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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
FDA
(US Medicines Agency)
for an emergency use authorization (USA)
and
a conditional marketing
authorization with the European Medicines Agency (EMA)
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
COVE phase 3 study of mRNA-1273
, carried out in 196 cases that confirms the efficacy of the vaccine, 94.1%.
Safety data continues to accumulate and the
study continues to be monitored by an
independent NIH-appointed
Data Security Oversight Board (DSMB)
.
Thus, the FDA has confirmed to the biotechnology company that it awaits a meeting of
the Advisory Committee on Vaccines and Related Biological Products
to decide on the situation of its candidate against SARS-CoV-2, mRNA-1273, on
December 17.
.
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
List of Emergency Use
.
The
COVE
study
recruited more than 30,000 participants in the US
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
has been 100%.
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,
on December 10 "a public meeting to review and discuss
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
seven days before Moderna
.
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,
the findings will only translate into a recommendation
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.
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