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my country's first monkeypox vaccine approved for clinical trials

2024-09-11

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on september 9, the shanghai institute of biological products of sinopharm group china national biotec group announced that its independently developed mva strain monkeypox live attenuated vaccine has officially obtained the clinical trial notification issued by the national medical products administration, marking that my country's first vaccine against monkeypox virus has successfully entered the clinical trial stage.

it is reported that the monkeypox attenuated vaccine approved for clinical trials this time is developed based on the replication-deficient vaccinia virus mva strain, and the safety and effectiveness of this vaccine strain have been fully demonstrated by clinical data. the vaccine adopts a mature cell factory production process with stable process and reliable quality. preclinical studies have proven that it has good safety and can produce good immune protection against monkeypox virus attack in non-human primate models.

monkeypox epidemic situation is serious

monkeypox is a viral zoonosis. initial symptoms of monkeypox in humans include fever, headache, muscle aches, back pain, and swollen lymph nodes, which can later develop into a widespread rash on the face and body. most people recover within a few weeks, but some can become seriously ill or even die.

since the monkeypox outbreak in 2022, there have been more than 100,000 confirmed cases and 226 deaths worldwide. my country (including hong kong, macao and taiwan) has also reported 2,567 confirmed cases. recently, a new more pathogenic and lethal monkeypox variant has appeared in africa, and the epidemic has spread to europe and southeast asia.

on august 14, local time, world health organization director-general tedros adhanom ghebreyesus announced that the monkeypox outbreak constituted an "international public health emergency". this is the second time since july 2022 that the who has issued the highest level of warning under the international health regulations regarding the monkeypox outbreak. this round of monkeypox outbreak was caused by the "monkeypox 1b virus variant" and quickly spread to 16 countries including burundi, kenya, rwanda and uganda.

at present, the entry and exit departments of many countries and regions have upgraded quarantine measures to prevent imported cases. the european centre for disease prevention and control and the singapore ministry of health have taken corresponding measures to deal with the possible risk of monkeypox epidemic.

on august 16, the general administration of customs website released an announcement to prevent the spread of monkeypox into my country. the announcement requires that people from countries (regions) where monkeypox outbreaks occur, if they have been in contact with monkeypox cases or have symptoms such as fever, headache, back pain, myalgia, swollen lymph nodes, rash and mucosal rash, should actively report to the customs upon entry, and customs personnel will take medical measures and conduct sampling and testing in accordance with the prescribed procedures; transportation vehicles, containers, goods and articles from countries (regions) where monkeypox outbreaks occur and are contaminated or may be contaminated should be sanitized in accordance with the prescribed procedures.

remarkable achievements have been made in the research and development of vaccines and testing products

vaccines are the most effective means of preventing infectious diseases and are crucial to controlling the spread of epidemics. currently, many countries have launched vaccine procurement and vaccination plans. for example, the democratic republic of the congo has received the first batch of monkeypox vaccines and plans to start vaccination in early october 2024; sweden has also authorized the health department to order monkeypox vaccines to respond to the epidemic.

my country has also achieved remarkable results in the research and development of monkeypox vaccines. in addition to the replication-deficient tiantan strain monkeypox vaccine developed by the beijing institute of biological products of sinopharm group and the chinese center for disease control and prevention, the mrna vaccine developed by the team of yang xiaoming of sinopharm group, the multivalent monkeypox mrna vaccine developed by the team of associate researcher zha gaofeng and associate researcher zhan xiaoyong of the seventh affiliated hospital of sun yat-sen university, and the recombinant protein vaccine developed by the team of gao fu of the institute of microbiology of the chinese academy of sciences have all shown significant effects.

in terms of testing, the national medical products administration approved daan gene's "monkeypox virus nucleic acid detection kit (fluorescence pcr method)" on august 18, 2024. this is the first monkeypox virus detection product approved for marketing in china. its monkeypox test kit is currently being sold in the domestic market.

with the continuous deepening of research and development work, i believe that more safe and effective monkeypox vaccines will be available in the future, and effective control of the monkeypox epidemic is just around the corner.

written by anna.an

editor | swagpp