'Moderna Vaccine 100 Per Cent Effective In Severe Cases', Company To Apply For Emergency Authorization Soon

The application for emergency authorization will set the drug giant product to be the second vaccine candidate to receive US emergency use authorization this year following Pfizer’s vaccine which showed an efficacy rate of 95 per cent in the trials.

American drug giant Moderna Inc will be applying for emergency authorization for its COVID-19 vaccine in the United States and the European Union on Monday after the late-stage clinical trials results showed it was 94.1% effective with no serious safety concerns, the company said.



Moderna also claimed that the vaccine's efficacy rate was consistent across age, race, ethnicity, and gender demographics as well as having a 100% success rate in preventing severe cases of a disease that has killed nearly 15 lakh people.

The application for emergency authorization will set the drug giant product to be the second vaccine candidate to receive US emergency use authorization this year following Pfizer’s vaccine which showed an efficacy rate of 95 per cent in the 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.

"We expect to be playing a major part in turning around this pandemic."

In the clinical trials, 196 volunteers who contracted COVID-19 in the trial with more than 30,000 people, 185 received a placebo while 11 got the vaccine.

The company reported 30 severe cases, all in the placebo group, which means the vaccine was 100% effective in preventing severe cases.

"As the numbers of cases reported grows, confidence grows that this amazing protection will be maintained in a product that can be rolled out to protect the public," said Alexander Edwards, associate professor in biomedical technology at Britain's University of Reading.

Moderna also said that it would seek conditional approval from the European Medicines Agency, after applying in the US, which has already begun a rolling review of its data and would continue to talk with other regulators.

Pfizer on the other hand earlier this week applied for emergency use authorization in the United States and Europe.

According to Moderna, the company has around 20 million doses of the vaccine ready to pump in the market of the US which is enough for 10 million people, by the end of 2020.

While Britain’s AstraZeneca is using traditional methods to develop their vaccines, both the US pharma giants have used a new technology called synthetic messenger RNA (mRNA), in the development.

AstraZeneca has announced an average efficacy rate of 70% for its shot and as much as 90% for a subgroup of trial participants who got a half dose, followed by a full dose.

But some scientists have expressed doubts about the robustness of the 90% efficacy figure for the smaller group.

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

"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.

With the benchmark of 50 per cent efficacy set by the US Food and Drug Administration (FDA), both the Moderna and Pfizer vaccines proved more effective than anticipated.

The positive results coming from the development of the vaccines have given high hopes that the pandemic is moving towards the end, as the stock markets are soaring high and economies coming back to normal.

Meanwhile, independent advisers to the FDA are scheduled to meet on December 17 to review Moderna's trial data and make a recommendation to the FDA.

The advisors are scheduled to review Pfizer's data on December 10. Moderna expects the vaccine to be shipped to distribution points throughout the United States by the government's Operation Warp Speed program and McKesson Corp, a drug distributor contracted by the US government, shortly after gaining emergency use authorization.

It is also worth mentioning, the distribution of Moderna’s vaccine will be easier than Pfizer’s because it needs to be stored in a freezer, rather than the ultra-cold temperature needed by Pfizer's vaccine.

Moderna said the 196 COVID-19 cases in its trial included 33 adults over 65 years old and 42 volunteers from racially diverse groups, including 29 Latinos, 6 Blacks, 4 Asian Americans, and 3 multiracial participants. There was one death related to COVID-19 in the placebo group.

Also, Moderna reported no new side effects since its interim analysis. The most common side effects were fatigue, injection site redness and pain, headache, and body aches, which rose after the second dose and were short-lived, which were found during the analysis.

Zaks said the vaccine caused significant flu-like symptoms in some participants, which, he said, "goes hand-in-hand with having such a potent vaccine." But it has not caused any significant safety concerns so far.



Moderna also plans to start a new trial to test the vaccine in adolescents before the end of the year, followed by another in even younger volunteers early in 2021.