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China Fosun mRNA COVID-19 vaccine is safe?

China Fosun mRNA COVID-19 vaccine is safe? On January 25, the mRNA COVID-19 vaccine COMIRNATY (BNT162b2, Chinese product name: FubitaiTM) jointly developed by Fosun Pharma and BioNTech of Germany was approved by the Food and Health Bureau of the Hong Kong Special Administrative Region for emergency use in Hong Kong.

With the launch of the COVID-19 vaccine, everyone is familiar with the COVID-19 vaccines of Sinopharm and Kexing, but little is known about the COVID-19 vaccine of Fosun. However, this COVID-19 vaccine may also be available in China in the near future. Before we start, we still need to understand it. What is an mRNA vaccine? Fosun’s COVID-19 vaccine belongs to an mRNA vaccine. mRNA is a nucleic acid molecule that carries genetic information. The mRNA vaccine introduces genetic information into the body so that cells in the body produce corresponding antigens, thereby inducing the body to produce neutralizing antibodies and stimulating T cell responses , Fight the virus through the dual mechanisms of humoral immunity and cellular immunity.

Compared with traditional vaccines, mRNA vaccines:

01. There is no virus content, no risk of infection;

02. Ability to rapidly develop new vaccine candidates;

03. The dual mechanism of humoral immunity and T cell immunity, strong immunogenicity;

04. It is easy to mass produce and supports the goal of global supply.

However, mRNA vaccines have very high temperature requirements. mRNA vaccines can only be stored at ultra-low temperatures. They can be stored for 6 months below minus 70 degrees Celsius, and can only be stored for 5 days at a regular temperature of 2-8 degrees Celsius. How to store vaccines becomes a major issue. problem. To solve this problem, Fosun Pharma introduces: The mRNA COVID-19 vaccine will be produced in Germany and transported to Hong Kong via cold chain within 48 hours. After entering the airport, it will enter the central storage warehouse with -75℃ ultra-low temperature refrigerator. .

When needed, the vaccine will be thawed in a refrigerator at 2-8°C, the package will be checked, and the date of use will be affixed to the vaccination site at a low temperature of 2-8°C. The temperature at the time of mRNA COVID-19 vaccination is no different from the flu vaccine and HPV vaccine that everyone receives daily. The development process of mRNA COVID-19 vaccine Germany BioNTech cooperated with Pfizer of the United States and China Fosun Pharma to jointly develop the mRNA vaccine BNT162b2, which has been approved for marketing in various countries since early December.

Due to the better control of the epidemic situation in China, the process of Fosun’s COVID-19 vaccine trial has been significantly slower. Let’s take a look at the development process of Fosun’s COVID-19 vaccine:

mRNA COVID-19 vaccine

March 13, 2020

BioNTech and Fosun Pharma have reached a strategic cooperation agreement. The two parties will jointly develop and commercialize vaccine products against the new coronavirus based on BioNTech’s proprietary mRNA technology platform in mainland China, Hong Kong, Macao and Taiwan.

July 14, 2020

Fosun Pharma announced that the mRNA vaccine (BNT162b1) licensed for the prevention of new coronaviruses from Shanghai Fosun Pharmaceutical Industry Development Co., Ltd., its holding subsidiary, has been accepted for clinical trial registration review by the State Food and Drug Administration.

August 5, 2020

Fosun Pharma and BioNTech announced that 72 subjects have received the BNT162b1 vaccine.

August 27, 2020

Fosun Pharma and BioNTech jointly announced that after clinical trials have confirmed the safety and effectiveness of the BNT162 vaccine candidate and approved by relevant regulatory authorities, they will supply 10 million doses of the COVID-19 vaccine to the Hong Kong Special Administrative Region of China and the Macao Special Administrative Region of China.

November 13, 2020

The BNT162b2 vaccine was approved by the NMPA clinical trial. Currently, Fosun Pharma is promoting Phase II clinical trials of this vaccine in Mainland China. As of January 12, 2021, the second injection of all subjects has been completed.

December 16, 2020

BioNTech and Fosun Pharma have reached an agreement that once the COVID-19 vaccine is approved for marketing in mainland China, BioNTech is expected to supply at least 100 million doses of vaccine to mainland China in 2021 in response to the COVID-19 pneumonia epidemic. The first batch of vaccines will be supplied by BioNTech’s production plant in Germany.

How safe is the mRNA COVID-19 vaccine? There is not much research data on Fosun’s mRNA COVID-19 vaccine. Dr. Hui Aimin, Global R&D President and Chief Medical Officer of Fosun Pharma mentioned:

The mRNA COVID-19 vaccine has been approved in China’s Phase II clinical trial in November 2020. So far, 960 people have completed the second dose of vaccination and followed up for more than half a month. No serious adverse reactions related to the vaccine were found, and some experienced pain and fatigue. , Disappear after one or two days.

In addition to the trial in China, according to the results of the previous global phase III clinical trial published by Pfizer, BioNTech’s mRNA COVID-19 vaccine has reached all the main efficacy endpoints, and its effectiveness in preventing COVID-19 infection is 95%, targeting people over 65 years of age. The effectiveness of adults exceeds 94%, showing consistent effectiveness across all ages, genders, races and ethnic groups.

Up to now, the vaccine has been authorized for use by health regulatory authorities in more than 50 countries and regions including the United Kingdom, the United States, Canada, and the European Union.

No serious safety issues have been found in the mRNA COVID-19 vaccine in more than 43,000 cases of Phase III clinical trials. Currently, the vaccination is provided to millions of people. Fosun Pharma is also further assessing, analyzing and tracking whether there are vaccine-related safety events, including Norway. Analysis of reports in other places showed that these events were not related to vaccination.

■ The virus continues to mutate, is the vaccine still effective?

In response to the mutation of virus strains, recently disclosed test data has shown that in previous tests, antibodies in the blood of subjects of all age groups of the BioNTech vaccine can neutralize about 20 mutant strains of viruses, including those from the United Kingdom The more infectious strain B.1.1.7, the study of the South African virus mutant strain is also expected to be published in medical journals in the short term.

■ When will it be listed in China?

Are you as concerned about when the mRNA COVID-19 vaccine will be launched in the mainland like Zhizhi?

Regarding the listing timetable for the mRNA COVID-19 vaccine in the Mainland, Fosun Pharma stated that it will submit the China Phase II clinical trial data and foreign phase III clinical data to the Drug Evaluation Center of the State Food and Drug Administration, and strive to use it in emergency or other ways as soon as possible Application in the mainland market.

There is a shortage of COVID-19 vaccines. If Fosun’s COVID-19 vaccine is approved for marketing in the Mainland, it may speed up the progress of COVID-19 vaccination.

If the mRNA COVID-19 vaccine is marketed in the Mainland, would you be willing to vaccinate it?