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As expected, the European Medicines Agency (EMA) recently granted a conditional marketing authorization for Astra Zeneca’s Corona vaccine. Nearly a year after the outbreak of the pandemic, this means a third vaccine is now available, in addition to those from Biontech/Pfizer and Moderna. The vaccine will be licensed for all persons 18 years of age and older. Previously, there had been speculation that it could only be approved for people under 65.
Formal approval
Now the EU Commission still has to formally approve the approval: This process can take only a few hours and is considered certain. In any case, Chancellor Sebastian Kurz (ÖVP) and Health Minister Rudolf Anschober (Grüne) welcomed the EMA’s decision. “Every vaccine approved by the EMA goes through a precise and responsible review process.”
Both politicians asked the National Vaccination Panel “to evaluate by Sunday whether for the over-65 group to wait for the submission of complementary studies, which are still planned in February, before using the vaccine for this age group, as was also recommended in Germany by the Permanent Vaccination Commission of the Robert Koch Institute.”
Unlike the first two approved vaccines, the one from Astra Zeneca is a vector vaccine. This requires a so-called carrier virus (“vector”) that is harmless to humans: In this case, the vaccine developers chose an attenuated cold virus from chimpanzees.
The EMA did not specify an upper age limit, even though there is not yet enough data on the efficacy of the AstraZeneca product in older people to assess how effective it is in them. In the run-up, experts had indeed expected that the EMA might initially recommend the vaccine only for people up to age 65. The EMA now argues that protection is expected because an immune response is observed in this age group. Scientists believe the vaccine can be used in older adults based on experience with similar vaccines. Further studies that include a higher proportion of older participants are expected to provide clarity. The company had always stressed that reliability was high even in over-70s.
The UK was the first country in the world to approve AstraZeneca’s vaccine. The vaccine has since received emergency approval in a number of other countries, including India, Argentina, Mexico and Morocco. The European Commission has signed a purchase agreement for up to 400 million doses of the vaccine. However, a dispute has erupted between the EU and AstraZeneca over supply problems.
According to the manufacturer, the vaccine is 70 percent effective, while Biontech’s is 95 percent effective.
The vaccine is administered as two injections in the arm, the second between 4 and 12 weeks after the first. The most common side effects were generally mild or moderate and improved within a few days. The most common side effects were pain and tenderness at the injection site, headache, fatigue, muscle aches, general malaise, chills, fever, joint pain, and nausea. The safety and efficacy of the vaccine will continue to be monitored during its use in the EU through the EU pharmacovigilance system and additional studies by the company and European authorities.
Supply unclear
Still unresolved is how many vaccine doses can be delivered by Astra Zeneca: For days, the pharmaceutical company and the EU Commission have been arguing regarding the group’s supply shortages. As late as Thursday evening, a Commission spokesman in Brussels had announced that Astra Zeneca would have to make proposals on how to meet its obligations under the supply contract.
— source: kurier.at/picture: swr.de
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