The New York Times
U.K. Approves Pfizer Coronavirus Vaccine, a First in the West
By Benjamin Mueller
Published Dec. 2, 2020
Updated Dec. 8, 2020, 8:35 a.m. ET
www.nytimes.com/2020/12/02/world/europe/pfizer-coronavirus-vaccine-approved-uk.html
U.K. Approves Pfizer Coronavirus Vaccine, a First in the West
The emergency approval, ahead of the United States and the European Union, clears the way for Britain to begin mass inoculations. “Help is on its way,” one official said.
www.nytimes.com
개인적 용도이며 잘못된 해석 있을 수 있음
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LONDON — Britain gave emergency authorization on Wednesday to Pfizer’s coronavirus vaccine, leaping ahead of the United States to become the first Western country to allow mass inoculations against a disease that has killed more than 1.4 million people worldwide.
inoculations [inὰkjuléiʃən] 접중, 주입
수요일 영국은 파이자(미국 제약사)의 코로나 바이러스 승인에 대한 긴급 승인을 내주었는데, 이는 미국을 뛰어넘어 (파이자 백신을 승인한) 첫 서구권 국가가 된 것이며, 전 세계적으로 140만명 이상의 목숨을 앗아간 질병에 대한 많은 이들의 접종을 가능하게 했다.
The decision cleared the way for a vaccination campaign with little precedent in modern medicine, encompassing not only ultracold dry ice but also a crusade against anti-vaccine misinformation.
이 결정은 현대 역사에서 그 전례를 찾아보기 어려운 예방접종 캠페인을 할 수 있도록 했는데, (수송및 보관을 위한) 엄청나게 차가운 드라이아이스 뿐만이 아니라 잘못된 백신거부 정보에 대한 치열한 싸움도 예상된다.
encompass 둘러싸다, 포함(포위)하다
Britain’s beating the United States to authorization — on a vaccine codeveloped by an American company, no less — intensified pressure on U.S. regulators, who are under fire from the White House for not moving faster to get doses to people. But it also fueled concerns that Britain was acting in haste for political reasons or trying to muscle its way to the front of the line for deliveries.
영국은 미국이 -미국 회사에 의해 공동개발된(이 백신은 미국 파이자사와 독일의 바이오앤테크사 공동 개발로 만들어졌다)- 이 백신을 승인하는 것보다 더 빨리 승인했고, 이는 미국 규제위원회에게는 압박이 되고 있는 상황인데, 미국 규제위원회는 현재 사람들에게 접종할 수 있도록 더 빨리 움직이고 있지 않다고 백악관을 부터 비난을 받고 있다.
하지만, 이는 또한 영국이 정치적 이유로 서두르고 있거나, (백신) 배송을 빨리 받으려고 무리하게 시도하고 있다는 염려에 기름을 붓고 있다.
intensify 격렬하게 하다
under fire 비난받다, 집중포화를 당하다
European regulators on Wednesday cast doubt on the rigor of Britain’s review and said that the authorization was limited to specific batches of the vaccine, a claim that Pfizer denied and British officials did not address.
수요일, 유럽의 규제위원회들은 영국이 제대로 조사했는지에 대해서 의문을 던지며, 그 승인은 그 백신에 대한 특별한 접종에만 제한되었다고 말했는데, 파이자사는 이를 부인했으며, 영국 관리들은 언급하지 않았다.
rigor [rígər] 엄격함, 어려움, 고됨
batch 1회분, 한 묶음, 한 다발
Britain’s move provoked a spirited debate among American scientists about whether U.S. regulators, who are known to be unusually meticulous, could afford to hold off any longer on authorizing a vaccine against a virus that is claiming more than 10,000 lives a day worldwide.
영국의 이러한 움직임은 미국 과학자들 사이에 다음과 같은 열띤 논쟁을 불러일아켰다 - 특별히 주의 깊은 것으로 알려져있는 미국의 규제 위원회가 전세계적으로 하루 10,000 명 이상의 목숨을 앗아가고 있는 바이러스에 대한 백신 승인을 더이상 유보하고 있을 수 있을 것이가.
provoke 자극하다, 유발하다, 촉발시키다
meticulous [mətíkjuləs] 주의 깊은, 꼼꼼하게 신경쓰는
American regulators have argued that they lag behind — if only by a matter of days — because they are virtually alone in reanalyzing thousands of pages of raw data from vaccine trials before approval. Backers of that approach say it is the only way to minimize unintended damage, in lives and in public trust, from vaccines not working.
