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Moderna filing for EU and US emergency approval of its COVID-19 vaccine

Jill Petzinger
·Germany Correspondent, Yahoo Finance UK
·2-min read
Staff set up an antibody production line at the Ibex building of Lonza, where the Moderna  mRNA coronavirus disease (COVID-19) vaccine will be produced, in Visp, Switzerland, September 29, 2020. REUTERS/Denis Balibouse
Staff set up an antibody production line at the Ibex building of Lonza, where the Moderna mRNA coronavirus disease (COVID-19) vaccine will be produced, in Visp, Switzerland, September 29, 2020. Photo: Denis Balibouse/Reuters

US-based Moderna (MRNA) said that it is filing today for authorisation for its COVID-19 vaccine with the US and EU medical regulatory bodies.

Final data from Moderna’s large-scale trial found the vaccine to be 94.1% effective at protecting people from the virus, barely any lower than the 94.5% it reported in its interims data. Today, the company reported a 100% efficacy rate in preventing severe cases of COVID-19.

READ MORE: Moderna’s COVID-19 vaccine nearly 95% effective in trials

“We believe that we have a vaccine that is very highly efficacious. We now have the data to prove it,” Moderna chief medical officer Tal Zaks said in a telephone interview, reported by Reuters. “We expect to be playing a major part in turning around this pandemic.”

“At this level of effectiveness, when you just do the math of what it means for the pandemic that’s raging around us, it’s just overwhelming,” said Zaks.

Moderna is the second company to file for emergency FDA authorisation, after Pfizer (PFE) and its partner, the vaccine developer BioNTech (BNTX) did so last last week.

READ MORE: Pfizer says their COVID-19 vaccine ‘94% effective in over 65s’

Both Moderna and BioNTech have developed vaccines based on messenger RNA (mRNA) technology – the first time this type of vaccine has been submitted for regulatory approval.

Messenger RNA vaccines transmit a genetic code to cells telling them to produce a protein, which in turn activates the immune system, whereas traditional vaccines involve putting weak or inactivated doses of a virus or bacteria into the body to make the immune systems produce antibodies.

Moderna’s vaccine may end up being an easier one for many countries to use because it can be stored at between 2C and 8C, which is the temperature of normal fridges, whereas the Pfizer/BioNTech vaccine needs to be kept mostly at -70C.

After Moderna announced its interims data in November, the European Commission signed an agreement to buy up to 160 million doses of its vaccine. The UK government reached a supply deal with Moderna for 5 million doses, which it expects to receive in spring 2021.

The EU Commission, which is buying vaccines for all 27 member states, will also take 300 million doses from BioNTech/Pfizer and 225 million doses from Germany’s CureVac (CVAC). It also has agreements with AstraZeneca (AZN.L), Sanofi-GSK (SNY) and Janssen Pharmaceutica, pending regulatory approval of their vaccines.

The US Food and Drug Administration is to meet on 10 December to assess Pfizer/BioNTech’s trial results, and a week later to review Moderna’s data.

Watch: Moderna seeks emergency use of COVID-19 vaccine