UK grants emergency authorization for Pfizer and BioNTech’s BNT162b2 Covid-19 vaccine

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted emergency use authorization (EUA) for the BNT162b2 Covid-19 vaccine candidate, developed by Pfizer and BioNTech. This critical decision comes after the release of positive results from the global phase 3 clinical trial, which demonstrated the vaccine’s efficacy in preventing Covid-19 infections.

With the vaccine’s emergency use approval now in place, Pfizer and BioNTech are poised to distribute the first doses of the BNT162b2 vaccine in the UK. The companies are also expecting further regulatory decisions across the globe in the coming weeks. According to the companies, they are ready to deliver doses following other necessary regulatory authorizations or approvals.

This significant milestone was made possible by the rolling submission process that included the phase 3 trial data. The results showed a 95% efficacy rate in preventing Covid-19, both in participants with and without prior exposure to the virus, meeting the primary and secondary objectives of the trial. The vaccine’s efficacy was measured seven days after participants received their second dose, reinforcing its reliability and effectiveness.

Pfizer’s Chairman and CEO, Albert Bourla, hailed the emergency use authorization as a historic moment in the fight against the pandemic. He emphasized the company’s ongoing commitment to moving swiftly and safely to ensure high-quality vaccine delivery worldwide. Bourla noted, “With thousands of people becoming infected every day, every day matters in the collective race to end this devastating pandemic.”

In addition to the emergency use authorization, the UK government is set to prioritize vaccine distribution according to guidance from the Joint Committee on Vaccination and Immunisation (JCVI). This decision is aimed at ensuring that the most vulnerable populations receive the vaccine first.

In July 2020, Pfizer and BioNTech entered into an agreement with the UK government to supply 30 million doses of BNT162b2, contingent upon the vaccine’s approval. By October, this agreement was expanded to 40 million doses, with distribution set to begin in December 2020 and continue throughout 2021. The companies expect to fulfil their delivery commitments within the specified time frame, marking a significant step towards widespread vaccination.

Looking forward, Pfizer and BioNTech are seeking emergency use authorization from the US Food and Drug Administration (FDA) and have also submitted a conditional marketing authorization (CA) request to the European Medicines Agency (EMA). These actions signal the companies’ readiness to expand their vaccine distribution further as regulatory approvals are granted in additional regions.

Ugur Sahin, CEO and co-founder of BioNTech, expressed confidence in the vaccine’s impact, saying that the authorization marks the first opportunity for citizens outside of clinical trials to be vaccinated. Sahin added that the vaccine rollout in the UK would help reduce hospitalizations in high-risk populations. “We aim to bring a safe and effective vaccine upon approval to the people who need it,” he said.

The ongoing global rollout of the BNT162b2 vaccine marks a monumental achievement in the fight against the Covid-19 pandemic, with both Pfizer and BioNTech committed to delivering the vaccine to the populations who need it the most.