UK first approves Pfizer-BioNTech Covid-19 vaccine for expansion “next week”
The UK became the first Western country to approve a Covid-19 vaccine for general use on Wednesday, as it announced the launch of Pfizer-BioNTech’s drugs from next week.
“The government has today accepted the recommendation of the Independent Medicines and Health Products Regulatory Authority (MHRA) to approve Pfizer-BioNTech’s Covid-19 vaccine for use,” the health department said in a statement.
“The vaccine will be made available across the UK from next week,” the statement said. Priority groups will include nursing homes, nursing staff, the elderly and the clinically extremely vulnerable.
After months of “rigorous” clinical trials and careful analysis of data, the MHRA “concluded that the vaccine has met its strict standards of safety, quality and efficacy,” the statement added.
“To help with the success of the vaccination program, it is important that everyone continues to play their part and follow the necessary restrictions in their area so that we can further suppress the virus and let the NHS (National Health Service) do its job without being overwhelmed. ”
Pfizer chairman Albert Bourla said it was a “historic moment in the fight against Covid-19”.
“This condition is a goal we have been working towards since we first declared that science will win, and we applaud the MHRA for their ability to make a careful assessment and take timely action to protect the people of Britain,” he said.
Other countries are expected to follow suit
Pfizer and BioNTech added that they expected further regulatory decisions from other countries “in the coming days and weeks”.
The move makes Britain one of the first countries to start vaccinating its population as it seeks to curb Europe’s deadliest Covid-19 outbreak.
Other countries are not far behind: The United States and the European Union are also investigating the Pfizer shot together with a similar vaccine from competitor Moderna Inc.
Pfizer said it would immediately start delivering limited deliveries to the UK – and has prepared for even wider distribution if given a similar nod by the US Food and Drug Administration, a decision expected as early as next week.
But doses everywhere are scarce, and initial deliveries will be rationed until more are produced in the first months of next year.
While the UK has ordered enough Pfizer vaccine for 20 million people, it is not clear how many will arrive by the turn of the year and adding to the challenges of distribution is that it must be stored at extremely cold temperatures.
Two doses three weeks apart are required for protection. First in line, says the British government, are frontline nursing staff and nursing homes, followed by older adults.
‘We can not afford to relax’
Prime Minister Boris Johnson, a Covid-19 survivor, managed to win a vote on parliamentary action late on Tuesday, despite significant opposition within his own Conservative ranks.
“All we need to do now is keep the nerve until these vaccines are really in our grasp and really injected into our arms,” he told lawmakers before the vote.
Until then, “we can not afford to relax, especially during the cold winter months,” he warned.
British regulators are also considering a new shot from AstraZeneca and Oxford University.
Each country has different rules for determining when an experimental vaccine is safe and effective enough to use. Intense political pressure to be the first to strike a carefully scientifically tested shot colored the race in the United States and Britain, although researchers promised to cut corners. However, China and Russia have offered different vaccinations to their citizens before testing in late stages.
The images from US-based Pfizer and its German partner BioNTech were tested on tens of thousands of people. And although that study is not complete, early results suggest that the vaccine is 95 percent effective in preventing mild to severe Covid-19 disease. The companies told regulators that of the first 170 infections detected in study volunteers, only eight were among those who had received the actual vaccine and the rest had received a dummy shot.
“This is an extremely strong protection,” says Dr. Ugur Sahin, CEO of BioNTech, recently to the Associated Press.
The companies also reported no serious side effects, although vaccine recipients may experience temporary pain and flu-like reactions immediately after injections.
But experts warn that a vaccine cleared for emergency use is still experimental and that the final testing must be completed. Still to be determined is whether Pfizer-BioNTech shots protect against people spreading coronavirus without showing symptoms. Another question is how long the protection lasts.
The vaccine has also been tested on only a small number of children, no younger than 12, and there is no information on its effects in pregnant women.
( Jowharwith AP and AFP)