Moderna CEO says the firm could get emergency FDA approval for a vaccine in December

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Moderna Inc says it is on track receive emergency approval for its experimental coronavirus vaccine next month. 

At the Credit Suisse Virtual Healthcare Conference on Wednesday, CEO Stéphane Bancel said interim results of the company’s Phase III trial are due in November.

Later this month, the Cambridge, Massachusetts-based firm should also have two months worth of safety data. 

Provided the results are positive, Bancel added that Moderna should be able to file for – and maybe even receive – Emergency Use Authorization (EUA) with the US Food and Drug Administration (FDA) by early December. 

The news just comes just two days after Pfizer Inc announced its COVID-19 vaccine was 90 percent more effective at protecting trial participants from infection than a placebo, according to early data.   

Dr Anthony Fauci, director of the National Institute for Allergy and Infectious Disease, told FT he predicts positive data from Moderna vey soon given Pfizer’s announcement. 

‘[I’d] be surprised if we didn’t see a similar degree of efficacy,’ he said. 

‘We were told that literally in the next few days to a week they’ll be doing the same thing of looking at the data as the Pfizer people did a week ago.’ 

Moderna Inc CEO Stéphane Bancel says the company is expecting the interim results of its coronavirus vaccine trial this month. Pictured: Bancel speaks during the World Medical Innovation Forum in Boston, Massachusetts, May 2017

If the results are positive, along with the two months of safety data, the firm will be ready to apply for emergency use approval with the FDA in December. Pictured: A sign marks the headquarters of Moderna in Cambridge, Massachusetts, May 2020

If the results are positive, along with the two months of safety data, the firm will be ready to apply for emergency use approval with the FDA in December. Pictured: A sign marks the headquarters of Moderna in Cambridge, Massachusetts, May 2020

If the results are positive, along with the two months of safety data, the firm will be ready to apply for emergency use approval with the FDA in December. Pictured: A sign marks the headquarters of Moderna in Cambridge, Massachusetts, May 2020

Last month, Moderna announced it is preparing for a global launch and has received $1.1 billion in deposits from governments around the world. Pictured: Volunteers are given the Moderna vaccine at Henry Ford Health System in Detroit, August 5

Last month, Moderna announced it is preparing for a global launch and has received $1.1 billion in deposits from governments around the world. Pictured: Volunteers are given the Moderna vaccine at Henry Ford Health System in Detroit, August 5

Last month, Moderna announced it is preparing for a global launch and has received $1.1 billion in deposits from governments around the world. Pictured: Volunteers are given the Moderna vaccine at Henry Ford Health System in Detroit, August 5

Even after knowing whether or not the vaccine is effective, Moderna has to wait for two-month follow up safety data before applying with the FDA.

Bancel said the company should have safety data in the second half of this month.  

He added that the FDA has set a bar of 50 percent efficacy and researchers were not yet sure how potent its vaccine could be.

‘It is difficult to guess efficacy unless you have data,’ Bancel said.  

In an earnings call last month, Moderna announced it is preparing for a global launch of its immunization and already taken $1.1 billion in deposits from governments around the world.

In August, the federal government signed a $1.5 billion contract with Moderna, placing an order 100 million doses for the US – enough for 50 million people.

WHO WILL GET THE COVID-19 VACCINE FIRST AND WHEN WILL THEY GET IT?

Pfizer’s vaccine is now on track for potential emergency approval as soon as this month, but it won’t immediately go to all Americans.  

Health care workers will be able to get the first doses in December or January, head of the  Advisory Committee on Immunization Practices (ACIP) Dr Jose Romero told NPR.  

Next, non-health care essential workers such as grocery store staff, elderly people and people with underlying conditions that put them at high risk for severe COVID-19 will probably get the vaccine. 

They can likely get the vaccine early next year. 

Elderly people include anyone over 65. People with heart disease, kidney disease, diabetes, obesity, cancer and autoimmune conditions are considered at-risk due to their medical histories. 

It’s not clear in what order these next three groups will likely be vaccinated. 

Dr Anthony Fauci said last month that the general public will likely start to get vaccinations ‘within the first quarter of 2021, by let’s see April of 2021,’ he told CBS Evening News. 

U.S. officials have not yet made official recommendations for who should get the COVID-19 vaccine yet.  

The ACIP will meet and make recommendations with in 24 to 48 hours of a vaccine getting emergency use authorization from the Food and Drug Administration (FDA).  

The contract with the Trump administration has the option to purchase an additional 400 million doses.

Japan has signed a contract for 50 million doses and Canada’s contact calls fro 20 million doses with option for additional 36 million doses.

Moderna has also made agreements with Switzerland, Israel and Qatar and is in ‘advanced talks’ with the European Union to supply between 80 and 160 million doses.  

It expects to price the vaccine between $32 to $37 per dose for the smaller orders, but offered the US a discount by pricing the initial 100 million doses at $25 each.

‘We are actively preparing for the launch of mRNA-1273 and we have signed a number of supply agreements with governments around the world,’ Bancel said.

‘Moderna is committed to the highest data quality standards and rigorous scientific research as we continue to work with regulators to advance mRNA-1273.’ 

In September, the company announced it was slowing enrollment to recruit more minorities including blacks, Hispanics and Native Americans, after falling short.

Now, the drugmaker says that 37 percent of all participants are people of color with 20 percent being Hispanic, 10 percent being black, four percent being Asian and three percent representing all other groups.

What’s more, 42 percent of volunteers are people at high-risk of falling seriously ill from COVID-19 either because they are above age 65 or have underlying conditions.

In the earnings call, Moderna said the three most common pre-existing conditions were diabetes, obesity and cardiac disease. 

Moderna’s vaccine was developed in partnership with the National Institutes of Health.

It uses part of the pathogen’s genetic code called messenger RNA, or mRNA, to get the body to recognize the coronavirus and attack it if a person becomes infected.

The candidate works by tricking the body into producing some of the viral proteins, which the immune system then recognizes and builds a defensive response against. 

Early clinical data showed that people who received the vaccine had higher levels of antibodies than COVID-19 survivors. 

For the trial, one group is given the vaccine and another group is given the placebo.

Researchers will then wait until 53 participants contract the virus and develop symptoms.

If the number of people infected is significantly higher in the placebo group, then the jab is considered effective. 

However, if the first analysis, does not show the efficacy of the vaccine, a second analysis will occur, and researchers will wait until 106 people have been infected with COVID-19.

Later on Wednesday, Moderna says it had completed case accrual for the interim analysis and says it expects the results to include ‘substantially more than 53 cases.’ 

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