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Britain granted emergency clearance to Pfizer’s coronavirus vaccine on Wednesday, ahead of the United States to become the first Western country to allow mass vaccines against a disease that has killed more than 1.4 million people across the world. world.
The decision kicked off a vaccination campaign with little precedent in modern medicine, encompassing not only ultra-cold dry ice and glass vial trays, but also a crusade against vaccine misinformation.
The fact that Britain beats the United States to obtain authorization – in a vaccine jointly developed by US pharmaceutical giant Pfizer, no less – may intensify pressure on US regulators, who are already under fire from the White House. for not moving faster to get doses to people. But the approval also fueled concerns that Britain had acted so quickly for political reasons, or even to ensure that it was at the forefront for deliveries from Pfizer’s Belgian manufacturing plant.
As of Wednesday, no country had licensed a fully tested coronavirus vaccine; Russia and China approved vaccines without waiting for large-scale efficacy trials.
British and European regulators rely more on companies ‘own analyzes, study vaccine manufacturers’ reports and, unless there are anomalies, base their decisions on those documents. And while US regulators await a meeting of outside experts on December 10 to make a decision, Britain’s committee of specialists met as needed for a total of 40 hours before the decision on Wednesday.
But whether Britain had moved more nimbly than the United States, or was quick to review the data, remained an open question on Wednesday. The British government, struck by its handling of the pandemic, rejoiced at the authorization.
“Help is on the way with this vaccine, and now we can say that with certainty, instead of all the warnings,” British Health Secretary Matt Hancock said Wednesday as the government rejoiced at his decision.
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While the go-ahead bodes well for Britain, which broke away from the regulatory orbit of the European Union to approve the injection early, it will have no effect on the distribution of the hundreds of millions of doses that other rich countries have purchased. in prepaid contracts.
It also offers little relief to poorer countries that cannot afford to buy supplies in advance and may find it difficult to pay for both vaccines and the exceptional demands to distribute them.
The Pfizer vaccine, developed with BioNTech, a smaller German company, must be transported at similar temperatures to the South Pole, a requirement that Britain said on Wednesday would initially restrict vaccines to a network of 50 hospitals. The government said those hospitals would initially vaccinate people 80 and older who already have medical appointments booked for the next few weeks, along with nursing home workers and doctors and nurses.
But the government did not clarify which other groups of National Health Service workers would be eligible for the vaccines. There was also confusion about how nursing home residents would be vaccinated, which are the top priority under the advisory committee’s plans.
Pfizer has said that its vaccine can be stored for five days in a regular refrigerator, but the government said Wednesday that the logistics involved in moving, thawing and preparing the vaccine meant that it could only be administered in hospitals to begin with. Later that would expand to nursing homes, and then smaller clinics and doctor’s offices, they said.
The government said on Wednesday that 800,000 doses will be available next week for healthcare workers to begin administering, as part of a huge distribution effort involving primary care physicians and mass vaccination centers that the military is setting up.
For Britain, which has suffered one of Europe’s highest per capita death rates from the virus, the decision by its drug regulator was the latest proof of a vaccination strategy that has been the most aggressive in the West.
After the government enforced an old law allowing Britain to exit the European Union’s regulatory framework in public health emergencies, its Medicines and Health Products Regulatory Agency accelerated a review of the Pfizer vaccine.
Britain pre-ordered 40 million doses of the vaccine, which was 95% effective in a late-stage clinical trial. It is part of a catalog of different vaccines that the government ordered, in total more than five doses for each person in the country.
British regulators are also examining a vaccine developed by AstraZeneca, a British-Swedish company, and the University of Oxford, which is cheaper and easier to store than Pfizer’s. Much of the world could trust him, but his regulatory path in the United States is unclear after scientists and industry analysts questioned the promising initial results.
The chemistry behind Pfizer’s vaccine has never before produced an approved injection, although the same class of vaccines has long been tested for other uses. To induce cells to produce a viral protein, called a spike, and elicit an immune response, the vaccine delivers genetic instructions, known as messenger RNA, locked into tiny globules of fat.
BioNTech made a prescient bet on technology and joined forces with Pfizer, one of the largest pharmaceutical companies in the world; they ended up delivering astonishing results, in a timeline unprecedented before this year.
“The emergency use authorization in the UK will mark the first time that non-trial citizens will have the opportunity to be immunized against Covid-19,” said Dr Ugur Sahin, CEO and co-founder of BioNTech.
The US Food and Drug Administration plans to decide on the emergency authorization for the Pfizer vaccine shortly after a meeting of an advisory panel on December 10. US officials have said vaccines could begin within 24 hours of approval.
Another US company, Moderna, whose messenger RNA vaccine was shown to be remarkably effective in large trials, said it would also seek emergency clearance from the FDA. If granted, it could go into use on December 21, the company said.
Britain’s power to approve vaccines before the European Union, which has its own drug regulator, applies for now only in emergencies. But it will become permanent after Britain completes its separation from the bloc on December 31, making the speed of Pfizer’s approval an early sign in the eyes of the government of the flexibility it will have once the country seizes. disengage completely from the rest of Europe. .
However, Brexit has also taken a toll, depriving Britain’s drug regulator of the money it used to get from contracts with the European Union.
The European Medicines Agency, which regulates vaccines throughout the European Union, is expected to make a decision on the Pfizer vaccine in late December. Like the FDA, the European Medicines Agency has scheduled a high-profile meeting with external experts prior to approval.
Pfizer has said it expects to be able to produce up to 50 million doses this year, about half of them for the United States. Since each person needs two doses, one month apart, up to 25 million people worldwide could start getting vaccinated before 2021.
The United States bought 100 million doses of Pfizer in advance and the European Union 200 million doses.
The approval came at a dangerous time in the pandemic in Britain, where the virus has killed nearly 70,000 people and hundreds more every day. A third of England’s hospital systems saw more Covid-19 patients in recent weeks than in the spring. Several intensive care units in central England were struggling to maintain emergency care.
And while closing restaurants and pubs for a month has halted the spread of the virus, it is being replaced by a new system of localized restrictions, with a concession for Christmas trips that scientists fear will lead to another spike in infections.
In a clinical trial, the Pfizer-BioNTech vaccine was shown to be effective among older adults, who are more vulnerable to developing severe Covid-19 and who do not respond strongly to some types of vaccines. It did not cause serious side effects.
Since Moderna’s vaccine is unlikely to be available in Britain until at least the 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 definitely accept a coronavirus inoculation.
Safety concerns have only been accentuated by the speed with which vaccines have moved towards approval, even though British regulators have repeatedly said they were not taking shortcuts.
Beyond those challenges, manufacturers will need to quickly generate hundreds of millions, eventually billions, of doses of the vaccine and move them to hospitals, clinics and pharmacies without compromising what’s inside.
The Pfizer vaccine makes this effort especially complex. It has to be stored at around minus 70 degrees Celsius (minus 94 Fahrenheit) until shortly before it is injected, which requires transporting it in boxes filled with dry ice. Moderna’s vaccine should also be frozen, but only to minus 20 degrees Celsius.
Those requirements, along with high costs, could substantially limit the number of countries and people that have access to those vaccines.
