UK Approves COVID-19 Vaccine from Pfizer, BioNTech

Medicines & Healthcare Products Regulatory Agency (MHRA) in the UK has granted a temporary emergency use authorization to Pfizer and BioNTech for their COVID-19 mRNA vaccine, BNT162b2.

This is the first emergency use authorization following a worldwide Phase 3 trial of the vaccine to help fight the pandemic. 

“We have carried out a rigorous scientific assessment of all the available evidence of quality, safety and effectiveness. The public’s safety has always been at the forefront of our minds – safety is our watchword,” June Raine, MD, chief executive officer of MHRA, said in the announcement. 

The temporary emergency use authorization was done using a regulatory process known as a “rolling review,” which is used to complete the assessment of a promising drug or vaccine during a public health emergency, MHRA explained.  

The agency’s decision was based on data from Pfizer and BioNTech’s Phase 3 clinical study, which found that BNT162b2 elicited a vaccine efficiency rate of 95 percent in 170 participants without prior SARS-CoV-2 infection. 

Each case was measured from seven days after the second dose.

Efficacy was consistent across age, gender, race, and ethnicity demographics, with an observed efficacy in adults age 65 years and older of more than 94 percent.  

Overall, BNT162b2 was well tolerated with no serious safety concerns. 

“Today’s Emergency Use Authorization in the U.K. marks a historic moment in the fight against COVID-19,” Albert Bourla, chairman and chief executive officer of Pfizer, said in a press release. 

“As we anticipate further authorizations and approvals, we are focused on moving with the same level of urgency to safely supply a high-quality vaccine around the world. With thousands of people becoming infected, every day matters in the collective race to end this devastating pandemic,” he continued. 

Pfizer and BioNTech are anticipating more regulatory decisions globally in the near future. The companies recently applied for emergency use authorization in the US. 

The companies said they are ready to deliver vaccine doses following potential regulatory authorizations or approvals. 

The UK will receive 40 million doses of BNT162b2, per an agreement reached between the government and Pfizer at the end of July. 

The doses will be allocated in stages throughout 2020 and 2021 to ensure a fair distribution of vaccines to patients. The first doses are expected to arrive in the UK in the coming days and complete delivery is anticipated for 2021. 

In the US, HHS and the Department of Defense (DoD), announced an agreement with Pfizer for large-scale production and nationwide delivery of 100 million doses of BNT162b2 in the US at the end of July. 

Under the agreement, the government will pay Pfizer and BioNTech $1.95 billion upon the receipt of the first 100 million doses. The US government can also acquire an additional 500 million doses for Americans.

“The Emergency Use Authorization in the U.K. will mark the first time citizens outside of the trials will have the opportunity to be immunized against COVID-19,” said Ugur Sahin, MD, CEO and Co-founder of BioNTech.

“The roll-out of the vaccination program in the U.K. will reduce the number of people in the high-risk population being hospitalized. Our aim is to bring a safe and effective vaccine upon approval to the people who need it. The data submitted to regulatory agencies around the world are the result of a scientifically rigorous and highly ethical research and development program.”