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The European Medicines Agency (EMA) will decide on Friday whether to approve AstraZeneca’s Covid-19 vaccine amid a fierce dispute over a drastic cut in expected deliveries by the British-Swedish pharmaceutical company.
The measure has spurred the EU to take measures to control exports of vaccines from the bloc.
German health authorities recommended on Thursday that AstraZeneca’s Covid-19 vaccine not be given to people over the age of 65 due to a lack of data, in a possible further blow to vaccination efforts in Ireland and across the European Union.
Currently, there is “insufficient data available to determine how effective vaccination is above age 65,” the vaccines committee of Germany’s main public health agency, the Robert Koch Institute, said in a statement. “The AstraZeneca vaccine, unlike mRNA vaccines, should only be offered to people ages 18 to 64 at each stage.”
The European Union’s contract with AstraZeneca for its Covid-19 vaccine contains binding orders, EU Commission President Ursula von der Leyen said on Friday, as the bloc continues to pressure the drugmaker to deliver supplies as required. promised.
AstraZeneca said last week that it would cut deliveries in the first quarter due to production problems at a Belgian factory.
An EU official said that meant the EU would receive 31 million doses in the period, or 60 percent less than initially agreed.
“There are binding orders and the contract is very clear,” Ms Von der Leyen told Deutschlandfunk radio, adding that it contained clear delivery quantities for December and the first three quarters of 2021.
“AstraZeneca has also explicitly assured us in this contract that no other obligation would prevent performance of the contract,” he added.
Ms Von der Leyen’s comments contradict statements by AstraZeneca CEO Pascal Soriot, who told newspapers on Tuesday that the EU contract was based on a “best effort” clause and did not commit the company. with a specific schedule for deliveries.
Only 341 people over the age of 65 in the AstraZeneca trial received the vaccine and 319 received a placebo, meaning there is very little data available to show with certainty the effectiveness of the vaccine in that age group, the committee said.
The UK has already launched the vaccine and thousands of people have received it in Northern Ireland. Public Health England has said that while there were too few cases in older people in the AstraZeneca trials to measure protection with certainty, the data on immune responses were “very reassuring.”
Data from the AstraZeneca trial is also being challenged in the United States, where a pension fund has filed a lawsuit on behalf of investors who blame the company for including too few seniors and for trial confusion in which some participants were only accidentally given half a dose as one of their injections.
The EMA is expected to make a decision on licensing the vaccine on Friday and has not so far indicated whether the doses could be approved only for younger age groups.
AstraZeneca would be the third Covid-19 vaccine available in the EU if approved, following BioNTech-Pfizer and Moderna, and is key to national vaccination strategies because it is easier to implement as it does not need to be deep frozen.
In Dublin, the government is developing contingency plans if it cannot manage AstraZeneca to those over 65. However, government sources said there is confidence that there will be enough supplies from Pfizer from mid-February onwards to allow for vaccination of the elderly, but admitted that logistical problems would be more challenging if necessary.
Sources said the third cohort on the vaccine list, those over 70, could still be ready by late spring, rather than March, if AstraZeneca were not available.
Novavax vaccine
Novavax Inc said Thursday that its coronavirus vaccine was 89.3% effective in preventing Covid-19 in a trial conducted in the UK, and was almost as effective in protecting against the most contagious variant of Covid. -19 first discovered in the UK, according to preliminary analysis.
A mid-stage trial of the vaccine in South Africa, where a potent variant of the virus is common, showed 60% effectiveness among people who did not have HIV.
Novavax said the UK trial, involving 15,000 people aged 18 to 84, is expected to be used to request a regulatory review in the UK, the EU and other countries. About 27 percent of the people in the trial are over 65.
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