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The UK government on Wednesday granted emergency use authorization for the COVID-19 vaccine developed by Pfizer Inc. and its German partner BioNTech SE, but experts warn the news does not mean the pandemic is on the verge of be completed.
The UK plans to start vaccinating frontline workers as early as next week, but many obstacles remain. The vaccine should be stored at minus 94 degrees Fahrenheit and should be transported to the UK from a facility in Belgium.
UK Health Secretary Matt Hancock acknowledged it would be a challenge, but did not give details on how it would be handled. Prime Minister Boris Johnson also acknowledged that a “huge logistical challenge” awaits him.
The initial batch should consist of about 800,000 doses, enough to inoculate just half of that number, as this is a two-dose regimen.
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“The fact that this EU product is so good that Britain approved it so quickly shows that in this crisis European and international cooperation is the best.”
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The UK’s National Health Service employs around 1.5 million people, according to the Nuffield Trust health think tank, making it the country’s largest employer and one of the world’s largest employers. The total population of the United Kingdom is around 67 million.
Hancock suggested the early clearance was possible “because of Brexit”, with the UK free from the perceived bureaucracy associated with the European Union, which it is in the process of leaving.
But as German Health Minister Jens Spahn pointed out, the vaccine was jointly developed by a German company, using funds from the European Union, and an American company.
“The fact that this EU product is so good that Britain approved it so quickly shows that in this crisis European and international cooperation is the best,” Spahn told reporters at a briefing. press release Wednesday.
The vaccine itself is still in phase 3 trials and participants in those trials should be monitored for several years. Vaccines generally take years to develop, as they require a lot of safety data to make sure they don’t have harmful side effects.
To see now: Dr Atul Gawande on COVID-19: ‘It’s never too late to save 100,000 more lives’
The COVID-19 pandemic has mobilized pharmaceutical companies, biotechnology and health agencies to act quickly to find vaccines and therapies, and new technologies are being deployed to speed up the process. The Pfizer and BioNTech PFE,
BNTX,
the vaccine was developed in a record 10 months.
The vaccine from Pfizer and BioNTech is a messenger ribonucleeuc acid, or mRNA, vaccine that sends a message to cells telling them to create proteins that can generate an immune response. While there are high hopes for the technology, no mRNA products have been approved in the United States for any indication.
To see now:AstraZeneca’s COVID-19 vaccine data fails to impress Wall Street analysts with effectiveness in clinical trials
Pfizer and BioNTech have yet to make data from the advanced stage trial fully publicly available, but said an analysis of the early data found the vaccine to be 95% effective and showing signs of safety. However, the initial data only covered 170 adult volunteers in a trial involving nearly 44,000 people, and only eight of them actually received the vaccine, with the remaining 162 receiving the placebo.
None of the drug manufacturers with candidate vaccines in the pipeline have yet published clinical data on vaccine performance in advanced clinical trials in peer-reviewed medical journals, which is considered the gold standard for sharing of medical research. So far, they have only shared provisional data points.
To see now:BioNTech and Pfizer’s COVID-19 vaccine is surprisingly effective, though experts wonder what effectiveness will look like in the real world
China and Russia have already deployed their own vaccines and have been criticized for doing so before completing Phase 3 trials.
“At the end of the day, even if a vaccination program were to start this month, the fact that two injections were needed means that it will likely take several months before you start to see a possible economic benefit in terms of easing restrictions. , since medical staff, along with the most vulnerable, are likely to be the first to benefit, with the general population at the back of the queue, ”said Michael Hewson, analyst at MC Markets.
This means UK citizens, like the general population of other countries, will need to continue to adhere to safety practices recommended by health experts – frequently washing their hands, socially distancing themselves and wearing face masks.
Still, Dr Paul Offit, a pediatrician at the Children’s Hospital of Philadelphia and co-inventor of the rotavirus vaccine, said the news was “reassuring.”
“Right now, all we know comes from corporate press releases. When regulators look at all the data, the data below the tip of the iceberg, and conclude that this vaccine is what it appears to be, it’s heartwarming, ”he said.
See: Paul Offit, Philadelphia pediatrician: Prepare to wear masks and move away socially even after receiving the COVID-19 vaccine
The Pfizer vaccine candidate – BioNTech is one of three pioneers being tested. MRNA of Moderna Inc.,
is also developing an mRNA vaccine, and said it generated a 94.5% efficacy rate in its advanced stage trial. Moderna is seeking emergency use authorizations in the US and the EU for its candidate.
See also:COVID-19 vaccines should be designed for people, not for profit
A third vaccine under development by AstraZeneca PLC AZN,
AZN,
with the University of Oxford – a viral vector-based vaccine – recently produced puzzling results, with the vaccine appearing 62% effective when tested as originally intended, but 90% effective when error manufacturing results in a reduction in initial drowsiness for some volunteers.
The U.S. Food and Drug Administration is scheduled to meet on Dec. 10 to review the Pfizer-BioNTech vaccine candidate and may also issue an emergency use authorization. Moncef Slaoui, head of the government’s “Operation Warp Speed” program to accelerate the development of a safe and effective vaccine, told ABC News he expects the FDA to come to the same conclusion as its UK counterpart. .
To see now:U.S. COVID-19 death toll surpasses 270,000 as CDC moves forward with planned vaccine deployment plans
Pfizer shares were up 2.8% on Wednesday and have gained 9% this year so far. BioNTech’s U.S. certificates of deposit rose 4.8% and jumped 253% in 2020. The SPDR S&P Biotech ETF X,
gained 39% over the same period, while the benchmark S&P 500 SPX,
grew by 13%.
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