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LONDON (AP) – Britain cleared the use of a COVID-19 vaccine on Wednesday, giving the green light to the first shot backed by rigorous scientific scrutiny. The first vaccinations are expected in a few days – a major step towards the end of the pandemic.
The green light for the vaccine from US drugmaker Pfizer and Germany BioNTech comes as the virus reappears in the US and Europe, putting pressure on hospitals and imposing new rounds of restrictions that have devastated the economy global. Officials have warned that several difficult months remain to come, even in Britain, given the scale of the operation needed to vaccinate large swathes of the population.
The Medicines and Health Products Regulatory Agency, which licenses medicines in the UK, recommended the vaccine for emergency use after reviewing a range of data, including results from clinical trials that have shown to be 95% effective and provide significant protection for older people, among those most at risk of dying from the disease. But the vaccine remains experimental during the final test.
“This is, without a shadow of a doubt, a historic day,” said David Harper, senior researcher in global health at the Chatham House think tank. “This is unprecedented science,” given that the vaccine was authorized less than a year after the discovery of COVID-19.
Other countries are not far behind: Regulators in the United States, the European Union and Canada are also reviewing the Pfizer vaccine with a similar vaccine made by competitor Moderna Inc. UK and Canadian regulators are also considering another photo taken by AstraZeneca and the University of Oxford.
British Health Secretary Matt Hancock said the UK would start receiving the first shipment of 800,000 doses of the Pfizer-BioNTech vaccine “within days” and people would start getting vaccinated. as soon as he gets here. Two doses three weeks apart are needed for protection.
The UK expects to receive “millions of doses” by the end of this year, Hancock said, adding that the exact number will depend on how quickly it can be manufactured and checked for quality.
“The doses we have for the UK are currently packed (by) our colleagues at the Pfizer plant in Belgium, ready to ship very, very quickly,” BioNTech Commercial Director Sean Marett said on Wednesday.
But doses are scarce as production increases. BioNTech, which owns the vaccine, has so far signed agreements to deliver 570 million doses globally in 2021, with options to deliver 600 million more, Marett said. He hopes to provide at least $ 1.3 billion in 2021.
The German company has partnered with Pfizer to deliver the vaccine worldwide, except in China where local company Fosun Pharma will handle the distribution.
BioNTech’s numbers are still only a fraction of what will be needed as public health officials attempt to immunize large parts of the world’s population. Experts said more vaccines would be needed to quickly end the pandemic, which has killed more than 1.4 million people worldwide.
In Britain, public health officials plan to offer the vaccine first to those most at risk of dying from the disease and to those whose work puts them at risk of contracting the virus and transmitting it to d ‘other. The immunization program will be extended to others as supplies become available.
The first vaccines will go to residents of nursing homes and those who care for them, followed by all people over 80 and healthcare workers. From there, the government’s plans call for vaccines to be offered roughly by age group, starting with the oldest people.
Drugmakers have said they will immediately begin shipping limited supplies to the UK – and prepare for wider distribution if the vaccine receives approval from the US Food and Drug Administration, an expected move from next week.
Despite how quickly they approved the vaccine, UK regulators insisted that “no corners were cut” during the review process.
The MHRA made its recommendation following an ongoing review that allowed it to assess information about the vaccine as soon as it became available. The agency began analyzing preclinical data in October, followed by information on manufacturing and quality assurance and finally results of clinical trials.
“Public safety will always come first,” Dr June Raine, the agency’s chief executive, told a press conference. “And I stress again that this recommendation was only given by the MHRA following the most rigorous scientific evaluation of each piece of data.”
Getting this message out to the public will be essential for any vaccination program to be successful. Some people worry about getting the vaccine, let alone a new vaccine.
Jacqueline Roubians, a retired nurse, hopes most people will get vaccinated.
“A lot of people are skeptical, but I think once they understand and see everyone having it without hesitation, I think you will find people will go and have it,” said Roubians, 76. , at Brixton Market in London. “People are dying from COVID, so you make this decision: do you want to die or do you want the vaccine?”
In addition to the massive logistical challenge of distributing billions of vaccines, the Pfizer-BioNTech must be stored and shipped in ultra-cold temperatures of around 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 will allow the company to track each shipment and make sure it stays cool.
The company also says it has agreed to work with other vaccine manufacturers to ensure a sufficient supply and range of vaccines, “including those suitable for global access.”
Each country has different rules for determining when an investigational vaccine is safe and effective enough to be used. Intense political pressure to be the first to roll out a rigorously scientifically tested plan colored the race in the United States and Britain, even as researchers pledged not to cut corners.
In contrast, China and Russia have offered different vaccinations to their citizens ahead of advanced stage testing.
The vaccine made by Pfizer and BioNTech has been tested on tens of thousands of people. And while the study is not complete, early results suggest 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 study volunteers, only eight were among those who received the actual vaccine and the rest received a dummy injection.
The companies also did not report any serious side effects, although people who were vaccinated may experience temporary pain and flu-like reactions immediately after the injections.
It remains to be seen whether the shots protect against people who spread the coronavirus without showing symptoms. Another question is how long the protection lasts.
The vaccine has also only been tested in a small number of children, none under the age of 12, and there is no information on its effects in pregnant women.
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Neergaard reported from Alexandria, Virginia. Associate Press Editors Frank Jordans in Berlin and Jill Lawless, Pan Pylas and Jo Kearney in London contributed
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Follow AP’s coverage at https://apnews.com/hub/coronavirus-pandemic and https://apnews.com/UnderstandingtheOutbreak.
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The Associated Press’s Department of Health and Science receives support from the Department of Science Education at the Howard Hughes Medical Institute. The AP is solely responsible for all content.
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