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Coronavirus The EMA endorses the vaccination with AstraZeneca and Health will reactivate its use
Doubts: Why was the AstraZeneca vaccination stopped?
New data on the Covid vaccine from AstraZeneca.
After completing a phase III trial in the United States, the pharmaceutical company has reported in a statement that its vaccine
does not carry a risk of thrombi
and is 79% effective in preventing symptomatic cases of Covid and 100% if it is tries to prevent serious illness and hospitalization.
The data, provided by the company and which has not yet been published in a scientific journal, is based on the analysis of
32,449 individuals
mainly from the US, although participants were also recruited from Peru and Chile.
Two-thirds of the sample received the AstraZeneca product
, while the rest were injected with a placebo.
In total, 141 cases of Covid were registered.
AstraZeneca ensures that the efficacy of the vaccine has been demonstrated in all ethnic and age groups
.
In fact, the note stresses that the effectiveness of immunization in people over 65, one of the doubts that has been planned for months about the product, was 80%.
About 20% of the participants were over 65 years old
, the statement details.
Of them, 60% had problems associated with an increased risk of developing severe Covid, such as diabetes, obesity or cardiovascular disease.
Due to concerns about a possible relationship with thromboembolic events, the investigation carried out a
specific review
of this aspect by an independent committee.
According to their data, no association was found with this type of complications, including cerebral venous thrombosis, of which no case was recorded.
"These findings reconfirm previous results seen in trials with AZD1222 in the adult population, but it is exciting to see similar efficacy results in people older than 65 for the first time," says Ann Falsey, a specialist at the University of Rochester School of Medicine and research leader in the statement distributed by AstraZeneca.
The new data, he adds, confirm that adults of all ages can benefit from the protection afforded by the vaccine.
AstraZeneca will continue to analyze data on the vaccine and prepare its application for approval by the United States Drug Administration (FDA), according to the text sent by the company, which also announces the intention to publish the results of these. analysis in a peer-reviewed scientific journal.
Security
Regarding the administration of the vaccine, the company points out that extending the interval between the two necessary doses to more than four weeks "could increase the efficacy and accelerate the number of people who can receive a first dose."
Last Thursday, after the meeting of its Pharmacovigilance and Risk Assessment Committee (PRAC), the European Medicines Agency (EMA) ratified the safety of the vaccine and gave the green light to the administration of the product, which had been suspended in several European countries -including Spain- due to the notification of cases of cerebral venous thrombosis in people who had received the vaccine.
"
The vaccine is safe and effective
in protecting against Covid-19, and its benefits continue to far outweigh the possible risks," said Sabine Straus, director of the PRAC.
"The number of thrombotic events reported among the vaccinated population - he added - is lower than expected in the general population, as observed by the committee," so it has been concluded that "there is no increase in the overall risk of the appearance of thrombi. However, there are still some uncertainties; we have seen some very rare cases describing a combination of thrombosis, thrombocytopenia and bleeding, in some cases starting with small thrombi between 7 and 14 days after vaccination, a condition known as coagulation disseminated intravascular. Also a few cases of cerebral sinus thrombosis. These conditions are related to thrombocytopenia and there is still not enough scientific evidence to determine if these events are related to the vaccine, although they are very rare, the PRAC will continue to investigate it " , he asserted.
After the decision of the EMA, the Ministry of Health decided to lift the suspension of the vaccine and announced that next Wednesday the administration of the product will be resumed.
It is expected that this Monday the Interterritorial Health Council will decide to which age groups the vaccine will be administered, which
until now was reserved for those under 55 years of age
.
The Health Minister ratified last Thursday the goal of vaccinating 70% of the population before the end of the summer.
"If the companies comply with the contracts, the commitment remains," he said.
The head of Health has pointed out that Janssen will begin to supply its single-dose vaccine in the second half of April.
In his speech on Thursday, Darias defended the paralysis of the campaign for a few days.
"It was a complicated decision, but the right one,"
said the minister.
"The vaccine was not suspended, what was done was to pause the vaccination until we had more data," said María Jesús Lamas, director of the Spanish Agency for Medicines and Health Products (AEMPS).
"I do not believe that this weakens confidence in vaccines," stressed the head of the AEMPS.
From his point of view, this episode shows that "the system works."
However, 52% of Spaniards now view AstraZeneca's COVID-19 vaccine as "unsafe", compared to 25% in February, according to a YouGov survey of more than 8,000 people in the UK , Germany, Italy, Spain, Denmark and Sweden, reports Europa Press.
According to the criteria of The Trust Project
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