United Kingdom approves Pfizer Covid-19 vaccineUK on Wednesday became the first country in the world to approve the Pfizer-BioNTech vaccine for use against COVID-19 and said that it will be rolled out from next week. The vaccine has been authorised for emergency use by the Medicines and Healthcare Products Regulatory Authority (MHRA), ahead of decisions by the US and Europe. The MHRA was given power to approve the vaccine by the government under special regulations before 1 January, when it will become fully responsible for medicines authorisation in the UK after Brexit.
British media have reported that hospitals in England have been told to get ready to start doing vaccinations for medical workers as early as next week.
Pfizer said it would immediately begin shipping limited supplies to the U.K. -- and has been gearing up for even wider distribution if given a similar nod by the U.S. Food and Drug Administration, a decision expected as early as next week. But doses everywhere are scarce, and initial supplies will be rationed until more is manufactured in the first several months of next year.
Pfizer CEO Albert Bourla called the U.K. decision “a historic moment.”
“We are focusing on moving with the same level of urgency to safely supply a high-quality vaccine around the world,” Bourla said in a statement.
While the U.K. has ordered enough Pfizer vaccine for 20 million people, it’s not clear how many will arrive by year’s end. Adding to the distribution challenges, the Pfizer vaccine must be stored at ultra-cold temperatures. Two doses three weeks apart are required for protection.
The U.K. government says frontline health care workers and nursing home residents will be first in line to get vaccinated, followed by older adults.
Pfizer says COVID-19 vaccine 95% effective
Earlier in November, Pfizer said a final analysis of clinical-trial data showed its Covid-19 vaccine was 95% effective, paving the way for the company to apply for the first US regulatory authorization for a coronavirus shot within days. The US drugmaker and partner BioNTech SE said their vaccine protected people of all ages and ethnicities, with no significant safety problems so far in a trial that included almost 44,000 participants.
The study reached 170 confirmed cases of COVID-19, with the vaccine candidate BNT162b2 demonstrating 95 per cent efficacy beginning 28 days after the first dose, Pfizer said. "Additionally, the safety milestone required by the US FDA (Food and Drug Administration) for Emergency Use Authorization (EUA) has been achieved. To date, no serious safety concerns related to the vaccine candidate have been reported," it said.
READ MORE | Vaccine 95% effective
Pfizer seeking emergency use of its COVID-19 vaccine in US
Pfizer said it is asking U.S. regulators to allow emergency use of its COVID-19 vaccine, starting the clock on a process that could bring limited first shots as early as next month and eventually an end to the pandemic -- but not until after a long, hard winter.
The companies said that protection plus a good safety record means the vaccine should qualify for emergency use authorization, something the Food and Drug Administration can grant before the final testing is fully complete. In addition to Friday’s FDA submission, they have already started “rolling” applications in Europe and the U.K. and intend to submit similar information soon.
READ MORE | Emergency use in US