LONDON (AP) – The UK approved the use of the COVID-19 vaccine on Wednesday, illuminating the first shot in green with a rigorous scientific review. The first vaccinations are expected in days – a big step towards the end of the pandemic.
The advancement of U.S. pharmaceutical maker Pfizer and German BioNTech vaccine comes at a time when the virus is rebounding in the U.S. and Europe, putting pressure on hospitals and forcing new restrictions on the world economy. Officials have warned that even difficult months await even Britain, given the scale of the operation required to vaccinate large numbers of the population.
The UK’s Medicines and Health Products Regulatory Agency recommended the vaccine for emergency use after reviewing a series of data, including the results of clinical trials, which showed that it provided 95% effective and significant protection for older people, their among those most at risk of death from the disease. But the vaccine will still remain experimental until the final test is performed.
“This is undoubtedly a historic day,” said David Harper, a senior global health consultant at the Chatham House think tank. “It’s a science never seen before,” given that the vaccine was approved less than a year after COVID-19 was discovered.
Other countries are not lagging behind: regulators in the United States, the European Union and Canada are also controlling the Pfizer vaccination, along with a similar shot by rival Moderna Inc.. British and Canadian regulators are also considering another shot at AstraZeneca and Oxford University.
British Health Secretary Matt Hancock said the UK would start delivering the first 800,000 doses of Pfizer-BioNTech vaccine “within days” and people would get the shots As soon as it arrives. Two doses are needed three weeks apart for protection.
The UK expects to receive “a million servings” by the end of this year, Hancock said, adding that the exact number depends on how quickly its quality can be produced and controlled.
“Doses for the UK are currently being packaged by our colleagues (at Pfizer’s facility in Belgium), ready for very, very fast delivery,” BioNTech Commercial Director Sean Marett told reporters on Wednesday.
But rations are scarce as production accelerates. The vaccine-owning BioNTech has so far signed to ship 570 million doses worldwide by 2021, with the option to deliver an additional 600 million, Marett said. He hopes to be able to deliver at least 1.3 billion in 2021.
The German company is working with Pfizer to deliver the vaccine worldwide, except in China, where the local company Fosun Pharma handles the distribution.
BioNTech’s data is still only a fraction of what will be needed as public health officials try to vaccinate much of the world’s population. Experts say more vaccinations will be needed to quickly end the epidemic, which kills more than 1.4 million people worldwide.
In Britain, public health officials plan to first offer the vaccine to those who are most at risk of dying from the disease and whose status puts them at risk of becoming infected with the virus and spreading it to other people. The vaccination program will be extended to others as soon as supplies become available.
The first vaccinations are given to people living in a nursing home and their carers, followed by everyone over the age of 80 and healthcare workers. From then on, the government plans to offer vaccines roughly based on age groups, starting with the oldest people first.
Pharmaceutical manufacturers have said they will begin shipping limited stocks to the UK immediately – and are preparing for wider distribution once the shot is approved by the US Food and Drug Administration, with a decision expected next week.
Despite how quickly the vaccine was approved, British regulators insisted that they “not cut corners” during the review process.
The MHRA made its recommendation following a comprehensive review, which allowed it to evaluate information about the vaccine as it became available. The agency began analyzing preclinical data in October, followed by information on manufacturing and quality assurance, and finally the results of clinical trials.
“Public safety will always come first,” Dr. June Raine, the agency’s CEO, said at a news conference. “And I emphasize once again that this recommendation was made by the MHRA only after the most rigorous scientific evaluation of all the data.”
Communicating this message to the public is critical if any vaccination program is to succeed. Some people are worried about getting any vaccine, don’t mind the new one.
Retired nurse Jacqueline Roubians hopes most people get the shot.
“A lot of people are skeptical, but I think once you understand and see that everyone else has it without hesitation, I think you realize people are going and getting it,” Roubians, 76, said at the Brixton market in London. “People are dying because of COVID, so you decide: do you want to die or do you want vaccination?”
In addition to the huge logistical challenge of distributing huge amounts of vaccine, Pfizer-BioNTech has to be stored and shipped at an extreme temperature of minus 70 degrees Celsius (minus 94 degrees Fahrenheit).
Pfizer says it has developed shipping containers that use dry ice to keep the vaccine cool. GPS sensors allow the company to track individual shipments and ensure they stay cool.
The company also said it has agreed to work with other vaccine manufacturers to ensure that sufficient vaccines are available, including vaccines for global access.
Each country has different rules for determining when an experimental vaccine is safe and effective to use. Intense political pressure to be the first to submit a rigorously scientifically tested shot has colored the competition in the United States and Britain, even as researchers pledged not to let go.
In contrast, China and Russia offered different vaccinations to their citizens before testing at a late stage.
The vaccine, made by Pfizer and BioNTech, has been tested on tens of thousands of people. And although the study is incomplete, early results suggest that the vaccine is 95% effective in preventing mild to severe COVID-19 disease. The companies told regulators that of the first 170 infections detected in the study’s volunteers, only eight were among the people who received the actual vaccination and the others were given a standing shot.
The companies also did not report any serious side effects, although recipients of the vaccine may experience transient pain and flu-like reactions immediately after injections.
It remains to be determined whether the shots will protect people who spread the coronavirus without showing symptoms. Another question is how long the protection will last.
The vaccine has also been tested in a small number of children under 12 years of age, and there is no information on its effects in pregnant women.
Neergaard reported from Alexandria, Virginia. Associated press writers Frank Jordans in Berlin and Jill Lawless, Pan Pylas and Jo Kearney in London contributed
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The Department of Health and Science at the Associated Press receives support from the Department of Science Education at the Howard Hughes Institute of Medicine. All content is the sole responsibility of the AP.