A draft recommendation from the German Vaccine Advisory Committee calls for the AstraZeneca vaccine to be offered to 18-64-year-olds only for the time being, citing insufficient information to assess its efficacy for older people.
The European Medicines Agency is expected to approve the AstraZeneca vaccine for use in the European Union with 27 countries on Friday. This is the third to be cleared for use in the EU after the BioNTech-Pfizer and Moderna vaccinations.
In a draft recommendation issued before the decision on Thursday, Germany’s permanent vaccination commission asked to use AstraZeneca’s vaccine for the 18-64 age group based on the available information. It is said that “there are currently insufficient data to determine vaccination effectiveness from age 65.”
WHY IT MUST BE TO MAKE COVID-19 VACCINE AND PROVISIONS
AstraZeneca noted earlier this week that UK regulators support its use in the older age group, despite the lack of effectiveness data in the late stages. The company pointed to earlier data published in the November issue of the journal Lancet “showing that older adults showed strong immune responses to the vaccine, while 100% of older adults generate a specific antibody after the second dose.”
But there are still questions about how well the vaccine protects older people. Only 12% of AstraZeneca research participants were older than 55 and they were enrolled later, so there was not enough time to see if they got sick at a lower dose than those who did not get the vaccine.
The company said after Thursday’s announcement of the German draft that “the latest clinical trial data analyzes for the AstraZeneca / Oxford COVID-19 vaccine support efficacy in the over 65 age group.” It added that it was awaiting the EMA’s decision.
MODERNA COVID 19 VACCINE ‘NOT RECOMMENDED’ FOR PREGNANT WOMEN WHO SAY
German Health Minister Jens Spahn emphasized that the committee’s recommendation was not his final decision, and that it would only be made after the vaccine had been cleared for use.
But he said that since the autumn, there has been a discussion about the fact that there is “little data – this is not about bad data, but little data” in studies on the efficacy of the AstraZeneca vaccine in older groups.
“It was expected that this would have an impact on the decision of the regulatory authorities and then the permanent vaccine commission,” Spahn said. “We just do not know how concrete yet – so let’s wait for the decision tomorrow on the approval and then the final recommendation of the permanent vaccine commission.”
When Britain approved the AstraZeneca emergency vaccine last month, it acknowledged that information on its effectiveness was ‘limited’ in the elderly.
CLICK HERE FOR FULL CORONAVIRUS COVERAGE
The vaccination committee, known under its German abbreviation STIKO, is an independent panel that provides advice to the government and the medical profession on whom immunizations should be given. It does not play a direct role in the approval process for vaccines, but the advice determines which vaccines are considered standard for which groups, and are therefore covered by health insurance.