GP Insights # 446, 6 December 2020
On 2 December, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) granted emergency-use authorization to the COVID-19 vaccine jointly developed by Pfizer and BioNTech, seven months after clinical trials. The UK became the first country to grant vaccine approval to Pfizer and BioNTech with an expected roll out from early next week. Marching ahead of the US and Germany, where both companies are based, the approval prompted international criticisms from both the EU and the US. Peter Liese, a member of the European Parliament's public health committee, called the UK's approval 'hasty'; and the head of the US National Institute of Allergies and Infectious Diseases, Anthony Fauci, called the process a "kind of ran around the corner of the marathon and joined it in the last mile." The UK defended its regulators and moved to order 40 million doses of the Pfizer and BioNTech jabs which can vaccinate 20 million people. Additionally, 100 million doses have been ordered for the shot developed by AstraZeneca PLC and the University of Oxford.
What is the background?
First, rising COVID-19 cases and strain on the UK's health service. The UK remains the only country in Europe to have crossed the 50,000 of COVID deaths with more than 1.6 million confirmed cases. Its National Health Services (NHS) has been burdened with overcrowded beds, tiring doctors and nurses. The emergency approval marks a moment of triumph for the administration, which has been criticized for mishandling the crisis and straining the NHS.
Second, the domestic divisions over COVID-19 restrictions and vaccine rollout. Earlier this month, Prime Minister Boris Johnson resisted a parliamentary rebellion from the Conservative party over new restrictions to combat the virus. The Tory parliamentarians voted against the new tiered system due to replace the current month-long national lockdown. Johnson's reputation within the party had plunged a record low over handling of the pandemic, the BREXIT trade talks and also the weakening economy. In this context, the fast-tracked authorization becomes one triumph to coalesce internal Tory divisions and wavering public opinion.
Third, quick approval by the UK and EU's vaccine scepticism. The UK has been laying the groundwork for authorization for some time with organized test runs, logistics of delivering a shot and storage at an ultralow temperature. The MHRA's independent regulatory mechanism aided in pacing the approval process as it remained in constant connection with Pfizer and BioNTech from October unlike the European Medicines Agency (EMA). Even though the education secretary credited BREXIT for the expedited approval, the UK has been able to work around the European law by making the authorization for emergency cases, an area that is vaguely defined in the EU regulation of human medicines. The UK remains one of the few European countries with large public support for vaccines. This is unlike France and Germany, where anti-lockdown protests and vaccine sceptics have made it hard for administrations to roll out changes quickly.
What does it mean?
Quick approval by the UK has shown the world what is needed: a bureaucracy that will work for a health emergency. Challenges remain for the UK to ease access for the low-income group. However, the vaccine authorization is an important moment for the UK because it shows that the country can work without delays and defeats that have distinctively marked its political history since the beginning of the BREXIT. The authorization of the vaccine being within the ambit of EU law is not an argument in favour of BREXIT, but an indication of what the UK wants to do in future.