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AstraZeneca Vaccine Injections Resume in Most of Europe, Not Yet Approved in U.S.

Photo: The AstraZeneca vaccine will now come with a warning label. Credit: https://www.nbcnews.com/health/health-news/after-reports-blood-clots-some-countries-pause-use-astrazeneca-covid-n1260888

UK Prime Minister Boris Johnson and French Prime Minister Jean Castex are rolling up their sleeves to receive their first jabs of the Oxford-AstraZeneca vaccine in an effort to restore public trust in it. A handful of patients reported experiencing blood clots after getting their AstraZeneca coronavirus vaccine, prompting multiple countries to halt injections. Now, as health officials say there’s nothing to worry about, leaders such as Johnson and Castex are doing damage control.

During the second week of March, several countries in the European Union, such as Spain, Germany, France and Italy, hit pause on administering the AstraZeneca vaccine. About 30 of the 20 million people who received a shot of the vaccine experienced rare blood clots in either the brain or veins throughout their body, causing countries to suspend its use as a precautionary measure. Doctors and health experts, however, sharply criticized the move, saying there’s no proven link between the blood clots and the vaccine.

“The decisions by France, Germany and other countries look baffling,” said Dr. Michael Head, senior research fellow in Global Health at the University of Southampton, U.K. “Halting a vaccine rollout during a pandemic has consequences. This results in delays in protecting people, and the potential for increased vaccine hesitancy, as a result of people who have seen the headlines and understandably become concerned. There are no signs yet of any data that really justify these decisions.”

The World Health Organization echoed these sentiments, saying that the AstraZeneca rollout should resume immediately and that the benefits of preventing the spread of the coronavirus far outweigh the risks. But the WHO will still investigate potential risks to prove that the vaccination oversight system is effective.

On Thursday, the European Medicines Agency announced that the AstraZeneca vaccine was safe and effective, but that it couldn’t rule out a possible link to blood clots. The EMA said it will add a warning label to the vaccine, but most countries have vowed to resume injections by Monday, March 22. 

However, because of the rollback, trust in the vaccine has certainly diminished. The Britain-born AstraZeneca vaccine was already seen as second-class due to its 79 percent efficacy rate compared to Pfizer’s 95 percent and Moderna’s 94.1 percent efficacy rates. However, the U.S. Food and Drug Administration says a vaccine only has to be 50 percent effective to meet approval regulations. The flu shot, for example, is encouraged each year but its efficacy rate often varies from 20 to 60 percent effective.

“I know that 50 percent does sound low but that is still some protection, and some protection is better than no protection,” said Dr. Jeff Kwong, professor of public health and family medicine and interim director of the Centre for Vaccine Preventable Diseases at the University of Toronto.

European countries’ decision to halt the vaccine reverberated around the world. On March 12, Thailand canceled its scheduled rollout plan for the vaccine but that decision was reversed days later when Thai Prime Minister Prayut Chan-o-cha received his first dose and encouraged the public to follow suit. Indonesia also hit pause early in the week, following in the footsteps of European countries, but it announced it would resume injections on Friday.

AstraZeneca, unlike Pfizer, Moderna or Johnson & Johnson, has not yet applied for emergency use authorization in the U.S. But because clinical trials have begun in the U.S., there are currently tens of millions of AstraZeneca doses sitting in American facilities that aren’t being used as it waits for the trial results. After weeks of negotiations, the U.S. announced on Thursday that it will send about 4 million of its unused doses to Mexico and Canada, which have both already approved the vaccine but lack the infrastructure to provide it to their entire populations. 

“Our first priority remains vaccinating the U.S. population,” White House press secretary Jen Psaki said. “But the reality is…the pandemic knows no borders, and ensuring our neighbors can contain the virus is a mission critical step.”

The bottom line is that the AstraZeneca vaccine is a critical component of the global inoculation process, and people around the world should not hesitate to get injected regardless of the manufacturer. AstraZeneca is expected to request emergency use authorization from the U.S. government in late March or early April, and, because of its delays and concerns in Europe, many doctors are worried that Americans are going to raise a lot of questions about its efficacy.
“It’s hard to unring that bell,” Dr. Paul Offit, a member of the FDA advisory committee said. “Once people are scared, it’s hard to unscare them.”

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