More risks to pregnant women, their newborns from COVID-19 than known before - Study

‘Pregnant women infected with COVID-19 and their newborn children face higher risks of complications than was previously known, a study by British scientists showed on Friday. An infection of the new coronavirus in such newborns is associated with a three-fold risk of severe medical complications, according to a study conducted by scientists at the University of Oxford. (https://bit.ly/3tNwkJ7)

‘Pregnant women are at higher risk of complications such as premature birth, high blood pressure with organ failure risk, need for intensive care and possible death. "Women with COVID-19 during pregnancy were over 50% more likely to experience pregnancy complications compared to pregnant women unaffected by COVID-19," said Aris Papageorghiou, co-lead of the trial and a professor of fetal medicine at Oxford University.’

Read here (Reuters, Apr 23, 2021)

Oxford University to test Covid-19 vaccine response among children for first time

‘The University of Oxford has launched a study to assess the safety and immune response of the Covid-19 vaccine it has developed with AstraZeneca in children for the first time, it said on Saturday (Feb 13).

‘The new mid-stage trial will determine whether the vaccine is effective on people between the ages of 6 and 17, according to an emailed statement from the university. Around 300 volunteers will be enrolled and first inoculations are expected this month, Oxford said.’

Read here (Straits Times, Feb 13, 2021)

Common asthma drug cuts Covid-19 hospitalisation risk, recovery time: Oxford study

‘A commonly used asthma treatment appears to reduce the need for hospitalisations as well as recovery time for COVID-19 patients if given within seven days of symptoms appearing, researchers at the University of Oxford said on Tuesday (Feb 9).

‘The findings were made following a mid-stage study of the steroid budesonide, sold as Pulmicort by AstraZeneca and also used for treating smoker's lung.

‘The 28-day study of 146 patients suggested that inhaled budesonide reduced the risk of urgent care or hospitalisation by 90 per cent when compared with usual care, Oxford University said.’

Read here (Channel News Asia, Feb 10, 2021)

Inhaled budesonide in the treatment of early Covid-19 illness: A randomised controlled trial

Background Multiple early hospital cohorts of coronavirus disease 2019 (COVID-19) showed that patients with chronic respiratory disease were significantly under-represented. We hypothesised that the widespread use of inhaled glucocorticoids was responsible for this finding and tested if inhaled glucorticoids would be an effective treatment for early COVID-19 illness.

Methods We conducted a randomised, open label trial of inhaled budesonide, compared to usual care, in adults within 7 days of the onset of mild Covid-19 symptoms. The primary end point was COVID-19-related urgent care visit, emergency department assessment or hospitalisation. The trial was stopped early after independent statistical review concluded that study outcome would not change with further participant enrolment.

Results 146 patients underwent randomisation. For the per protocol population (n=139), the primary outcome occurred in 10 participants and 1 participant in the usual care and budesonide arms respectively (difference in proportion 0.131, p=0.004). The number needed to treat with inhaled budesonide to reduce COVID-19 deterioration was 8. Clinical recovery was 1 day shorter in the budesonide arm compared to the usual care arm (median of 7 days versus 8 days respectively, logrank test p=0.007). Proportion of days with a fever and proportion of participants with at least 1 day of fever was lower in the budesonide arm. Fewer participants randomised to budesonide had persistent symptoms at day 14 and day 28 compared to participants receiving usual care.

Conclusion Early administration of inhaled budesonide reduced the likelihood of needing urgent medical care and reduced time to recovery following early COVID-19 infection.

Evidence before this study The majority of interventions studied for the COVID-19 pandemic are focused on hospitalised patients. Widely available and broadly relevant interventions for mild COVID-19 are urgently needed.

Added value of this study In this open label randomised controlled trial, inhaled budesonide, when given to adults with early COVID-19 illness, reduces the likelihood of requiring urgent care, emergency department consultation or hospitalisation. There was also a quicker resolution of fever, a known poor prognostic marker in COVID-19 and a faster self-reported and questionnaire reported symptom resolution. There were fewer participants with persistent COVID-19 symptoms at 14 and 28 days after budesonide therapy compared to usual care.

Implications of all the available evidence The STOIC trial potentially provides the first easily accessible effective intervention in early COVID-19. By assessing health care resource utilisation, the study provides an exciting option to help with the worldwide pressure on health care systems due to the COVID-19 pandemic. Data from this study also suggests a potentially effective treatment to prevent the long term morbidity from persistent COVID-19 symptoms.

Read here (Medrxiv, Feb 8, 2021)

FLCCC Alliance issues open letter to UK researchers planning a new trial to test ivermectin for use in Covid-19

‘The Front Line COVID-19 Critical Care Alliance (FLCCC) has issued an open letter to researchers  in England at the University of Oxford who are planning to conduct a double-blind, Randomized Controlled Trial (RCT) of ivermectin for use in COVID-19.  The letter states, “Our manuscript, which reviewed both epidemiologic data and the existing clinical trials evidence base, concluded that ivermectin should be the standard of care in COVID-19.”

