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The Portuguese pharmaceutical company has already explained that vaccine trials are still ongoing and which are shared with the European Medicines Agency, which assesses vaccine data as it becomes available.
The company assured that the authorities know all the relevant information and that, if the vaccine is approved by the European regulator, will begin to be distributed to 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 trying to speed up the evaluation and approval process. One of them is UK, which could be one of the first to receive the vaccine, if authorized.
The British Government has asked the country’s regulatory authority to evaluate the AstraZeneca vaccine so that it can be approved as soon as possible. For the Executive of Boris Johnson, this is an “important first step” for the distribution of the vaccine. The government’s most recent request to the regulatory agency comes about a week after it asked the same agency to evaluate the vaccine developed by Pfizer / BioNTech.
“We formally ask the regulator to evaluate the Oxford / AstraZeneca vaccine, so they can understand the data and determine if it meets strict safety standards.”Said British Health Secretary Matt Hancock.
The UK Government’s request to the Medicines and Health Products Regulatory Agency comes after AstraZeneca announced that the vaccine, produced in conjunction with the University of Oxford, has proven to be “highly effective” in final clinical trials.
The UK has already reserved 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 dose “no reason to worry”
The British order comes after AstraZeneca announced that it would conduct an “additional study” on the results of the effectiveness of its vaccine, after revealing that there were unforeseen dose changes in the first trial.
A group of volunteers received the full dose of the vaccine, with a result of 62 percent effectiveness, while another took a half dose, followed by a full dose a month later, a method that was shown to be 90 percent effective.
Oxford admitted that initially it was not intended to inoculate a half dose of the vaccine to any volunteers, but that this was the result of an error in the manufacturing process of the product.
As soon as it was detected that the first vaccine had begun to be inoculated with a concentration below the planned level, it was decided to change the study protocol, according to the health “regulator”, the university reported in a note.
“Now that we’ve discovered what appears to be the most effective formula, we need to validate it through additional studies.”Soriot said.
Despite the unexpected, company president Pascal Soriot said these new tests are not expected to delay approval of the vaccine by health regulators in the UK and the European Union.
The British government has also sought to reassure the public, and Minister Robert Jenrick said there is no reason to worry about the AstraZeneca data, as the vaccine will be evaluated by the independent regulatory body.
“I don’t think there is any cause for concern”he told the Sky News station. “We have already written to the regulatory body that it will independently evaluate the efficacy and safety of the vaccine. Now we have to let this independent evaluation take place”.
Since its first appearance nearly a year ago, the new coronavirus has spread around the world and infected nearly 61 million people, of whom 39 million have since recovered. Covid-19 has so far caused 1.4 million deaths.
with agencies
