The pharmaceutical company in Portugal has already explained that vaccine trials are still ongoing and which are being shared with the European Medicines Agency, which evaluates vaccine data as they become available.
The company ensured that the authorities are aware of all relevant information and that, if the vaccine is approved by the European regulator, will start 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 prepared 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 the United Kingdom, 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 vaccine to be distributed. 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 it can understand the data and determine whether it meets strict safety standards”, British Health Secretary Matt Hancock said.
The UK Government’s request to the Medicines and Health Products Regulatory Agency comes after AstraZeneca has advanced that the vaccine, produced in conjunction with the University of Oxford, has proved “highly effective” in the 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.
Dosage unforeseen “no reason to worry”
The British order comes after AstraZeneca has advanced that it would carry out an “additional study” for the results of the effectiveness of its vaccine, after revealing that there were unforeseen changes in dosage 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 half a dose, followed by a full one month later, a method that proved to be 90 percent effective.
Oxford admitted that it was not initially planned to inoculate half a dose of the vaccine to any volunteer, but that it was the result of an error in the product’s manufacturing process.
As soon as it was detected that the first vaccine had started 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 said in a note.
“Now that we have discovered what appears to be the most effective formula, we need to validate it through an additional study”, said Soriot.
Despite the unexpected, the company’s chairman, 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 population, with Minister Robert Jenrick ensuring that there is no reason to worry about AstraZeneca’s data, since the vaccine will be evaluated by the independent regulatory body.
“I don’t believe there is any reason for concern”, told Sky News station. “We have already written to the regulatory body that it will independently assess the vaccine’s efficacy and safety. Now we have to let this independent evaluation take place”.
Since it first appeared almost a year ago, the new coronavirus has spread around the world and infected almost 61 million people, of which 39 million have since recovered. Covid-19 has so far made 1.4 million deaths.
w / agencies
– .
