Showing posts with label clinical trial. Show all posts
Showing posts with label clinical trial. Show all posts

Wednesday 23 December 2020

Special Reuters report: How a British Covid-19 vaccine went from pole position to troubled start

‘Much was riding on the Oxford vaccine, a British-led endeavour also involving UK drugs firm AstraZeneca. Prime Minister Boris Johnson’s government was desperate for a success story after its early mishandling of the pandemic contributed to one of the world’s highest death tolls from COVID-19 - around 65,000 by mid-December. The government has secured 100 million doses. On Nov. 23, Oxford and AstraZeneca delivered positive news. They announced that the regimen of a half dose followed by a full dose booster appeared to be 90% effective in preventing COVID-19. Two full doses scored 62%. Oxford researchers have said they aren’t certain why the half-dose regimen was much more effective.

‘Johnson called the vaccine team and tweeted his thanks “for their brilliant work.” He went on, “These results are incredibly encouraging and a major step forward in our fight against COVID-19.” Oxford and AstraZeneca are now hoping for quick authorization by Britain’s regulator. But questions about the trial and the results won’t go away...’

Read here (Reuters, Dec 24, 2020)

Thursday 10 December 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)

Thursday 26 November 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)

Thursday 19 November 2020

The end of the pandemic is now in sight

‘Both vaccines, from Moderna and from Pfizer’s collaboration with the smaller German company BioNTech, package slightly modified spike-protein mRNA inside a tiny protective bubble of fat. Human cells take up this bubble and simply follow the directions to make spike protein. The cells then display these spike proteins, presenting them as strange baubles to the immune system. Recognizing these viral proteins as foreign, the immune system begins building an arsenal to prepare for the moment a virus bearing this spike protein appears... This overall process mimics the steps of infection better than some traditional vaccines, which suggests that mRNA vaccines may provoke a better immune response for certain diseases...

‘All of this is how mRNA vaccines should work in theory. But no one on Earth, until last week, knew whether mRNA vaccines actually do work in humans for COVID-19. Although scientists had prototyped other mRNA vaccines before the pandemic, the technology was still new. None had been put through the paces of a large clinical trial. And the human immune system is notoriously complicated and unpredictable. Immunology is, as my colleague Ed Yong has written, where intuition goes to die. Vaccines can even make diseases more severe, rather than less. The data from these large clinical trials from Pfizer/BioNTech and Moderna are the first, real-world proof that mRNA vaccines protect against disease as expected. The hope, in the many years when mRNA vaccine research flew under the radar, was that the technology would deliver results quickly in a pandemic. And now it has.’

Read here (The Atlantic, Nov 19, 2020)

Monday 9 November 2020

Who are the candidates in the Covid-19 vaccine race?

‘Almost 200 Covid-19 vaccine candidates are being studied by scientists around the world. Of these, 44 are already in clinical trials, which means they are being tested on humans. The Straits Times highlights some of the prominent candidates in the Covid-19 vaccine race.’

Read here (Straits Times, Nov 10, 2020)

First ‘milestone’ vaccine offers 90% protection

‘The first effective coronavirus vaccine can prevent more than 90% of people from getting Covid-19, a preliminary analysis shows. The developers - Pfizer and BioNTech - described it as a "great day for science and humanity". Their vaccine has been tested on 43,500 people in six countries and no safety concerns have been raised. The companies plan to apply for emergency approval to use the vaccine by the end of the month.’

Read here (BBC, Nov 9, 2020) 

Friday 6 November 2020

India tops global survey on Covid-19 vaccination intent; rising hesitancy in many other countries

‘Indians are the keenest on getting vaccinated whenever a Covid-19 vaccine is available, even as people in 10 out of 15 countries showed a growing reluctance about getting vaccinated, according to a global survey. 

‘In the World Economic Forum/Ipsos survey of 18,526 adults from 15 countries, 73 per cent said they would get a Covid-19 vaccine if available, down from 77 per cent in August. While vaccination intent has remained unchanged at 87 per cent in India since August, it has declined in 10 of the 15 countries surveyed, most of all in China, Australia, Spain, and Brazil.

‘Globally, the two main reasons for not wanting to get a Covid-19 vaccine are concerns about side effects (cited by 34 per cent) and concerns about clinical trials moving too fast (cited by another 33 per cent). In India also, 34 per cent respondents.’

Read here (Deccan Herald, Nov 6, 2020)

Monday 19 October 2020

World’s vaccine testing ground deems Chinese Covid candidate ‘the safest, most promising’

‘Brazil is one of the world’s top COVID-19 vaccine testing grounds. Now officials there say that CoronaVac, the experimental COVID-19 vaccine from Chinese developer Sinovac, is the safest of the coronavirus immunizations evaluated in the country so far.

“The first results of the clinical study conducted in Brazil prove that among all the vaccines tested in the country, CoronaVac is the safest, the one with the best and most promising rates,” São Paulo Gov. João Doria told reporters in Brazil on Monday.’

Read here (Fortune, Oct 20, 2020)

Monday 5 October 2020

White House blocking strict guidelines for vaccine approval

‘The White House has blocked new Food and Drug Administration (FDA) guidelines that would have likely prevented a vaccine from being approved before next month's presidential election, the New York Times and the Associated Press reported, citing Trump administration officials.

‘The FDA had proposed stricter guidelines for the emergency approval and release of a coronavirus vaccine. One such requirement involved following vaccine trial candidates for two months to ensure there were no side effects and that the vaccines provided lasting protection from the virus. FDA Commissioner Stephen Hahn has previously said that scientists, not politicians, will decide whether the vaccines work and are safe.’

