Fosun Pharma announced for the first time the progress of the domestic clinical trials of the mRNA COVID-19 vaccine, and the safety and effectiveness data show that it is consistent with overseas

April 13, 2021/MedClub News/--The new crown epidemic continues to raging around the world, and countries all over the world urgently need an effective and long-lasting new crown vaccine.

Since the outbreak of the new crown epidemic, China has laid out 5 vaccine technology routes, covering inactivated vaccines, recombinant protein vaccines, adenovirus vector vaccines, attenuated influenza virus vector vaccines, and nucleic acid vaccines (including mRNA vaccines and DNA vaccines).

As a leading pharmaceutical and health industry group in China, Fosun Pharma responded quickly, determined the anti-epidemic task of developing a new crown vaccine in the first time, and combined its own global resource advantages to cooperate with German BioNTech to carry out international cooperation.

Recently, Fosun Pharma announced for the first time the progress of the Phase I clinical trial of this new crown vaccine in mainland China.
The data showed that the effectiveness, safety and durability are consistent with overseas data.

 More than 70 countries and regions around the world have approved the use of BNT162b2 in Hong Kong and Macao and have received more than 330,000 doses.
According to Our world in data, as of April 10, about 774 million doses of vaccine have been administered globally.

New coronavirus vaccines based on mRNA technology are widely used.

At present, two mRNA vaccines have been approved for use worldwide, namely BNT162b2 jointly developed by Germany's BioNTech, Pfizer and Fosun Pharma, and mRNA-1273 developed by Moderna in the United States.

The phase 3 clinical data of the two vaccines showed that the effective rates reached 95% and 94.
1%, respectively.

Up to now, the BNT162b2 vaccine has been authorized for use by health regulatory authorities in more than 70 countries and regions including the United Kingdom, the United States, Canada, Israel, and the European Union.

Fosun Pharma is responsible for the R&D and commercialization of the BNT162b2 vaccine in the Greater China region.
It was approved for emergency use in Hong Kong, China on January 25, 2021, and was granted a special import permit in Macau, China on February 23, 2021.

As of April 11, 2021, since the launch of the vaccination program, the Hong Kong Special Administrative Region government has vaccinated the citizens with a total of about 339,500 doses of BNT162b2, including about 230,300 citizens who have received the first dose of the vaccine.
, There are about 109,200 citizens who have received the second dose of vaccine.
There are currently 21 community vaccination centers in Hong Kong that provide appointments for vaccination of Fubitai™ vaccine.

In the Macao Special Administrative Region, a total of 118,370 people have made appointments for vaccinations against the new crown vaccine (including the inactivated vaccine and Fubitai™ mRNA vaccine), of which 67,431 people have completed the vaccination.

At present, no new coronavirus vaccine based on mRNA technology has been approved for use in mainland China.

Gao Fu, director of the Chinese Center for Disease Control and Prevention, called for “mRNA vaccines” at the 2021 National Vaccine and Health Conference.
He said that we cannot ignore mRNA vaccines just because there are already several new coronavirus vaccines in our country.

Innovative thinking is needed to create mRNA vaccines creatively.

In addition, Gao Fu said that mRNA technology will provide various opportunities for infectious diseases, AIDS, genetic diseases, rare diseases, and tumors.
He hopes that when developing classic traditional vaccines, it will take into account the benefits that mRNA vaccines may bring to humans.

 The global Phase III clinical trial showed 100% protection for the juvenile population.
The domestic Phase II clinical trial was smooth, with no serious adverse reactions consistent with foreign data.
According to the results of the global Phase III clinical trial, the BNT162b2 mRNA Covid-19 vaccine has reached all major efficacy endpoints.
The effectiveness of the new coronavirus infection is 95%, and the effectiveness for adults over 65 years old is more than 94%, showing consistent effectiveness across all ages, genders, races, and ethnic groups.

Compared with the placebo group, it showed obvious protective effect as early as 12 days after the first injection, and the protection rate reached 52% after only one injection.

In terms of safety, the local side effects of each dose of BNT162b2 within 7 days after vaccination are mostly mild to moderate, mainly pain at the injection site, which can be relieved within 1-2 days after vaccination; systemic side effects are mostly mild to moderate , Mainly fatigue and headache, which can also be relieved within 1-2 days of vaccination; for serious adverse events, the incidence is extremely low.
According to system organ classification, the incidence of serious adverse events is ≤0.
1%.

