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LONDON – Britain gave emergency approval for Pfizer’s coronavirus vaccine on Wednesday, edging out the United States to become the first Western country to allow mass vaccinations against a disease that has killed more than 1.4 million people around the world.
Authorization to use the vaccine developed by Pfizer, an American pharmaceutical giant, and BioNTech, a much smaller German company, launched a vaccination campaign with little precedent in modern medicine, encompassing not only ultra dry ice. cold and glass vial trays, but also a crusade against anti-vaccine misinformation.
The specter of Britain beating the US for approval – on a vaccine co-developed by a US company, plus – may intensify pressure on US regulators, who are already under fire from the White House so as not to go faster to deliver doses to people. . And it has sparked a global debate on how to weigh the desperate need for a vaccine with the imperative to assure people that it is safe.
Russia and China have already approved vaccines without waiting for the results of large-scale efficacy tests, a move that scientists say poses serious risks in some cases.
If the green light bodes well for Britain, which broke away from the European Union’s regulatory orbit to approve the shot early, it will have no effect on the distribution of the hundreds of millions of doses that other rich countries have obtained under prepaid contracts.
It also offers little relief to poorer countries that cannot afford to purchase supplies in advance and may struggle to pay for both the vaccines and the exceptional demands of their distribution.
The Pfizer-BioNTech vaccine is to be transported at temperatures similar to those of the South Pole, a requirement that already dictates who will be vaccinated: Nursing home residents were supposed to be Britain’s top priority in plans for a advisory committee, but limit on number of times Officials say the vaccine can be moved before it loses its effectiveness means that National Health Service staff will receive the vaccines first.
The government was hesitant about how quickly it could stock hospitals after approval, but doctors and nurses were preparing to start vaccinating their colleagues within days.
After the government strengthened an old law that allows Britain to exit the EU regulatory framework in public health emergencies, its Medicines and Health Products Regulatory Agency accelerated a review of the vaccine developed by Pfizer, based in New York, and BioNTech, a small German company.
Britain has pre-ordered 40 million doses of the vaccine, which was 95% effective in an advanced clinical trial. The government has ordered a catalog of different vaccines in development – in all, more than five doses for every person in the country.
He has put his greatest hopes on a vaccine developed by AstraZeneca, an Anglo-Swedish company, and the University of Oxford, which is under emergency approval in Britain. Much of the world could count on it because it’s cheaper and easier to store than Pfizer’s, but its regulatory path in the United States is unclear after scientists and industry analysts questioned the first promising results.
The chemistry behind the Pfizer-BioNTech vaccine had never previously produced an approved vaccine. It relies on sending genetic instructions via a molecule called “messenger RNA” to trigger an immune response. BioNTech made a prophetic gamble on the technology, then partnered with Pfizer, one of the world’s largest pharmaceutical companies; they ended up delivering amazing results, on an unheard of timeline before this year.
The U.S. Food and Drug Administration plans to decide on emergency clearance for the Pfizer-BioNTech vaccine shortly after an advisory committee meeting on December 10. U.S. officials have said vaccinations could begin within 24 hours of approval.
Another American company, Moderna, and the National Institutes of Health, have also developed a vaccine using messenger RNA that has been shown to be extremely effective – 94.1% – in large trials. Moderna recently said he would seek emergency approval from the FDA which, if granted, could result in the first injections as early as December 21.
Britain’s power to approve vaccines before the European Union, which has its own drug regulator, currently only applies in emergencies. But it will become permanent after Britain consummates its separation from the bloc on December 31, making the speed of Pfizer’s approval an early sign to the government of the flexibility the country will be granted once it will break away from the rest of Europe.
Yet Brexit also demanded costs, depriving the British regulator of the drugs it used to draw from contracts with the European Union.
The European Medicines Agency, which regulates vaccines across the European Union, is expected to approve the same vaccine in mid-December, Germany’s Health Minister recently said, opening the door to vaccinations that will start before the end of the year. As US regulators look at raw data from vaccine makers to validate their trial results, their counterparts in Britain and elsewhere in Europe are relying more on the companies’ own analyzes.
The UK government has also gone directly to its medical regulator, asking it to undertake an emergency review of certain coronavirus vaccines, rather than waiting for vaccine makers to do so.
Pfizer said it expects to be able to produce up to 50 million doses this year, of which about half are in the United States. Since each person needs two doses, one month apart, up to 25 million people worldwide could start vaccination before 2021.
The United States pre-purchased 100 million doses from Pfizer and the European Union 200 million doses.
The approval came at a perilous time in Britain’s pandemic, where the virus has killed 66,000 people, and hundreds more every day. A third of English hospital systems were treating more Covid-19 patients in recent weeks than in spring. Several intensive care units in central England were struggling to maintain emergency care.
And while the month-long closure of restaurants and pubs has put the brakes on the spread of the virus, it is being replaced by a new system of localized restrictions, with a Christmas travel allowance that scientists fear will spark a new one. increased infections.
In a clinical trial, the Pfizer-BioNTech vaccine was found to be particularly effective in older people, who are more vulnerable to the development of severe Covid-19 and who do not respond strongly to certain types of vaccines. It did not cause any serious side effects.
With Moderna’s vaccine unlikely to be available in Britain at least until spring, the government has not formally requested that it undergo an emergency evaluation.
As vaccines become widely available, the scientific feat of developing them will give way to the social and political problem of convincing people to take them. In Britain, the source of some of the most virulent modern misinformation about vaccines, just over half of people have said in surveys that they would certainly accept an innoculation of the coronavirus.
Safety concerns were only compounded by how quickly the vaccines headed for approval, although UK regulators have repeatedly said they are not taking shortcuts.
Beyond these challenges, manufacturers will quickly need to manufacture hundreds of millions, if not billions, of doses of vaccine and get them to hospitals, clinics and pharmacies without compromising what’s inside.
The vaccine developed by Pfizer and BioNTech makes this effort particularly complex. It should be stored at around minus 70 degrees Celsius (minus 94 Fahrenheit) until shortly before injection, which requires transport in boxes filled with dry ice. Moderna’s vaccine should also be frozen, but only at minus 20 degrees Celsius.
These requirements, coupled with high costs, could significantly limit the number of countries and people with access to these vaccines.
Because of this, much of the world has been eagerly awaiting results from AstraZeneca and Oxford, which will cost just a few dollars per dose and are easy to store for long periods of time. Great Britain has also staked a considerable part of its vaccine strategy on the AstraZeneca vaccine, purchasing 100 million doses.
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