U.Ok. Approves Pfizer Coronavirus Vaccine, a First within the West

LONDON – The UK on Wednesday granted emergency approval for Pfizer’s coronavirus vaccine, becoming the first western country to allow mass vaccination against a disease that killed more than 1.4 million people worldwide.

The decision paved the way for a vaccination campaign with little precedent in modern medicine that included not only ultra-cold dry ice but also a crusade against vaccine misinformation.

Britain’s beating against the United States – nothing less than a vaccine co-developed by an American company – put pressure on US regulators, who are under fire from the White House for not moving faster to get doses to people. But there was also concern that for political reasons the UK was acting in a rush or trying to take the lead in deliveries.

European regulators on Wednesday expressed doubts about the rigor of the UK’s review, stating that approval was limited to specific lots of the vaccine, a claim Pfizer denied and which UK officials have not addressed.

The UK’s move sparked a lively debate among American scientists about whether US regulators, known to be unusually meticulous, could afford to approve a vaccine against a virus that kills more than 10,000 people worldwide to interrupt longer.

American regulators have argued that they are lagging, if only by a few days, because they practically alone re-analyze thousands of pages of raw data from vaccine trials prior to approval. Supporters of this approach say it is the only way to minimize unintended harm to life and public trust from malfunctioning vaccines.

UK and European regulators rely more on companies’ own analysis and occasionally review their numbers, but otherwise base their decisions on reports from vaccine manufacturers. While the more cautious American approach may be valuable, some scientists have said that Europeans are scrutinizing vaccine manufacturers and it is imperative to act quickly to contain the suffering caused by the pandemic.

“When you say it’s okay to wait another week or two, you’re saying that it’s okay that many thousands of people are going to die,” said Dr. Walid F. Gellad, director of the Center for Drug Policy and Prescribing at the University of Pittsburgh.

As of Wednesday, no country had approved a fully tested coronavirus vaccine. Russia and China approved vaccines without waiting for large-scale efficacy tests.

The UK government, affected by the management of the pandemic, was delighted with the approval.

“With this vaccine, help is on the way – and we can now say that with certainty and not with all restrictions,” said British Health Minister Matt Hancock on Wednesday.

While the clearance bodes well for the UK, which stepped out of the European Union’s regulatory orbit to pre-approve the vaccine, it does not affect the distribution of the hundreds of millions of doses that the US and other wealthy countries have sourced prepaid Contracts.

It also offers little relief to poorer countries that could not afford to buy supplies in advance and may have difficulty paying for both the vaccines and the exceptional requirements for their distribution.

Around 800,000 doses of the Pfizer vaccine, which was being developed with BioNTech, a smaller German company, were packaged for shipment to the UK on Wednesday at the company’s Belgian manufacturing facility. How and when they arrive is a secret for security reasons, the company said.

The complicated logistics involved in moving, thawing and preparing the vaccine meant that it was initially only intended to be administered in 50 UK hospitals. The vaccine must be transported at temperatures similar to the south pole and in bowls with 975 doses.

First, doctors and nurses from the country’s National Health Service are vaccinated, along with nursing home workers and people aged 80 and over with pre-scheduled doctor appointments. A government advisory council has suggested that elderly or more vulnerable health workers, as well as doctors and nurses working with fragile patients, be among the first.

However, the government has not said when other National Health Service employees would be eligible for vaccines. Basic workers such as teachers, transport workers and first responders would only be vaccinated after people 50 years old and over and those with underlying health problems were shot.

The advisory board’s plans had given nursing home residents top priority, but they will have to wait for the government to begin distributing vaccines beyond hospitals. Pfizer and BioNTech have suggested that this is possible because the vaccine can be stored in a regular refrigerator for five days.

Eventually, people will get their shots at mass vaccination centers set up by the military in football stadiums and on racetracks, or in doctors’ offices and pharmacies.

