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Tuesday, June 15, 2021

Here’s What To Expect As Europe’s Medicines Regulator And The WHO Meet To Review Shot

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Experts from the European Medicines Agency (EMA) and the World Health Organization are set to meet on Tuesday to review the Oxford-AstraZeneca Covid-19 vaccine after reports of blood clots led a string of countries to suspend the shot—here’s what to expect.  

Key Facts

Sweden became the latest country to suspend the vaccine’s rollout Tuesday as a “precautionary measure” pending the results of the EMA meeting—the scandinavian state joins a fast-growing wave of countries to temporarily ban the shot over safety concerns, including Germany, France, Spain and Italy which did so Monday. 

In light of the bans—which many, including the head of Italy’s medicines authority, say are motivated by politics, not science—experts from the WHO and Europe’s medicines regulator are both set to convene Tuesday to discuss the vaccine’s safety and continued use.

Though both organizations will thoroughly review any new and existing evidence, each is expected to clear the vaccine for further use given the dangers of the pandemic and having already authorized the vaccine for widespread use.  

The EMA, which is expected to issue a decision on the vaccine as soon as Thursday, has previously defended the shot in a statement, saying there is “no indication that vaccination has caused these conditions,” which have occurred at a rate “no higher than the number seen in the general population,” and that its position is still that the “vaccine’s benefits continue to outweigh its risks.”  

The WHO has also defended the shot against claims it causes blood clots, stating that there is “no evidence” linking the two. 

“As soon as WHO has gained a full understanding of these events, the findings and any unlikely changes to current recommendations will be immediately communicated to the public,” the BBC reported WHO spokesman Christian Lindmeier.

Chief Critic 

A raft of regulators, experts and officials have condemned the move to block the vaccine with only scant scientific evidence to back the decision, especially given the globally important role many believe it will play in stopping the pandemic. Dr Phil Bryan, vaccines safety lead at the U.K. ‘s medicines regulator (MHRA), said there was no evidence the shot caused problems in the 11 million doses given out in the U.K., stressing that blood clots are not uncommon and can occur naturally. 

Crucial Quote

AstraZeneca has contested claims its vaccine is linked to reports of blood clots. The company told Forbes that it found “no evidence” of an increased risk of pulmonary embolism or deep vein thrombosis in any particular group or country from an analysis of more than 10 million records, which actually showed “these types of events” to occur at rates “significantly lower” in vaccinated people than “would be expected among the general population.” 

Surprising Fact

Thailand’s prime minister, along with a group of senior politicians, received the shot Tuesday just days after the country suspended its rollout over fears of blood clots. 

Key Background

Although trials have shown the AstraZeneca vaccine to be safe, well tolerated and effective in preventing disease, it has encountered setbacks as it is rolled out around the world. Methodological issues in its Phase 3 clinical trial created confusion over the study and suggested dosing regimen. A failure to recruit enough people over a certain age group left many regulators reluctant to clear it for use in the elderly, many of whom are now reluctant to roll up their sleeves now the decision has been reversed. 

What To Watch For

Despite its approval by major European regulators and the World Health Organization, the AstraZeneca shot is not authorized for use in the U.S.. The company hasn’t actually applied yet, likely waiting for results in its U.S.-based clinical trial. The New York Times reported the U.S. is sitting on tens of millions of doses ahead of this approval, doses other countries sorely need. 

Further Reading

Experts Defend Safety Of AstraZeneca Covid-19 Vaccine After Several Countries Suspend The Shot (Forbes)

Politics, Not Science, May Be Behind Suspensions Of AstraZeneca’s Covid Vaccine (Forbes)

Germany, France, Italy, Spain Suspend Use Of AstraZeneca Vaccine Over Blood Clot Concerns (Forbes)

AstraZeneca Defends Covid-19 Vaccine Safety As Germany And Ireland Join Others In Suspending Use (Forbes)

Growing Number Of Nations Suspend AstraZeneca Covid Vaccine Amid Blood Clot Concerns (Forbes)

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