Pfizer/BioNTech Vaccine First to Get Approval for Roll-Out in UK

Pfizer/BioNTech Vaccine First to Get Approval for Roll-Out in UK
Vials of COVID-19 vaccine and a medical syringe are seen in front of a displayed Pfizer logo on Oct. 31, 2020. (Dado Ruvic/Reuters)
Mary Clark
12/2/2020
Updated:
12/2/2020

The Pfizer/BioNTech vaccine is the first to be approved by the UK regulator and will be available for use in the UK within days, the government said on Wednesday.

“The government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer/BioNTech’s COVID-19 vaccine for use,” a UK government spokesperson said in a statement.

“This follows months of rigorous clinical trials and a thorough analysis of the data by experts at the MHRA who have concluded that the vaccine has met its strict standards of safety, quality, and effectiveness.”

Albert Bourla, Pfizer’s chairman and chief executive officer, praised the MHRA for its speed in approving the vaccine.

“Today’s Emergency Use Authorisation in the UK marks a historic moment in the fight against COVID-19,” he said.

“This authorisation 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.”

Roll-out of the first approved vaccine in the Western world against the CCP (Chinese Communist Party) virus will begin next week across the UK.

It will start with people in priority groups such as care home residents, health care staff, older people, and the clinically vulnerable, the government spokesperson said.

To support the success of its impending immunisation programme, the government called on people to continue to follow local restrictions put in place to slow the spread of the virus and said it would give further details in due course.

The Pfizer/BioNTech vaccine is the first to be approved for use in the population among several vaccine candidates.

Last month it showed 90 percent effectiveness in large Phase 3 studies, and the UK government ordered 40 million doses.

‘Hope Has Been Realised’

Scientists have welcomed the news.
“This is a momentous day for us all,” professor Arne Akbar, president of the British Society for Immunology, said in a statement.

“COVID-19 has impacted all our lives in so many ways and hope of an exit strategy has relied on a safe and effective vaccine. Today that hope has been realised.”

Dr. Michael Head, a senior research fellow in global health at the University of Southampton, said, “This is excellent news and a huge landmark in the global efforts to address this pandemic.”

He added, however, that “the Pfizer vaccine does require storage at around -70C, which will pose significant logistical challenges for all countries that choose to use it.”

Countries where vaccine trials have been taking place include the UK, the United States, Italy, Canada, Germany, Cuba, and Australia.
Britain had recently secured 355 million doses of a combination of seven vaccine candidates including the one now approved from Pfizer/BioNTech.
Other vaccines in Phase 3 trials that are still awaiting regulatory approval before they can be rolled out include the Oxford/AstraZeneca, Moderna, and Novavax candidates.