Moderna asks the FDA for emergency approval for its coronavirus vaccine

• Direct.Latest news about the coronavirus

• Vaccines.Moderna affirms that its vaccine against Covid is almost 95% effective and that it could arrive in Spain in early 2021

• HEALTH: When will Moderna and Pfizer vaccines arrive in Spain?

Moderna is going to formally apply to the

(US Medicines Agency)

and

authorization

for its anticovid vaccine.

At the same time, they would continue with the continuous reviews, which have already begun with the international regulatory agencies.

This represents an important step towards having the green light through more agile and rapid mechanisms, based on the need and urgency for solutions in the pandemic.

The laboratory today announces this step based on the main efficacy analysis of the

, carried out in 196 cases that confirms the efficacy of the vaccine, 94.1%.

Safety data continues to accumulate and the

independent NIH-appointed

.

Thus, the FDA has confirmed to the biotechnology company that it awaits a meeting of

to decide on the situation of its candidate against SARS-CoV-2, mRNA-1273, on

.

On the other hand, Moderna seeks to obtain the prequalification (PQ) of its vaccine from the World Health Organization (WHO) and that it be included in its

.

The

study

and is conducted in collaboration with the National Institute of Allergies and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Authority for Advanced Biomedical Research and Development ( BARDA), which is part of the Office of the Assistant Secretary for Preparedness and Response of the US Department of Health and Human Services.

The efficacy analysis has included 196 patients infected by Covid-19, of which 30 had severe symptoms.

In these, it

Pfizer or Moderna?

One week difference in deadlines

Pfizer-BioNTech

already has on the agenda of the Advisory Committee on Vaccines and Related Biologicals of the FDA,

the safety and efficacy data that were part of our submission for an Authorization for Emergency Use ", as indicated by sources from the US company.

This would take place

.

From Pfizer they assure that "this step represents a fundamental milestone in our continuous efforts to develop a Covid-19 vaccine and make it available to as many people as possible, quickly and safely."

As with any FDA advisory committee,

to the agency on whether or not the vaccine candidate is licensed for emergency use, with the agency making the final decision.

Along with the Pfizer candidate, which has also been shown to be more than 90% effective, and pending further safety data and regulatory review, the United States could have two vaccines licensed for emergency use in December with up to 60 million doses vaccine available by the end of the year.

Previous steps in Europe

Moderna has already launched, since last November 17, the EMA's Committee for Medicinal Products for Human Use (CHMP), a rolling review procedure for its vaccine against Covid-19 mRNA-1273.

This rolling review procedure, or staggered review, is one of the regulatory avenues that the EMA uses to accelerate the evaluation of a promising product - drug or vaccine - in a public health emergency situation.

According to the criteria of The Trust Project

Know more

• Science and Health

• Covid 19

• Coronavirus

• Vaccinations

• United States

• Infectious diseases

SaludEspaña will have 80 million doses to vaccinate against Covid

SaludEspaña allocates Pfizer-BioNTech vaccines before the EU closes the purchase

Interview "When I tested positive I thought 'I wish they gave me the vaccine and not the placebo'"

See links of interest

• News

• Translator

• Programming

• Films

• 2021 calendar

• 2020 calendar

• Topics

• Coronavirus

• Barcelona - Osasuna, live

• Albacete - Tenerife

• Southampton - Manchester United

• Bologna - Crotone

• Milan - Fiorentina