The UK Becomes the First Country to Approve Pfizer/BioNTech Vaccine

By Adriaan Brits Wednesday, December 2, 2020

The United Kingdom became the first country in the world to officially approve Pfizer-BioNTech’s coronavirus vaccine on Wednesday. The government said the most vulnerable groups are expected to get the vaccine early next week.

40 Million Doses Ordered

UK Prime Minister Boris Johnson said the authorization represents a major triumph as the pandemic took almost 1.5 million lives worldwide, battered the global economy, and disrupted normal life.

“It’s fantastic,” Johnson said. “The vaccine will begin to be made available across the UK from next week. It’s the protection of vaccines that will ultimately allow us to reclaim our lives and get the economy moving again.”

The UK officials said the most vulnerable and first groups to get the vaccine include older people, people in home care, and health care workers. Furthermore, the British government originally signed the contract for 30 million doses of Pfizer/BioNTech vaccine in July, a number which was raised to 40 million doses in October.

Less than a month after Pfizer released its data from final phase trials, which showed that their vaccine was more than 90% effective, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) gave the emergency use approval.

The global leaders were in a rush over recent months to develop a vaccine as it represents a crucial first step towards recovery. Becoming the first Western country to approve the use of the vaccine may be seen as a major win for Johnson’s government after he faced heavy criticism over the ways he dealt with the crisis.

Pfizer and BioNTech said the approval of a vaccine, after only a year of the outbreak in China, represents a big triumph for science.

“This authorization is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the UK,” said Pfizer’s Chief Executive Albert Bourla.

“The data submitted to regulatory agencies around the world are the result of a scientifically rigorous and highly ethical research and development [program],” said Ugur Sahin, CEO and co-founder of BioNTech.

However, the European Union’s drugs regulator wasn’t happy with the speed at which the approval was obtained, saying longer procedures to authorize the use of the vaccine were more adequate as the approval should be based on more tests and data.

FDA Chief Summoned to White House

According to Axios, Mark Meadows, White House Chief of Staff, called a meeting with the FDA Commissioner Dr. Stephen Hahn to talk about why the agency failed to approve the use of Pfizer’s vaccine earlier.

An administration official said Dr. Hahn’s preparation for the meeting included discussion points focused solely on therapies and vaccines. Hahn reportedly wanted to provide Meadows with an update “on where things stand.”

“Let me be clear — our career scientists have to make the decision and they will take the time that’s needed to make the right call on this important decision,” Hahn told news agency Axios.

Accordingly, Meadows wanted to ask Hahn why he spent a week working remotely from North Carolina last month, implying that the commissioner was on a vacation during a crucial period for vaccine authorization.

However, FDA spokesman Michael Felberbaum said it wasn’t a vacation, but that instead, Hahn has “recently quarantined out of an abundance of caution following a potential exposure to COVID-19 while working at the FDA’s White Oak campus.”

The US Food and Drug Administration (FDA) scheduled a meeting on December 10, where the agency is expected to decide whether it will recommend the emergency use approval of Pfizer’s vaccine, while the European Medicines Agency said it could approve the emergency use by December 29.

Summary

The UK is the first country to approve the emergency use of Pfizer-BioNTech’s coronavirus vaccine, marking a historical moment in the fight against the pandemic. Elsewhere, the White House Chief of Staff Mark Meadows has reportedly summoned FDA commissioner Dr. Stephen Hahn to discuss why the agency failed to authorize the emergency use of the vaccine earlier in the US.

About the Author


Headshot for author Adriaan Brits
As an analyst of global affairs, Adriaan has an MSC from Oxford, with diverse interests in the digital economy, entertainment, and business. He is a specialist trainer in Advanced Analytics & Media.

Related Articles