• ‘A meta-analysis of existing data of ivermectin as a therapeutic finds large, statistically significant reductions in time to clinical recovery, length of hospitalization, and death.
• ‘The Declaration of Helsinki – Ethical Principles for Medical Research involving Human Subjects” states that “when combining medical research with medical care, patients can only be studied...if the physician has good reason to believe that participation in the research study will not adversely affect the health of the patients who serve as research subjects.”

Read here (Newswire, Jan 25, 2021)

Download FLCCC Aliiance PDF here

Oxford’s PRINCIPLE trial: Bringing ivermectin directly into the developed world in the battle against Covid-19

‘The University of Oxford soon kicks “the PRINCIPLE Trial” into a higher gear now, in what they consider a pathbreaking “high-quality trial” of Ivermectin, a generic drug already evidencing significant efficacy in over two dozen clinical trials around the world, according to some researchers. The UK government also backs this pivotal study via the Department of Health and Social Care. 

‘Searching for early-onset, home-based ambulatory treatments for COVID-19, the PRINCIPLE Trial seeks to meet a gap in research in the world’s richest nations to date. Nearly all of the taxpayer-financed research-based expenditures of governments in the US, UK and Europe, for example, have gone into vaccines, novel monoclonal antibodies, and novel therapeutics, with an emphasis on treating severely ill patients. 

‘Ivermectin, hailed as the “wonder drug” or “the People’s medicine” for COVID-19, gains growing attention worldwide made more widely available, frankly, partly due to TrialSite’s consistent chronicling of these trials around the world since the original University of Monash breakthrough.’

Read here (TrialSite News, Jan 23, 2021)

Oxford-AstraZeneca vaccine: Bogus reports, accidental finds - the story of the jab

‘In the early hours of Saturday 11 January, Prof Teresa Lambe was woken up by the ping of her email. The information she had been waiting for had just arrived in her inbox: the genetic code for a new coronavirus, shared worldwide by scientists in China. She got to work straight away, still in her pyjamas, and was glued to her laptop for the next 48 hours. "My family didn't see me very much that weekend, but I think that set the tone for the rest of the year," she says...

‘That weekend was the first step on a journey to create a vaccine at lightning speed, for a disease that would, in a matter of months, claim more than 1.5 million lives. I have been following the efforts of the Oxford scientists since the start. There have been dramas along the way, including:

• A rush to charter a jet when a flight-ban prevented vaccine from getting into the country
• Dismay at totally false reports on social media that the first volunteer to be immunised had died
• Concern that falling infection rates over the summer would jeopardise the hope of quick results
• How an initial half-dose of the vaccine unexpectedly provided the best protection
• An admission from the chief of Oxford's partner, drug company AstraZeneca, that it would have run the trials "a bit differently".

Read here (BBC, Dec 14, 2020)

WHO to make decisions on Pfizer, Moderna, AstraZeneca COVID-19 vaccines in weeks

‘The World Health Organization expects to make decisions on whether to give emergency use approval to COVID-19 vaccines from Pfizer, Moderna and AstraZeneca in the coming weeks, its chief scientist said on Friday (Dec 11).

‘Soumya Swaminathan said the global health body could decide on Pfizer's vaccine candidate in the next "couple of weeks", and later said it could also review Moderna's and AstraZeneca's candidates in a few weeks.’

Read here (Channel News Asia, Dec 12, 2020)

Covid: Trials to test combination of Oxford and Sputnik vaccines

‘UK and Russian scientists are teaming up to trial a combination of the Oxford-AstraZeneca and Sputnik V vaccines to see if protection against Covid-19 can be improved. Mixing two similar vaccines could lead to a better immune response in people. The trials, to be held in Russia, will involve over-18s, although it's not clear how many people will be involved.’

Read here (BBC, Dec 11, 2020)

Blunders eroded US confidence in early vaccine front-runner

‘On the afternoon of Sept. 8, AstraZeneca officials had a conference call with the Food and Drug Administration. The discussion covered important ground: What would AstraZeneca need to do to win the F.D.A.’s blessing for the coronavirus vaccine it was developing with the University of Oxford?

‘But the AstraZeneca representatives neglected to mention a crucial development: Two days earlier, the company had quietly halted trials of its vaccine around the world, including a late-stage study in the United States. It acted after a participant in Britain fell ill.

‘A few hours after the conference call, the story broke about the halted trials. That was how key F.D.A. officials heard the news, according to people with knowledge of the discussions.’

Read here (New York Times, Dec 8, 2020)

Neutralising the threat of Covid-19

Informative and interesting talk with Q&A relevant to Malaysia, live-streamed on Dec 7, 2020. Professor William James, is Professor of Virology and Tutor in Medical Sciences, Jeffrey Cheah Professorial Fellow, and is attached to The Sir William Dunn School of Pathology. He is currently contributing to the work on the Oxford University AstraZeneca COVID-19 vaccine. The talk is moderated by Prof. Abhi Veerakumarasivam, Co-Chair & Professor, ASEAN Young Scientists Network & Sunway University.

View here (YouTube, Dec 7, 2020)

What you need to know about the Pfizer, Moderna and AstraZeneca vaccines

‘All three drugmakers have moved at record speed, and the first shots of the Pfizer and Moderna vaccines could be given in the coming weeks. This article answers a list of questions that ordinary people need to know before they commit to the vaccinations.’

