UK approves Pfizer coronavirus vaccine, first in the West

LONDON – Britain on Wednesday gave emergency clearance for Pfizer’s coronavirus vaccine, 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.

The decision launched 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 anti-vaccine misinformation.

Britain beating the US on clearance – on a vaccine co-developed by US pharmaceutical giant Pfizer, no less – may step up pressure on US regulators, who are already under White House fire for not to go faster to deliver doses to people. And it has sparked a global debate about how to weigh the desperate need for a vaccine with the imperative to assure people that it is safe.

No country until Wednesday had authorized a fully tested coronavirus vaccine; Russia and China have approved the vaccines without waiting for large-scale efficacy testing.

“Help is on the way with this vaccine – and now we can say that with certainty, rather than with all the warnings,” British Health Secretary Matt Hancock said on Wednesday as the government cheered in authorization.

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 vaccine, developed with BioNTech, a small German company, must be transported at temperatures similar to those of the South Pole, a requirement that could dictate who will be vaccinated first in Britain: Residents of nursing homes were supposed to be the top priority under plans for an advisory committee, but efforts to limit vaccine transport and ensure it stays cold may mean National Health Service staff will receive the vaccines first.

The government said on Wednesday that 800,000 doses would be available by next week for health workers to start administering, as part of a huge distribution effort involving primary care doctors and vaccination centers in mass set up by the military.

For Britain, which has suffered one of the highest per capita death rates in Europe from the virus, its drug regulator’s decision was the latest evidence of a vaccination strategy that has been the more aggressive in the West.

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 Pfizer vaccine review.

Britain has pre-ordered 40 million doses of the vaccine, which was 95% effective in an advanced clinical trial. It is part of a catalog of different vaccines the government has ordered – in all, more than five doses for every person in the country.

The government of Prime Minister Boris Johnson, beaten by its handling of the pandemic, presented this authorization as a sign that Britain is leading “the charge of humanity against this disease”. But the swift approval also fueled concerns about the opening of a new politicized competition between countries to quickly clear vaccines so they can claim the first shipments.

As US regulators look at raw data from vaccine makers to validate trial results, their counterparts in Britain and elsewhere in Europe are relying more on the companies’ own analyzes. Yet the decisions of UK regulators are seen as influential on a global scale, and its analysts examine not only test results, but also manufacturing processes and controls.

British regulators are also looking at a vaccine developed by AstraZeneca, an Anglo-Swedish company, and the University of Oxford that is cheaper and easier to store than that of Pfizer. Much of the world could count on him, but his regulatory evolution in the United States is unclear after scientists and industry analysts questioned promising early results.

The chemistry behind Pfizer’s vaccine had never previously produced an approved vaccine, although the same class of vaccines had long been tested for other uses. In order to cause cells to make a viral protein called a spike and trigger an immune response, the vaccine delivers genetic instructions, called messenger RNA, locked in tiny globs of fat.

BioNTech made a prophetic bet on technology and 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 emergency use authorization in the UK will mark the first time that citizens outside of trials will have the opportunity to be immunized against Covid-19,” said Dr Ugur Sahin, managing director and co -Founder of BioNTech.

The U.S. Food and Drug Administration plans to decide on emergency clearance for the Pfizer vaccine shortly after an advisory committee meeting on Dec. 10. U.S. officials have said vaccinations could begin within 24 hours of approval.

Another US company, Moderna, whose messenger RNA vaccine has also been shown to be extremely effective in large trials, said it would also seek emergency clearance from the FDA. If granted, it could be used as early as December 21, the company said.

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 split from the bloc on December 31, making the speed of Pfizer’s approval an early sign to the government of the flexibility it will have once the country breaks away. completely from the rest of the country. 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 make a decision on the Pfizer vaccine later in December. Like the FDA, the European Medicines Agency has scheduled a high-level meeting with outside experts before approval.

Pfizer said he hopes to be able to produce up to 50 million doses this year, about half of which in the United States. Since each person needs two doses, one month apart, up to 25 million people around the world 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 England’s 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 shown to be effective in the elderly, 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 agree to an inoculation with 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 vaccine doses and ship them to hospitals, clinics, and pharmacies without compromising what’s inside.

The Pfizer vaccine 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.

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