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AstraZeneca’s Covid jab faces crisis of confidence as Europe halts vaccinations due to adverse events
The AstraZeneca-Oxford adenovirus vaccine has been embroiled in controversies ever since the drugmaker announced results from its clinical trial in November last year. The curious case of AstraZeneca’s jab got curiouser recently when over a dozen European countries — including Denmark, Iceland, Norway, Ireland, Holland, France, Germany, Sweden, Latvia and Italy — and Indonesia temporarily halted the administration of the two-dose vaccine.
In fact, throughout this month, vaccination programs in Europe have got impacted due to some adverse events related to this vaccine. Reports of thromboembolisms (obstruction of a blood vessel by a blood clot) affecting people after they got the Astra vaccine have raised concerns across Europe about the efficacy of the vaccine. In Norway, three health workers who had received the vaccine had to be treated in hospital for bleeding, blood clots and a low count of blood platelets.
Similarly, in Denmark, a 60-year old woman died of a blood clot after receiving Astra’s vaccine. According to a Reuters report, she had “highly unusual” symptoms, such as a low number of blood platelets and clots in small and large vessels, accompanied by bleeding. This week, Netherlands said it had seen 10 cases of adverse side-effects from the Astra vaccine, hours after the government put its vaccination program on hold.
Several experts took to Twitter to raise awareness about the issue, terming the halting of the vaccine as “hysteria”. Some also perceived it as ‘vaccine nationalism’ while others pointed out how other vaccines, such as the one from Pfizer, have reported even higher adverse events.
AstraZeneca’s shot is among the first and most affordable vaccine to enter markets with emergency use authorizations. However, with so many European countries halting its administration, the AstraZeneca vaccine is facing a crisis of confidence.
Confusing results from clinical trials
When AstraZeneca and Oxford announced results from their clinical trials last year, concern was raised over how much protection the Covid vaccine would offer. The trial had produced two different sets of results from two dosing regimens. The partners had said their vaccine was 90 percent effective when a half-dose was given before a full-dose booster, and that two full doses had shown a lower efficacy rate of 62 percent. Later, it was revealed that the lower dose was the result of a manufacturing discrepancy and was only tested in a younger group.
At the time, AstraZeneca CEO Pascal Soriot had said the company would set up an additional, probably global, trial to verify the 90 percent efficacy rate.
In an article published in STAT News, Desmond-Hellmann, who ran drug development at Genentech, said she believes concerns about AstraZeneca’s vaccine stem, at least in part, from its rollout. “The clinical trial for the AstraZeneca vaccine was extremely confusing and led to, I think, an overall lack of confidence,” she said.
Experts, WHO, EMA say benefits outweigh risks
Overall though, experts, the World Health Organization (WHO) and even the European Medicines Agency (EMA) are of the view that the vaccine’s benefits — preventing Covid-19 and helping in putting an end to the pandemic — outweigh its risks. They note that the number of people to report the side effect is relatively small, and no causal link has been established.
Recently, the EMA called an “extraordinary meeting” to analyze the risks of the vaccine.
“While its investigation is ongoing, EMA currently remains of the view that the benefits of the AstraZeneca vaccine in preventing Covid-19, with its associated risk of hospitalization and death, outweigh the risks of side effects,” the agency said in a statement. EMA will release results of its investigation into the adverse effects on March 18 afternoon.
The WHO, on its part, has appealed to countries not to pause vaccination campaigns. Its advisory panel is reviewing reports related to the vaccine. “As of today, there is no evidence that the incidents are caused by the vaccine and it is important that vaccination campaigns continue so that we can save lives and stem severe disease from the virus,” WHO spokesman Christian Lindmeier said.
On its part, AstraZeneca said: “A careful review of all available safety data of more than 17 million people vaccinated in the European Union and UK with Covid-19 vaccine AstraZeneca has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis or thrombocytopenia, in any defined age group, gender, batch or in any particular country.”
In fact, the vaccine has found support from the Prime Minister of France, Jean Castex, who said he has decided to go for the Astra-Oxford vaccine once the suspension was lifted. Ireland’s deputy chief medical officer, Ronan Glynn, also stressed that there is no proof that this vaccine causes blood clots. In Asia, countries like Thailand were initially doubtful. And even though Indonesia said it would wait for the air to clear up, Thailand said it plans to go ahead with the AstraZeneca shot.
EU not to get supplies of Astra jabs from US
AstraZeneca has not yet filed with the US Food and Drug Administration (FDA) as the agency is learnt to be waiting for results of the US trials on the vaccine.
According to a Reuters report, results of AstraZeneca’s US Covid-19 vaccine trial are being reviewed by independent monitors, and emergency authorization could come in about a month.
Independent monitors are analyzing data from the 32,000-person US study to determine whether the vaccine is safe and effective. According to Francis Collins, director of the National Institutes of Health (NIH), if the results are positive and all goes well, the FDA would review the data and issue the authorization.
“We expect data from our US Phase 3 trial to be available soon, and we plan to file for emergency use authorization shortly thereafter,” AstraZeneca spokeswoman Michele Meixell said.
In fact, the US has informed the EU that it should not expect to receive AstraZeneca’s vaccines manufactured at their plant near Baltimore, which is run by Catalent, any time soon. This would affect supplies of the vaccine to Europe. The Baltimore plant is listed in the EU supply contract with AstraZeneca as a “back-up supply site” and has been authorized by the EMA as a manufacturer of vaccine ingredients.
Earlier this year, AstraZeneca had told the EU that it would cut its supplies of the vaccine in the second quarter of 2021 by at least half — or to less than 90 million doses. Therefore, the US stance could jeopardize AstraZeneca’s attempts to bring deliveries closer to its contractual obligation with the EU of 180 million doses in April-June 2021.
Our view
The AstraZeneca-Oxford case of ‘crisis of confidence’ appears to be the result of a combination of factors — such as hurried trials, confused results from the clinical trials, vaccine nationalism, geopolitics, as well as genuine concerns over the efficacy of vaccines.
As more drugmakers hold clinical trials of their experimental coronavirus vaccines and the existing Covid-19 shots continue to draw conclusions from their ongoing trials, such news is bound to increase. In our view, vaccines will now be competing on both efficacy and side-effects. The game has only just begun.
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Image Credit : COVID-19 vaccine ready for roll-out: SII CEO by Devender Singh is licensed under CC BY 2.0 // Modification: text & logo was added to the original image
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