Trump tells FDA to 'act quickly' to approve Moderna vaccine that is 94.1% effective so that the first doses can be dished out in December

Trump on Monday told the FDA to act 'quickly' and grant emergency authorization to Moderna for its COVID-19 vaccine so that the first doses can be dished out in December, before his term ends. 

The company will apply for approval both in the US and in the EU today and hopes to be able to distribute the first doses in December, at the end of the month. 

The first people to receive the vaccine will be those at highest risk of severe symptoms and frontline healthcare workers, but an exact plan on how it will be rolled out has not yet been revealed by the federal government. 

Some states, like New York, say they plan to review the safety of it first for themselves before making it available. 

Moderna is the second US company to submit for emergency approval; Pfizer submitted last week. Its vaccine is 90 percent effective. 

Trump tweeted on Monday: 'Moderna now applying for Emergency Vaccine Approval..FDA MUST ACT QUICKLY!!! 

'“Operation Warp Speed has been a great modern day miracle.”'  

Moderna says its data also showed a  100% 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 authorization this year.

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

Moderna will ask for emergency FDA approval on Monday for its COVID-19 vaccine

'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 , was 95% effective. Pfizer has applied for emergency use authorization, putting it about a week ahead of Moderna.

HOW DO THE MODERNA AND PFIZER/BIONTECH VACCINES COMPARE? 

Moderna and Pfizer/BioNTech have both released interim results of the final stage clinical trials of their vaccines, with both suggesting they are extremely effective.

Here's how they compare: 

CREATOR:

MODERNA

PFIZER & BIONTECH

How it works: 

mRNA vaccine – Genetic material from coronavirus is injected to trick immune system into making 'spike' proteins and learning how to attack them.

mRNA vaccine – both Moderna's and Pfizer and BioNTech's vaccines work in the same way.

How well does it work?

94.1% effective (90 positive in placebo group, 5 positive in vaccine group) 

90% effective (estimated 86 positive in placebo group, 9 positive in vaccine group)

How much does it cost?

US has secured 100million doses for $1.525billion (£1.16bn), suggesting it will cost $15.25 (£11.57) per dose; $30.50 (£23.14) per person.

US will pay $1.95bn (£1.48bn) for the first 100m doses, suggesting a cost of $19.50 (£14.80) per dose; $39 (£29.61) per person.

Can we get hold of it?

Moderna will produce 20m doses this year, and the first will go to frontline workers and high risk patients but the government will choose who gets it and when

First vaccinations expected in December in the US with the government rolling them out 

What side effects does it cause? 

Moderna said the vaccine is 'generally safe and well tolerated'. Most side effects were mild or moderate but included pain, fatigue and headache, which were 'generally' short-lived. 

Pfizer and BioNTech did not produce a breakdown of side effects but said the Data Monitoring Committee 'has not reported any serious safety concerns'.

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 94.1 percent effectiveness, a difference that Zaks said is not statistically significant.

Both the Moderna and Pfizer vaccines proved more effective than anticipated and far superior to the 50% benchmark set by the U.S. Food and Drug Administration.

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

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

Still, the past few weeks of positive vaccine results have ignited hopes for an end to a pandemic that has battered economies and claimed more than 1.45 million lives worldwide. 

It comes as new infections and COVID-19 hospitalizations are at record levels across the United States.

Independent advisers to the U.S. Food and Drug Administration are scheduled to meet on Dec. 17 to review Moderna's trial data and make a recommendation to the FDA. They will meet on Dec. 10 to review Pfizer's data.

Shortly after gaining emergency use authorization, Moderna expects the vaccine to be shipped to designated distribution points throughout the United States by the government's Operation Warp Speed program and McKesson Corp, a drug distributor contracted by the U.S. government.

Its distribution is expected to be easier than Pfizer's because while it needs to be stored in a freezer, it does not require the ultra-cold temperature needed by Pfizer's vaccine.

Of the 196 volunteers who contracted COVID-19 in the more than 30,000-person trial, 185 had received a placebo versus 11 who got the vaccine. The company reported 30 severe cases - all in the placebo group - which means the vaccine was 100% effective at preventing severe cases. The trial included one COVID-19-related death in the placebo group.

Moderna said the vaccine's efficacy was consistent across age, race, ethnicity and gender demographics. The 196 cases included 33 adults over 65 and 42 volunteers from racially diverse groups, including 29 Latinos, 6 Blacks, 4 Asian Americans and 3 multiracial participants.

Zaks said the vaccine has been developed during a period of 'political acrimony' and having a highly effective vaccine may go a long way toward erasing some of that distrust.

'This is as black and white as an effect on a population will be. Your chances of actually being sick if you've been vaccinated are decreased 20-fold,' he said.

Moderna reported no new side effects since its interim analysis on Nov. 16. Based on that analysis, the most common side effects were fatigue, injection site redness and pain, headache and body aches, which increased after the second dose and were short-lived.

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

The company hopes to have the vaccine available for adolescents by September of next year, Zaks said.

Other vaccine makers have said they are studying their vaccines in young people as well.

Moderna said it was on track to have about 20 million doses of its vaccine ready to ship in the United States by the end of 2020, enough to inoculate 10 million people.

Only 51 percent of Americans say they are willing to get a COVID-19 vaccine 

A poll by Pew Research in September revealed that only 51 percent of Americans are willing to get a COVID-19 vaccine when it becomes available. 

At the time, neither Pfizer nor Moderna had announced the results of their studies into the vaccines' efficacy and safety.

However, an enormous amount of people indicated distrust in it. 

Among the reasons are that the vaccines were developed under the Trump administration, as part of Operation Warp Speed. They will be independently reviewed by non-partisan organizations, according to Dr. Anthony Fauci, but many are hesitant and say they were rushed. 

It indicated a huge drop since May, when 71 percent of people said they would probably or definitely get a vaccine once it became available. 

There has been little information released on the White House's plan to work with the incoming Biden administration to roll out the vaccine. 

Biden will be inaugurated on January 20. 

The first vaccine doses should have already been dished out by then but there remains no clear cut plan on how it will be distributed to the general public.

On Monday, Saad E. Omer, director of the Yale Institute for Global Health, and a professor at the Yale University schools of medicine and public health, wrote in The Washington Post there needed to be a national education campaign about the vaccine that was completely non-partisan for it to be distributed widely enough. 

'Unfortunately, there has been minimal investment in such a campaign and other efforts to increase confidence in a vaccine. 

'While the Centers for Disease Control and Prevention received $200 million for vaccine preparedness from the Cares Act, this money is supposed to cover all activities, including distribution and administration, not just communication and education. 

'This money is not enough for vaccine distribution, let alone for communication and education,' he said. 

The scale of the immunization is unprecedented. 

A study by Yale researchers found that Americans are more willing to take a vaccine that has been recommended by Dr. Anthony Fauci than they are one that has been jointly recommended by Trump and House Speaker Nancy Pelosi.