미국의 규제위원회는 그들이 -설령 단 며칠 차이라고 하더라도- 그들이 뒤쳐져있는 상태이며 그 이유는 백신에 대한 승인 이전에 수천페이지에 관한 자료들을 재분석하는 실제로 유일한 기관이기 때문이라고 주장했다.
이러한 주장에 대한 지지자들은 이것이 제대로 효과를 내지 못하는 백신때문에 생명이나 공공의 신뢰상에 있어서의 의도치 못한 손상을 최소화 시키는 유일한 방법이라고 주장한다.
British and European regulators lean more heavily on the companies’ own analyses, auditing their figures occasionally but otherwise grounding their decisions on vaccine makers’ reports. While the more cautious American approach can be valuable, some scientists said the Europeans subject vaccine makers to considerable scrutiny, and it is imperative to move quickly to curb the suffering wrought by the pandemic.
영국과 유럽의 규제위원회는 보다 더 그 회사(파이자) 자체의 분석을 믿고 있는데, 가끔씩은 제조사들이 보고하는 수치를 면밀히 조사하지만, 그렇지 않는 경우, 그들의 결정을 백신 제조사의 보고에 의존한다.
일부 과학자들은 이렇게 말한다 - 보다 더 신중한 미국식 접근방법이 더 좋겠지만, 유럽인들은 백신제조사들을 좀 더 면밀하게 조사하여야 하고, 현재의 전 세계적인 유행병의 상황때문에 빚어진 고통을 줄이기 위해서는 빠른 움직임이 필수적이다.
audit [ɔ́ːdit] 회계감사, 철저한 검사
subject A to B A를 B에 종속시키다, 복속시키다, 맡기다
scrutiny [skrúːtəni] 정밀 조사
imperative 명령의, 명령조의, 긴급한, 필수의
curb 보도의 연석, 억제하다, 억누르다
wrought [rɔːt] (상황, 변화등을) 가져오다, 불러오다 / 만들어진, 형체가 갖추어진
“When you say it’s OK to wait another week or two, you’re saying it’s OK that many thousands of people are going to die,” said Dr. Walid F. Gellad, who leads the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh.
No country until Wednesday had authorized a fully tested coronavirus vaccine; Russia and China approved vaccines without waiting for large-scale efficacy tests.
“Help is on its way with this vaccine — and we can now say that with certainty, rather than with all the caveats,” the British health secretary, Matt Hancock, said Wednesday.
While the go-ahead bodes well for Britain, which broke from the European Union’s regulatory orbit to approve the vaccine early, it will have no effect on the distribution of the hundreds of millions of doses that the United States and other wealthy countries have procured in prepaid contracts.
It also offers little relief to poorer countries that could not afford to buy supplies in advance and may struggle to pay for both the vaccines and the exceptional demands of distributing them.
Roughly 800,000 doses of the Pfizer vaccine, developed with BioNTech, a smaller German firm, were being packaged at the company’s Belgian manufacturing plant on Wednesday for shipment to Britain. How and when they will arrive is a secret for security reasons, the company said.
The complicated logistics of moving, defrosting and preparing the vaccine meant it was going to be given only at 50 British hospitals to begin with. The vaccine must be transported at South Pole-like temperatures, and in trays of 975 doses.
First to be vaccinated will be doctors and nurses in the country’s National Health Service, along with nursing home workers and people 80 and over with previously scheduled doctors’ appointments. A government advisory committee has suggested that older or more vulnerable health workers, and doctors and nurses who work with fragile patients, would be among the first in line.
But the government has not said when other employees of the National Health Service would be eligible for vaccines. Essential workers, like teachers, transport workers and first responders, would not be vaccinated until after people 50 and over and those with underlying health problems received shots.
