The US has the largest number of Covid-19 vaccines in late-stage clinical development compared to other top pipeline geographies, according to GlobalData’s Pipeline Drug Database in the Pharma Intelligence Center. The EU follows closely behind the US with the second largest number of late-stage Covid-19 vaccines. This will lead to the earliest possible distribution of the vaccine. Pfizer/BioNTech’s Covid-19 vaccine became the first mRNA vaccine in the world to receive emergency use approval from the UK Medicines & Healthcare Products Regulatory Agency (MHRA) on 2 December 2020. The FDA and European Medicines Agency (EMA) plan to commence Covid-19 vaccine roll-out before the end of the year, so the race is on for those bio/pharma companies to seek out authorisation from regulators within the coming weeks.
The US currently has a total of twelve Covid-19 vaccines in Phases II and III compared to the EU, which has eleven, as shown in Figure 1. The approval of a Covid-19 vaccine by the EMA would mean authorisation of the vaccine for all current 27 European member states. The UK withdrew from the EU on 31 January 2020 and is in a transition phase until 31 December 2020. However, the UK recently modified legislation allowing the MHRA to issue temporary UK-only authorisation before any approval from the EMA in the case of urgent public need.
Figure 1: Total Number of Phase III and II Covid-19 Vaccines By Pipeline Geography.
Pipeline Geography is the Geography intended for market.
Credit: GlobalData, Pharma Intelligence Center Deals Database (Accessed: 27 November 2020).
Pfizer and BioNTech have submitted for both US and EU emergency use authorisation (EUA), with the FDA’s decision to be made on 10 December 2020 for their Phase III mRNA Covid-19 vaccine BNT-162b2. Moderna is following suit with both US and EU authorisation submissions, with FDA’s decision to be made on the 17 December, for their Phase III mRNA-1273 Covid-19 vaccine on 30 November 2020 based on their positive primary Phase III vaccine efficacy results showing a 94.1% efficacy against Covid-19.
The EMA, which licenses drugs across the EU, will decide next month whether to approve Pfizer and BioNTech’s BNT-162b2 and Moderna’s mRNA-1273. Pfizer said 50 million vaccine doses will be available by the end of the year and 1.3 billion in 2021, and Moderna plans to have 20 million vaccine doses for the US by the end of 2021, and 500 million to one billion doses globally in 2021. The US Operation Warp Speed program has spent over $10B to help vaccine development, manufacturing, and distribution in reaching its goal to deliver 300 million doses by January 2021 within the US.
The World Health Organization (WHO), the GAVI vaccines alliance, and the Coalition for Epidemic Preparedness Innovations (CEPI) are running COVAX, a procurement scheme for high-, middle-, and low-income countries. So far, 184 countries including the EU and Japan have signed up, but the US has not joined the alliance. However, the results of the US election may mean that the US will join COVAX soon; talks are expected with President-elect Joe Biden’s team about the COVAX plan. Higher-income countries have paid upfront to reserve their doses; these funds will pay for manufacturing scale-up. Nine candidate vaccines are currently being supported by CEPI with the aim of at least three viable vaccines. COVAX has signed formal agreements with vaccine manufacturers and sponsors to secure two billion doses by the end of 2021.