The mRNA vaccine has become the first officially approved COVID-19 vaccine in the world. How is the domestic marketing progress?

• by EVOMT
• 2021-08-29

On August 23 local time, the world had the first officially approved COVID-19 vaccine with complete phase III clinical data

On the same day, the US Food and Drug Administration (FDA) approved the application for biological product license (BLA) of the mRNA COVID-19 vaccine (trade name COMIRNATY) jointly developed by Pfizer and BioNTech

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

At the same time, the vaccine still has an emergency use range (EUA), which is suitable for vaccination among people aged 12 to 15 years, as well as enhanced vaccination for some people with low immune function (the third dose). EUA is a US legal mechanism that serves as a special drug review channel for FDA in the event of public health emergencies

Reuters quoted Anthony Fauci, the chief medical adviser of the White House, as saying that the official approval of the mRNA COVID-19 vaccine will pave the way for more people to be vaccinated. "If the vast majority of Americans have been vaccinated, the United States will be able to control the COVID-19 epidemic and return to normal before the spring of 2022."

Image from AFP

For official approval, the report reached 340000 pages

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

To officially obtain approval, on May 7th this year, the vaccine research and development organization submitted a comprehensive data package to the FDA, which amounted to 340000 pages. It includes long-term research data for 44000 people, efficacy and safety data six months after the second injection, and production and equipment data required for licensing. According to FDA data, the effective rate of this vaccine in preventing COVID-19 infection reached 91%, and the prevention rate of severe infection reached 95%

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

According to the real-time statistics of Worldhometer, as of 6:30 on August 25, Beijing time, 38912537 cases of COVID-19 had been confirmed in the United States, and 647913 cases had died. In recent weeks, the vaccination rate has been improved in some areas severely hit by the COVID-19 variant Delta. The BBC said that this is a reflection of people's confidence in the COVID-19 vaccine

According to a study published by the New England Journal of Medicine in mid July, the prevention effect of the aforementioned mRNA COVID-19 vaccine on symptomatic infection of Delta mutant strains reached 88%

"There is no time to waste in the vaccination of COVID-19. Please complete the vaccination today," said US President Biden

Photo caption: On August 23, local time, people lined up outside a COVID-19 vaccination site in New York, the United States/ Xinhua News Agency

Some regions or industries will "compulsory vaccination"

According to the US Centers for Disease Control and Prevention, the United States has received more than 204 million doses of COVID-19 vaccine

CNBC reported that formal approval will have many practical impacts on vaccination. For example, research and development enterprises will be able to advertise in the media, directly promote and sell vaccines to consumers, and price them based on market demand. Even if the epidemic ends, the relevant vaccines can still be sold on the market

More importantly, this will promote "compulsory vaccination"

Reuters reported that according to the EUA, people must be informed of the benefits and risks of vaccines and actively choose to accept or reject them. However, with the official approval of the FDA, state governments can use vaccination as an additional condition for employment or education

Pentagon spokesman John Kirby said Defense Secretary Lloyd Austin is fulfilling his statement earlier this month that once fully approved by the FDA, 1.3 million active military personnel will be required to receive vaccinations. "The Pentagon is developing guidelines and will provide a timetable in the next few days."

Some local governments and enterprises have also issued a "compulsory vaccination" statement. Bill De Brasio, Mayor of New York City, 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 COVID-19 vaccine before September 27. Chicago Mayor Lori Lightfoot announced on the same day that she would require municipal employees to be vaccinated, but did not specify the vaccination period

Many large companies, such as Disney and Wal Mart, have announced that all or part of their employees need to complete vaccination this fall. Morgan Stanley and Citibank say vaccinated people can only return to the office. The New York Stock Exchange has mandated vaccination for trading floor personnel

This also helps eliminate some of the "vaccination hesitation". According to public opinion survey data released by the Kaiser Family Foundation in the United States at the end of June, about 30% of non vaccinated people said they would be more likely to receive the vaccine if the vaccine was officially approved by the FDA. Among those who adopt a wait-and-see attitude towards vaccines, this number has risen to 50%

China may achieve "localization"

Peter Marks, director of the FDA's Center for Biological Product Evaluation and Research, said: "Our scientific and medical experts have made a thorough and deliberate evaluation of this vaccine. We have evaluated hundreds of thousands of pages of scientific data and information, analyzed the safety and effectiveness of COMIRNATY, and made a detailed evaluation of the production process, including the inspection of production facilities. The COVID-19 epidemic continues, and the public expects a safe and effective vaccine. The public and the medical community can believe that, although we quickly approved this "Vaccine, but it fully meets the existing high standards for vaccines in the United States."

"Today's official FDA approval underscores the good efficacy and safety of this vaccine. We have delivered over 1 billion doses of vaccine to the world. We will continue to make unremitting efforts to expand the scope of use of the vaccine and prepare for possible escape variants," said Dr. Ugur Sahin, CEO and co founder of BioNTech

BioNTech is the marketing license holder for the aforementioned vaccines in the United States, the European Union, and the United Kingdom. In Greater China, Fosun Pharmaceuticals announced a strategic cooperation agreement with BioNTech as early as March 16, 2020. Fosun Pharmaceuticals was authorized by BioNTech to exclusively develop and commercialize vaccine products for COVID-19 based on its proprietary mRNA technology platform in Chinese Mainland, Hong Kong, Macao and Taiwan

In the global joint research and development process, Fosun Pharma has conducted in-depth cooperation with BioNTech in clinical research, pharmacological data, pharmacovigilance, and other aspects. The successful development of this mRNA COVID-19 vaccine contains the wisdom of the Chinese scientific research team

In the first half of 2021, this vaccine has obtained emergency use approval from Hong Kong, China, and special import approval from Macao, China. It has been put into vaccination plans in Hong Kong and Macao, China. According to the 2021 semi-annual report disclosed by Fosun Pharmaceutical on August 23, as of August 20, the vaccine had been inoculated with 4.314 million doses in Hong Kong, China, and 8.7 million doses in Macao, China, respectively

It is understood that the vaccine is in the stage of phase II clinical bridging trials in China (excluding Hong Kong, Macao, and Taiwan), and relevant data, including global phase III clinical data, has been submitted in a rolling manner. The approval process for the conditional listing of this vaccine in China is under normal progress. Previously, on May 9, 2021, Fosun Pharmaceutical announced that its holding subsidiary Fosun Pharmaceutical Industry planned to invest in a joint venture with BioNTech to realize the localization and commercialization of mRNA COVID-19 vaccine products. According to the announcement, Fosun Pharmaceutical will provide a production facility with an annual capacity of up to 1 billion doses of mRNA COVID-19 vaccine

Once approved, Fosun Pharmaceuticals and BioNTech will quickly promote domestic localization production and become a home-made mRNA COVID-19 vaccine

Source: Medical Affairs

Source:

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 fully licensed vaccine in the United States mean mandatory vaccination? BBC