Pfizer's new crown vaccine has been approved for emergency use in the UK

On December 2, Pfizer and BioNTech announced that the Uk Medicines and Health Products Administration (MHRA) had granted an emergency use authorization (EUA) for the MRNA vaccine (BNT162b2) for COVID-19.
is the world's first new crown vaccine approved for emergency use after Phase III clinical trials.
government said the vaccine would go on sale next week.
, Pfizer and BioNTech are now ready to deliver the first dose of the vaccine to the UK immediately, and under a supply agreement between the UK government and it, the two companies will supply a total of 40m doses of the vaccine to the UK between 2020 and 2021.
The approval of BNT162b2 by MHRA with an efficiency of 95% was based on relevant data, including Phase 3 clinical studies, which showed that BNT162b2 had a 95% effect on COVID-19 28 days after the first administration, and that vaccine effectiveness was consistent among different age, gender, race and ethnic groups, with more than 94% of the protective effect observed in adults 65 years and older.
tests, the overall tolerance of BNT162b2 was good, and to date the Data Monitoring Committee has not reported serious safety issues.
Pfizer filed an application for emergency authorization with the FDA and the European Medicines Agency (EMA) after final data for Phase III clinical trials were released.
BioNTech expects both to announce their decision on the use of licensing applications in December.
The number of confirmed cases of emergency use in the UK is approaching 1.6 million and the death toll is close to 60,000.
2 december, the UK approved the emergency use of the BNT162b2 vaccine.
the UK has now ordered 40m doses of BNT162b2, enough to vaccinate 20m people twice, three weeks apart, with an advance dose of 800,000 doses arriving in the UK next week and being on the market by Christmas.
, the health secretary, said there were three ways to distribute vaccines: through hospitals, through vaccine centres and third through communities such as GPs.
Health England said the first people to be vaccinated were the elderly and staff in nursing homes, followed by the over-80s, health and care workers, and that by March or April 2021 the vaccine covered all over-50s in the UK.
, British Prime Minister Boris Johnson also warned the public not to expect too much vaccine, let than therefore relax the alert for the new crown outbreak, still seriously abide by the epidemic prevention regulations.
special transport insulation box BNT162b2 vaccine storage and transportation conditions compared with AstraZenecon, Moderna is more stringent - minus 70 degrees storage and transportation, maintain 6 months of stability, 2-8 degrees environment can only stabilize for 5 days.
estimates that nearly two-thirds of the world's countries are unable to meet such cold chain conditions for the transport and storage of vaccines at ultra-low temperatures.
Pfizer says it has extensive experience and expertise in cold chain transportation and has a well-developed infrastructure to deliver vaccines worldwide.
it is understood that Pfizer and BioNTech have designed suitcase-sized transport insulation boxes for the BNT162b2 vaccine, each with a capacity of 1,000 to 5,000 doses of mRNA vaccine, which can be kept at the recommended storage temperature (-70C±10C) for up to 10 days simply by adding dry ice to the insulation box.
and once the insulation box is opened, the recommended storage temperature (-70C±10C) can be maintained for up to 30 days as long as dry ice is replenished every 5 days according to operating instructions.
addition, GPS temperature monitoring systems are enabled in each insulation box to track the location and temperature of each batch of vaccines 24 hours a day, 7 days a week.
thawed, vaccine bottles can be stored in cold storage (2-8 degrees C) for up to 5 days.
Pfizer is also planning to buy an average of 20 aircraft a day from FedEx, UPS and DHL International to carry the vaccine, the Wall Street Journal reported.
BioNTech, which has a capacity of 1.3 billion doses by 2021, said bioNTech will be able to produce new mRNA crown vaccines for commercial use after producing candidate vaccines for clinical trials through existing mRNA production sites in mainz and Idar-Oberstein, Germany.
addition, once production begins at a third plant in Germany, Bairnteko will increase its production capacity by 2021 to provide further capacity for the global supply of potential vaccines.
companies have previously said they expect to produce as many as 50 million doses of vaccine globally by 2020 and as much as 1.3 billion doses by 2021, and will begin distributing vaccines within hours of approval.
other countries, according to previous media reports, BNT162b2 vaccine in addition to the Current 40 million doses of orders in the United Kingdom, there are 300 million doses in Europe, 120 million doses in Japan, 20 million doses in Canada, 10 million doses in Australia, 100 million doses in the United States and so on.
, Fosun Pharma and BioNTech reached a strategic partnership in March to develop and commercialize vaccine products for the new coronavirus based on BioNTech's proprietary mRNA technology platform in China.
November 24, BNT162b2 conducted Phase II clinical trials in Taizhou and Sushui, Jiangsu Province, China, with a plan to recruit 960 healthy subjects aged 12-85.
BNT162b2 is tentatively named Fubitai in China.
According to Caijing Magazine, the BNT162b2 Vaccine Phase II clinical trial conducted in China was conducted by the Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Provincial Institute of Public Health), and the test site was located in Taizhou China Pharmaceutical City Vaccine Engineering Center and the Sushui County CDC, Taizhou City People's Hospital, Sushui County People's Hospital and other units.
plans to recruit 960 healthy subjects online, ages 18 to 85, to assess the safety and immunogenicity of the vaccine candidate to support future applications for the vaccine in China.
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