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Clinical human trials begin for COVID-19 vaccine in China

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Two new COVID-19 vaccines in phase three trials

By ZHANG ZHIHAO | chinadaily.com.cn | Updated: 2022-03-08 13:04
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Wang Zhigang, Minister of Science and Technology, answers questions on the sidelines of the ongoing two sessions on March 8. [Photo by Wang Jing/chinadaily.com.cn]

China is making progress in the development of nucleic acid vaccines for COVID-19, with a mRNA vaccine and a DNA vaccine in phase three clinical trials overseas, Wang Zhigang, Minister of Science and Technology, said on the sidelines of the ongoing two sessions on Tuesday.

Wang did not provide specific information about the vaccines. At the moment, China has granted conditional market approval to five vaccines, including three inactivated vaccines, one adenovirus vector vaccine and one recombinant protein subunit vaccine.

China has also approved one neutralizing antibody treatment for COVID-19 and Chinese scientists are researching drugs that may work on multiple COVID-19 strains including Delta, Omicron and other mutated variants, he said.

Meanwhile, China is also exploring new methods to administer COVID-19 vaccines, such as by inhalation or via nasal spray. "They are showing good progress," Wang said.

"The more tools for tackling COVID-19 that science and technology can provide, the better our anti-epidemic measures can become," he said.
 
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UAE grants emergency approval to next-gen Sinopharm jab
By Wang Xiaoyu | chinadaily.com.cn | Updated: 2021-12-28 20:02
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Photo taken on June 1, 2021 shows vials of the Sinopharm vaccine in Beijing, capital of China. [Photo/Xinhua]

Health authorities of the United Arab Emirates have recently approved a second-generation COVID-19 vaccine made by Chinese company Sinopharm for emergency use, the company said on Tuesday.

The company said in a notice the vaccine can provide wide-spectrum protection against multiple variants of the novel coronavirus.

It added the vaccine is the world's first second-generation COVID-19 vaccine that has received emergency authorization.

The product is of the recombinant protein subunit type that typically requires three doses for full immunization.

In the UAE, the vaccine will be used as a booster shot to spike immunity for people fully vaccinated with Sinopharm's two-dose inactivated vaccine, according to the notice.

Preliminary research involving about 2,000 participants in the country shows the vaccine is safe and capable of inducing high levels of neutralizing antibodies against the original strain of the novel coronavirus and major variants.

The emergency use approval has been announced as global scientists are studying whether mixing and matching different types of vaccines can further boost immunity.
Safety and immunogenicity of a hybrid-type vaccine booster in BBIBP-CorV recipients: a randomized controlled phase 2 trial https://medrxiv.org/cgi/content/short/2022.03.08.22272062v1… #medRxiv

Abstract​

The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants with immune escape ability raises the urgent need for developing cross-neutralizing vaccines against the virus. NVSI-06-08 is a potential broad-spectrum recombinant COVID-19 vaccine that integrates the antigens from multiple SARS-CoV-2 strains into a single immunogen. Here, we evaluated the safety and immunogenicity of NVSI-06-08 as a heterologous booster dose in adults previously vaccinated with the inactivated vaccine BBIBP-CorV in a randomized, double-blind, controlled, phase 2 trial conducted in the United Arab Emirates (NCT05069129). Three groups of healthy adults over 18 years of age (600 participants per group) who had administered two doses of BBIBP-CorV 4-6-month, 7-9-month and >9-month earlier, respectively, were vaccinated with either a homologous booster of BBIBP-CorV or a heterologous booster of NVSI-06-08. The primary outcome was immunogenicity and safety of booster vaccinations. The exploratory outcome was cross-reactive immunogenicity against multiple SARS-CoV-2 variants of concerns (VOCs). The incidence of adverse reactions was low in both booster vaccinations, and the overall safety profile of heterologous boost was quite similar to that of homologous boost. Heterologous NVSI-06-08 booster was immunogenically superior to homologous booster of BBIBP-CorV. Both Neutralizing and IgG antibodies elicited by NVSI-06-08 booster were significantly higher than by the booster of BBIBP-CorV against not only SARS-CoV-2 prototype strain but also multiple VOCs. Especially, the neutralizing activity induced by NVSI-06-08 booster against the immune-evasive Beta variant was no less than that against the prototype strain, and a considerable level of neutralizing antibodies against Omicron (GMT: 367.67; 95%CI, 295.50-457.47) was induced by heterologous booster, which was substantially higher than that boosted by BBIBP-CorV (GMT: 45.03; 95%CI, 36.37-55.74). Our findings showed that NVSI-06-08 was safe and immunogenic as a booster dose following two doses of BBIBP-CorV, which was immunogenically superior to homologous boost with another dose of BBIBP-CorV. Our study also indicated that the design of hybrid antigen may provide an effective strategy for broad-spectrum vaccine developments.​
 
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CanSino Biologics's inhaled #COVID19 vaccine can apply for emergency use in China, as it started phase III clinical trial on 10,000 people to evaluate its efficacy, safety, and immunogenicity, chief scientist Zhu Tao said at the #TwoSessions, The Paper reported yesterday.

