COVID-19 Vaccine From Pfizer And Biontech Was Authorized For Emergency Use In UK

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COVID-19 Vaccine From Pfizer And Biontech Was Authorized For Emergency Use In UK On December 2, 2020, Pfizer and BioNTech announced that the British Medicines & Healthcare Products Regulatory Agency (MHRA) granted a temporary authorization for their COVID-19 mRNA vaccine (BNT162b2) against for COVID-19. It is the first country in the world to be granted emergency use authorization for BNT162b2. Pfizer and BioNTech stated that in the coming days and weeks, it is expected to obtain emergency use authorization in more countries around the world, and both of them are also ready for vaccine supply.

MHRA's authorization is also based on the rolling listing application materials of BNT162b2. In a phase III study, 7 days after the second dose of BNT162b2 was inoculated, it showed a 95% protective effect on people who were not infected or infected with SARS-CoV-2. This means that effective protection can be obtained 28 days after vaccination with BNT162b2 vaccine. As research continues, the ultimate protective efficacy of the vaccine may change. DMC has not reported any serious safety hazards and recommends that the study continue and collect other safety and effectiveness data as planned.

Preliminary data from the Phase I/II study of the BNT162b2 vaccine showed that subjects in all age groups were well tolerated after vaccination, with mild to moderate adverse events. After detecting the IgG concentration of the receptor binding domain binding pool and the SARS-CoV-2 neutralization titer, it was found that the vaccine can produce

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dose-dependent immunogenicity. In addition, in subjects vaccinated with BNT162b2, T cells in their bodies can recognize more epitopes of the SARS-CoV-2 virus spike protein.

In July, Pfizer and BioNTech signed an agreement with the British government to provide 30 million doses of vaccine to the UK once the BNT162b2 vaccine is authorized for emergency use. At the beginning of October this year, the number of vaccine supplies was adjusted to 40 million.

On November 20, Pfizer and BioNTech has also submitted an emergency use authorization (EUA) application for BNT162b2 to the FDA for the prevention of COVID-19.

It is expected to be put into use in the United States from mid-December to the end of 2020. The two companies also submitted a rolling listing application for BNT162b2 to EMA. Pfizer and BioNTech is committed to ensuring the production and supply of the BNT162b2 vaccine. Both of them stated that they have the ability to supply 50 million vaccines in 2020 and 1.3 billion vaccines in 2021. In order to ensure product quality, the two companies have developed a special COVID-19 vaccine insulated transport box. The insulated transport box does not require additional equipment except dry ice. Without being opened, the storage temperature of the vaccine during transportation can be controlled at -70°C ±10°C for 10 days, so that it can be shipped globally. If it is unpacked and dry ice is added every 5 days, the special insulated shipping transport box can effectively store BNT162b2 for 30 days.

Huateng Pharma, a professional pharmaceutical intermediates manufacturers in China, is also committed to developing & producing many kinds of pharmaceutical intermediates such as Remdesivir intermediates and Favipiravir intermediates, both of them were being studied for experimental treatment of the emergent COVID-19 since February 2020.

Reference: PFIZER AND BIONTECH ACHIEVE FIRST AUTHORIZATION IN THE WORLD FOR A VACCINE TO COMBAT COVID-19 Related article: COVID-19 Vaccine Data Raises Hope for Three of Candidates