LONDON – The first rigorously tested coronavirus vaccine was given the green light for use in the UK on Wednesday. The vaccine doses of the American pharmaceutical giant Pfizer and a small German company, BioNTech, will be injected from next week, the government said.
When the UK jumped before the United States to allow mass vaccination, it increased pressure on American drug regulators, who were called to the White House by President Trump’s chief of staff on Tuesday to explain why they were unwilling to do the same.
Why did the UK approve a vaccine before the US?
The two countries study vaccines differently. While American regulators sift through vaccine manufacturers ‘raw data to validate their results, their counterparts in the UK and elsewhere rely more on the companies’ own analyzes.
The US Food and Drug Administration also consults an external panel of experts before making a decision. In the case of the Pfizer vaccine, this panel will meet on December 10th. UK regulators also seek opinions from a technical committee, but this group has the flexibility to review data and meet as needed. In total, the committee met for more than 40 hours on the Pfizer vaccine, its chairman said on Wednesday.
Like the US regulators, their UK counterparts, whose decisions are seen as influential, have checked the vaccine dates upon arrival. Experts have batch tested vaccines for quality and read more than 1,000 pages of data. And different teams worked in parallel instead of waiting for other parts of the review to complete.
“If you are climbing a mountain, prepare and prepare,” said Dr. June Raine, executive director of the UK drug and health products regulator, on Wednesday. “We started this in June.”
When the first results came in on November 10, she said, “We were in base camp.” And later she said, “When we got the final analysis, we were ready for the final sprint.”
What about the rest of Europe?
The UK has left the European Union’s regulatory orbit to get early approval for a vaccine as the bloc gives countries emergency powers in the event of a pandemic. Once the UK separates from the European Union on December 31st, those vaccine-only powers will become permanent.
The countries remaining in the European Union are waiting for their regulator, the European Medicines Agency, to approve a vaccine. Like the F.D.A. the European regulator has scheduled a meeting to consult outside experts and provide an opinion on the Pfizer vaccine. That will happen on December 29th.
The agency’s work is complicated by its obligation to share the views of all 27 E.U. Countries. That process was accelerated during the pandemic, but it will be a few more days for countries to weigh in after the December 29 meeting, which will likely delay vaccinations until early January.
When will the first cans arrive in the UK?
Pfizer plans to ship 800,000 cans to the UK in the coming days. As of Tuesday evening, these cans were being prepared for shipment at a factory in Puurs, Belgium, BioNTech said.
The cans are packed in cardboard boxes of several thousand cans each, with dry ice keeping them at the south pole-like temperatures they need before they are put on trucks or planes and taken to the UK. They will arrive at state distribution warehouses over the weekend, Pfizer said on Wednesday.
UK hospitals have already started emailing staff to inform them of vaccination schedules. A London hospital system states that the first doses are given at 7 a.m. on Monday. The UK has placed pre-orders for 40 million doses of the Pfizer vaccine, but most of them are expected to be administered over the next year. Each patient needs two, one month apart.
Will UK approval affect delivery of the vaccine by other countries?
The British decision will not in itself bring vaccinations any closer. However, Pfizer executives said Wednesday they had heard from other countries that they wanted to speed up their own approval processes in light of the UK launch.
American regulators, despite months of pressure from Mr. Trump, have claimed that they are following their plan and using Pfizer’s vaccine to F.D.A. standards. will check.
The US has pre-ordered 100 million doses of the Pfizer vaccine. Most of the supply will come from a separate factory in Kalamazoo, Michigan. Still, many questions remain unanswered as to how vaccine manufacturers like Pfizer will fulfill the orders of wealthier nations that have pre-sourced supplies.
The UK decision offered 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 requirements for their distribution.
Who will be vaccinated first in the UK?
A government advisory board published his List of vaccine priority groups On Wednesday. Nursing home residents and workers are at the top of the list, followed by people over 80 and health and social care workers.
In practice, however, government officials have indicated that frontline hospital workers may receive vaccines faster due to the difficulty of storing Pfizer vaccine and bringing it to nursing homes and other locations. It must be stored at around minus 70 degrees Celsius until days before the injection.
Pfizer has said the vaccine can survive for five days in a regular refrigerator. However, the UK’s National Health Service still needs to consider issues such as staffing off-hospital sites and transportation difficulties within the country to decide how to administer the vaccine.
The National Health Service has around 150,000 doctors and more than 330,000 nurses and midwives.
