Germany recommends against giving Oxford-AstraZeneca vaccine to over 65s

The experts endorsed the vaccine’s rollout for people aged 18 to 64.

The European Union’s drug regulator, the European Medicines Agency, will hand down its verdict on the vaccine on Friday.

Australia has rights to 53.8 million doses of the vaccine developed by AstraZeneca and the University of Oxford, representing the bulk of its initial portfolio.

The Therapeutic Goods Administration (TGA) has also been scrutinising AstraZeneca’s trial data ahead of an expected decision in February on whether to grant approval. The TGA has been talking with its counterparts in Europe and Britain.

The British-Swedish pharmaceutical company giant has acknowledged over 65s represented a small proportion of trial participants but insists the jab will provide a strong shield against serious illness and death in all age groups.

Millions of elderly residents in the United Kingdom have already been given the jab and work is under way to assess its efficacy in the real-world.

Prime Minister Boris Johnson said he did not agree with Germany’s decision. He said British authorities think the AstraZeneca vaccine “is very good and efficacious” and gives a high degree of protection after one dose and even more after two doses.

Australian Health Minister Greg Hunt has described the AstraZeneca vaccine as the “ace in the hole” of the country’s inoculation strategy.

Any restrictions on using AstraZeneca for over 65s will complicate government rollout strategies because older people are due to be prioritised given their vulnerability to COVID-19.

If the TGA made a similar finding to Germany, the Morrison government would have to rely more heavily on the Pfizer-BioNTech vaccine during the initial rollout.

Australia has secured 10 million doses of the Pfizer vaccine, enough to protect 5 million people given the requirement for two doses per person. About 3.9 million Australians are aged 65 or older, according to census data.

One option available to the TGA is to wait for more data from AstraZeneca’s rollout in Britain before making a final decision on use in Australia.

In a statement, AstraZeneca insisted its product would protect older age groups. “The latest analyses of clinical trial data for the AstraZeneca-Oxford vaccine support efficacy in the over 65 years age group,” a spokesperson said.

“We await a regulatory decision on the vaccine by the European Medicines Agency in the coming days.”

German Health Minister Jens Spahn noted the vaccine committee’s recommendation was not a final decision, but said the lack of trial data for those aged over 65 was a well-known issue.

“It was to be expected that this would have an influence on the decision of the regulatory authorities and then the vaccine commission,” Spahn said.

“We just don’t know yet how concretely, so let’s wait for the decision tomorrow on clearance and then the final recommendation from the vaccine commission.”

The German committee analysed trial data where people aged 65 and over represented less than 6 per cent of the 11,636 participants.

One group of 341 people aged over 65 was given the vaccine and another group of 319 people injected with a placebo. One person in each group subsequently tested positive to COVID-19.

The small number of older participants meant the German experts were unable to reach a reliable estimate of how effective the jab was for over 65s.

AstraZeneca has previously explained that the trial featured a low number of older volunteers because they were recruited later, once researchers were confident the vaccine was safe with younger participants.

The company’s chief executive officer Paul Soriot told Italy’s La Repubblica newspaper this week that its researchers had been finalising new analysis of the vaccine’s impact on over 65s.

“Essentially, because Oxford started vaccinating older people later, we don’t have a huge number of older people who have been vaccinated,” Soriot said. “So that’s what the debate is.

“But we have strong data showing very strong antibody production against the virus in the elderly, similar to what we see in younger people.

“It’s possible that some countries, out of caution, will use our vaccine for the younger group. But honestly, it is fine. There’s not enough vaccines for everybody. So if they want to use another vaccine for older people and our vaccine for younger people, what’s the problem?”

AstraZeneca shares closed 1.6 per cent lower after the announcement.

Comment was sought from the Therapeutic Goods Administration and Health Minister Greg Hunt.