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AstraZeneca’s COVID vaccine faced new controversy this week after a trial participant in India alleged that the vaccine caused him serious “neurological and psychological” symptoms.

The accusation was the latest in a series of complaints or concerns surrounding Covishield, the AstraZeneca vaccine being developed in partnership with Oxford University.

Yet despite concerns about safety and trial design, countries are already spending billions of dollars in taxpayer funds to purchase AstraZeneca’s vaccine, in part because, compared with frontrunners Moderna and Pfizer, AstraZeneca’s vaccine is easier to store and faster to distribute.

The latest news also hasn’t changed plans by the Global Alliance for Vaccine Initiative (GAVI), a public-private partnership founded by the Bill & Melinda Gates Foundation, to distribute the AstraZeneca COVID vaccine globally, once it’s approved.

Second participant reports neurological adverse effect

On Nov. 21, a 40-year-old participant in AstraZeneca’s clinical trial, who lives in India, sent a legal notice to the Serum Institute of India alleging that the vaccine caused him to develop acute neuro encephalopathy.

In the notice, the participant said he “must be compensated, in the least, for all the sufferings that he and his family have undergone and are likely to undergo in the future.”

The Serum Institute, which has a deal with AstraZeneca to manufacture a billion doses of the vaccine, maintains that the participant’s medical complications are unrelated to the vaccine trial.

A spokesperson for the Institute said the trial participant is “falsely laying the blame for his medical problems on the COVID vaccine trial” and that “it is evident that the intention behind the spreading of such malicious information is an oblique pecuniary motive.”

A statement released by the Institute claimed that they are “sympathetic with the volunteers medical condition” but also that they claim to take legal action against the injured participant for maligning the company’s reputation, seeking damages in excess of $13 million.

On Tuesday, Indian Health Secretary Rajesh Bhushan said that the adverse event “will not affect the timeline in any manner whatsoever.”

Bioethicists and scientists are questioning the ethics of the Serum Institute, which has received at least $18.6 million from the Bill and Melinda Gates Foundation. “This is the first time I have ever heard of a sponsor threatening a trial participant,” said Dr. Amar Jesani, editor of the Indian Journal of Medical Ethics.

Dr. John Jacob, virologist and former professor at Christian Medical College, agreed the actions of the institute were uncalled for. He told the Times of India, “The trial should have been halted the next day after the adverse event was reported. And within a week it could have been investigated. That would have instilled confidence and trust in the minds of people. Stonewalling, refusing to answer, waiting for a lawsuit to bring things out, it speaks volumes about the lack of professionalism.”

This wasn’t the first time a trial participant has complained that the AstraZeneca vaccine caused a neurological injury. In July, a trial volunteer developed symptoms of transverse myelitis, a rare debilitating neurological disorder linked to vaccines.

In September, global trials were temporarily paused after another participant in the UK developed symptoms also consistent with transverse myelitis.

In October, a participant in Brazil died, though in that case, AstraZeneca suggested that the person was part of the control group and thus hadn’t received the COVID-19 vaccine. The Brazil trial wasn’t paused. Covishield trials are currently taking place in the UK, South Africa, Brazil and Japan.

As reported by The Defender in November, according to the company’s own data, it took only one dose of AstraZeneca’s vaccine during Phase I/II trials in the UK to cause more than 50% of participants to experience adverse events.

If the AstraZeneca vaccine, once approved, does produce harmful side effects and adverse reactions in the U.S., the company won’t be held accountable. In March 2020, the U.S. Department of Health and Human Services issued a COVID-19-specific declaration under the Public Readiness and Emergency Preparedness Act, providing liability immunity “against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures,” including COVID-19 vaccines.

The European Union and Australia have also followed suit, indemnifying vaccine manufacturers from liability.

Drugmaker’s trial design also at issue

In addition to reports of vaccine-related injuries, there have been other problems with AstraZeneca’s trials. For example, trial administrators gave the control group in the UK Pfizer’s Nimenrix, a meningitis vaccine.

A saline solution is the gold standard placebo because researchers can be sure it won’t cause any  adverse reactions. Using Pfizer’s meningitis vaccine as a placebo allows AstraZeneca to undercut any adverse reactions in its COVID vaccine group by showing the control group suffered adverse reactions as well.

“The meningitis vaccine in the AstraZeneca trial is what I would call a ‘fauxcebo,’ a fake control whose real purpose is to disguise or hide injury in the vaccine group,” said Mary Holland, general counsel at Children’s Health Defense. “The trial sponsor can say, ‘look, the vaccine group is as safe as the control group,’ when in fact the trial proves that the control group was as dangerous as the vaccine group.”

In a tweet, Oxford University’s Oxford Vaccine Group explained the decision, stating that it only made sense to use Pfizer’s meningitis vaccine as a placebo because “otherwise participants who have any reaction to the injection would be able to guess that they had received the ChAdOx1-nCoV-19 vaccine,” indicating that adverse reactions are expected.

In November, AstraZeneca released data showing a 90% efficacy rate but citing the fact that there were only 2,741 participants in the test group. Dr. Saad Omer, director of the Yale Institute for Global Health, told CNN that the test group was “relatively small” and said “it might not hold up when more people are given this regimen.”

After releasing the data, AstraZeneca acknowledged a “mistake” in the amount of vaccine given to some trial participants. That news led the New York Times to report that the company had undercut its own credibility.

“I think that they have really damaged confidence in their whole development program,” Geoffrey Porges, an analyst for the investment bank SVB Leerink, told the Times.

Dr. Natalie Dean, a biostatistician and expert in vaccine trial design at the University of Florida, wrote on Twitter that overall, Oxford and AstraZeneca get “a poor grade for transparency and rigor when it comes to the vaccine trial results they have reported.”

Price, speed and connections to Gates Foundation key to big contracts

At only a few dollars a dose, Covishield is often hailed as cheaper, easier to store and faster to distribute compared with the vaccines developed by frontrunners Pfizer and Moderna. As CNN reported, Covishield will “be far easier to transport and distribute in developing countries than its rivals.”

When the Thomson Reuters Foundation asked several experts which COVID-19 vaccine could “reach the poorest soonest,” all three who answered declared a preference for the AstraZeneca candidate.

Oxford and AstraZeneca already have a plan to provide more than 1 billion doses of their vaccine, commonly referred to as the COVID-19 vaccine that will be able to meet the requirements of the developing world. Europe will receive 400 million doses of the vaccine while the U.S. and GAVI will receive 700 million doses, and India 1 billion doses. The company’s plan relies heavily on its connections to the Gates Foundation.

Dr. Andrew Pollard, director of the Oxford Vaccine Group which is producing the Oxford-AstraZeneca vaccine, is tightly intertwined with the Gates Foundation. His employer, the University of Oxford, has received $11 million for vaccine development research from the foundation over the past three years, and $208 million in grants over the past decade.

In 2016, the Gates Foundation gave $36 million for research into vaccine development by a team of researchers which was headed by Pollard. In addition, Pollard’s private laboratory is funded by the Gates Foundation.

Pollard is also chair of the UK Committee on Vaccination and Immunisation which advises the government policy on immunization and vaccines, and a member of the National Institute for Biological Standards and Control Scientific Advisory Committee, which advises the Medicines and Healthcare Products Regulatory Agency.

“Dr. Pollard’s ties to Oxford, AstraZeneca, the Gates Foundation and the U.K. government make plain what vaccine public-private partnerships mean in practice,” Holland said.