AstraZeneca Vaccine trials resume after a hiccup; successful animal trials of Covaxin glimmer of hope for Indians

HEALTH
Adrija Ray Chaudhury | Team PresentMirror | Updated: Sept. 15, 2020, 9:09 a.m.

After facing an uncharted hiccup in the Phase 3 studies of Covid-19 vaccine being developed by AstraZeneca and the University of Oxford and trials put on hold due to a suspected serious adverse reaction of a participant in the United Kingdom, the trials have now resumed. On the other hand, the development and subsequent success of India’s Covaxin in the animal trials might help to assuage the concerns of many.

The multinational biopharmaceutical company headquartered in Cambridge, England, paused global trials of its coronavirus vaccine following the detection of an unexplained illness in one of the participants' body which may or may not be related to the vaccine. The trials have been held in abeyance pending further investigation by an independent committee. National Institutes of Health Director Francis Collins, testifying at a Senate hearing on Wednesday, said such an action was “not at all unprecedented.”

Image Source : AirInfinity, AstraZenca ahead in the race of all vaccines for COVID-19

The world was plunged into utter despair following the ominous and unprecedented announcement. However, the encouraging result of Bharat Biotech's Covid-19 vaccine Covaxin emboldened us to breathe again as it has shown positive reaction in the animal trial.

But why was AstraZeneca, one of the most accountable and promising vaccines put on hold?

National Institutes of Health Director Francis Collins, described this disease as transverse myelitis though AstraZeneca has claimed that there is no final diagnosis and the disease is still being checked and more tests are carried out. Transverse myelitis is a rare inflammation of the spinal cord that can be caused by viral infections and has only rarely been associated with vaccinations. There are about 1,400 cases in the United States each year. Symptoms include pain, sensory problems, weakness in the legs and possibly the arms, and bladder and bowel problems, according to an NIH website.

However, researchers are still not sure if the adverse event is tied to the vaccine and hence strongly abhors unnecessary fulmination against the vaccine. AstraZeneca and the University of Oxford have said the decision to pause was the result of a standard review of the data, and the incident will be probed by an independent committee of experts.

AstraZenca shares have gained after trials were announced to resume in UK

Most likely, the trials will resume today in the United Kingdom if no further negative effects are detected. The company has however given no information on the present medical condition of the patient and details on the side effect. Trials in US and other countries remain on hold as of now. Serum Institute of India has categorically said that they have faced no difficulty in their trials so far and all is well here, yet they have paused trials and wait for further nod from DCGI.

We are reviewing the situation and pausing India trials till @AstraZeneca restarts them. We are following DCGI's instructions and will not be able to comment further on the same. You can connect with DCGI for more updates on this front.#SII #Latestnews #Covid_19 pic.twitter.com/CUeFY5oLus
— SerumInstituteIndia (@SerumInstIndia) September 10, 2020

Covaxin's spectacular performance

Bharat Biotech proudly announces the animal study results of COVAXIN™ - These results demonstrate the protective efficacy in a live viral challenge model.

Read more about the results here - https://t.co/f81JUSfWpD @icmr_niv #BharatBiotech #COVAXIN #Safety #Vaccine #SARSCoV2 pic.twitter.com/fva1SOcLOr
— BharatBiotech (@BharatBiotech) September 11, 2020

The animal trials of unactivated SARS-Cov 2 vaccine, Covaxin BBV 152 was administered on 20 monkeys. The primates were divided into 4 groups of which three groups were provided with 2 doses of the vaccine while the remaining one group was not vaccinated. The three vaccinated groups did not develop pneumonia, while the non-vaccination group developed pneumonia.

Bharat Biotech said that the vaccine candidates were found to generate robust immune responses. "The potent desired immunity was developed preventing infection and disease in the primates upon high amounts of exposure to live SARS-CoV-2 virus," reported IANS.

The phase I/II clinical trials of Covaxin are being conducted on 1,125 patients at 12 institutes across India, including All India Institute of Medical Sciences in New Delhi and Patna, King George Hospital in Visakhapatnam, Nizam’s Institute of Medical Sciences in Hyderabad and PGIMS in Rohtak.

While looking at the tremendous difficulties under which scientists are working day in, day out to develop a vaccine against COVID-19, these are niggardly crumbs. This accomplishment of Covaxin is a welcome site to the beleaguered doctors, frontline workers and the downhearted hoi polloi. Nevertheless, researchers at AstraZeneca, obsequious and indefatigable campaigners against COVID-19 as they are, are fighting tooth and nail to find the loophole that kept them from reaching their goal of rehabilitating the world.

The Covaxin has demonstrated protective efficacy and immunogenicity in non-human primates in Phase I clinical trials in India. According to the official note released by Bharat Biotech, there have not been any adverse side-effects noted in the animal trials.

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