“We waited and hoped for the day when the headlights of science would locate our invisible enemy and give us the power to stop that enemy from making us sick,” Prime Minister Boris Johnson said Wednesday. “And now the scientists have done it.”

For the UK, which has suffered one of the highest death tolls per capita in Europe from the virus, its Medicines Agency’s decision was the latest evidence of a vaccination strategy that has been most aggressive in the West.

Britain will remain under the authority of the European Union’s drug regulator until it separates from the bloc on December 31st. However, the government recently strengthened an old law that allows him to get out under the bloc’s roof in case of public health emergencies. This allowed for a quick review of the Pfizer vaccine, which was 95 percent effective in a late clinical study.

The UK had pre-ordered 40 million doses of the vaccine and 315 million doses of competing vaccines and distributed its bets to ensure it could vaccinate the country’s 67 million people.

UK ministers cited the speed of Pfizer approval as an early example of the new flexibility the country will have if it completely breaks away from European regulation. However, Brexit also created costs and the UK drug regulators starved for money it received from contracts with the European Union.

UK regulators are also reviewing a vaccine developed by Oxford University and AstraZeneca, a British-Swedish company. It’s cheaper and easier to store than Pfizer’s, so much of the world could rely on it, but its regulatory path in the US remains unclear after scientists and industry analysts questioned promising early results.

The chemistry behind Pfizer’s vaccine had never produced an approved shot before, but scientists have experimented with it for years and tested vaccines that never made it onto the market. To get cells to make a viral protein called a spike and trigger an immune response, this class of vaccine provides genetic instructions known as messenger RNA, which are enclosed in tiny globules of fat.

BioNTech made a prophetic bet on the technology and partnered with Pfizer, one of the world’s largest pharmaceutical companies. They delivered impressive results on a timeline that was not known before this year.

The US Food and Drug Administration plans to decide on an emergency approval for the Pfizer vaccine shortly after an advisory board meeting on December 10th. American officials said vaccinations could start within 24 hours of approval.

Another American company, Moderna, and the National Institutes of Health have also developed a messenger RNA vaccine that has been shown to be effective in large studies. The FDA will review its emergency clearance application shortly after Pfizer’s.

The European Medicines Agency, which regulates vaccines across the European Union, is expected to make a decision on the Pfizer vaccine in December.

Pfizer expects to produce up to 50 million doses this year, around half of which will go to the US. Since every person needs two doses one month apart, up to 20 million people worldwide could start vaccinating before 2021.

The United States bought 100 million cans in advance from Pfizer and the European Union bought 200 million cans.

The approval came at a dangerous time in the UK pandemic, where the virus has killed nearly 70,000 people and hundreds more are dying every day. A third of UK hospital systems have been caring for more Covid-19 patients in recent weeks than at the height of the first wave in spring.

Months of restaurant and pub closings have slowed the spread of the virus, but this is being replaced by a less stringent system of local restrictions, taking into account Christmas travel, which scientists fear will further spur infections.

In a clinical study, the Pfizer BioNTech vaccine was found to be highly effective in older adults who are more prone to developing severe Covid-19 and who do not respond strongly to some types of vaccines. It did not cause any serious side effects.

Once vaccines are widely used, the scientific effort to develop them will give way to the social and political problem of convincing people to take them. In the UK, the source of some of the most virulent modern day vaccine disinformation, just over half of people polled said they would definitely accept vaccination.

Safety concerns were heightened by the speed of vaccine testing and approval, despite UK regulators repeatedly saying they would not take short cuts.

In addition to these challenges, manufacturers must quickly make billions of cans and bring them to hospitals, clinics and pharmacies.

The Pfizer vaccine makes this effort particularly complex. It must be stored at around minus 70 degrees Celsius until shortly before the injection and must be transported in boxes filled with dry ice.

Matina Stevis-Gridneff reported from Brussels, Katie Thomas from Chicago and Rebecca Robbins from Bellingham, Washington.

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