British authorities have recommended that the AstraZeneca Covid-19 vaccine not be given to adults under 30 where possible because of strengthening evidence that the shot may be linked to rare blood clots.
Regulators in the United Kingdom and the European Union emphasised that the benefits of receiving the vaccine continue to outweigh the risks for most people — even though the European Medicines Agency said it had found a "possible link" between the shot and the rare clots. British authorities recommended that people under 30 be offered alternatives to AstraZeneca but the EMA advised no such age restrictions, leaving it up to its member-countries to decide whether to limit its use.
The UK recommendation threatens Australia's vaccine rollout due to the country's reliance on the AstraZeneca vaccine, with the vast majority of Australians expected to be jabbed with the locally produced AZ shot this year.
Recommendations to restrict use of the vaccine could have flow-on effects in Australia, Prime Minister Scott Morrison said in a press conference yesterday. "There is always the conditioning factor right across the vaccination rollout of the medical advice," Morrison said. "There are no absolute guarantees when it comes to this. We will follow the medical advice. We will continue to ramp up production here in Australia. And we will continue to move through the distribution channels that can deliver the supply of vaccines that we have."
Australia's chief medical officer Brendan Murphy said that the cases of blood clots were extremely rare, but Australian officials were working closely to assess the risks.
"We are working very closely with our counterparts in UK who have now done well over 18 million doses of this vaccine, and in Europe that have done many million, to look at the data that they're getting from their signals and their regulatory bodies," Murphy said. "The benefit of vaccination outweighs any potential risk. But we are continually reviewing the situation."
EU and UK regulators held simultaneous news conferences Wednesday (local time) to announce the results of investigations into reports of blood clots that sparked concern about the rollout of the AstraZeneca vaccine.
The EU agency described the clots as "very rare" side effects. Dr Sabine Straus, chair of its Safety Committee, said the best data was from Germany, where there was one report of the clots for every 100,000 doses given, although she noted far fewer reports in the UK. Still, that's less than the clot risk that healthy women face from birth control pills, noted another expert, Dr Peter Arlett.
The agency said most of the cases reported were in women under 60 within two weeks of vaccination, though it was unable to identify specific risk factors based on current information. Experts reviewed several dozen cases that came mainly from Europe and the UK, where around 25 million people have received the AstraZeneca vaccine.
"The risk of mortality from Covid is much greater than the risk of mortality from these side effects," said Emer Cooke, the EMA's executive director. Arlett said there is no information suggesting an increased risk from the other major Covid-19 vaccines.
In a statement, AstraZeneca said both UK and EU regulators had requested their vaccine labels be updated to warn of these "extremely rare potential side effect[s]".
"Both of these reviews reaffirmed the vaccine offers a high-level of protection against all severities of Covid-19 and that these benefits continue to far outweigh the risks," it said.
In March, more than a dozen countries, mostly in Europe, suspended their use of AstraZeneca over the blood clot issue. Most restarted — some with age restrictions — after the EMA said countries should continue using the vaccine.
Britain, which relies heavily on AstraZeneca, however, continued to use it.
The suspensions were seen as particularly damaging for AstraZeneca because they came after repeated missteps in how the company reported data on the vaccine's effectiveness and concerns over how well its shot worked in older people. That has led to frequently changing advice in some countries on who can take the vaccine, raising worries that AstraZeneca's credibility could be permanently damaged, spurring more vaccine hesitancy and prolonging the pandemic.
Dr Peter English, who formerly chaired the British Medical Association's Public Health Medicine Committee, said the back-and-forth over the AstraZeneca vaccine could have serious consequences.
"We can't afford not to use this vaccine if we are going to end the pandemic," he said.
In some countries, authorities have already noted hesitancy toward the AstraZeneca shot.
"People come and they are reluctant to take the AstraZeneca vaccine, they ask us if we also use anything else," said Florentina Nastase, a doctor and coordinator at a vaccination center in Bucharest, Romania. "There were cases in which people didn't show up, there were cases when people came to the centre and saw that we use only AstraZeneca and refused [to be inoculated]."
Meanwhile, the governor of Italy's northern Veneto region has said that any decision to change the guidance on AstraZeneca would cause major disruptions to immunisations — at a time when Europe is already struggling to ramp them up — and could create more confusion about the shot.
"Put yourself in the place of citizens, it is hard to understand anything," Luca Zaia told reporters.
The latest suspension of AstraZeneca came in Spain's Castilla y León region, where health chief Verónica Casado said that "the principle of prudence" drove her to put a temporary hold on the vaccine that she still backed as being both effective and necessary.
French health authorities had said they, too, were awaiting EMA's conclusions, as were some officials in Asia.
On Wednesday, South Korea said it would temporarily suspend the use of AstraZeneca's vaccine in people 60 and younger. In that age group, the country is only currently vaccinating health workers and people in long-term care settings.
After the EMA's announcement, Belgium's health minister, Frank Vandenbroucke, promptly said the country would disregard the agency's advice. He declared a four-week ban on administering the AstraZeneca vaccine to people under 56, but said that would have little impact on the vaccination campaign, since few from that age group are in line to get the shots this month.
Italian health officials have also said that AstraZeneca would be recommended for people over 60 years of age.
"For the vast majority of people the benefits of the Oxford AZ vaccine far outweigh any extremely small risk,″ said Dr Anthony Harnden, the deputy chair of Britain's vaccination committee. "And the Oxford AZ vaccine will continue to save many from suffering the devastating effects that can result from a Covid infection."
Additional reporting: News.com.au