Budapest Post

Cum Deo pro Patria et Libertate
Budapest, Europe and world news

Oxford/AstraZeneca vaccine results face growing scrutiny

Oxford/AstraZeneca vaccine results face growing scrutiny

Share price drops as critics question claim vaccine could protect up to 90% of people
The Oxford University/AstraZeneca vaccine will undergo a new global trial as critics questioned the claim that it could protect up to 90% of people against coronavirus.

On Thursday Sir John Bell, Oxford’s regius professor of medicine and the UK government’s life sciences adviser, dismissed suggestions the previous trial had not been properly set up or reported. “We weren’t cooking this up as we went along,” he said, adding that he hoped the full, peer-reviewed data would be published in the Lancet medical journal at the weekend.

In spite of the public excitement generated by the announcement that a third vaccine had been successful – with particular promise for developing countries as it is relatively cheap and can be stored at fridge temperature – AstraZeneca’s share price dropped.

One analyst in the US wrote in an investor note that “we believe that this product will never be licensed in the US” and alleged the company had tried to “embellish” the results.

It comes after the headline figure for the vaccine’s overall efficacy was put at 70% – as announced by the company on Monday and discussed in a press briefing by the Oxford researchers. But a sub-set of fewer than 3,000 people in the UK was given a lower dose regime – originally by accident – where the efficacy rose to 90%. In most trial volunteers in Brazil and the UK, it was 62%.

Sir Mene Pangalos, AstraZeneca’s head of biopharmaceuticals R&D, has confirmed that the low-dose trial included nobody over the age of 55. This led to concerns that younger age may have been a factor – particularly relevant given that vulnerable elderly people are most at risk from Covid-19.

Researchers had no explanation for the 90% result in people given a half dose followed by a whole dose of the vaccine, instead of two whole doses in other arms of the trial.

On Thursday AstraZeneca said it would undertake a new global trial using the lower-dose regimen. The timeline for regulatory approval and rollout of the vaccine in the UK and Europe should not be affected.

Critics have also claimed the trials did not include enough ethnic diversity, gender and age balance to satisfy the US regulator, the Food and Drug Administration.

Defending the vaccine trials, Bell told a symposium run by the Faculty of Pharmaceutical Medicine: “[The] MHRA [Medicines and Healthcare Products Regulatory Authority] knew perfectly well what we were doing. They approved all the protocols.”

It had been widely accepted before any of the vaccine trials reported results that 60% efficacy would be enough for a licence and would be useful, he said. “We are well in excess of that. I can’t imagine any reason why regulators won’t accept that.”

America had not yet seen the full data, he said, which he hoped would be published in the Lancet at the weekend. “I think when they see the data, it will be a great deal easier to have these conversations.”

Scientists at Oxford and the company admitted they were surprised by the finding that a lower dosing regime got better results. Pangalos called it serendipity.

“It could be that by giving a small amount of the vaccine to start with and following up with a big amount, that’s a better way of kicking the immune system into action and giving us the strongest immune response and the most effective immune response,” said Prof Sarah Gilbert, who led the vaccine research at Oxford.

AstraZeneca’s CEO told Bloomberg it would begin an international trial using the lower-dose regimen, while previously it had been expected merely to add an arm to the existing trial in the US.

The move will be seen as a bid to satisfy the FDA and compete, if they do win a licence in the US, with Pfizer and Moderna which have both published data suggesting 95% efficacy.

“Now that we’ve found what looks like a better efficacy [in the half dose/full dose regime], we have to validate this, so we need to do an additional study,” CEO Pascal Soriot said on Thursday. The study would probably be global “but this one could be faster because we know the efficacy is high so we need a smaller number of patients”.

Peter Openshaw, professor of experimental medicine at Imperial College London, said more data would need to be collected if the low-dose arm of the trial included only under-55s.

“If this is true, it may mean we don’t have any information about this regimen in older adults,” he said. “We have to wait for the full data and to see how the regulators view the results of the phase 3 trials. The US and European regulators might possibly take a different view. All we have to go on is a limited data release.”

It was possible, he said, that the protection from the Oxford/AstraZeneca vaccine might be less than that from the Pfizer/BioNTech and Moderna vaccines, which were developed with a different technology based on RNA, “but we need to wait and see”.

Paul Hunter, professor in medicine at the University of East Anglia and an adviser on methodology to the World Health Organization, said he was always wary of sub-group analyses in trials.

“Most of the time when you get these incredibly good results in a sub-group analysis, you have to be incredibly careful about believing them,” he told the Guardian. There could be something about the smaller group that was not true of the larger group.

He was also worried by the suggestion the sub-group had nobody over 55. “I’m not saying this isn’t going to be a fantastic vaccine at the end of the day, but we need a lot better understanding of the data,” he said.