Read here (DW, Oct 6, 2020)

Wednesday 23 September 2020

Dozens of COVID-19 vaccines are in development. Here are the ones to follow

‘Though it’s too soon to say which candidates will ultimately be successful, here’s a look at the prospects that have reached phase three and beyond—including a quick primer on how they work and where they stand.’

Read here (National Geographic, Sept 24, 2020)

Tuesday 22 September 2020

UK mulling vaccine trials that deliberately expose volunteers to Covid-19

‘The British government is exploring the possibility of clinical trials in which volunteers are deliberately exposed to coronavirus to test the effectiveness of vaccine candidates, the UK Department for Business, Energy, and Industrial Strategy (BEIS) revealed Wednesday in a statement... In so-called "challenge trials," researchers give study subjects an experimental vaccine and then intentionally expose them to coronavirus to see if the vaccine works. Such trials were used in early research with smallpox, yellow fever and malaria.’

Read here (CNN, Sept 23, 2020)

Sunday 20 September 2020

A Covid-19 vaccine for children may not arrive before Fall 2021

‘The pandemic has many parents asking two burning questions. First, when can I get a vaccine? And second, when can my kids get it? It may come as a surprise that the answers are not the same. Adults may be able to get a vaccine by next summer. But their kids will have to wait longer. Perhaps a lot longer.

‘Thanks to the U.S. government’s Operation Warp Speed and other programs, a number of Covid-19 vaccines for adults are already in advanced clinical trials. But no trials have yet begun in the United States to determine whether these vaccines are safe and effective for children.’

Read here (New York Times, Sept 21, 2020)

Thursday 17 September 2020

Covid-19 vaccine leaders make trial plans public in transparency push

‘Makers of the leading coronavirus vaccine candidates disclosed detailed information about their pivotal late-stage clinical trials and how they plan to gauge their shots' safety and effectiveness. The moves by first Moderna Inc, and then later from Pfizer Inc and its partner BioNTech SE, follow increasing worry that the effort to develop a Covid-19 vaccine is becoming politicised, and that an inoculation could be rushed to market before it is proven safe and effective. AstraZeneca said in an e-mail it would share its plans as well, though it hadn't as of Thursday (Sept 17) evening in the US.’

Read here (Straits Times, Sept 18, 2020)

Monday 14 September 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)

Monday 7 September 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)

Sunday 16 August 2020

Coronavirus vaccine: Chinese scientists plan joint trials with Russia despite doubts over ‘world-beating’ breakthrough

‘Chinese scientists have offered to carry out joint vaccine trials with their Russian counterparts in what could be seen as a vote of confidence following Moscow’s decision to rush through approval for a Covid-19 vaccine. The plan was announced by China’s top respiratory diseases expert Zhong Nanshan on Sunday during a symposium with Russian scientists. He did not specify which vaccine candidate would be tested or where the trials would take place.’

Read here (South China Morning Post, August 17, 2020) 

China's lead in coronavirus vaccines raises concern as well as hope

‘China has emerged as a leader in novel coronavirus vaccines, a development that will enhance it as a global power but also raises concerns over safety and the potential for Beijing to use its status in territorial disputes. The country has nine vaccine candidates in clinical trials, including five in Phase 3, the final stage of the process toward approval. This achievement is the result of years of state-led research on infectious diseases. Last week, Chinese drugmaker CanSino Biologics announced it would conduct a Phase 3 trial in Saudi Arabia with 5,000 volunteers. Of the 29 new vaccines in clinical trials around the world, nine are in China, the most of any country. Of the seven that are in Phase 3, China has five. Chinese vaccines are expected to be in practical use as early as the next few months.’

[This story is behind a paywall]

Read here (Nikkei Asian Review, August 17, 2020)

Sunday 9 August 2020

Hopes for a Covid-19 vaccine in early 2021, but that’s only the start of the story, experts say

‘With six Covid 19 vaccine candidates undergoing final clinical trials, initial data about whether they can protect people from the disease is expected to be available in the next two to three months, assuming all goes well. That gives hope to the possibility that a vaccine could hit the market by early next year...

“Most of the data so far supports the notion that they all do what it says on the tin: induce neutralising antibody and T-cells,” said Daniel Altmann, a professor in the department of medicine at Imperial College London. “But it is a long way from there to proof of safe, long-term, protective immunity.”

Read here (South China Morning Post, August 10, 2020)

Wednesday 22 July 2020

Trials for three Covid-19 vaccines show promise but much more work still needed, say experts

‘The global fight against Covid-19 received a boost on Monday with the release of encouraging findings from human trials of three coronavirus vaccines, including a closely watched one being developed by Oxford University. The results showed that the vaccines being tested did not cause any dangerous side effects, and that they could coax a protective response from the human body. But experts said that while the results were encouraging, much more work is still needed to plug remaining gaps in knowledge before a vaccine can be made commercially available.’

Read here (Straits Times, July 22, 2020)

Monday 20 July 2020

Protein treatment trial ‘a breakthrough’

‘The preliminary results of a clinical trial suggest a new treatment for Covid-19 dramatically reduces the number of patients needing intensive care, according to the UK company that developed it. The treatment from Southampton-based biotech Synairgen uses a protein called interferon beta which the body produces when it gets a viral infection... The initial findings suggest the treatment cut the odds of a Covid-19 patient in hospital developing severe disease - such as requiring ventilation - by 79%.’

Read here (BBC, July 20, 2020

Worst ever Covid variant? Omicron

John Campbell shares his findings on Omicron.  View here (Youtube, Nov 27, 2021)