Covid: EU drugs regulator approves AstraZeneca vaccine
The EU drug regulator has approved the use of the Covid Oxford-AstraZeneca vaccine for all adults. The European Medicines Agency (EMA) said the AstraZeneca vaccine was approximately 60% effective in the trials on which it based its decision.
The move comes in the midst of a crisis. dispute over whether AstraZeneca is breaching its vaccine delivery commitments to the EU. The European Commission has published its contract with the Anglo-Swedish pharmaceutical company, hoping to show a breach. the AstraZeneca vaccine last year.
In a press conference later Friday, Astra-Zeneca CEO Pascal Soriot said that while “of course there will be failures” in manufacturing, the important thing is that the world has developed several vaccines in a year 40 to 440, said Soriot. AstraZeneca had millions of doses ready to ship to the EU and was working 24 hours a day, 7 days a week to increase capacity.
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The European Commission has now given final approval for the vaccine.
Vaccine supplying will be the big test
It would have been very surprising if EU regulators had not given the go-ahead for this vaccine for which they have been requesting hundreds of millions of doses. The UK approved it weeks ago, and millions of people in Britain have already received its application. first shot that should give them protection very soon.
Trials show that it is very effective in preventing serious illness and deaths from coronavirus, but there have been questions about how well it works in people 65 and older, because there is not as much data for that age group, less than 10% of the trial volunteers were in this age group. However, there is other evidence to suggest that the vaccine works very well in older adults.
Studies show that, like other age groups, those over 65 have a strong immune response to the vaccine. After you get the injections, your blood has many of the necessary antibodies that can fight the coronavirus. It will be up to each country to decide to whom (including age groups). The bigger question will be how soon EU nations can get large deliveries of the vaccine. Supplies of this and other Covid vaccines are in high demand, but there is a limit to how much can be manufactured at a pace.
What is the supply row about?
Last week, AstraZeneca said vaccine supplies would be reduced due to problems in one of its EU factories.
The shortfall is expected to be around 60% in the first quarter of 2021. The EU has also received fewer than expected doses of the other two vaccines it has approved – from Pfizer-BioNTech and Moderna.
The EU has stated that AstraZeneca must meet its commitments and deliver the bursts it has ordered by diverting UK-made doses The BBC told the BBC that AstraZeneca’s UK facilities were required by law to do so, saying, “This is not an option, it is a contractual obligation.”
The UK facilities are not backup facilities. They are part of the main network, the source added.
The company’s CEO, Mr Soriot, said earlier this week that the contract required AstraZeneca to use its “best efforts” to meet EU demand without accepting it force to adhere to a certain schedule – a claim by the EU disputed.
“There are binding regulations and the contract is crystal clear,” said the head of the European Commission, Ursula von der Leyen, in an interview with the German radio on Friday morning.
“The best efforts have been made while it was still unclear whether they could develop a vaccine. That time is behind us. The vaccine is there.
“AstraZeneca has also explicitly assured us in this contract that no other obligation would prevent performance of the contract,” he said.
What is the EU going to do about shortages?
The European Commission announced on Friday that it had agreed to a plan to introduce export controls on coronavirus vaccines, meaning that each member state will decide whether or not to allow the export of vaccines produced on territory. It will be in place until the end of March.
EU Health Commissioner Stella Kyriakides told a press conference that controls were being introduced to ensure that all EU citizens have access to vaccines and to ensure that all parties play by the rules.
“This approach is built on trust, transparency and accountability,” she said. .
“Commitments must be kept and agreements are binding. Advance purchase agreements must be honored.
” Today we have developed a system which will allow us to know whether vaccines are being exported from the EU. also come with the responsibility of the EU to authorize, together with our Member States, these vaccine exports. ”
The World Health Organization’s Mariangela Simao, assistant director of access to medicines and health products, called the export ban a worrying trend.
Is the AstraZeneca vaccine effective?
The German Vaccine Commission has stated that it cannot recommend the use of the sting in people over 65 years of age because there are no data on how this affects this age group.
The individual EU countries are free to decide who should give vaccines after their decision to be approved.
However, the UK has been using the AstraZeneca vaccine for weeks in its mass immunization program, and public health officials say it is safe and offers “a high level of protection” .
Research has shown it is highly effective and received the Oxford – Vaccine in studies was hospitalized or became seriously ill from Covid.
The vaccine is given via two injections in the arm, the second between 4 and 12 weeks after the first.
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Confirming that they have approved the AstraZeneca vaccine, the European Pharmaceutical Authority (EMA) says most of the people participating in the trial studies are between 18 and 55 years old. Humans,It said that while there were not yet enough results to show how the vaccine will work in older people, “expected protection, assume that immune responses are seen in this age group and based on experience with other vaccines.”
AstraZeneca says the US study will soon provide additional data on the vaccine’s effectiveness in the elderly.
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