Summary

• AstraZeneca has stopped the phase 3 trials of its Covid-19 vaccine candidate, AZD1222, due to a suspected unfavorable reaction reported in a UK volunteer.
• AstraZeneca said on 8 September 2020, that the company’s general review process initiated a halt to global vaccination trials for facilitating necessary review of the safety data.
• AstraZeneca has accelerated the review for the single reported incident to reduce any impact on the vaccine’s trial timeline.
• It is possible that the reported incident must have happened in the company’s ongoing phase 2/3 in Britain.
• In another development, Synairgen unveiled positive data from interim analysis of its drug for pulmonary illness.

AstraZeneca plc (LON: AZN) has put on hold the phase 3 trials of its Covid-19 vaccine candidate, AZD1222, due to a suspected unfavorable reaction being developed in a UK volunteer. The vaccine maker has halted the vaccine trials voluntarily to facilitate its independent committee conduct a review on the vaccine’s safety. AstraZeneca, a leader in the race for a Covid-19 vaccine, said on 8 September 2020, that the company’s general review process initiated a halt to global vaccination trials for facilitating necessary review of the safety data.

In another development from the medicine space, Synairgen plc (LON:SNG) unveiled positive data from interim analysis of its drug for pulmonary illness. We present a discussion on the details from the two companies along with their stock performances.

AstraZeneca’s reaction

AstraZeneca has reacted by explaining that illnesses could also happen by chance in large clinical trials. The pharmaceutical giant emphasised that an independent review is critically important to check this and the vaccine maker is committed to the safety of the volunteers in addition to maintaining required standards of conduct in its trials.

The pharmaceutical company from Britain has developed this vaccine for the respiratory illness along with University of Oxford. It is to be noted that the World Health Organisation (WHO) has described this vaccine from the British drug maker as the most advanced vaccine candidate for Covid-19 till date.

Describing the halt as a routine action that that usually happens whenever an unexplained illness occurs during the trials, AstraZeneca, stressed that while it would be investigated, the vaccine maker would ensure maintaining integrity of the trials. The pharmaceutical major also said that it has undertaken the acceleration of the review for the single reported incident to reduce any impact on the vaccine’s trial timeline.

Highlighting the company’s initiative to put the Covid-19 vaccine study on hold for the time being, AstraZeneca informed that at present the type of the adverse reaction and its timings were not known. The suspected adverse reactions could comprise of symptoms that might require getting admitted to hospitals for treatment. Though, it is yet to be declared the clinical trial in which the incident was reported, there is a possibility that it might have been from the ongoing phase 2/3 in Britain.

The severity and rarity of the incident is also not clear, but the findings could suggest the speed at which the efficacy data from the UK trial would be available. These statistics would help AstraZeneca to apply for emergency use authorisation for the Covid-19 vaccine from the US Food and Drug Administration (USFDA). Any delay is likely to hamper the efforts by US President Donald Trump’s to fast-track a vaccine before the scheduled US presidential election in early November.

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Key impacts of holding the Covid-19 vaccine trial

However, as per people familiar with the incident, the volunteer who has suffered the illness due to the company’s experimental Covid-19 vaccine is likely to recover. The researchers were informed that the trial for Astrazeneca’s vaccine candidate is on hold because of caution. Sources stated on conditions of anonymity that the recent incidence of the volunteer’s illness could temporarily impact the ongoing trials for AstraZeneca’s other Covid-19 vaccine candidate, besides the clinical trials that have been undertaken by other vaccine companies.

It is not new to see a clinical trial being paused. Given the uncertainty on the time that AstraZeneca might take, the world is desperately eyeing the progress on trials by AstraZenaca as well as other companies developing the vaccine for Covid-19. There is an urgent need to check the Covid-19 infections. At present, there are a total of nine vaccine candidates undergoing phase 3 trials, among which AstraZeneca’s vaccine candidate was the first in the last stage (phase 3) Covid-19 vaccine trial that has been put on hold.

Some industry insiders viewed that after this incidence of suspected illness in a volunteer for AstraZeneca’s Covid-19 vaccine, researchers that are undertaking similar trials are now being vigilant regarding similar cases of adverse reactions from the experimental vaccines for Covid-19. They are searching the insights and data reviewed by Data and Safety Monitoring Board (DSMB). The DSMB reviews the study data for volunteers or participants for safety, besides recommending continuation, modification, or termination of the trial.

Also read: 5 Vaccine Stocks Doing Well in the UK

Also read: When Will A Covid-19 Vaccine Be Available In Britain?

