Following a recommendation from the national medicines regulator, the UK government has authorized the BioNTech/Pfizer vaccine for emergency use against COVID-19.

The United Kingdom is the first nation to approve this vaccine for broad application, establishing a pathway for the immunization of individuals considered to be at the greatest risk – such as residents of elderly care facilities and healthcare professionals on the front lines – before the year concludes.

According to reports from the BBC, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has confirmed the vaccine’s safety for distribution starting next week, although the specific groups initially receiving the vaccine remain to be determined.

BioNTech and Pfizer submitted their request for emergency authorization to the MHRA last month, alongside submissions to regulatory bodies in Australia, Canada, Europe, Japan, and the United States; however, none of these other entities have yet granted approval.

In a released statement, Albert Bourla, chairman and CEO of Pfizer, characterized the Emergency Use Authorization in the U.K. as “a pivotal moment in the battle against COVID-19”.

“This authorization represents a goal we have been diligently pursuing since we initially asserted that science would prevail, and we commend the MHRA for its thorough evaluation and prompt action to safeguard the health of the people of the U.K.,” he stated. “As we anticipate further authorizations and approvals, we remain dedicated to delivering a high-quality vaccine globally with the same sense of urgency. Every day is critical in the collective effort to overcome this devastating pandemic, with thousands contracting the virus daily.”

The UK’s approval is grounded in trial data, including a global Phase 3 clinical study conducted by BioNTech/Pfizer, which demonstrated a 95% efficacy rate for the vaccine and revealed no significant safety issues.

The vaccine’s effectiveness was also established in participants both with and without prior SARS-CoV-2 infection, based on measurements taken seven days after the completion of the second dose.

Reported efficacy remained consistent across various demographic groups, including age, gender, race, and ethnicity, with an observed efficacy exceeding 94% in adults aged 65 and older, according to the companies.

This morning, UK prime minister Boris Johnson announced the formal authorization via Twitter, stating that the vaccine “will begin to be distributed throughout the UK from next week”. A subsequent tweet indicated that widespread vaccination will “eventually” facilitate a return to normal economic activity.

The UK has procured 40 million doses of the BioNTech/Pfizer vaccine, sufficient to vaccinate 20 million individuals, as the vaccine requires a two-dose regimen; however, the complete delivery of these doses will occur over a period of time.

“The delivery of the 40 million doses will be phased throughout 2020 and 2021, to ensure equitable distribution of vaccines to regions with existing contracts,” the companies explained in a press release.

“With the vaccine now authorized in the U.K., we will promptly initiate the delivery of vaccine doses. Initial doses are anticipated to arrive in the U.K. within days, with complete fulfillment of the order expected in 2021,” they added.

The UK’s National Health Service is preparing for what NHS chief executive, Sir Simon Stevens, has described as “the largest vaccination program in our nation’s history”. The BBC reports that approximately 50 hospitals are prepared, and vaccination centers are being established in locations such as conference centers.

During remarks to journalists this morning, health secretary Matt Hancock stated that 800,000 doses of the vaccine will be available next week, with the majority of the rollout occurring in the new year. “We will deploy it at the rate at which it is manufactured,” he added.

Hancock indicated that the initial doses will be prioritized for “the most elderly” and residents of care homes, along with their caregivers. “Following that, priority will be determined by age range. NHS staff are also a high priority, as are individuals who are clinically extremely vulnerable… those particularly susceptible to coronavirus,” he added.

The vaccine necessitates two doses administered 21 days apart. At a press conference today, officials from the MHRA and the UK’s Joint Committee on Vaccination and Immunisation confirmed that full immunity develops seven days after the second dose, although they noted that partial immunity may arise several days after the first dose.

Dr. June Raine, CEO of the MHRA, stated at the press conference that the public can have “complete confidence” in the rigorous standards applied to the data review that led to the vaccine’s approval, describing them as “comparable” to those employed by international counterparts such as the US’ Food and Drug Administration, which has not yet authorized the vaccine for use.

The UK’s expedited process was attributed to months of preparation beginning in the summer, including the formation of teams and the expansion of capacity to enable parallel work streams, she explained.

When questioned about whether Brexit influenced the regulator’s quicker authorization compared to EU counterparts – a claim made by Hancock – Raine stated that the UK benefitted from being able to utilize provisions under European law that remain in effect until January 1 (when the Brexit transition period concludes).

The MHRA’s rapid approval relied on access to ongoing data and specialized expertise, she said, raising concerns about whether the UK’s impending departure from the EU may impede the approval of future COVID-19 vaccines.

“Our progress has been entirely dependent on the availability of data in our rolling review and the rigorous assessment and independent advice we have received, so I hope that clarifies the point about the European relationship,” Raine added.

Officials from the JVCI stated that logistical constraints related to the BioNTech/Pfizer vaccine’s requirement for ultra-cold storage (-70 degrees) may introduce some “flexibility” in implementing the initial phase of the vaccination program, which otherwise intends to offer it to priority groups in the following order:

The UK is sourcing its supply of the BioNTech/Pfizer vaccine from within the EU, specifically from a manufacturing facility in Belgium. It remains uncertain whether the approaching end of the Brexit transition period will present any logistical obstacles to a consistent future supply of the vaccine, potentially hindering Hancock’s plan to roll it out at the pace of manufacture. This uncertainty stems from ongoing negotiations between the UK and the EU regarding a potential post-Brexit trade agreement, with concerns about significant border delays resulting from customs checks in the event of a no-deal outcome.

Another outstanding question – not specific to the UK – is the duration of the vaccine’s protection. Given the rapid development of the BioNTech/Pfizer vaccine – within months – long-term data are currently unavailable to answer this question.

The same holds true for other COVID-19 vaccine candidates under development.

“The Emergency Use Authorization in the U.K. will represent the first opportunity for citizens outside of clinical trials to receive immunization against COVID-19,” said Ugur Sahin, M.D., CEO and co-founder of BioNTech in a supporting statement. “We believe that the implementation of the vaccination program in the U.K. will reduce the number of individuals in high-risk populations requiring hospitalization.”

“Our objective is to make a safe and effective vaccine available to those who need it upon approval. The data submitted to regulatory agencies worldwide are the result of a scientifically rigorous and ethically sound research and development program.”

This report was updated with additional detail from press conferences and ministers comments this morning