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The pharmaceutical company in Portugal has already explained this vaccine trials are still ongoing and which are shared with the European Medicines Agency, which evaluates vaccine data as they become available.
The company ensured that the authorities were aware of all relevant information and that, if the vaccine is approved by the European regulator, it will begin to be distributed in the countries of the European Union at the end of this year.
The distribution agreement for Europe is up to 400 million doses. Worldwide, AstraZeneca is poised to produce three billion doses of the vaccine.
With the possibility of an effective vaccine ever closer to becoming a reality, some countries are looking to speed up the evaluation and approval process. One of them is the UK, which may be one of the first to receive the vaccine, if authorized.
The UK government has asked the country’s regulator to evaluate the AstraZeneca vaccine so that it can be approved as soon as possible. For Boris Johnson’s executive, this is an “important first step” in vaccine distribution. The government’s most recent request to the regulatory agency comes about a week after it asked the same body to evaluate the vaccine developed by Pfizer / BioNTech.
“We formally ask the regulator to evaluate the Oxford / AstraZeneca vaccine, so that they can understand the data and determine if it meets rigorous safety standards.”British health secretary Matt Hancock said.
The UK government’s request to the Medicines and Health Products Regulatory Agency comes after AstraZeneca advanced that the vaccine, produced in collaboration with the University of Oxford, was shown to be “highly effective” in final clinical trials.
The UK has already pre-ordered 100 million doses of this vaccine. Of these, four million are expected to arrive in the country by the end of the year and 40 million by the end of March 2021.
Unexpected “no reason to worry” dosage
The UK order comes after AstraZeneca advanced that it would carry out an “additional study” on the results of its vaccine efficacy, after revealing that there had been unexpected changes in dosage in the first study.
A group of volunteers received the full dose of the vaccine, with a 62% efficacy result, while another took half a dose, followed by a full month later, a method that was found to be 90% effective.
Oxford admitted that it was not originally intended to inoculate half a dose of the vaccine to any volunteer, but that it was the result of an error in the manufacturing process of the product.
As soon as it was found that the first vaccine had begun to be inoculated at a concentration below the expected level, it was decided to change the study protocol, according to the health “regulator,” the university said in a statement.
“Now that we have discovered what appears to be the most effective formula, we need to validate it through an additional study.”, Soriot said.
Despite the unexpected, company president Pascal Soriot said these new tests should not delay the approval of the vaccine by health regulators in the UK and the European Union.
The British government has also tried to reassure the population, with Minister Robert Jenrick assuring that there is no reason to worry about AstraZeneca’s data, as the vaccine will be evaluated by the independent regulator.
“I don’t think there is cause for concern”he told the Sky News station. “We have already written to the regulator which will independently assess the vaccine’s efficacy and safety. Now we must let this independent assessment take place“.
Since it first appeared nearly a year ago, the new coronavirus has spread around the world and infected nearly 61 million people, of whom 39 million have recovered. Covid-19 has killed 1.4 million so far.
with agencies
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