Moderna pushes for urgent approval of its vaccine
Moderna announced it will apply for emergency approval of its Covid-19 vaccine yesterday after results from its late stage study showed it is 94.1 per cent effective against coronavirus. The vaccine has no serious side effects.
The company has also reported a 100 per cent success rate in preventing severe cases of Covid-19.
The company’s filing means it’s likely the drug will be the world’s second vaccine to receive emergency use authorisation in the US this year. Moderna also announced its intention to apply for emergency authorisation in Europe.
“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.
“We expect to be playing a major part in turning around this pandemic.”
The announcement from Moderna follows news from other pharmaceutical companies Pfizer Inc and BioNTech SE that their vaccines are 95 per cent effective. Pfizer applied for emergency use authorisation shortly after announcing its vaccine’s effectiveness.
What comes next
The FDA has pledged that before it decides to roll out any Covid-19 vaccines, its scientific advisers will publicly debate whether there’s enough evidence behind each candidate.
First up on December 10, Pfizer and BioNTech will present data suggesting their vaccine candidate is 95 per cent effective. Moderna will present data on December 17.
Rationing initial doses
If the FDA allows emergency use, Moderna expects to have 20 million doses ready for the US by year’s end. Recipients will need two doses, so that’s enough for 10 million people.
Pfizer expects to have 50 million doses globally in December. Half of them — or enough for 12.5 million people — are earmarked for the US.
Shipments are set to begin to states within 24 hours of FDA clearance.
The US is expected to reserve scarce first doses for health care workers and, if the shots work well enough in the frail elderly, for residents of long-term care facilities.
As more vaccine gradually becomes available in coming months, other essential workers and people at highest risk from the coronavirus would get in line. But enough for the general US population isn’t expected until at least March.
Outside the US, Zaks said significant supplies from Moderna would be available later, “in the first quarter” of next year.
“Obviously we are doing everything in our power to increase the capacity and accelerate the timelines,” he said.
Britain’s government has ordered 7 million doses from Moderna and 40 million doses of the Pfizer-BioNTech vaccine, although it’s not clear how much of the companies’ limited December supply could go toward that order. British hospitals are gearing up to receive some doses as early as next week.
The Oxford University and AstraZeneca vaccine, which has been shown to be 70 per cent effective, could be available to Australians as soon as March next year.—