An AstraZeneca spokesperson said an independent data safety monitoring board ensures the safety and quality of the trials. “The studies were conducted to the highest standards,” it said in a statement. “More data will continue to accumulate and additional analysis will be conducted refining the efficacy reading and establishing the duration of protection.”
AI Disclaimer: An advanced artificial intelligence (AI) system generated the content of this page on its own. This innovative technology conducts extensive research from a variety of reliable sources, performs rigorous fact-checking and verification, cleans up and balances biased or manipulated content, and presents a minimal factual summary that is just enough yet essential for you to function as an informed and educated citizen. Please keep in mind, however, that this system is an evolving technology, and as a result, the article may contain accidental inaccuracies or errors. We urge you to help us improve our site by reporting any inaccuracies you find using the "Contact Us" link at the bottom of this page. Your helpful feedback helps us improve our system and deliver more precise content. When you find an article of interest here, please look for the full and extensive coverage of this topic in traditional news sources, as they are written by professional journalists that we try to support, not replace. We appreciate your understanding and assistance.
Newsletter

Related Articles

0:00
0:00
Close
Vatican hosts first Catholic LGBTQ pilgrimage
Apple Unveils iPhone 17 Series, iPhone Air, Apple Watch 11 and More at 'Awe Dropping' Event
France joins Eurozone’s ‘periphery’ as turmoil deepens, say investors
France Faces New Political Crisis, again, as Prime Minister Bayrou Pushed Out
Nayib Bukele Points Out Belgian Hypocrisy as Brussels Considers Sending Army into the Streets
France, at an Impasse, Heads Toward Another Government Collapse
The Country That Got Too Rich? Public Spending Dominates Norway Election
EU Proposes Phasing Out Russian Oil and Gas by End of 2027 to End Energy Dependence
More Than 150,000 Followers for a Fictional Character: The New Influencers Are AI Creations
EU Prepares for War
Trump Threatens Retaliatory Tariffs After EU Imposes €2.95 Billion Fine on Google
Tesla Board Proposes Unprecedented One-Trillion-Dollar Performance Package for Elon Musk
Gold Could Reach Nearly $5,000 if Fed Independence Is Undermined, Goldman Sachs Warns
Uruguay, Colombia and Paraguay Secure Places at 2026 World Cup
Trump Administration Advances Plans to Rebrand Pentagon as Department of War Instead of the Fake Term Department of Defense
Big Tech Executives Laud Trump at White House Dinner, Unveil Massive U.S. Investments
Tether Expands into Gold Sector with Profit-Driven Diversification
‘Looks Like a Wig’: Online Users Express Concern Over Kate Middleton
Florida’s Vaccine Revolution: DeSantis Declares War on Mandates
Trump’s New War – and the ‘Drug Tyrant’ Fearing Invasion: ‘1,200 Missiles Aimed at Us’
"The Situation Has Never Been This Bad": The Fall of PepsiCo
At the Parade in China: Laser Weapons, 'Eagle Strike,' and a Missile Capable of 'Striking Anywhere in the World'
The Fashion Designer Who Became an Italian Symbol: Giorgio Armani Has Died at 91
Putin Celebrates ‘Unprecedentedly High’ Ties with China as Gazprom Seals Power of Siberia-2 Deal
China Unveils New Weapons in Grand Military Parade as Xi Hosts Putin and Kim
Rapper Cardi B Cleared of Liability in Los Angeles Civil Assault Trial
Google Avoids Break-Up in U.S. Antitrust Case as Stocks Rise
Couple celebrates 80th wedding anniversary at assisted living facility in Lancaster
Information Warfare in the Age of AI: How Language Models Become Targets and Tools
The White House on LinkedIn Has Changed Their Profile Picture to Donald Trump
"Insulted the Prophet Muhammad": Woman Burned Alive by Angry Mob in Niger State, Nigeria
Trump Responds to Death Rumors – Announces 'Missile City'
Druzhba Pipeline Incident Sparks Geopolitical Tensions
Cost of Opposition Leader Péter Magyar's Economic Plan Revealed
Germany in Turmoil: Ukrainian Teenage Girl Pushed to Death by Illegal Iraqi Migrant
United Krack down on human rights: Graham Linehan Arrested at Heathrow Over Three X Posts, Hospitalised, Released on Bail with Posting Ban
Asian and Middle Eastern Investors Avoid US Markets
Ray Dalio Warns of US Shift to Autocracy
Eurozone Inflation Rises to 2.1% in August
Russia and China Sign New Gas Pipeline Deal
Von der Leyen's Plane Hit by Suspected Russian GPS Interference in an Incident Believed to Be Caused by Russia or by Pro-Peace or by Anti-Corruption European Activists
China's Robotics Industry Fuels Export Surge
Suntory Chairman Resigns After Police Probe
Gold Price Hits New All-Time Record
UK Fintechs Explore Buying US Banks
Greece Suspends 5% of Schools as Birth Rate Drops
Apollo to Launch $5 Billion Sports Investment Vehicle
Bolsonaro Trial Nears Close Amid US-Brazil Tension
European Banks Push for Lower Cross-Border Barriers
Poland's Offshore Wind Sector Attracts Investors
×