Abstract​

The SARS-CoV-2 Omicron variant has become the dominant SARS-CoV-2 variant around the world and exhibits immune escape to current COVID-19 vaccines to some extent due to its numerous spike mutations. Here, we evaluated the immune responses to booster vaccination with intramuscular adenovirus-vectored vaccine (Ad5-nCoV), aerosolized Ad5-nCoV, a recombinant protein subunit vaccine (ZF2001) or homologous inactivated vaccine (CoronaVac) in those who received two doses of inactivated COVID-19 vaccines 6 months prior. We found that the Ad5-nCoV booster induced potent neutralizing activity against the wild-type virus and Omicron variant, while aerosolized Ad5-nCoV generated the greatest neutralizing antibody responses against the Omicron variant at day 28 after booster vaccination, at 14.1-fold that of CoronaVac, 5.6-fold that of ZF2001 and 2.0-fold that of intramuscular Ad5-nCoV. Similarly, the aerosolized Ad5-nCoV booster produced the greatest IFNγ T-cell response at day 14 after booster vaccination. The IFNγ T-cell response to aerosolized Ad5-nCoV was 12.8-fold for CoronaVac, 16.5-fold for ZF2001, and 5.0-fold for intramuscular Ad5-nCoV. Aerosolized Ad5-nCoV booster also produced the greatest spike-specific B cell response. Our findings suggest that inactivated vaccine recipients should consider adenovirus-vectored vaccine boosters in China and that aerosolized Ad5-nCoV may provide a more efficient alternative in response to the spread of the Omicron variant.​
 
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SZ-developed COVID vaccine shows promise​

Writer: Windy Shao | Editor: Holly Wang | From: Shenzhen Daily | Updated: 2022-03-17

Shenzhen Bay Laboratory joined hands with the Medical Institute of Tsinghua University to release research results on a new vaccine against Omicron at the preprint website BioRxiv on Tuesday.

The study, entitled “Development of a ferritin-based nanoparticle vaccine against the SARS-CoV-2 Omicron variant,” can help solve the problem of vaccine protection decline, the report said.

Omicron was first detected in South Africa, and this variant has a stronger transmission capability than the previous ones. It can highly resist the existing vaccines and neutralizing antibodies. Omicron rapidly spread to the world and became the main epidemic variant.

Recently, China saw a new surge of COVID cases with local cases being reported in Jilin, Guangdong, Shandong and other places, all caused by the Omicron variant. The development of effective vaccines against mutant strains has attracted extensive attention of researchers all over the world.

In this article, the researchers took ferritin 24 polymer nanoparticles as the core and combined them with Omicron RBD protein to develop a highly stable and strong nanoparticle vaccine (FNP-Fc-RBDOmicron). The vaccine can be prepared within one week, and relevant evaluation can be carried out.

According to a recent WHO statement, existing vaccines are still effective against Omicron, but they need to be updated to provide adequate protection and respond to future variants of COVID-19.

As COVID continues to mutate, this study will help solve the problem of vaccine protection decline, Shenzhen Special Zone Daily said.

First authors of the paper include Tai Wanbo, an associate researcher of the Shenzhen Bay Laboratory, as well as Chai Benjie and Feng Shengyong, both of whom are postdoctoral researchers of the Medical Institute of Tsinghua University.

The research was supported by the Shenzhen Bay Laboratory, Guangzhou National Laboratory, China National Natural Science Foundation and China National Key R&D Plan.

