British authorities recommended Wednesday 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.   The recommendation came as regulators in the United Kingdom and the European Union emphasized 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.   Also Read: EU agency: Rare clots possibly linked to AstraZeneca shot   Several countries have already imposed limits on who can receive the vaccine, and any restrictions are closely watched since the vaccine, which is cheaper and easier to store than many others, is critical to global immunization campaigns and is a pillar of the U.N.-backed program known as COVAX that aims to get vaccines to some of the world’s poorest countries.   “This is a course correction, there’s no question about that,” Jonathan Van-Tam, England’s deputy chief medical officer, said during a news briefing.   Van-Tam said the effect on Britain’s vaccination timetable — one of the speediest in the world — should be “zero or negligible,” assuming the National Health Service receives expected deliveries of other vaccines, including those produced by Pfizer-BioNTech and Moderna. EU and U.K. regulators held simultaneous news conferences Wednesday 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 U.K. 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 U.K., 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.   The EMA’s investigation focused on unusual types of blood clots that have occurred along with low blood platelets. One rare clot type appears in multiple blood vessels and the other in veins that drain blood from the brain.   “We are not advising a stop to any vaccination for any individual in any age group,” said Wei Shen Lim, who chairs Britain’s Joint Committee on Vaccination and Immunization. “We are advising a preference for one vaccine over another vaccine for a particular age group ... out of the utmost caution rather than because we have any serious safety concerns.”   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 center and saw that we use only AstraZeneca and refused (to be inoculated).”   After the EMA announcement Wednesday, officials in Spain said AstraZeneca would be limited to people over 60 years of age, and Italy issued a similar recommendation.   Belgium’s health minister, Frank Vandenbroucke, 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.   Earlier Wednesday, South Korea had 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.   “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.”  

The European Union’s drug regulator will announce the conclusions of its investigation into the possible connection between AstraZeneca’s coronavirus vaccine and rare blood clots later Wednesday, including recommendations that could have far-reaching effects on the use of the shot that is key to global efforts to end the pandemic. Earlier this week, a senior official from the European Medicines Agency said there was a causal link between the AstraZeneca vaccine and the rare clots that have been seen in dozens of people worldwide, among the tens of millions who have received at least one dose of the shot. Also Read: Canada pauses AstraZeneca vaccine for under 55 Marco Cavaleri, head of health threats and vaccine strategy at the Amsterdam-based agency, said in comments to Rome’s Il Messaggero newspaper on Tuesday that “it is becoming more and more difficult to affirm that there isn’t a cause-and-effect relationship between AstraZeneca vaccines and the very rare cases of blood clots associated with a low level of platelets.” But Cavaleri acknowledged the agency hadn’t yet figured out how exactly the vaccine might be causing these rare side effects. The agency said its evaluation “has not yet reached a conclusion and the review is currently ongoing.” The EMA is particularly focused on two types of rare blood clots: one that appears in multiple blood vessels and another that occurs in a vein that drains blood from the brain. It is also evaluating reports of people who had low levels of blood platelets, which puts them at risk of severe bleeding. Also Read: UK regulator says AstraZeneca jab safe after 7 clot deaths The EMA, the World Health Organization and numerous other health authorities have said repeatedly that the AstraZeneca vaccine is safe and effective and that the protection it offers against COVID-19 outweighs the small risks of rare blood clots. As recently as last week, the EMA said “there is no evidence that would support restricting the use of this vaccine in any population” — a response to several countries doing just that — though an expert said more brain clots were being reported than would be expected. To date, most of the cases have been reported in younger women, who are more susceptible to developing such rare clots anyway, making understanding what is causing the clots potentially more difficult. “The problem is these clots are very unusual, and we don’t really know what the background rate of them is, so it’s very hard to know if the vaccine is contributing to this,” said Dr. Peter English, who formerly chaired the British Medical Association’s Public Health Medicine Committee. A full investigation would likely take months, but English said given the urgency of the continuing pandemic, regulators would likely make a quick decision. Also Read: What we know about AstraZeneca blood clot reports “It’s very likely we will see a suspension of the vaccine’s use in certain groups while they do the further investigations to give us clearer answers,” English 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 potentially life-saving vaccine. 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. English said the back-and-forth over the AstraZeneca vaccine globally could have serious consequences. “We can’t afford not to use this vaccine if we are going to end the pandemic,” he said. That’s because the vaccine is cheaper and easier to store than many others, is critical to Europe’s immunization campaign and a pillar of the U.N.-backed program known as COVAX that aims to get vaccines to some of the world’s poorest countries. It has been endorsed for use in more than 50 countries, including by the 27-nation EU and WHO. U.S. authorities are still evaluating the vaccine. The governor of Italy’s northern Veneto region said any decision to change the guidance on AstraZeneca would cause major disruptions to immunizations — at a time when Europe is already struggling to ramp them up — and could create more confusion about the shot. “If they do like Germany, and allow Astra Zeneca only to people over 65, that would be absurd. Before it was only for people under 55. Put yourself in the place of citizens, it is hard to understand anything,” Luca Zaia told reporters on Wednesday. The latest suspension of AstraZeneca came in Spain’s Castilla y León region, where health chief Verónica Casado said Wednesday 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. “If there are in fact individuals of a certain age group that could have a higher risk (of clotting) then we need to adjust its use,” Casado told Spanish public radio. “We are not questioning AstraZeneca. We need all the vaccines possible to reach the goal of 70% of the adult population.” French health authorities said they, too, were awaiting EMA’s conclusions and would follow the agency’s recommendations, especially for the 500,000 people who have received a first dose of AstraZeneca. Even officials in Asia said they were keen to hear the EMA’s decision. 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. The Korea Disease Control and Prevention Agency said it would also pause a vaccine rollout to school nurses and teachers that was to begin on Thursday, while awaiting the outcome of the EMA’s review. English, the former chair of the British drug regulator, said that even rare, serious side effects are seen with established vaccines and that policymakers often decide that bigger public health goals warrants their use, citing the polio vaccine as an example. For every million doses that are given of the oral polio vaccine, about one child is paralyzed from the live virus contained in the vaccine. On Tuesday, AstraZeneca and Oxford University, which developed the vaccine, paused a study of the shot in children while the U.K. regulator evaluates the link between the shot and rare blood clots in adults.