The UK Simply Permitted the Pfizer Covid Vaccine. What Occurs Subsequent?

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 put 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.

The two countries study vaccines differently.

Rather than accepting the vaccine manufacturers’ results, American regulators are carefully re-analyzing the raw data from the studies to validate the results, considering what regulators described as thousands of pages of documents. Dr. Stephen Hahn, the commissioner for the Food and Drug Administration, said Tuesday that the FDA is “one of the few regulators in the world actually looking at the raw data.”

Regulators in the UK and other European countries rely more on in-house analysis. Instead of sifting through the raw study data and figuring out the numbers themselves, regulators often examine a drug manufacturer’s reports and, if there are no anomalies, justify their decisions in company-provided documents.

Whether the UK was rushing to approve a vaccine or whether the US was wasting valuable time as the virus kills around 1,500 Americans a day sparked a lively debate among scientists and industry experts on Wednesday. European regulators said UK approval is so limited that it only applies to certain lots of the vaccine, a claim Pfizer denied and which UK officials failed to address.

Dr. Paul Offit, a professor at the University of Pennsylvania and a member of the FDA’s Vaccine Advisory Council, said in an interview Wednesday that regulators’ success in getting vaccines approved while minimizing unforeseen errors justifies a rigorous approach.

“It is remarkable that we were able to access viruses with so few casualties,” he said, adding that American regulators were only days away from completing their own review.

The FDA has scheduled a meeting of an independent panel of experts on December 10th to review Pfizer’s vaccine. UK regulators also seek opinions from a technical committee, but this group has the flexibility to review and meet data as needed so that it can be implemented more quickly.

“In the UK, they could just say, ‘We have the data, we have the meeting,” said Stephen Evans, Professor of Pharmacoepidemiology at the London School of Hygiene & Tropical Medicine.

To speed up the process, the UK Medicines and Health Products regulator had their experts review vaccine dates as soon as they were available, and separate teams worked in parallel on different parts of the process rather than waiting for another to complete.

“If you are climbing a mountain, prepare,” said Dr. June Raine, executive director of the agency, 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.”

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 31, 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 FDA, the European regulator has scheduled a meeting on December 29th to consult outside experts and provide an opinion on the Pfizer vaccine.

The agency’s task is made more difficult by its obligation to seek the views of all 27 EU countries. This process was sped up during the pandemic, but it will be a few more days for countries to weigh in after the meeting, which will likely delay vaccinations until early January.

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 packaged in cardboard boxes, using dry ice to keep them at the south pole-like temperatures they need, before being placed 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 on Monday at 7 a.m. 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.

A government advisory council released its list of vaccine priority groups on Wednesday. At the top of the list are residents and workers of nursing homes, followed by people over the age of 80 and health and social care workers.

In practice, however, government officials said Wednesday that they would initially limit vaccinations to a network of 50 hospitals due to the difficulty of storing and shipping the Pfizer vaccine. As a result, nurses, doctors, nursing home staff, and people 80+ who had made appointments would come first for the vaccine before residents of the nursing home.

Pfizer has said the vaccine can survive for five days in a regular refrigerator. However, the UK’s National Health Service has yet to consider issues such as staffing at locations outside the hospital 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.

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 the face of UK approval.

American regulators, despite months of pressure from Mr. Trump, have claimed that they will follow their plan and review Pfizer’s vaccine to FDA standards.

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.

Comments are closed.