UK regulator Medicines and Healthcare Products Regulatory Authority (MHRA) has given emergency approval to Pfizer and BioNTech’s vaccine on December 2, making the UK the first Western nation to approve a COVID-19 vaccine for widespread use.
The UK purchased 40 million vaccine doses and is set to receive 10 million this year, with higher risk individuals such as care home residents and staff, people over 80 and other health and social care workers receiving priority. The first doses will be made available next week, according to the MHRA.
The vaccine — which demonstrated 95% efficacy in the phase 3 trials reported by Pfizer and BioNTech — took only 10 months to be developed, making it the fastest vaccine to have been developed in history.
Pfizer and BioNTech reportedly said that their manufacturing network can produce up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021. The UK has also ordered 7 million doses from another vaccine frontrunner, Moderna, whose vaccine makes use of a similar RNA technique as Pfizer’s and offers 94.5% efficacy, and is expected to receive those by the spring of next year. In addition, the country has ordered 100 million vaccine doses from Oxford University and AstraZeneca.
Pfizer and BioNTech have not made any commitments towards the non-enforcement of its patents or the granting of royalty-free licenses related to the COVID-19 vaccine, unlike other pharmaceutical companies developing COVID-19 vaccines such as Moderna and AstraZeneca.
Moderna pledged in October 2020 that it would not enforce its patents related to the COVID-19 vaccine during the pandemic and that it is committed to reducing IP barriers after the pandemic through vaccine licensing agreements. Similarly, AstraZeneca, who co-developed the vaccine with the public institution Oxford University, is committed to providing royalty-free and non-exclusive licenses related to the COVID-19 vaccine in line with its agreement with the university.
Other Vaccine Approval Developments To Watch
Pfizer and BioNTech have received orders of 100 million vaccine doses from the US and another 200 million doses from Europe, according to British media. Both are expected to grant their approvals in the coming weeks. Moreover, the MHRA is reported to be carrying out a rolling approval process for vaccines and is studying results from early trials as they come in.
Russia and China are both developing COVID-19 vaccines, with China approving one made by CanSino Biologics for military use in June 2020. CanSino Biologics is reportedly in talks with several countries for early approval since August 2020. The Russian Direct Investment Fund, who is jointly developing Russia’s Sputnik V COVID-19 vaccine with the Gamaleya Research Center, has submitted applications for accelerated registration under emergency use listing and prequalification to the World Health Organization in October 2020.