New medical technology

MRNA vaccine has become the world's first officially approved new crown vaccine. How is the domestic market going?

  On August 23 local time, the world had the first officially approved new crown vaccine with complete phase III clinical data.

  On the same day, the US Food and Drug Administration (FDA) approved the biological product license application (BLA) of the mRNA new crown vaccine (trade name comirnaty) jointly developed by Pfizer and biontech.

  This is the first new crown vaccine officially approved by FDA. Approved, it will be used for people aged 16 and above to prevent COVID-19 infection. Fosun Pharmaceutical of China participated in the joint research and development of this vaccine, and its trade name in Hong Kong and Macao is fubitai.

  At the same time, the vaccine still has the scope of emergency use (EUA), which is suitable for the vaccination of people aged 12-15 years, and the intensive vaccination of some people with low immune function (the third dose). EUA is an American legal mechanism and a special drug audit channel for FDA in case of public health emergencies.

  Reuters quoted Anthony middot, the White House's chief medical adviser; Fudge said that the formal approval of the mRNA new crown vaccine (comirnaty) will pave the way for more people to be vaccinated& ldquo; If most Americans were vaccinated, the United States could control COVID-19 and return to normal before the spring of 2022. rdquo;

  Picture from AFP

  For formal approval, the report reached 340000 pages

  On December 11, 2020, FDA approved the EUA application for the aforementioned vaccine.

  In order to be officially approved, on May 7 this year, the vaccine R & D agency submitted a comprehensive data package to FDA, amounting to 340000 pages. Including the long-term study data of 44000 people, the efficacy and safety data 6 months after the second injection, and the production and equipment data required for the license. FDA data show that the vaccine has an effective rate of 91% for the prevention of new crown infection and 95% for the prevention of severe infection.

  The Wall Street Journal said the FDA had planned to approve the full authorization on September 6. However, due to the severe epidemic situation, health officials were under a lot of pressure from the scientific community and vaccine advocacy groups, so they accelerated the approval.

  Novel coronavirus pneumonia cases were diagnosed in 38912537 cases in Beijing, around 6:30 in August 25th, according to Worldometer real-time statistics. 647913 cases died. In recent weeks, vaccination rates have been raised in some areas hit by COVID-19 mutant Delta. The BBC said that this is a manifestation of people's increased confidence in the new crown vaccine.

  According to a study published in the New England Journal of medicine in mid July, the preventive effect of the above mRNA new crown vaccine on the symptomatic infection of delta mutant strain was 88%.

  “ In novel coronavirus pneumonia vaccine, there is no time to waste. Please complete the vaccination today& rdquo; US President Biden said.

  Photo caption: on August 23 local time, people lined up outside a new crown vaccination site in New York, USA/ Xinhua News Agency

  Some regions or industries will & ldquo; Compulsory vaccination & rdquo;

  According to the data of the Centers for Disease Control and prevention, the United States has received more than 204 million doses of new crown vaccine.

  CNBC reported that the formal approval will have many practical effects on vaccination. For example, R & D enterprises will be able to advertise in the media, directly publicize and sell vaccines to consumers, and price according to market demand. Even if the epidemic ends, the relevant vaccines can still be sold on the market.

  More importantly, this will drive & ldquo; Compulsory vaccination & rdquo;.

  Reuters reported that according to the EUA, people must be informed of the benefits and risks of the vaccine and take the initiative to accept or reject it. However, after being officially approved by FDA, state governments can take vaccination as an additional condition for employment or education.

  Pentagon spokesman John & middot; Kirby said Defense Secretary Lloyd & middot; Austin is fulfilling what it said earlier this month that once the FDA has fully approved it, it will force 1.3 million active servicemen to be vaccinated& ldquo; The Pentagon is developing guidelines and will provide a timetable in the coming days& rdquo;

  Some local governments and enterprises have also issued & ldquo; Compulsory vaccination & rdquo; Statement. Bill middot, mayor of New York City; De brasio announced on the 23rd that all public school teachers and other public officials in the city must be vaccinated with at least one dose of new crown vaccine before September 27. Lori middot, mayor of Chicago; Wright foot announced on the same day that municipal employees were required to be vaccinated, but did not specify the vaccination period.

