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How AstraZeneca’s Latest Vaccine Problems Could Slow Global Recovery




European drug regulators confirmed a link between the Oxford-AstraZeneca Covid-19 vaccine and rare blood clots Wednesday, but stopped before recommending that its use be limited. British authorities have recommended that people under the age of 30 take alternative vaccines.
This is the last setback for AstraZeneca (AZN), which has been criticized for its communication with the public and regulators, the design of its vaccine trials and severe production delays that have slowed the rollout of injections in Europe.

Authorities argue that the benefits of the vaccine outweigh the risks for most age groups. Yet shifts in focus and concerns about blood clots risk losing distribution efforts in many countries. Germany suspended use of the AstraZeneca vaccine last week in people under the age of 60, while Australia said Thursday it would not give it to people under the age of 50.

Safety issues could have even greater implications for developing and middle-income countries, many of which are now relying on their economic return because it is cheaper than other vaccines and can be stored more easily. Many are accessing it through Covax, a global vaccine-sharing program, which got more than half of its supply from AstraZeneca in March.

Overall, orders for about 2.4 billion doses of the AstraZeneca vaccine have been confirmed, according to the Duke Global Health Innovation Center. This represents about 28% of the world total.

“There is a lot of uncertainty here,” said Ben May, director of macroeconomic research at Oxford Economics. He said AstraZeneca’s developments were not enough to revise near-term growth forecasts, but that he would continue to monitor the situation closely.

The World Health Organization said in a statement Wednesday that “based on current information, a cause and effect relationship between the vaccine and the occurrence of blood clots with low platelet counts is considered plausible but not is not confirmed “.

AstraZeneca said that nearly 200 million people worldwide have already received its vaccine and that reviews by European and UK regulators “reaffirmed that the vaccine offers a high level of protection against all severities of Covid-19 and that these the benefits continue to outweigh the risks by far. “

A medical worker prepares to inoculate a woman with a dose of AstraZeneca vaccine in Hyderabad on April 5.

A difficult start

AstraZeneca received emergency use authorization from the UK at the end of December and from the European Union a month later. Because the vaccine was cheaper and could be stored at higher temperatures than those developed by Pfizer (PFE) and Modern (RNAm), it was heralded as a breakthrough, especially for less wealthy countries that lack sophisticated logistics networks.

The company has also generated a lot of goodwill by pledging to provide its vaccine for no profit during the pandemic and by partnering with the Serum Institute of India, which has agreed to produce more than a billion doses for countries at low and middle income. AstraZeneca has already supplied more than 30 million doses to more than 58 countries via Covax.

However, a string of missteps generated a string of bad headlines for the Anglo-Swedish drug maker.

The first problem came in November, when the company faced questions about large-scale test data. Volunteers were given different doses due to a manufacturing error, creating confusion as to its actual effectiveness.

EU agency finds AstraZeneca vaccine can cause rare blood clots, UK advises other vaccines for under 30s

AstraZeneca did not mention that an error caused the dosage discrepancy in its initial announcement, raising concerns about a lack of transparency.

“I hate to criticize my college colleagues, or anyone for that matter, but posting information like this is like asking us to try to read tea leaves,” said vaccine specialist Dr Saad Omer. at the Yale School of Medicine. time.

Other stumbles followed. The German Vaccine Commission said in January that AstraZeneca injections should not be given to people over the age of 65, citing insufficient data for the age group. France also initially limited AstraZeneca vaccines to those under 65. The two countries changed course last month.

Jeffrey Lazarus, head of the health systems research group at the Barcelona Institute for Global Health, previously told CNN Business that this was an “easily avoidable” problem with the design of the trials. .

If the vaccine rollout had gone smoothly, these stumbles could have been forgotten. But the persistent shortages of supply of the AstraZeneca blows in Europe, which is now mired in a third wave of coronavirus infections, have triggered a huge political backlash in the block. The leaders have imposed restrictions on vaccine exports.

“If we had received 100% of the AstraZeneca vaccines contracted to us, the European Union would today be at the same level as Great Britain in terms of vaccines”, said European Commissioner Thierry Breton in a recent interview with the newspaper Le Parisien. “So I can say that the pocket of turbulence we have experienced is solely due to AstraZeneca’s inability to deliver.”

AstraZeneca’s future role

The company also clashed with US regulators last month when submitting test data from the country. The US National Institute of Allergy and Infectious Diseases expressed concern that the efficacy information submitted was “out of date”. AstraZeneca quickly sent in revised data, but Dr Anthony Fauci, director of the agency, called it an “unforced error”.

Now, as fears about the scarcity of blood clots force governments around the world to re-evaluate the risk-benefit analysis of administering vaccines to all age groups, the United States has indicated that it is not did not need the doses of AstraZeneca.

“We have enough of the very good vaccines,” Fauci, who also serves as chief medical adviser to President Joe Biden, told CNN Wednesday.

However, not all countries will have this luxury. India, for example, relies heavily on AstraZeneca’s shot as it attempts to fight a alarming peak in cases.

Lazarus said on Thursday that if richer countries decide to reduce their dependence on AstraZeneca, he is hopeful that shots can be sent to other countries in need, as data still indicates it is safe and effective.

EU offers vaccine checks as 'raid' in Italy reveals millions of doses of AstraZeneca

“There are a lot of other countries that don’t have other options because of the logistics … and the cost,” he said.

He is concerned, however, that all the bad publicity will affect people’s willingness to accept an AstraZeneca vaccine when it becomes available.

“This will definitely impact the reputation of the AstraZeneca vaccine,” Lazarus said. “[It] will lead to lower consumption. “

This could be bad news for the global economic recovery. This week, the International Monetary Fund raised its forecast for global growth this year to 6%. But this estimate depends in part on the pace of vaccine deployment.

“Anything that could actually reduce vaccine availability is obviously not good news,” said May of Oxford Economics.

The vaccine “is still usable for the most vulnerable segments of the population,” he noted. But coupled with supply shortages, new restrictions could complicate the recovery in countries where AstraZeneca’s vaccine is at the heart of pandemic exit strategies, May said.

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