The United Kingdom approved Pfizer’s COVID-19 vaccine on Wednesday, overtaking the United States and Europe to become the first country in the West to formally endorse a vaccine that will reach the most vulnerable people early next week.
Prime Minister Boris Johnson saw the approval by the Food and Drug Administration as a global victory and a ray of hope amidst the gloom of the novel coronavirus that has killed nearly 1.5 million people worldwide, shaken the global economy and transformed normal life.
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) granted emergency approval for the Pfizer BioNTech vaccine, which it says has 95% efficacy in preventing disease, in record time – just 23 days after Pfizer published the first data from the final phase of its clinical trial.
The world’s major powers have been racing for months for a vaccine to begin the long road to recovery, seeing it as a coup by the Johnson administration, which has been criticized for its handling of the crisis.
“This is fantastic,” Johnson said. “The vaccine will be made available across the UK from next week. It is the protection of the vaccines that will ultimately allow us to get our lives back and get the economy back on track”.
The approval of a vaccine for use almost exactly one year after the emergence of the novel coronavirus in Wuhan, China, is a triumph for science, according to Pfizer CEO Albert Bourla and his German biotechnology partner BioNTech.
But the breakneck speed at which the approval was granted has drawn criticism from Brussels, where the European Union’s drug regulatory authority, in an unusually blunt statement, said its longer procedure for approving vaccines was more appropriate because it was based on more evidence and required more controls.
British politicians said that while they would like to get a vaccine themselves, priority must be given to those most in need – the elderly, people in nursing homes and health workers.
The U.S. drug company said Britain’s emergency use approval marks a historic moment in the fight against COVID-19. Pfizer announced its vaccine breakthrough on November 9th with results from stage III clinical trials.
“This approval is a goal we have been working towards since we first stated that science will win, and we applaud the MHRA for their ability to conduct a thorough evaluation and take timely action to protect the people of the UK,” said CEO Bourla.
The UK Medicines Agency approved the vaccine in record time by conducting a “rolling” simultaneous analysis of the data and manufacturing process while Pfizer rushed to complete the trials.
“There was no saving at every turn,” said MHRA Chief June Raine in a televised statement from Downing Street, adding that the first data on the vaccine was received in June and subjected to rigorous analysis in accordance with international standards.
“Safety is our motto,” she said. Asked if the threat of Britain’s withdrawal from orbit of the European Union on December 31 had played a role, Raine said that the accelerated vaccine approval had been granted under European law.
“With 450 people dying every day in the UK from COVID-19 infection, the benefits of accelerated vaccine approval outweigh the potential risks,” said Andrew Hill, Senior Visiting Research Fellow in the Department of Pharmacology at the University of Liverpool.
The U.S. Food and Drug Administration (FDA) will meet on December 10 to discuss whether to recommend emergency approval of the Pfizer/BioNTech vaccine, and the European Medicines Agency said it could grant emergency approval for the vaccine by December 29.
“The data submitted to regulatory authorities around the world are the result of a scientifically rigorous and highly ethical research and development program,” said Ugur Sahin, CEO and co-founder of BioNTech.
Meanwhile, anti-poverty campaigners warned that rich countries are hoarding the vaccine at the expense of poorer countries. “The worst thing we can do at the moment is to monopolize access to such vaccines for a small number of countries,” said Romilly Greenhill, the UK director of the ONE organization.
FIRST IN LINE?
The UK said it would start vaccinating the most vulnerable people early next week after receiving 800,000 doses from Pfizer’s production center in Belgium.
“Age is by far the most important factor in terms of the risk of contracting COVID-19,” said Wei Shen Lim, head of the UK Vaccine Committee for COVID-19. Lim said there had been no proposal that a vaccine should be mandatory.
The speed to market will depend on how quickly Pfizer can manufacture and deliver the vaccine – and the extreme temperature of -70C (-94F) at which the vaccine must be stored.
Johnson said last month that the UK ordered 40 million doses of Pfizer’s vaccine – enough for nearly a third of the population, as two vaccinations per person are needed to achieve immunity.
Health Secretary Matt Hancock said hospitals are ready to receive the vaccines and vaccination centers will be set up across the country, but he admitted that distribution would be a challenge if stored at temperatures typical of an Antarctic winter.
Pfizer said that the vaccines can be stored in thermal shipping boxes for up to 30 days, compared to up to 15 days previously. After that, the vaccine can be stored at refrigerator temperatures for up to five days.
Another frontrunner in the vaccine race is the U.S. biotech company Moderna, which has a 94% success rate in late-stage clinical trials. Moderna and Pfizer have developed their vaccines using the new messenger RNA (mRNA) technology.
AstraZeneca said last month that its COVID-19 injection, which is based on traditional vaccine technology, has been 70% effective in pivotal studies and could be up to 90% effective.