Read here (Washington Post, Nov 30, 2020)

AstraZeneca says its Covid-19 vaccine needs 'additional study'

‘The head of British drug manufacturer AstraZeneca said on Thursday (Nov 26) further research was needed on its COVID-19 vaccine after questions emerged over the protection it offers, but the additional testing is unlikely to affect regulatory approval in Europe.

‘Instead of adding the trial to an ongoing US process, AstraZeneca might launch a fresh study to evaluate a lower dosage of its vaccine that performed better than a full dosage, AstraZeneca chief executive Pascal Soriot was quoted as saying in a Bloomberg News report.’

Read here (Channel News Asia, Nov 27, 2020)

Scientists are puzzling over one crucial number as they evaluate the Oxford-AstraZeneca coronavirus vaccine

‘The Oxford-AstraZeneca vaccine candidate is given to people as two doses, at least one month apart. The trial data, which comes from late-stage studies in the UK, Brazil and South Africa, suggests that the vaccine is 62% effective if people get two full doses, but 90% effective when they get a half-strength version of the first dose. The information was provided in a press release and hasn't been published in a peer-reviewed journal. AstraZeneca and Oxford said they're submitting the results for review and publication.’

Read here (Business Insider, Nov 24, 2020)

Oxford vaccine: How did they make it so quickly?

‘Ten years' vaccine work achieved in about 10 months. Yet no corners cut in designing, testing and manufacturing... They are two statements that sound like a contradiction, and have led some to ask how we can be sure the Oxford vaccine - which has published its first results showing it is highly effective at stopping Covid-19 - is safe when it has been made so fast. So, this is the real story of how the Oxford vaccine happened so quickly.’

Read here (BBC, Nov 23, 2020)

AstraZeneca Covid-19 vaccine candidate shows promise among elderly in trials

‘A potential Covid-19 vaccine developed by AstraZeneca and Oxford University produced a strong immune response in older adults, giving hope it may protect some of those most vulnerable to the disease, data from mid-stage trials showed. The data, reported in part last month but published in full in The Lancet medical journal on Thursday (Nov 19), suggest that those aged over 70 - who are at higher risk of serious illness and death from Covid-19 - could build robust immunity to the disease, researchers said.

"The robust antibody and T-cell responses seen in older people in our study are encouraging," said Dr Maheshi Ramasamy, a consultant and a co-lead investigator at the Oxford Vaccine Group.’

Read here (Straits Times, Nov 20, 2020)

US states that imposed few restrictions now have the worst outbreaks

‘Coronavirus cases are rising in almost every U.S. state. But the surge is worst now in places where leaders neglected to keep up forceful virus containment efforts or failed to implement basic measures like mask mandates in the first place, according to a New York Times analysis of data from the University of Oxford. Using an index that tracks policy responses to the pandemic, these charts show the number of new virus cases and hospitalizations in each state relative to the state’s recent containment measures.’

Read here (New York Times, Nov 18, 2020)

The anti-lockdown scientists’ cause would be more persuasive if it weren’t so half-baked

‘The [Great Barrington] declaration, which calls for an immediate resumption of “life as normal” for everyone except the “vulnerable”, is written by three science professors from Harvard, Oxford and Stanford, giving it the sheen of academic respectability. But there is much to set alarm bells ringing. It makes claims about herd immunity – the idea that letting the virus rip among less vulnerable groups will allow a degree of population-level immunity to build up which will eventually protect the more vulnerable – that are unsupported by existing scientific evidence... And what are scientists doing fronting a campaign whose back office is run by a thinktank that flirts with climate change denial?’

Read here (The Guardian, Oct 11, 2020)

NIH ‘very concerned’ about serious side effect in coronavirus vaccine trial​

‘A great deal of uncertainty remains about what happened to the unnamed patient, to the frustration of those avidly following the progress of vaccine testing. AstraZeneca, which is running the global trial of the vaccine it produced with Oxford University, said the trial volunteer recovered from a severe inflammation of the spinal cord and is no longer hospitalized.

‘AstraZeneca has not confirmed that the patient was afflicted with transverse myelitis, but Nath and another neurologist said they understood this to be the case. Transverse myelitis produces a set of symptoms involving inflammation along the spinal cord that can cause pain, muscle weakness and paralysis. Britain’s regulatory body, the Medicines and Healthcare Products Regulatory Agency, reviewed the case and has allowed the trial to resume in the United Kingdom.’

Read here (Scientific American, Sept 15, 2020)

AstraZeneca Covid-19 vaccine study put on hold due to suspected adverse reaction in participant in the UK

‘A large, Phase 3 study testing a Covid-19 vaccine being developed by AstraZeneca and the University of Oxford at dozens of sites across the U.S. has been put on hold due to a suspected serious adverse reaction in a participant in the United Kingdom. A spokesperson for AstraZeneca, a frontrunner in the race for a Covid-19 vaccine, said in a statement that the company’s “standard review process triggered a pause to vaccination to allow review of safety data.” 

Read here (STAT News, Sept 8, 2020)