The Testing of the chimpanzee adenovirus-based vaccine had been repeatedly called into question for the “dangerous” lack of sufficient trials on chimp viruses as well as the unclear consequences of the new technology. The trials of AstraZeneca vaccine candidate remain on hold in the US.
Days after AstraZeneca halted clinical trials of its COVID-19 vaccine over the case of unexplained neurological illness in one volunteer taking part in the study, the British-Swedish pharmaceutical company released an 111-page trial blueprint, which promises an anti-coronavirus drug with “50% effectiveness”. That was the first time AstraZeneca revealed the second case of serious illness by one of the participants of its Phase 3 trials in the UK.
The firm has already resumed the trials in the UK even though one of the participants developed transverse myelitis, an inflammation of spinal cord, while a diagnosis of the second volunteer remains to be confirmed. However, The New York Times cited a source familiar with the situation as suggesting that the second person suffered the same side-effect earlier, which has never been reported by AstraZeneca before. It turned out, that “the first pause, in July, was not publicly revealed and the trial was restarted”, says the article by The Telegraph.
Despite the pressure to conduct deeper studies after the two cases of serious illness, AstraZeneca has already restarted the trials in Britain, Brazil, India and South Africa, though the trials are still on hold in the US after the vows from the National Institutes of Health. “The highest levels of NIH are very concerned,” Dr. Avindra Nath, intramural clinical director and a leader of viral research at the National Institute for Neurological Disorders and Stroke, an NIH division told the CNN.
Same position was shared by the FDA experts.
“We’re here to protect the American public and we’re going to do very significant work with the company to figure out if there’s a significant safety issue or not,” FDA Commissioner Stephen Hahn said during an Instagram Live interview with Republican U.S. Senator Tim Scott of South Carolina.
“We don’t have all facts, so we don’t know the causation per se of this, but we really need to look into it. And our prime responsibility is the safety of the American people,” Hahn said.
AstraZeneca has been repeatedly criticized for the lack of transparency by the scientific community.
William A. Haseltine, PhD, ex-professor at Harvard Medical School and Harvard School of Public Health told Forbes: “Details for the hold on trials by AstraZeneca have not been fully disclosed and internal discussions are not publicized. It is encouraging to see that they paused trials for the safety of a patient, yet the lack of transparency by the drug company is cause for caution. This vaccine is meant to save lives and return the world to normalcy, but the public is not allowed to know about the daily advancements of the drug? People ought to know more about the safety event in question.”
A Dangerous Gamble
The document alongside the disrupted clinical trials of AstraZeneca’s coronavirus drug have exposed the risks associated with the excessive reliance upon new unverified technologies – the chimpanzee adenovirus. By contrast with human adenoviral vector which has been extensively studied and effectively used to produce a number of vaccines and other medicines, the chimpanzee adenovirus has never been used before in any approved vaccine worldwide. According to Russian scientists the main aspect here is the absence of long-term studies of these vaccines: no one knows if they pose any cancer risks or affect the fertility.
The human adenovirus approach is used by a number of pharmaceutical companies to produce the COVID-19 vaccine. These are the Chinese CanSino and the American Johnson&Johnson as well as by the Russian Sputnik V vaccine produced by the Gamaleya Research Institure.
Russia’s Sputnik V: First Registered COVID-19 Drug
On August 11, the Russian Gamaleya Institute officially registered the world’s first vaccine, dubbed Sputnik V, after 2 successful phases of testing had proved it capable of building immunity against the virus for all of the volunteers involved in the tests. Currently, Russia is holding the third phase of the post-registration clinical trials of the drug, involving around 2,000 people.
The adenoviral vector vaccine consists of two shots administered consequently with a 3 weeks delay.
Russia’s RDIF has already announced plans to manufacture 500 million doses of the vaccine over the next year, with production and clinical trials expected to take place in five other countries as well.
Earlier in September, distinguished medical journal The Lancet published the results of Phase 1 and Phase 2 trials of Russia’s Sputnik V vaccine, concluding that the Russian drug is safe and effective, and the scientists didn’t find any serious adverse effects from it.