The global data at the 2021 National Vaccine and Health Conference is very good, but what is the progress of the mRNA vaccine clinical trials carried out by Fosun Pharma in China? On April 10, 2021, the 2021 National Vaccine and Health Conference jointly organized by the Chinese Preventive Medicine Association and the Chinese Center for Disease Control and Prevention was held in Chengdu, Sichuan.
The theme of this conference was "Promoting COVID-19 vaccination and safeguarding national public safety".
Attracted the participation of many experts in the field of vaccines.

At the special exchange meeting on the development and application of mRNA new crown vaccine held on-site, the reporter of Yimike obtained the latest clinical data on the vaccine in China.

Dr.
Hui Aimin, CEO and Chief Medical Officer of Fosun Pharma, first interpreted the latest global phase III clinical data of the BNT162b2 mRNA new crown vaccine.
The data showed that the vaccine has a protection rate of 100% for the 12-15 year-old age group (2260 cases).

It is worth noting that this vaccine also showed a 100% protection rate in South Africa where the B.
1.
135 variant strain is the main epidemic strain.

Subsequently, Dr.
Hui Aimin publicly shared the data from the domestic phase I clinical trial of BNT162b1 for the first time, which once again confirmed the effectiveness and safety of the mRNA new crown vaccine.

On March 16, 2020, BioNTech and Fosun Pharma announced a strategic cooperation agreement.
The two parties will jointly develop and commercialize vaccine products against the new coronavirus in Greater China based on BioNTech's proprietary mRNA technology platform.

In April 2020, Fosun Pharma and the Institute of Medical Laboratory Animals of the Chinese Academy of Medical Sciences launched a mouse challenge test, and shared the test results with the partners in time.
The research showed that BNT162b2 has a good protective effect on mice.
The research results It has been published in the famous international vaccine magazine "Vaccine".

On July 18, 2020, Fosun Pharma launched the Phase I clinical trial of BNT162b1 in China.

A total of 144 healthy participants between the ages of 18 and 85 were recruited.
After the two doses of vaccination, the neutralizing antibody induced response was obvious, and reached a peak 21 days after the second vaccination.

In addition, from the perspective of cellular immunity, 7 days and 21 days after the two doses of vaccines were inoculated, there was an obvious induction of T cell response, showing that this mRNA vaccine has a good protective and protective effect through the dual mechanisms of humoral immunity and T cell immunity.
Immunogenicity.

The safety and tolerability are also very good, consistent with foreign data, and related content will also be published in the journal Nature Medicine in the near future.

 Hui Aimin said that the domestic phase II clinical trial of the mRNA new crown vaccine BNT162b2 jointly developed by Fosun Pharma and German BioNTech is progressing smoothly.
A total of 960 participants have been recruited.
After the completion of two doses of inoculation, no vaccine-related information has been received at the current follow-up stage.
Reports of serious adverse reactions.

The real-world data of the BNT162b2 vaccine is gratifying from a safety point of view.

In mainland China, Fosun Pharma is also actively communicating with the drug administration and other departments.
Everyone has the same goal.
They want to introduce safe and effective vaccines to mainland China as soon as possible to benefit more people.

Conclusion At present, my country's epidemic prevention and control has achieved major strategic results, and the epidemic has been effectively controlled overall, but the risk of rebound cannot be ignored in the slightest.

The global epidemic is still in a pandemic, and normalized epidemic prevention and control still cannot be relaxed.

Carrying out new crown pneumonia vaccination is the most powerful measure to prevent and control the epidemic, and it is also the most important strategy for my country's current prevention and control of the new crown pneumonia epidemic.

In view of the current situation of hesitation in vaccination is still common, at the 2021 National Vaccine and Health Conference, experts have stated that the new crown virus is the common enemy of all mankind, and the world should not take the epidemic lightly before herd immunity is reached in the world.

At present, the production capacity and accessibility of the new crown vaccine are improving, and the current citizens must accelerate the process of vaccination, so as to protect their health and return to normal life as soon as possible.

Recommended reading: Fosun Pharma's mRNA COVID-19 vaccine is approved for emergency use in Hong Kong.
The first batch of about 1 million doses is expected to arrive in Hong Kong from Germany in late February.
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