Pfizer vaccine gets UK govt’s approval
Roll-out next week with 800,000 doses, says Prime Minister Boris Joshnson
The United Kingdom on Wednesday became the first country in the world to approve a vaccine for the coronavirus disease ( Covid- 19), jumping ahead of the United States and Europe, with 800,000 doses due to be rolled out from next week, a development widely welcomed as the “best news in a long time”.
Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) granted emergency use approval to Pfizer-BioNTech’s Covid-19 vaccine after a thorough analysis of the data that was submitted to it on a rolling basis, a spokesperson said.
The Pfizer vaccine, which they say is 95% effective in preventing the illness, was approved in record time — just 23 days since the US drugmaker published the first data from its final stage clinical trial.
The usual prolonged process of vaccine development over several years of design, clinical trials and regulatory scrutiny has been speeded up to within 10 months in the case of Covid-19, marking a new phase in the history of global public health.
It’s the protection of vaccines that will ultimately allow us to reclaim our lives and get the economy moving BORIS JOHNSON, UK PM
Vaccine has only been approved because strict tests have been complied with... no corners were cut JUNE RAINE, MHRA CEO
This authorisation is a goal we have been working toward since we first declared that science will win ALBERT BOURLA, Pfizer CEO
“The government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer-BioNTech’s Covid- 19 vaccine for use,” the spokesperson said.
“This follows months of rigorous clinical trials and a thorough analysis of the data by experts at the MHRA who have concluded that the vaccine has met its strict standards of safety, quality and effectiveness… The vaccine will be made available across the UK from next week.”
The vaccine needs to be initially refrigerated at a temperature between minus 70 and minus 80 degrees Celsius -- the sort of temperature typical of an Antarctic winter -- and administered in two doses, 21 days apart. Since hospitals have the infrastructure, it will be initially given to hospital staff and to vulnerable care-home residents.
The UK has ordered 40 million doses of the Pfizer-BioNTech vaccine, with 800,000 doses arriving from the com
pany’s production base in Belgium next week.
Prime Minister Boris Johnson hailed the development as “fantastic,” while a “thrilled” health secretary Matt Hancock reiterated his belief that normalcy would return by April.
Johnson said: “It’s the protection of vaccines that will ultimately allow us to reclaim our lives and get the economy moving again”.
Hancock, however, sounded a note of caution, asking Britons to see through the winter months by following restrictions until vaccines are rolled out on a wide scale. “We can’t lower our guard yet”, said Chris Whitty, England’s chief medical officer.
The world’s big powers have been racing for a vaccine for months in an attempt to be first to begin the long road to recovery. The deadly virus has killed nearly 1.5 million people globally, hammered the world economy and upended normal life.
The approval of a vaccine for use almost exactly a year since the coronavirus emerged in Wuhan, China, is a triumph for science, Pfizer boss Albert Bourla and his German biotechnology partner BioNTech.
China has already given emergency approval for three experimental vaccines and has inoculated around 1 million people since July. Russia has been vaccinating frontline workers after approving its Sputnik V shot in August before it had completed late-stage testing on safety and efficacy.
But the European Union’s drug regulator said on Wednesday that its longer approval process for Covid-19 vaccines was safer, as it was based on more evidence and checks that the emergency procedure chosen by Britain.
British leaders said that, while they would love to get a jab themselves, priority had to be given to those most in need - the elderly, those in care homes and health workers.
Arrangements are being made by the National Health Service (NHS) for mass vaccination across the UK in the near future.
The MHRA spokesperson added: “The NHS has decades of experience in delivering large scale vaccination programmes and will begin putting their extensive preparations into action to provide care and support to all those eligible for vaccination”.
“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 to do its work without being overwhelmed.”
The MHRA is also analysing data from trials of the University of Oxford-AstraZeneca and Moderna vaccines; the former is expected to be the mainstay of countering the virus in the UK, India and elsewhere due to its low cost and logistical ease. ‘Historic moment’
The US drugmaker said UK’s emergency use authorisation marks a historic moment in the fight against Covid-19. Pfizer announced its vaccine breakthrough on November 9 with stage 3 clinical trial results.
“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,” said CEO Bourla.
“As we anticipate further authorisations and approvals, we are focused on moving with the same level of urgency to safely supply a high-quality vaccine around the world.”
UK’s medicines regulator approved the vaccine in record time -- partly by doing a “rolling” concurrent analysis of data and the manufacturing process while Pfizer raced to conclude trials.
The US Food and Drug Administration (FDA) is set to meet on December 10 to discuss whether to recommend emergency use authorisation of the Pfizer/BioNTech vaccine and the European Medicines Agency said it could give emergency approval for the shot by December 29.
“The data submitted to regulatory agencies around the world are the result of a scientifically rigorous and highly ethical research and development programme,” said Ugur Sahin, chief executive and co-founder of BioNTech.
Pfizer has said the shots can be kept in thermal shipping boxes for up to 30 days, from up to 15 days previously guided.
Afterwards, the vaccine can be kept at fridge temperatures for up to five days.
MHRA did not cut any corners in the rolling review process, its chief executive June Raine said, describing the review as thorough and rigorous. “Our expert scientists and clinicians have worked round the clock, carefully, methodically, poring over tables and analyses and graphs on every single piece of data, hundreds, over a thousand pages of data and, absolutely critically, analysing the pre-clinical evidence, the clinical trials, the manufacturing and quality controls, and then down to the final sampling.”