LONDON – Britain granted emergency approval to the Pfizer’s coronavirus vaccine on Wednesday, overtaking the United States to become a western country that allowed mass vaccination against the disease that killed more than 1.4 million people worldwide.
The authorization to use the vaccine developed by Pfizer, an American pharmaceutical giant, and BioNTech, a much smaller German firm, closed a vaccination campaign with little precedent in modern medicine, which included not only ultrasecond dry ice and Trays of glass vials are included. Crusade against anti-vaccine misinformation.
Britain’s audience approving the United States – on a vaccine co-developed by an American company – could increase pressure on US regulators, who are already White House caught fire Not moving fast to get a dose for people. And it has sparked a global debate on how to reduce the need for a vaccine, along with the imperative of reassuring people.
Russia and China have already approved the vaccines without waiting for the results of large-scale efficacy tests, a decision that scientists have said in some cases Poses serious risks.
While the go-ahead bods for Britain were well-off, which broke from the EU’s regulatory orbit to approve the shot early, it would have no effect on the delivery of hundreds of millions of doses that other wealthy countries had in prepaid contracts. Have bought.
It also gives little relief to poor countries who cannot afford to buy supplies in advance and may struggle to pay for both vaccines and the extraordinary demands to deliver them.
Pfizer-BioNtech Vaccine should be Taken at temperatures like the South PoleA requirement that is already being decided as to who will be vaccinated: nursing-home residents should have been under Britain’s highest priority Schemes of an advisory committee, But officials have held that a limit on how often the vaccine can be transferred before losing effectiveness means that National Health Service staff members will receive the first shots.
The government is in a dilemma about how soon it can operate hospitals after approval, but doctors and nurses had been preparing to start vaccinating their colleagues for days.
After the government strengthened an old law that allows Britain to opt out of public health emergencies under the EU regulatory umbrella, its Medicine and Healthcare Products Regulatory Agency reviewed a vaccine developed by Pfizer in New York Fast-tracked to, and BioNTech, a small German firm.
Britain has pre-ordered 40 million doses of the vaccine, which was 95 percent effective In a late stage clinical trial. The government has prepared a list of various vaccines that are under development – in all, more than five doses for each person in the country.
It has stalled its biggest hopes on a vaccine developed by the British-Swedish company AstraZeneca, and the University of Oxford, which is being approved for emergency approval in the UK. Most of the world can rely on it because it is cheaper and easier to use than Pfizer, but its regulatory path in the United States is not clear once it moves forward Scientists and industry analysts question initial results.
The chemical underlying the Pfizer-BioNTech vaccine had never produced an approved vaccine before. It relies on sending genetic instructions through a molecule called “messenger RNA” to signal an immune response. BioNTech made a prediction on the technology And then joined one of the world’s largest pharmaceutical companies with Pfizer; They provided surprising results at times unheard of before this year.
The US Food and Drug Administration plans to set an emergency authority for the Pfizer-BioNotech vaccine soon after an advisory panel meeting on 10 December. US officials have said that vaccination can begin within 24 hours after approval.
Another American company, Modern, and the National Institutes of Health have also developed a vaccine using messenger RNA that has proven to be exceptionally effective – 94.1 percent – in large trials. Modern recently stated that it would apply to the FDA for emergency approval, which if approved, the first injection could be given on December 21.
Britain’s power to approve vaccines before the European Union, which has its own drug regulator, now only applies on an emergency basis. But Britain will become permanent once it breaks out of the blast on 31 December, making Pfizer’s momentum an early signal in the government’s eye of resilience, which will take it away from the country once it is borne. rest of Europe.
Nevertheless, Brexit has also exacted costs, with Britain’s drug regulator as it draws from contracts with the European Union.
The European Medical Agency, which regulates vaccines in the European Union, is expected to approve the vaccine in mid-December, Germany’s health minister said recently, opening the door for vaccination to begin before the end of the year. While US regulators withheld raw data from vaccine makers to validate their test results, their counterparts in the UK and Europe rely more on analyzes from companies.
The British government has also gone directly to its medical regulator, calling for an emergency review of some coronavirus vaccines, rather than waiting for vaccine manufacturers to do so.
Pfizer Where are you It expects to be able to produce 50 million doses this year, with about half of them moving to the United States. Since each person requires two doses, a month apart, 25 million people worldwide can begin vaccination before 2021.
The US has purchased 100 million in advance from Pfizer and the European Union 200 million doses.
The approval reached a dangerous moment in the epidemic in Britain, where the virus has killed 66,000 people, and hundreds more each day. A third of England’s hospital systems were caring for more Kovid-19 patients in recent weeks than in the spring. Many intensive care units in central England were struggling to maintain emergency care.
And while a month-long shutdown of restaurants and pubs has halted the spread of the virus, it is being replaced by a new system of local sanctions, with an allowance for Christmastime travel that scientists fear is one of the infections. Will seed the growth.
In a clinical trial, the Pfizer-BioNotech vaccine proved to be particularly effective among older adults, who are more vulnerable to developing severe Kovid-19 and who do not strongly respond to certain types of vaccines. There were no serious side effects.
With the possibility of a modernization vaccine available in the UK at least until spring, the government has not formally requested that it undergo an emergency assessment.
As soon as vaccines become widely available, the scientific will to develop them will give rise to the social and political problem of convincing people to take them. In Britain, the source of the most viral modern disinformation about vaccines, more than half of people have said in surveys that they would certainly accept a coronovirus innocence.
Security concerns have only been driven by the pace with which vaccines have moved toward approval, despite UK regulators repeatedly saying they were not taking shortcuts.
Beyond those challenges, manufacturers will quickly need to make hundreds of millions – eventually billions – of vaccine supplements and transfer them to hospitals, clinics and pharmacies, without jeopardizing what’s inside.
The vaccine developed by Pfizer and BioNotech complicates the effort. It should be stored around minus 70 ° C (minus 94 Fahrenheit) until it is injected, requiring transportation in a box filled with dry ice. Modernity vaccines also need to be frozen, but only at minus 20 Celsius.
Those requirements with high requirements may limit the number of countries and people who have access to those vaccines.
For that reason, most people in the world were expecting results from AstraZeneca and Oxford, which would only cost a few dollars per dose and are easy to store for long periods. The UK, too, has bought 100 million doses of a major part of its vaccine strategy on the AstraZeneca vaccine.