 
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#吉林为何出现2例死亡病例#?国家卫健委解答】3月19日,国务院联防联控机制召开新闻发布会,介绍从严从实科学精准抓好疫情防控工作有关情况。会上,国家卫健委医政医管局局长焦雅辉介绍,吉林新增的2例死亡病例,其中1位是高龄,另外1位年纪也超过60岁,都合并严重的基础疾病;其中1位没有接种过新冠肺炎疫苗。她介绍,两人新冠肺炎的病情本身不重,是轻型,直接的死亡原因由基础疾病导致。​
死亡病例1,男,65岁,合并慢性肾衰竭-尿毒症、肾病综合征、肾淀粉样变性、冠状动脉粥样硬化性心脏病等基础性疾病。2021年起开始透析治疗。2022年3月9日因晕厥,到吉林正大国际医院就诊,收入隔离病房。后因新冠肺炎核酸检测阳性,转入吉林医药学院附属医院治疗。患者入院后给予一级护理、吸氧、多功能心电监护、连花清瘟颗粒、降钾树脂、阿莫西林抗感染、退热、扩冠、止痛等对症治疗。在院治疗过程中,患者无诱因突然出现呼之不应,呼吸深大,经抢救无效,临床死亡。死亡原因:高钾血症、严重代谢性酸中毒、低血糖、急性非ST段抬高性心肌梗死。​
死亡病例2 ,男性,87岁。2022年3月11日摔倒后,出现双下肢乏力,言语模糊不清,在当地医院就诊。后因核酸检测阳性,转运至吉林市中心医院救治。患者合并患有脑梗死、高血压等基础性疾病,腰部外伤。入院后给予一级护理,多功能监护、鼻导管吸氧、连花清瘟胶囊口服、雾化吸入及适当补液,同时给予抗炎、祛痰、导尿等治疗。在院治疗过程中,患者突发呼吸困难、心脏停跳,抢救无效死亡。死亡原因:急性大面积肺栓塞。​
当前吉林市新冠肺炎为奥密克戎株,其主要临床表现为疲倦、头痛、肌肉酸痛、咽喉痒痛、咳嗽、流涕。从全球病例看,老人由于慢性病、基础病的影响,感染新冠病毒后,发生重症、死亡的风险远远高于年轻人和儿童,据有关统计,目前新冠患者平均死亡年龄都在70岁以上。​
因此,对于老年人,平时要加强基础疾病的治疗,增加营养,增强免疫力,呼吁老年朋友们要合理饮食、加强锻炼、积极接种疫苗,适时尽快接种加强针。(央视新闻)#吉林新增2例死亡病例#

Beijing Toutiao
22-3-19 15:26 from Weibo

[Jilin why there are 2 deaths? Answers from the National Health Commission]

On March 19, the Joint Prevention and Control Mechanism of the State Council held a press conference to introduce the situation of strict, practical, scientific and precise efforts to prevent and control the epidemic. At the meeting, Jiao Yahui, director of the National Health and Medical Commission's Medical Administration and Hospital Administration Bureau, introduced that there were two new deaths in Jilin, one of them was elderly, and the other was over 60 years old, both of whom had serious underlying diseases; one of them was Not vaccinated against COVID-19. She introduced that the two people's COVID-19 case is not serious, it is mild, and the direct cause of death is caused by the underlying disease.

Death case 1, male, 65 years old, complicated with chronic renal failure-uremia, nephrotic syndrome, renal amyloidosis, coronary atherosclerotic heart disease and other basic diseases. Dialysis treatment will start in 2021. On March 9, 2022, due to syncope, he went to Jilin Chia Tai International Hospital for treatment and was admitted to the isolation ward. Later, due to the positive nucleic acid test for new coronary pneumonia, he was transferred to the Affiliated Hospital of Jilin Medical College for treatment. After admission, the patients were given primary care, oxygen inhalation, multifunctional ECG monitoring, Lianhua Qingwen granules, potassium-lowering resin, amoxicillin for anti-infection, antipyretic, coronary expansion, pain relief and other symptomatic treatments. During the treatment in the hospital, the patient suddenly appeared unresponsive without any incentive, breathing deeply, and the rescue was invalid, and he died clinically. Causes of death: hyperkalemia, severe metabolic acidosis, hypoglycemia, acute non-ST-segment elevation myocardial infarction.

Death case 2, male, 87 years old. After falling on March 11, 2022, she developed weakness in both lower limbs and slurred speech. She went to the local hospital for treatment. Later, due to the positive nucleic acid test, he was transferred to Jilin Central Hospital for treatment. The patient suffered from underlying diseases such as cerebral infarction, hypertension, and lumbar trauma. After admission, he was given first-level nursing care, multi-functional monitoring, nasal cannula oxygen inhalation, oral administration of Lianhua Qingwen capsules, atomization inhalation and appropriate rehydration, as well as anti-inflammatory, expectorant, catheterization and other treatments. During the treatment in the hospital, the patient suffered sudden dyspnea and cardiac arrest, and the rescue failed and died. Cause of death: acute massive pulmonary embolism.

At present, the COVID-19 cases in Jilin City is the Omicron strain, and its main clinical manifestations are fatigue, headache, muscle aches, sore throat, cough, and runny nose. From the perspective of global cases, due to the influence of chronic diseases and basic diseases, the risk of severe illness and death of the elderly after contracting is much higher than that of young people and children. According to relevant statistics, the average age of death of COVID-19 patients is over 70 years old.

Therefore, for the elderly, it is usually necessary to strengthen the treatment of underlying diseases, increase nutrition, and enhance immunity. We call on elderly friends to have a reasonable diet, strengthen exercise, actively vaccinate, and receive booster shots as soon as possible. (CCTV News) #2 new deaths in Jilin#
 
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