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UK Regulators Greenlight Pfizer-BioNTech COVID-19 Vaccine

Inoculations in the UK could begin as early as next week, as US regulators consider emergency use authorization

Britain’s regulators have approved the Pfizer-BioNTech COVID-19 vaccine for widespread use in the UK. The government’s health ministry has accepted a recommendation from the independent Medicines and Healthcare Products Regulatory Agency giving the vaccine emergency approval.

Government officials say the vaccine will start being made available by next week. It will be made available to frontline healthcare workers first, followed by residents of senior care facilities.

Large scale Phase III clinical trials showed the Pfizer-BioNTech vaccine better than 90 percent effective against the SARS-CoV-2 virus, and 95 percent effective in protecting people over age 65. The trials revealed no serious safety concerns around the vaccine.

Britain’s medical authorities approved the vaccine for use just days after the results of the Pfizer-BioNTech trials were released. The speed with which approval was granted drew criticism from other drug regulators, notably from the EU, which currently is reviewing the results of the vaccine trial, but is not expected to make a decision before the end of December.

However, Britain’s regulatory body did what they termed was a “rolling” concurrent review of data and the manufacturing process beginning at the early stages of the trials, enabling them to speed the approval process.

“The development of this vaccine has been adapted so that the trials are overlapping, and the next one can start before a particular phase has finished,” said June Raine, the chief executive of the MHRA, at a press briefing. “Everyone can be absolutely confident that no corners whatsoever have been cut.”

Meanwhile in the US, a panel of outside advisors is scheduled to meet on Dec. 10 to review the data and make recommendations to the Food and Drug Administration regarding emergency use authorization on the Pfizer-BioNTech vaccine.

While the vaccine awaits FDA authorization, Pfizer has already begun shipments of the vaccine to the US in anticipation of a large-scale rollout.

Two other vaccine candidates that have shown promising results in late-stage clinical trials are also undergoing review by regulators. Biotech firm Moderna applied for emergency use authorization just days after Pfizer did with a vaccine that was 94 percent successful, and a vaccine from AstraZeneca and Oxford University, was found to be up to 90 percent effective.