FDA:

FDA: “Moderna vaccine against Covid, extremely effective”

New data from the agency that regulates the marketing of drugs in the US confirmed this Tuesday that the Moderna biotech vaccine is extremely effective against covid-19, which paves the way for its authorization this week.

“Moderna’s vaccine has a favorable safety profile and no specific safety problems have been identified that prevent the issuance of an emergency authorization,” highlights the analysis published this Tuesday by the Food and Drug Agency (FDA), the US regulator.

APPROVAL MAY COME ON FRIDAY

That 54-page document confirms the efficacy and safety of the vaccine and represents the first step for its approval, something that could occur this Friday, a source familiar with the process told The Washington Post and The New York Times.

Before, however, Moderna will have to get the go-ahead of an FDA advisory committee, which will meet on Thursday and which has already recommended the approval of the vaccine from the US pharmaceutical company Pfizer and its German partner BioNtech, which began this Monday. to be distributed in different parts of the country.

That way, the US could have two vaccines against COVID-19 by the end of this week and on Monday they could start administering the first doses manufactured by Moderna.

Specifically, if all goes well, the US Government will send within the next week 6 million doses to 3,285 points across the country, as part of Operation Warp Speed, launched by the White House with the help of the Pentagon to facilitate the fastest possible distribution.

Unlike Pfizer, Moderna has maintained a very close relationship with those in charge of Operation Warp Speed ​​and has been able to access 2.5 billion dollars in federal funds to buy new materials, expand its facilities and increase its workforce by 50%.

MODERN VACCINE, ESPECIALLY EFFECTIVE AGAINST SEVERE CASES

Another difference between Pfizer, One of the largest pharmaceutical companies in the US, and Moderna, until recently a start-up, is its ability to prevent severe cases of COVID-19.

Data released Tuesday by the FDA confirms that Moderna has enough data to show that its product is especially effective in severe cases. Specifically, in their study, 30 volunteers developed severe symptoms, but all of them belonged to the group that received the placebo and not the actual vaccine.

In the case of Pfizer, the FDA did not find such conclusive evidence, since 10 of the people who received the placebo suffered severe symptoms and one of the vaccinated individuals also developed the same condition.

The FDA considered that this statistical sample was not significant because it was too small and therefore no definitive conclusions could be drawn.

THE MESSENGER RNA

The two vaccines, however, have several similarities: both must be administered in two doses and Moderna’s is 94.1% effective, while Pfizer’s 95%.

In addition, the two vaccines use messenger RNA or mRNA, which is introduced into human cells so that the body itself produces viral proteins that serve to generate the antibodies it needs to defend itself.

However, each vaccine uses its own type of lipid coat to protect the messenger RNA, so the possible allergic reactions could be different.

However, the analysis released today by the FDA did not identify any serious allergic reactions to Moderna’s vaccine, and neither did it last week in the case of Pfizer.

In the UK, when the immunization campaign began, two people with a history of severe allergies had a negative reaction to Pfizer’s vaccine, prompting UK authorities to ask severe allergies not to get immunized.

Another difference between Pfizer’s serum and Moderna’s is its cold storage: the former requires temperatures between -60 and -80 degrees Celsius, while the latter requires only -20 degrees.

100 MILLION VACCINATIONS IN EARLY 2021

This new step to approve Moderna’s vaccine comes at a critical time for the US, which this Monday exceeded 300,000 deaths from covid-19 and is registering 3,000 deaths a day, a figure higher than the number of people who lost their lives. in the attacks of September 11, 2001.

For this reason, the US Government is preparing for one of the most ambitious immunization campaigns in its history and with which it wants to distribute some 200 million doses of Moderna and Pfizer vaccines in the first quarter of 2021.

Since two doses are required, that number would immunize 100 million people in the US.

To make sure it has enough vaccines, the US Executive announced last week that it had bought another 100 million doses of Moderna for the second quarter of the year.

At the moment, the first to be vaccinated are health workers and people who live or work in facilities dedicated to long-term medical care, such as nursing homes or centers for people with disabilities.

However, the following vaccines are expected to target other groups at risk, such as those over 65 years of age.

Melissa Galbraith
Melissa Galbraith is the World News reporter for Globe Live Media. She covers all the major events happening around the World. From Europe to Americas, from Asia to Antarctica, Melissa covers it all. Never miss another Major World Event by bookmarking her author page right here.