  Many large companies, such as Disney and Wal Mart, have announced that all or some employees need to be vaccinated this autumn. Morgan Stanley and Citibank say vaccinated people can go back to the office. The New York Stock Exchange has forced the staff on the trading floor to be vaccinated.

  This also helps eliminate some & ldquo; Vaccination hesitation & rdquo;. According to the public opinion survey data released by the Kaiser Family Foundation at the end of June, about 30% of non vaccinated people said that if the vaccine was officially approved by FDA, they would be more likely to be vaccinated. Among those who took a wait-and-see attitude towards the vaccine, this figure rose to 50%.

  China or realize & ldquo; Localization & rdquo;

  Peter & middot, director of FDA Center for biological products evaluation and research; Max said: & ldquo; Our scientific and medical experts have made an extremely thorough and thoughtful evaluation of this vaccine. We evaluated hundreds of thousands of pages of scientific data and information, analyzed the safety and effectiveness of comirnaty, and evaluated the production process in detail, including the inspection of production facilities. COVID-19 continues to expect safe and effective vaccines. The public and the medical community can believe that although we approved the vaccine soon, it fully meets the high standards of the existing vaccine in the United States& rdquo;

  “ Today's FDA official approval emphasizes the good efficacy and safety of the vaccine. We have delivered more than 1 billion doses of vaccine to the world. We will continue to make unremitting efforts to expand the scope of vaccine use and prepare for possible escape variants& rdquo; Said Dr. Ugur Sahin, CEO and co-founder of biontech.

  Biontech is the marketing license holder of the aforementioned vaccines in the United States, the European Union and the United Kingdom. In the Greater China region, Fosun medical announced a strategic cooperation agreement with BioNTech in March 16, 2020. Fuxing medicine was authorized by BioNTech to develop and commercialize vaccine products targeting COVID-19 in Chinese mainland and Hong Kong, Macao and Taiwan, and commercialized based on its proprietary mRNA technology platform.

  In the process of global joint research and development, Fosun Pharmaceutical has conducted in-depth cooperation with biontech in clinical research, pharmacological data, pharmacovigilance and other aspects. The successful development of this new mRNA crown vaccine includes the wisdom of the Chinese scientific research team.

  In the first half of 2021, the vaccine has obtained the emergency use approval of Hong Kong, China and the special import approval of Macao, China, and has been put into the vaccination plan in Hong Kong and Macao, China. According to the 2021 semi annual report disclosed by Fosun medicine on August 23, as of August 20, the vaccine had been inoculated with 4314000 doses and 87000 doses in Hong Kong, China and Macao, China respectively.

  It is understood that the vaccine is in the phase II clinical bridging trial stage in China (excluding Hong Kong, Macao and Taiwan), and relevant data including global phase III clinical data have been submitted on a rolling basis. The approval of conditional listing of the vaccine in China is in normal progress. Previously, on May 9, 2021, Fosun Pharmaceutical announced that its holding subsidiary Fosun Pharmaceutical industry planned to invest and establish a joint venture with biontech to realize the localized production and commercialization of mRNA new crown vaccine products. According to the announcement, Fosun Pharmaceutical will provide a production facility with an annual production capacity of up to 1 billion doses of mRNA new crown vaccine.

  Once approved, Fosun Pharmaceutical and biontech will quickly promote domestic localized production and become a domestic mRNA new crown vaccine.

  Source: Medical sound and medical affairs


  1.Pfizer-BioNTech COVID-19 Vaccine COMIRNATY® Receives Full U.S. FDA Approval for Individuals 16 Years and Older. BioNTech

  2.FDA grants full approval to Pfizer/BioNTech Covid-19 vaccine, opening door to more vaccine mandates. CNN

  3.FDA Approves First COVID-19 Vaccine. FDA

  4.US Covid-19 vaccine approval is 'seismic' shift for legality of mandates, experts say. Reuters

  5.US could control Covid by spring 2022 if more people get shots: Fauci. Reuters

  6. Pfizer-BioNTech COVID-19 Vaccine Frequently Asked Questions. FDA

  7. Does Pfizer / biontech become the first vaccine fully authorized by the United States mean compulsory vaccination? BBC

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