Post Mortem

Safety concerns over AstraZeneca

By Nagaland Post | Publish Date: 4/9/2021 1:44:50 PM IST

 There is no coronavirus vaccine on Earth more closely scrutinized than AstraZeneca’s right now. The vaccine, developed by the Anglo-Swedish drug giant with Oxford University researchers, was widely hyped in the early days of the pandemic for its speedy development and innovative technology.

But the rollout has been plagued by issues including questions over misleading data and missed deliveries that clouded public perceptions of AstraZeneca as other vaccines raced ahead.

This week, renewed concerns about rare but serious blood clots among those who have received the vaccine were bolstered by Europe’s top drug agency. The European Medicines Agency said Wednesday that it was “plausible” the blood clots were linked to the vaccine, but also “stressed that the benefits of vaccination still outweigh the risks,” my colleagues reported.

Even so, the latest news from Europe will travel far beyond the continent’s borders — and AstraZeneca’s woes are likely to have an outsized global impact.

Unlike many of its peers, the vaccine is relatively cheap and easy to administer. And crucially, it forms a major part of the supplies planned for Covax, a global vaccine initiative linked to the World Health Organization that aims to ensure supply to lower-middle and low-income nations.

Research published last month by the Think Global Health program of the Council on Foreign Relations found that AstraZeneca was expected to make up almost 50 percent of global vaccine supply in lower-middle income nations and a third of vaccine supply in low-income nations.

This scramble to receive AstraZeneca doses contrasts with the concurrent concerns about its safety. A number of European countries had already made changes to their vaccination programs before the EMA’s announcement, with Denmark and Norway pausing use of the vaccine completely.

Italy on Wednesday announced it would be recommending the AstraZeneca vaccine only for those over 60, following similar recent moves in France and Germany.

The British government, which had spoken proudly in the past of Oxford’s role in the vaccine development, offered milder warnings too, saying that adults under 30 should be offered an alternative vaccine.

Even if the blood clots were rare, the EMA said, they appeared to be more severe for younger people, with most reported cases in women under 60.

Polling suggests that many Europeans already view the vaccine as unsafe. In Romania, officials said this week that more than 200,000 people had canceled their appointments to get the vaccine, while almost 100,000 did not turn up for their appointment, despite the high numbers of new daily cases in the country.

But as some nations balk at the vaccine, others are struggling to get their doses. So far, there is no sign that AstraZeneca’s problems will temper the demand for it in many corners of the world. Yet export controls, such as those put in place last month by the Indian government after a surge in domestic cases, pose a problem.

Amid a disastrous surge in cases last month, the Indian government imposed restrictions on the export of vaccines. The move hit the Pune-based Serum Institute, the largest manufacturer in the world by volume, which was producing the Oxford-developed vaccine under an agreement with AstraZeneca.

India, which has been generous with vaccine donations to poorer neighbors, has pushed back on media descriptions of an export ban. “We should not call it scaling down,” VK Paul, a top health official in India, told The Washington Post last week, admitting that there would be “some slowing down” but suggesting it would be resolved in weeks.

Najwa Mekki, a UNICEF spokesperson, said last week that Covax had so far received only 28 million AstraZeneca doses from the Serum Institute of the 90 million it was expecting in March and April, but that it was expecting normal exports to resume in May.

But Adar Poonawalla, the CEO of the Serum Institute, voiced a more pessimistic viewpoint Tuesday, telling the Associated Press that exports may not fully resume until June if the surge in India doesn’t subside. “We are going to have to keep supplying to India, and not anywhere else. Because we have to protect our nation,” Poonawalla said.

Some countries are already saying their vaccination targets could be affected. John Nkengasong, director of the Africa Centers for Disease Control and Prevention, said that last week that the delay in delivery of AstraZeneca doses could be “catastrophic” for meeting the continent’s vaccine schedule. Indonesia, the Philippines and Vietnam have also said they expect slowdowns.

And India is not the only country that has limited exports. Australia had a contract for 3.8 million doses to be delivered in January and February, but those hopes were dashed in March after the European Commission introduced export restrictions and Italy blocked the shipment of 250,000 doses destined for Australia.

The United States has also placed strict limits on the exports of vaccines too, resulting in tens of millions of doses of the AstraZeneca vaccine gathering dust in U.S. plants, even as the drug has not been approved for domestic use.

Vanity Fair reported this week that U.S. contracts with major drug manufacturers, including AstraZeneca, included specific language that forbids the sharing of excess doses with the rest of the world. “It is a complete and total ban,” an unnamed administration official said of the contracts.

Even so, Tom Bollyky of the Council on Foreign Relations has argued that the United States could negotiate more ways to share vaccines. 

Andrea Taylor, a researcher at Duke University who tracks vaccine supply, said one reason India’s export controls have had such an effect is because they were unexpected. The United States, on the other hand, made clear early in the pandemic that it would prioritize domestic vaccine supply.

“The U.S. could have played a significant role in vaccine access for the world, but never planned to, at least not in 2021,” Taylor wrote in an email. “This is because their starting position was so nationalistic rather than global.”

With its own vaccination program steaming ahead without approval of the AstraZeneca vaccine, the United States has been largely insulated from its woes. Anthony S. Fauci, the nation’s top infectious-disease doctor, said last week that it was “still up in the air” whether the United States would need its AstraZeneca doses at all.

But for much of the rest of the world, that is not the case. And as vaccination remains in high demand, concern about the twin problems of safety and supply will remain high with it.

(Adam Taylor)

Launched on December 3,1990. Nagaland Post is the first and highest circulated newspaper of Nagaland state. Nagaland Post is also the first newspaper in Nagaland to be published in multi-colour.

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