“Today’s authorization is a landmark moment in our company’s history and in the global fight against COVID-19,” said Stéphane Bancel, CEO, Moderna yesterday [January 4]. “This is the third regulatory authorization for the COVID-19 Vaccine Moderna, and its first outside of North America. We hope to continue to see authorizations in additional markets in the coming days, weeks and months.”
The MOH has secured 6 million doses of COVID-19 Vaccine Moderna. First deliveries are expected to begin shortly, said the biotech.
The decision from the MOH is based on a rolling submission of data and on the totality of scientific evidence shared by the US biotech, including a data analysis from the pivotal Phase 3 clinical study announced on November 30, 2020.
The European Medicines Agency (EMA) is due to deliver its conclusions on Moderna’s request for authorization of Moderna's vaccine in the EU-27 tomorrow [January 6]. The US authorized the emergency use of the vaccine on December 18, while Canada did so on December 23, 2020.
Additional authorizations for COVID-19 Vaccine Moderna are currently under review in Singapore, Switzerland and the UK.
Israel secured supplies of the Pfizer-BioNTech vaccine following negotiations very early on in the pandemic. It is now winning the race in terms of global vaccination campaigns, having inoculated a higher proportion of its population against COVID-19 than any other country.
However, media reports indicate that the country is delivering shots so quickly its supply of the Pfizer-BioNTech vaccine is challenged. Health officials there were reportedly looking at interim solutions such as delaying giving the first round of shots to younger people to deliver the second jabs to the elderly, as per the two-dose regime recommended with that vaccine.
Yesterday, Moderna provided a supply update for its COVID-19 vaccine candidate, increasing its base-case global production estimate from 500 to 600 million doses for 2021. The biotech said it was continuing to invest and add staff to build up to potentially 1 billion doses for 2021.
The company said it expects about 100 million doses to be available in the US by the end of Q1 2021, with 200 million doses in total available there by the end of Q2. It reported that around 18 million doses have been supplied to the US government to date.
Moderna has partnered with Lonza for production inside and outside the US. Fill-finish services are provided by Catalent in the US, and by ROVI and Recipharm outside the US.
The US government has agreed to purchase 200 million doses of the Moderna COVID-19 vaccine with options for potential purchase of an additional 300 million doses. The Canadian government has agreed to buy 40 million doses, while the EU Commission has ordered 160 million doses of it in total.