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Vaccination.Pfizer-BioNTech and Moderna, differences between the first vaccines that will arrive in Spain
The European Medicines Agency has approved this Wednesday the vaccine against COVID19 developed by the American pharmaceutical company Moderna for use in the European Union, with which the European Commission has an agreement for the purchase of 160 million doses that could arrive in the next weeks.
"
This vaccine provides us with another tool to overcome the current emergency
," said Emer Cooke, EMA Executive Director, "It is a testament to the efforts and commitment of all involved that we have this second positive vaccine recommendation, just under a year since the World Health Organization declared the pandemic, "Cooke added in a statement.
This is the second vaccine that the EMA (for its acronym in English) authorizes for use in the EU after two weeks ago it authorized for use the drug developed by the North American giant Pfizer and the German company BionTech.
Moderna's drug is already used in the United States and Canada
where it has been approved urgently and the pharmaceutical company says it is ready to begin distribution in the coming weeks, which would accelerate a vaccination campaign that Europe began two weeks ago but is progressing slowly.
Moderna's vaccine is still not suitable for young people and children.
Unlike the Pfizer and BioNTech vaccine, which can only be used in adults over 16 years of age, the Moderna vaccine can only be distributed from 18 years of age, although it has shown an efficacy of up to 94.1% in protecting against the COVID19 in other age groups.
"As with all medicines, we will closely monitor data on the safety and efficacy of the vaccine to ensure the continued protection of the European population.
Our work will always be guided by scientific evidence and our commitment to safeguarding the health of individuals.
EU
citizens
, "insisted the executive director.
In addition, the EMA
continues to study the vaccine developed by AstraZeneca
in collaboration with the University of Oxford to which the British Medicines and Health Products Regulatory Agency gave the urgent green light on December 30, although there is still no date for its approval in Europe.
"The EMA will complete its evaluation in accordance with its usual standards of quality, safety and efficacy," the Agency said in a statement.
160 million doses
The decision comes at a particularly difficult time, with most countries registering a significant increase in cases and in the middle of the vaccination campaign, after
supply problems
have been experienced
due to delays in the production
of Pfizer's vaccine. and BioNTech that cannot cope with the demand.
The CEO of BionTech, Ugur Sahin, asked a few days ago in an interview to accelerate the approval process of other vaccines to meet the distribution problems, although he clarified that they are trying to increase production by putting into operation new development points of the vaccine, that requires
very low temperatures for its maintenance and distribution
.
Moderna, which also has agreements with the US and Canadian governments, estimates that it will be able to produce at least
600 million doses in 2021
and is working to reach one billion.
The Commission reached an agreement with the pharmaceutical company in November for the purchase of 80 million doses but has decided to increase the order to 160 to respond to the growing demand in the EU.
The executive must still give the green light to its commercialization, a decision that could be a matter of hours.
As with the Pfizer and BionTech vaccine, the EMA's decision involves what is known as conditional clearance of compliance.
This type of procedure is exceptionally planned for drugs that address needs not met by the market, the drug in question treats life-threatening diseases or when it is a public health emergency, such as COVID19.
In addition, it is given on the basis of less complete data than usual, but which must indicate that the risks are less important than the benefits and require monitoring of its placing on the market and that the manufacturer complete the information provided in the future.
In addition to the Moderna vaccine licensed this Monday and the BioNTech and Pfizer vaccine on December 21, the evaluation of the vaccines developed by AstraZeneca is also ongoing.
The Commission closed a contract for the purchase of 300 million doses
in August with the pharmaceutical company, and also for the purchase of the drug developed by Janssen Cilag, as soon as they are available.
In total, the executive has secured more than two billion doses with half a dozen companies.
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