More AstraZeneca bans on COVID-19 vaccine use in elderly

Three more European countries have joined Germany in refusing to approve the AstraZeneca vaccine for use in the elderly.

A member of the vaccine team prepares a syringe with a dose of the AstraZeneca-Oxford Covid-19 vaccine in Edinburgh, Scotland. Picture: AFP

Three more European countries have joined Germany in refusing to approve the AstraZeneca vaccine for use in the elderly.

France and Sweden both granted approval to the AstraZeneca vaccine, but only for use in people younger than 65. Poland has approved the vaccine for use only in people aged under 60.

It follows a conditional approval from German authorities last week, where the AstraZeneca vaccine will be given only to those aged under 65.

The Therapeutic Goods Administration in Australia is assessing the AstraZeneca vaccine prior to an approval expected some time in March.

The regulator is considering data from a phase III clinical trial conducted by Oxford University and AstraZeneca, together with additional data provided by the company following the real-world rollout of the vaccine, including to the elderly, in countries such as Britain, where the vaccine has been granted approval in all age groups.

The European Medicines Agency has also cleared the vaccine for use in all age groups, but European countries make their own decisions about how the vaccine should be administered.

French President Emmanuel Macron described the AstraZeneca vaccine as “quasi-ineffective” on people aged over 65.

The head of the French regulator, HAS, said the country would revisit the use of the vaccine in the elderly when more data was available.

According to German authorities, in AstraZeneca phase III trial conducted last year in the UK, Brazil and South Africa, only 341 people aged over 65 were given doses of the AZD1222 vaccine, which represented 6.5 per cent of participants. There were 319 people in the control group.

By the end of the trial, there had been one COVID-19 positive case recorded in the vaccine group and one in the control group. Germany decided that no conclusions could be reached on the efficacy of the vaccine in the elderly, a view now shared by France, Sweden and Poland.

The Food and Drug Administration in the US has said it will not approve the AstraZeneca vaccine at all until it receives the results of a larger phase III study being carried out in the US involving 40,000 participants.

Australia has a contract with AstraZeneca to purchase 53 million doses of its viral vector ­vaccine.

Apart from five million citizens who are in line to receive the Pfizer jab, the Astra­Zeneca vaccine will be given to most of the population in Australia.

Acting Chief Medical Officer Michael Kidd has said the TGA is examining data provided by ­AstraZeneca as well as looking at the results of published efficacy data.

“We’re told that there is further research being done in the elderly, and of course we have the real-world experience of vaccines being rolled out under emergency provisions in different countries around the world,” Professor Kidd said last week.

“So all of that data will come together at the TGA.

“The scientific and clinical experts at the TGA are poring over (it) and making recommen­dations for Australia.”

The pharmaceutical company CSL has been contracted to manufacture 50 million doses of the AstraZeneca vaccine onshore.

It has already started manufacturing, with the first million doses expected to become available from late March.