Moderna requests emergency clearance for vaccine

 

Moderna Inc said it will apply for U.S. and European emergency authorisation of its COVID-19 vaccine on Monday based on full results from a late-stage study showing its vaccine was 94.1 per cent effective with no serious safety concerns.

It also reported a 100 per cent success rate in preventing severe cases. The filing sets Moderna's product up to be the second vaccine likely to receive U.S. emergency use authorisation this year.

"We believe that we have a vaccine that is very highly efficacious. We now have the data to prove it," Moderna Chief Medical Officer Dr. Tal Zaks said in a telephone interview. "We expect to be playing a major part in turning around this pandemic."

Zaks said he was emotional after seeing the 94.1 per cent result over the weekend: "It was the first time I allowed myself to cry. 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."

Moderna's announcement follows news from Pfizer Inc and German partner BioNTech SE that their vaccine, which also uses a new technology called synthetic messenger RNA (mRNA), was 95 per cent effective. Pfizer has applied for emergency use authorisation, putting it about a week ahead of Moderna.

In addition to filing its U.S. application, Moderna said it would apply for conditional approval from the European Medicines Agency, which has already begun a rolling review of data, and would continue to talk with other regulators conducting rolling reviews.

Moderna's latest efficacy result is slightly lower than an interim analysis released on Nov. 16 of 94.5 per cent effectiveness, a difference that Zaks said is not statistically significant.

 

INSIDE THE GLOBAL VACCINE RACE

It took just 303 days to develop and test the first vaccines against COVID-19 but a global vaccine coalition wants to speed that up to just 100 days when the next pandemic strikes.

And some vaccines may not even need a needle to be administered - nasal sprays, skin patches and electrical pulses are all being trialled as delivery methods.

This month three COVID-19 vaccines made by Pfizer, Moderna and cc reported final stage clinical trial results showing an efficacy of between 70 and 95 per cent.

These developers have achieved in 10 months a feat which normally takes 10 years.

In the past, the fastest vaccine ever produced took four years to get off the ground.

The philanthropic group CEPI which helped fund the development of three of the first successful COVID-19 jabs met its initial target to have a candidate vaccine ready for testing within 16 weeks of the disease's genetic code being sequenced.

Next time it wants to do even better.

"Well one of the things CEPI is talking about is could we have 100 days as a reasonable objective," said CEPI representative and former Australian Health Department chief Jane Halton.

Coalition for Epidemic Preparedness Innovation Chair Jane Halton. Picture: AAP
Coalition for Epidemic Preparedness Innovation Chair Jane Halton. Picture: AAP

She said the legacy of COVID-19 is a series of new plug and play technologies that will speed up vaccine development against future pandemics.

Traditionally vaccines were based on weakened or harmless versions of the agent that caused the disease, which take a long time to make.

The flu vaccine takes six months to update every year because the new strains have to be grown for weeks then injected into hens' eggs, duplicated, harvested and killed.

Pfizer and Moderna's COVID-19 vaccines use a revolutionary new method involving a single-stranded RNA molecule (mRNA), made using a chemical process rather than a biological one as in the flu vaccine.

This means it can be scaled up and mass produced much faster.

Within days of the genetic code of the virus that causes COVID-19 becoming available scientists at these labs were able to produce the mRNA code for vaccine testing.

 

In future pandemics the same platform could be used again and scientists would simply plug in the mRNA code from whatever new pathogen emerges.

These types of vaccines had never been involved in large scale human clinical trials before and the proof they worked so well - preventing over 90 per cent of cases of serious disease - is a huge scientific win.

The problem is they need to be kept at super-low temperatures which makes their distribution problematic. Work is underway to see if they can be freeze dried and perhaps administered using a skin patch

The Oxford/AstraZeneca vaccine uses another plug and play platform, called ChAdOx1, based on a chimpanzee adenovirus, similar to the virus that causes a common cold in humans.

The Oxford team used this virus as a carrier and added it to the DNA sequence for the spike protein from the virus that causes COVID-19.

The Nucleus Network’s Paul Griffin is running clinical trials on four COVID-19 vaccines.
The Nucleus Network’s Paul Griffin is running clinical trials on four COVID-19 vaccines.

Using funding from CEPI the Oxford group had previously tested ChAdOx1 vaccines against MERS, flu and tuberculosis and knew it worked. This allowed them to quickly transition over to making the COVID-19 vaccine.

The other factor in vaccine speed is the vast amounts of money that allowed the vaccine makers to run several different clinical trial stages simultaneously and ramp up production of the vaccines even before they knew they worked.

"Normally at every stage when the phase one trial is complete, you're scrambling for funds to fund the phase two, and it's only when that is compliant that we can try and access funds for the phase three," Nucleus Network's Paul Griffin, who is running clinical trials on four COVID-19 vaccines, said.

Originally published as Moderna requests emergency clearance for 100 per cent effective vaccine


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