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EU agency to share results of probe into AstraZeneca shot

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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.

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.

“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 health workers and people in long-term care settings who are 60 or younger.

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.

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Biden to name Asian American-Pacific Islander liaison

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WASHINGTON — President Joe Biden will name Erika Moritsugu, a Capitol Hill veteran and vice-president of a women’s rights advocacy group, as his liaison to the Asian American and Pacific Islander community, according to two sources familiar with the decision.

Biden committed to creating a senior-level role focused on the AAPI community after he received criticism from Democratic Sens. Tammy of Duckworth of Illinois and Mazie Hirono of Hawaii for the lack of Asian American and Pacific Islander representation in his cabinet. The two senators threatened to hold up his nominees unless Biden remedied the situation, but reversed their stance after the White House said it would create the position.

Katherine Tai, who is Taiwanese American, is in the Cabinet as Biden’s top trade envoy. Dr. Vivek Murthy, the son of Indian parents, was confirmed Tuesday as surgeon general, a sub-Cabinet position. And Vice-President Kamala Harris is of Indian-American descent as well. But the senators expressed concerns that they had no direct liaison within the White House to make their concerns heard.

Biden is set to meet with the Congressional Asian Pacific American Caucus at the White House on Thursday, though Moritsugu is not expected to attend, according to two sources granted anonymity to speak freely about internal discussions.

Moritsugu is the vice-president for the National Partnership for Women & Families, and prior to that held a number of roles on Capitol Hill, working for Duckworth, former Sen. Daniel Akaka of Hawaii and the Senate Democratic Policy Committee under former Senate Majority Leader Harry Reid. She also served in the Obama administration as an official at the Department of Housing and Urban Development and the Consumer Financial Protection Bureau.

The pick comes as the Senate has taken up legislation aimed at combating anti-Asian hate crimes, in the wake of a raft of violence against Asian Americans over the past month.

Alexandra Jaffe, The Associated Press

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Iran calls Natanz atomic site blackout ‘nuclear terrorism’

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While there was no immediate claim of responsibility, suspicion fell immediately on Israel, where its media nearly uniformly reported a devastating cyberattack orchestrated by the country caused the blackout.
If Israel was responsible, it further heightens tensions between the two nations, already engaged in a shadow conflict across the wider Middle East. Israeli Prime Minister Benjamin Netanyahu, who met Sunday with U.S. Defence Secretary Lloyd Austin, has vowed to do everything in his power to stop the nuclear deal.

Details remained few about what happened early Sunday morning at the facility, which initially was described as a blackout caused by the electrical grid feeding its above-ground workshops and underground enrichment halls.

Ali Akbar Salehi, the American-educated head of the Atomic Energy Organization of Iran, who once served as the country’s foreign minister, offered what appeared to be the harshest comments of his long career, which included the assassination of nuclear scientists a decade ago. Iran blames Israel for those killings as well.

He pledged to “seriously improve” his nation’s nuclear technology while working to lift international sanctions.

Salehi’s comments to state TV did not explain what happened at the facility, but his words suggested a serious disruption.

“While condemning this desperate move, the Islamic Republic of Iran emphasizes the need for a confrontation by the international bodies and the (International Atomic Energy Agency) against this nuclear terrorism,” Salehi said.

The IAEA, the United Nations’ body that monitors Tehran’s atomic program, earlier said it was aware of media reports about the incident at Natanz and had spoken with Iranian officials about it. The agency did not elaborate.

However, Natanz has been targeted by sabotage in the past. The Stuxnet computer virus, discovered in 2010 and widely believed to be a joint U.S.-Israeli creation, once disrupted and destroyed Iranian centrifuges at Natanz amid an earlier period of Western fears about Tehran’s program.

Natanz suffered a mysterious explosion at its advanced centrifuge assembly plant in July that authorities later described as sabotage. Iran now is rebuilding that facility deep inside a nearby mountain. Iran also blamed Israel for the November killing of a scientist who began the country’s military nuclear program decades earlier.

Multiple Israeli media outlets reported Sunday that an Israeli cyberattack caused the blackout in Natanz. Public broadcaster Kan said the Mossad was behind the attack. Channel 12 TV cited “experts” as estimating the attack shut down entire sections of the facility.

While the reports offered no sourcing for their information, Israeli media maintains a close relationship with the country’s military and intelligence agencies.

“It’s hard for me to believe it’s a coincidence,” Yoel Guzansky, a senior fellow at Tel Aviv’s Institute for National Security Studies, said of Sunday’s blackout. “If it’s not a coincidence, and that’s a big if, someone is trying to send a message that ‘we can limit Iran’s advance and we have red lines.’”

It also sends a message that Iran’s most sensitive nuclear site is “penetrable,” he added.

Netanyahu later Sunday night toasted his security chiefs, with the head of the Mossad, Yossi Cohen, at his side on the eve of his country’s Independence Day.

“It is very difficult to explain what we have accomplished,” Netanyahu said of Israel’s history, saying the country had been transformed from a position of weakness into a “world power.”

Israel typically doesn’t discuss operations carried out by its Mossad intelligence agency or specialized military units. In recent weeks, Netanyahu repeatedly has described Iran as the major threat to his country as he struggles to hold onto power after multiple elections and while facing corruption charges.

Speaking at the event Sunday night, Netanyahu urged his security chiefs to “continue in this direction, and to continue to keep the sword of David in your hands,” using an expression referring to Jewish strength.

Meeting with Austin on Sunday, Israeli Defence Minister Benny Gantz said Israel viewed America as an ally against all threats, including Iran.

“The Tehran of today poses a strategic threat to international security, to the entire Middle East and to the state of Israel,” Gantz said. “And we will work closely with our American allies to ensure that any new agreement with Iran will secure the vital interests of the world, of the United States, prevent a dangerous arms race in our region, and protect the state of Israel.”

The Israeli army’s chief of staff, Lt. Gen. Aviv Kochavi, also appeared to reference Iran.

The Israeli military’s “operations in the Middle East are not hidden from the eyes of the enemy,” Kochavi said. “They are watching us, seeing (our) abilities and weighing their steps with caution.”

On Saturday, Iran announced it had launched a chain of 164 IR-6 centrifuges at the plant. Officials also began testing the IR-9 centrifuge, which they say will enrich uranium 50 times faster than Iran’s first-generation centrifuges, the IR-1. The nuclear deal limited Iran to using only IR-1s for enrichment.

Since then-President Donald Trump’s withdrawal from the Iran nuclear deal in 2018, Tehran has abandoned all the limits of its uranium stockpile. It now enriches up to 20% purity, a technical step away from weapons-grade levels of 90%. Iran maintains its atomic program is for peaceful purposes.

The nuclear deal had granted Tehran sanctions relief in exchange for ensuring its stockpile never swelled to the point of allowing Iran to obtain an atomic bomb if it chose.

On Tuesday, an Iranian cargo ship said to serve as a floating base for Iran’s paramilitary Revolutionary Guard forces off the coast of Yemen was struck by an explosion, likely from a limpet mine. Iran has blamed Israel for the blast. That attack escalated a long-running shadow war in Mideast waterways targeting shipping in the region.

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Associated Press writers Nasser Karimi in Tehran, Iran, and Josef Federman and Ilan Ben Zion in Jerusalem contributed to this report.

Jon Gambrell, The Associated Press

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