The advisory committee plans had made nursing home residents a top priority, but they will have to wait until the government begins distributing vaccines beyond hospitals. Pfizer and BioNTech have suggested that is possible, given that the vaccine can be stored for five days in a normal refrigerator.
Eventually, people will get their shots in mass vaccination centers being set up by the military at soccer stadiums and racecourses, or at doctors’ offices and pharmacies.
“We’ve been waiting and hoping for the day when the searchlights of science would pick out our invisible enemy, and give us the power to stop that enemy from making us ill,” Prime Mister Boris Johnson said on Wednesday. “And now the scientists have done it.”
For Britain, which has suffered one of Europe’s highest per capita death tolls from the virus, the decision by its drug regulator was the latest evidence of a vaccination strategy that has been the most aggressive in the West.
Britain remains under the authority of the European Union’s drug regulator until it consummates its split from the bloc on Dec. 31. But the government recently strengthened an old law that allows it to step out from under the bloc’s regulatory umbrella in public health emergencies. That allowed it to fast-track a review of the Pfizer vaccine, which was 95 percent effective in a late-stage clinical trial.
Britain had pre-ordered 40 million doses of the vaccine and 315 million doses of competing vaccines, spreading its bets to assure it can inoculate the country’s 67 million people.
British ministers cast the speed of the Pfizer approval as an early example of the new flexibility the country will have once it fully untethers itself from European regulation. Yet Brexit has also exacted costs, starving Britain’s drug regulator of money it used to draw from contracts with the European Union.
British regulators are also vetting a vaccine developed by the University of Oxford and AstraZeneca, a British-Swedish company. It is cheaper and easier to store than Pfizer’s, so much of the world could rely on it, but its regulatory path forward in the United States is unclear after scientists and industry analysts questioned promising early results.
The chemistry underlying Pfizer’s vaccine had never before produced an approved shot, but scientists have experimented with it for years, testing vaccines that did not make it to market. In order to coax cells to make a viral protein, called a spike, and elicit an immune response, this class of vaccine delivers genetic instructions, known as messenger RNA, encased in tiny fat globules.
BioNTech made a prophetic bet on the technology and joined forces with Pfizer, one of the world’s largest drug companies; they ended up delivering stunning results, on a timeline that was unheard-of before this year.
The U.S. Food and Drug Administration plans to decide on emergency authorization for the Pfizer vaccine shortly after a meeting of an advisory panel on Dec. 10. American officials have said vaccinations could begin within 24 hours after approval.
Another American company, Moderna, and the National Institutes of Health have also developed a messenger RNA vaccine that has proved effective in large trials. The F.D.A. will consider their application for emergency authorization shortly after Pfizer’s.
The European Medicines Agency, which regulates vaccines across the European Union, is expected to make a decision about the Pfizer vaccine later in December.
Pfizer has said it expects to be able to produce up to 50 million doses this year, about half of them going to the United States. Since each person needs two doses, a month apart, up to 25 million people worldwide could begin vaccination before 2021.
The United States has bought 100 million doses in advance from Pfizer, and the European Union 200 million doses.
The approval arrived at a perilous moment in the pandemic in Britain, where the virus has killed nearly 70,000 people, and hundreds more die each day. A third of England’s hospital systems were caring for more Covid-19 patients in recent weeks than at the height of the first wave in the spring.
A monthlong shutdown of restaurants and pubs has stanched the spread of the virus, but that is being replaced by a less stringent system of localized restrictions, with allowances for Christmastime travel that scientists fear will seed another uptick in infections.
In a clinical trial, the Pfizer-BioNTech vaccine proved highly 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 caused no serious side effects.
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 disinformation about vaccines, just over half of people have said in surveys they would definitely accept an inoculation.
Safety concerns have been accentuated by the speed of vaccine testing and approval, despite Britain’s regulators saying repeatedly they were not taking shortcuts.
Beyond those challenges, manufacturers will quickly need to eventually make billions of doses and move them to hospitals, clinics and pharmacies.
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 injection, requiring transportation in boxes stuffed with dry ice.
Matina Stevis-Gridneff contributed reporting from Brussels, Katie Thomas from Chicago and Rebecca Robbins from Bellingham, Wash.
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