The United Kingdom steps forward the United States and Europe and became the first Western country to approve a Covid-19 vaccine for general use as it announced on Wednesday a rollout of Pfizer-BioNTech’s drug from next week.
After months of “rigorous” clinical trials and thorough analysis of the data, the Healthcare products Regulatory Agency (MHRA) “concluded that the vaccine has met its strict standards of safety, quality and effectiveness”, the UK department of health said in a statement.
The vaccine, which must be stored at ultra-cold temperatures, will be available across the country “from next week” and there will be priority groups including care home residents, health and care staff, the elderly and the clinically extremely vulnerable.
“This authorisation is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the UK,” Pfizer chairman Albert Bourla said.
“The government has today accepted the recommendation from the independent MHRA to approve Pfizer-BioNTech's Covid-19 vaccine for use,” MHRA statement added.
“To aid the success of the vaccination programme it is vital everyone continues to play their part and abide by the necessary restrictions in their area so we can further suppress the virus and allow the NHS (National Health Service) to do its work without being overwhelmed.”
The government ordered enough doses for 20 million people, but it is not clear how many will arrive by year’s end.
Prime Minister Boris Johnson said that “all we need to do now is to hold our nerve until these vaccines are indeed in our grasp and indeed being injected into our arms,” he told lawmakers before the vote.
Until then “we cannot afford to relax, especially during the cold months of winter”, he warned after winning a vote on the measures in parliament late Tuesday.
Pfizer said it would immediately begin shipping limited supplies to the UK – and has been gearing up 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 supplies will be rationed until more is manufactured in the first several months of next year.
BREAKING NEWS: The Government has accepted @MHRAgovuk recommendation for authorisation of @Pfizer and @BioNTech_Group's #COVID19 vaccine for use in the UK.— Department of Health and Social Care (@DHSCgovuk) December 2, 2020
✅ clinical trials
✅ analysis of the data
✅ MHRA authorised
Read full statement: https://t.co/2aCQFySAAT pic.twitter.com/XhPVN9cc5Q
Doses of US-based Pfizer and its German partner BioNTech were tested in tens of thousands of people. And while that study isn’t complete, early results suggest the vaccine is 95 percent effective at preventing mild to severe Covid-19 disease.
However, experts asked by Associated Press (AP) caution that a vaccine cleared for emergency use is still experimental and the final testing must be completed. The vaccine protects against people spreading the virus without showing symptoms, but we still don’t know how long this protection lasts and that’s one of the questions that still needs an answer.