The UK became the first country to approve a fully tested COVID-19 vaccine for its citizens on 2 December when it accepted the Pfizer vaccine for emergency use.
Russia and China have allowed the emergency use of vaccines manufactured in those countries, but did so before safety and efficacy trials were completed (SN: 8/11/20; SN: 21/07/20). The United Arab Emirates has also granted early emergency use authorization for two Chinese-made vaccines.
The U.S. Food and Drug Administration's vaccine regulators will review Pfizer's application for emergency use authorization on Dec. 10. Many experts expect the vaccine, developed with Germany-based BioNTech, to receive the nod from the FDA because its effectiveness is well above the 50 percent threshold the agency had previously. said would be necessary for authorization. In November, Pfizer announced that its vaccine was 95 percent effective in preventing disease in a large clinical trial in the United States (SN: 18/11/20).
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Pfizer and BioNTech began a “continuous review” process in the UK in October, giving healthcare regulators time to review the data as it became available. Scientists and doctors considered data from laboratory studies, animal studies and data on safety and efficacy of clinical trials in people when making the decision, the Medicines and Health Products Regulatory Agency said in a press release.
Pfizer has contracted with the UK to provide 40 million doses of vaccine to be administered in 2020 and 2021. Given that the vaccine requires two doses, it is enough to immunize 20 million people. The first doses will arrive in a few days from the company's factory in Puurs, Belgium, the company said in a press release.
The vaccine uses messenger RNA or mRNA to deliver instructions to human cells to build one of the coronavirus proteins. Once cells begin to make protein, the immune system builds antibodies and other defenses that prevent future invasions of the virus from making people sick. The vaccine must be stored at -70 ° C for it to be effective, so it requires special shipping and storage conditions that can make its release more difficult than for traditional vaccines, which only need refrigeration (SN: 20/11/20) .
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