(CNN) — The pharmaceutical company Moderna intends to apply this Monday to the US Food and Drug Administration for authorization of its vaccine against covid-19.
The company will ask the FDA to review an expanded data set showing that the vaccine is 94.1% effective in preventing COVID-19 and 100% effective in preventing severe cases of the disease.
What follows after the authorization of Moderna’s vaccine?
“This is surprising,” said Dr. Paul Offit, a member of the FDA’s vaccine advisory committee. “These are amazing facts.”
Another company, Pfizer, has already applied for FDA clearance for a coronavirus vaccine, with efficacy data very similar to Moderna’s. The FDA is expected to review the applications from both companies in December, and Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said he expects the first vaccines in the US to be ready “by the end of December. ».
By the end of 2020, Moderna expects to have approximately 20 million doses of its vaccine available in the United States, and is on track to manufacture 500 to 1 billion doses globally next year, according to the company’s press release. Monday.
How does an emergency authorization work?
The FDA is the government entity responsible for protecting public health in the United States. The agency guarantees the safety and efficacy of medicines, biological products and medical devices for human and veterinary use.
It is important to understand that it is not FDA officials who usually decide the efficacy of the drugs or medical devices they evaluate.
In order to achieve greater transparency and scientific weight in its decisions, the FDA convenes groups of US and international experts to help it make its final determinations.
Those advisory groups, such as the one that will meet on December 10 to analyze the data of the Pfizer vaccine candidate, meet for one or more days to examine in detail all the documentation sent by the requesting company.
This review of the data by independent scientists is a fundamental point to assure the public that the drugs or devices that are approved are backed by a solid scientific foundation.
The emergency authorization of Moderna’s vaccine
In this case, what is at stake is the emergency authorization of the candidate vaccine. In simple terms, it means that, because we are in an emergency situation –– that is, a pandemic–– the use of the vaccine can be authorized more quickly.
This speed does not mean that the process is being cut short and that a product that is not properly studied will be authorized.
Experts review the data that companies have reported. They will determine the scientific strength of the study and decide if the vaccine can be used as an emergency in humans.