose in 2 schedule groups (injections on days 0 and 14 [n = 84] vs alum only [n = 28], and days 0 and 21 [n = 84] vs alum only [n = 28]).
The phase 3 study is a multicenter, randomized, double-blind, parallel placebo-controlled, clinical trial to evaluate the protective efficacy, safety, and immunogenicity of inactivated SARS-CoV-2 vaccines in healthy population 18 years old and above.
China National Pharmaceutical Group Co., Ltd. (Sinopharm) is a large healthcare group directly under the State-owned Assets Supervision and Administration Commission of the State Council, with 128,000 employees and a full chain in the industry covering R&D, manufacturing, logistics and distribution, retail chains, healthcare, engineering services, exhibitions and conferences, international business and financial services.
New Crown COVID-19 Vaccine Indication
The Sinopharm New Crown COVID-19 vaccine candidate is indicated to prevent COVID-19 disease caused by infection with the SARS-CoV-2 virus.
New Crown COVID-19 Vaccine News
November 18, 2020 - Local media reported 'Almost 1 million Chinese have been given an experimental Covid-19 vaccine developed by the state-owned Sinopharm under the government’s emergency use scheme, Liu Jingzhen, chairman of China National Pharmaceutical Group (Sinopharm), said in an interview with a Sichuan-based digital media company. “Until now, all our progress, from research to clinical trials to production and emergency use, we have been leading the world."
September 14, 2020 - The UAE granted emergency approval for health workers to use a COVID-19 vaccine currently in its third phase of testing. Health minister Abdulrahman Al-Owais said the vaccine would be available for “first-line-of-defense heroes, who are most at risk of catching COVID-19, protecting them from any danger that they may be exposed to due to the nature of their work.”
September 5, 2020 - China National Biotec Group announced 4 more countries have agreed to run late-stage clinical tests of their coronavirus vaccine candidates. Trials have already begun in United Arab Emirates, Bahrain, Peru, Morocco, Argentina, and Jordan.
August 13, 2020 - Interim Analysis of 2 Randomized Clinical Trials. Effect of an Inactivated Vaccine Against SARS-CoV-2 on Safety and Immunogenicity Outcomes
July 17, 2020 - Sheikh Abdullah bin Mohammed Al Hamed, Chairman of the Department of Health - Abu Dhabi was the first person given Phase III inactivated vaccine for Covid-19. The Department of Health - Abu Dhabi has announced the registration of 5,000 volunteers in Abu Dhabi.
July 1, 2020 - China National Biotec Group (CNBG) announced it has completed the construction of a new plant for coronavirus vaccines, doubling its capacity to more than 200 million doses a year. CNBG, a unit of the state-owned China National Pharmaceutical Group (Sinopharm), has two COVID-19 vaccine candidates in human trials and plans a large-scale Phase 3 human testing in the United Arab Emirates.
June 28, 2020 - The 2nd vaccine developed by Sinopharm has been found to be safe and able to generate high titers of antibodies among participants in phase I and II clinical trials, according to a Weibo posting by Sinopharm Group. All the participants get 2 shots at either 3- or 4-week intervals that have generated neutralizing antibodies, a measurement of the vaccine’s ability to stimulate a specific immune response to the coronavirus.
June 23, 2020 - China and Afghanistan signed a clinical cooperation agreement on the spot, marking the official launch of the world's first international clinical trial (Phase III) of the new crown inactivated vaccine. The cooperation between Chinese and UAE technology companies marks new and important progress in international anti-epidemic cooperation.
June 17, 2020 - A vaccine candidate developed by Sinopharm’s Wuhan Institute of Biological Products Co. has shown no serious adverse reactions during phase I and II clinical trials, according to a Weibo posting on Tuesday by China National Biotec Group, a subsidiary of the company’s parent. That sent Sinopharm shares up by as much as 15% in Hong Kong to be the best performer in the MSCI Asia Pacific Index.
New Crown COVID-19 Vaccine Clinical Trials
Phase 1/2 Clinical Trial: The randomized, double-blind, and placebo-controlled trials of the vaccine are conducted in Jiaozuo, Henan Province.
- The vaccine involved 1,120 volunteers aged between 18 and 59 in its clinical trials, which started on April 12.
- The vaccine receivers inoculated with two injections in different procedures and doses have all produced high titers of antibodies.
- Sinopharm said that the candidate demonstrated a good safety profile so far, with the trial participants still under observation. The results revealed a good safety record, with no cases of severe adverse effects found in the clinical trials.
- For those receiving two middle-dose injections at intervals of 14 days and 21 days, the seroconversion rate of neutralizing antibodies reached 97.6 percent.
- For those receiving two middle-dose injections at an interval of 28 days, the seroconversion rate of neutralizing antibodies reached 100 percent.
Phase 3 Clinical Trial - Last Update Posted: October 30, 2020.
- The announcement of phase 3 clinical trials for the inactivated new crown vaccine, which may consist of whole, inactivated agents developed by China National Pharmaceutical Group Sinopharm (Sinopharm) was held online in China's Beijing and Wuhan, and the UAE's Abu Dhabi.
- The New Crown COVID-19 inactivated vaccine candidate had not shown any severe adverse effects in the first two phases of clinical trials, and it is the first vaccine candidate in the world to show favorable immunogenicity and safety.
- Multicenter, Randomized, Double Blind, Parallel Placebo Controlled, Phase III Clinical Trial to Evaluate the Protective Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) in Healthy Population Aged 18 Years Old and Above.