Recent developments in Covid-19 vaccine trial by AstraZeneca

It is to be noted that in late August 2020, AstraZeneca began the phase 3 trial of its potential vaccine in the United States (US) at 62 sites. As per clinicaltrials.gov, a government registry, enrollment of volunteers at some sites is yet to begin. The pharmaceutical major earlier began the phase 2/3 trials in the UK, Brazil, and

The National Institutes of Health informed in the first week of September 2020 that the phase 3 trial in the US targets to enroll about 30,000 participants at 80 sites. The step forward for study sites in the US is yet to be cleared. But, any clinical hold during ongoing studies requires a halt in enrolling new volunteers, besides giving shots to the already enrolled participants.

The July 2020 report for AstraZeneca’s potential vaccine candidate mentioned that about 60 per cent of the 1000 volunteers who got the Coivid-19 vaccine shots suffered some side effects. These mild side effects that subsided during the course of study were mainly fever, muscle pain, headache, and reactions on body parts where the injection was given.

The potential Covid-19 vaccine called AZD1222 uses an adenovirus having a gene for one of the several proteins found in SARS-COV2, the coronavirus responsible for causing Covid-19 disease. The adenovirus is known to encourage the human being’s immune system to develop protective response against SARS-2. AstraZeneca has not used this in its vaccine approved by the USFDA.

Recent financial updates from AstraZeneca

The British pharmaceutical company, a frontrunner in the vaccine for Covid-19, announced its H1 2020 results in end-July 2020. In the first half of the year, the firm’s revenue, profit, and cash-flow showed a growth as it successfully launched new medicines. During the coronavirus pandemic, the pharma company gave priority to safe supply of medicines for patients, and the company would continue with its endeavour in future as well.

AstraZeneca responded well to the Covid-19 infections and has built capacities to supply more than two billion doses of its potential vaccine candidate, besides its monoclonal antibodies and new trials regarding the usage of Calquence and Farxiga to treat Covid-19 patients. With expected variations in the quarterly performance the company remained confident about the future. It retained its guidance for the full year that would be mainly underpinned by the concentration on commercial execution and new medicines being developed.

Stock performance of AstraZeneca

On 9 September 2020, at 11.17 AM, the company’s stock (LON: AZN) was trading at £8,233.00 down 1.35 per cent from its previous day’s close of £ 8,348.00. The 52 week low high range was recorded as 6,221.00 and 9,320.00. With a market capitalisation (Mcap) of £109,549.78 million, the stock provided a positive return on price, which was plus 8.98 per cent on a year to date (YTD) basis. The total volume of shares traded at the time of reporting was recorded at 991,975.

Synairgen unveils positive data from interim analysis of drug for pulmonary illness

Synairgen plc (LON:SNG) announced a positive interim data from its phase 2 study of medicine for inhaled interferon beta drug called SNG001 for patients suffering from chronic obstructive pulmonary disease (COPD). This data also supported the company’s Covid-19 programme. The study showed that the elderly population tolerated the medicine quite well as their lung antiviral responses enhanced considerably. The outcome of the study would help in carrying ahead the treatment in COPD patients whose conditions have worsened and need treatment with an anti-inflammatory drug known as corticosteroid or antibiotics.

The study is pertinent as it potentially made the case for Synairgen’s Covid-19 programme. Synairgen mentioned that it was in talks with several regulatory agencies across the globe to formulate a way regarding the approval for its drug to treat patients with severe symptoms of Covid-19 infections.

Stock performance of Synairgen

Synairgen is into discovery and development of drugs. The company focuses mainly on diseases such as asthma and chronic obstructive pulmonary disease (COPD).

On 9 September 2020, at 12.10 PM, the company’s stock (LON:SNG) was trading at £190.00 down 2.56 per cent down from its previous day’s close of £ 195.00. The 52 week low high range was recorded as 5.88 and 249.00. The company’s market capitalisation (Mcap) was £291.40 million. The total volume of shares traded at the time of reporting was recorded at 1,108,068.

Conclusion

The announcement by AstraZeneca to pause the clinical trials of its potential vaccine for Covid-19 infection due to suspected incident of a volunteer falling ill has come as a disappointment. Though, the pharmaceutical company mentioned that it would expedite the review process to meet the timelines of the trials, it raises likely concerns around the trials of other vaccine candidates as well. The global pandemic has financially strained companies across the sectors, leaving many people jobless apart from the rise in number of fatalities that have been reported till date. Both the public health and economic concerns are likely to suffer in coming times till the pandemic dissipates. A safe and effective vaccine is the only hope in these scenarios.