#Oxford vaccine against Covid-19 in final stage of clinical trials

[few-favorite-things]

বড় সাফল্য অক্সফোর্ডের ! সব ঠিক থাকলে বছর শেষেই মিলবে করোনার ভ্যাক্সিন| Oxford vaccine against Covid-19 in final stage of clinical trials | coronavirus-latest-news

এই প্রথম ক্লিনিক্যাল ট্রায়ালের চূড়ান্তে পর্যায় পৌঁছল কোনও করোনা ভাইরাসের ভ্যাক্সিন Bangla Editor | News18 Bangla | June 25, 2020, 4:38 PM IST

1/ 6

বড় সাফল্য ! অক্সফোর্ড বিশ্ববিদ্যালয় ও AstraZeneca Plc. -এর প্রস্তুত করা করোনার ভ্যাক্সিন প্রথম, দ্বিতীয় ট্রায়াল পার করেছিল আগেই, এবার ব্রিটেনে তৃতীয় ও চূড়ান্ত ট্রায়ালেও সাফল্য মিলবে বলে আশাবাদি ভাইরোলজিস্ট সারা…

[covid-19cleaningservices]

Russia Approves Coronavirus Vaccine Before Completing Tests

MOSCOW — Russia has become the first country in the world to approve a vaccine for the coronavirus, President Vladimir V. Putin announced on Tuesday, though global health authorities say the vaccine has yet to complete critical, late-stage clinical trials to determine its safety and effectiveness.

Mr. Putin, who told a cabinet meeting on Tuesday morning that the vaccine “works effectively enough,” said that his own daughter had taken it. And in a congratulatory note to the nation, he thanked the scientists who developed the vaccine for “this first, very important step for our country, and generally for the whole world.”

The major powers are locked in a global race for a vaccine that President Trump, Mr. Putin and China’s president, Xi Jinping, are treating as a proxy war for their personal leadership and competing national systems. The United States, with an effort called Operation Warp Speed, and China have poured billions into the pursuit, and health officials worry that Russia is trying to snatch a victory by cutting corners.

By skipping large-scale clinical trials, the Russian dash for a vaccine has raised widespread concern that it is circumventing vital steps — and potentially endangering people — in order to score global propaganda points.

Russia’s vaccine sped through early monkey and human trials with apparent success. But Moscow was cautioned just last week by the World Health Organization not to stray from the usual methods of testing a vaccine for safety and efficacy.

Beyond that, the United States, Canadian and British governments have all accused Russian state hackers of trying to steal vaccine research. Russian officials have denied the accusations, and say their vaccine is based on a design developed years ago by Russian scientists to counter the Ebola virus.

A vaccine is seen as the most likely avenue for defeating the novel coronavirus and alleviating a worldwide health crisis that has killed at least 734,900 people and decimated national economies. Western regulators have said repeatedly that they do not expect a vaccine to become widely available before the end of the year at the earliest.

Around the world, more than 30 vaccines — out of a total of more than 165 under development — are now in various stages of human trials. Currently, eight vaccines have entered the final phase of mass human testing, including ones produced by Moderna in the United States, Oxford University and AstraZeneca in Britain and several Chinese companies.

Some of those Chinese companies have been accused of cutting corners themselves. One offered the vaccine to employees at the national oil company, while another has teamed up with the People’s Liberation Army to conduct human trials.

In Russia, the minister of health, Mikhail Murashko, has said the country will begin a mass vaccination campaign in the fall, and said on Tuesday that it would start with teachers and medical workers this month.

The governor of Texas says virus cases are still too numerous to warrant reopening. Emerging clusters at U.S. schools and on high school teams raise concerns about wider community spread. ‘It’s really risky.’ Russia approving a vaccine before it completed Phase 3 tests prompts alarm from experts.

In Moscow, the announcement was greeted with a mixture of national pride and nagging doubts by Russians who have been schooled by experience to treat such boasts with a healthy dose of skepticism.

Lidiya Ivleva, 70, a retired nurse out for a walk in a Moscow park Tuesday afternoon, embodied both sentiments. While calling the vaccine “a great achievement” for Russian scientists, she said she would not rush to get it herself because of the “hasty” testing.

“Those who fear the pandemic more will take it first, and good for them,” she said. If in a year or so it is clearly shown to be safe, she said, then she will reconsider.

Vaccines generally go through three stages of human testing before being approved for widespread use. The first two phases test the vaccine on relatively small groups of people to see if it causes harm and stimulates the immune system. The last phase, known as Phase 3, compares the vaccine to a placebo in tens of thousands of people.

The Russian scientific body that developed the vaccine, the Gamaleya Institute, has yet to conduct Phase 3 trials.

That final phase, however, is the only way to know with statistical certainty whether a vaccine can prevent an infection, and how effective it is. And because it tests a much larger group of people, a Phase 3 trial can also detect more subtle adverse effects of a vaccine that earlier trials could not.

Experts warn that, among other things, a faulty vaccine could actually render those inoculated more vulnerable to severe forms of Covid-19, the disease caused by the virus, a potential disaster that can be ruled out only through extensive testing on human volunteers.

Image“It works effectively enough, forms a stable immunity and I repeat, it has gone through all necessary tests,” President Vladimir V. Putin said. “It works effectively enough, forms a stable immunity and I repeat, it has gone through all necessary tests,” President Vladimir V. Putin said.Credit...Aleksey Nikolskyi/Sputnik, via Reuters The Russian vaccine uses two strains of adenovirus that typically cause mild colds in humans. Scientists genetically modified them to cause infected cells to make proteins from the spike of the new coronavirus, officials have said.

The approach is similar to the one used in a vaccine developed by Oxford University and AstraZeneca that is now undergoing Phase III tests in Britain, Brazil and South Africa.

The W.H.O. is in close contact with the Russian authorities and discussing proper procedures, Tarik Jasarevic, a spokesman for the organization, told reporters in Geneva on Tuesday. But he emphasized that obtaining the organization’s seal of approval would require “rigorous review of safety and efficacy data” derived from clinical trials.

The Russian Ministry of Health did not respond to detailed written questions sent last week about human trials and research into potentially harmful side effects.

CORONAVIRUS SCHOOLS BRIEFING: How is the pandemic reshaping education? Get the latest news and tips as students go back to school. Sign Up The Gamaleya Institute developed the Russian vaccine using a human cell line first cultured in 1973 — the same line used in the Oxford-AstraZeneca vaccine. Like a number of other cell lines used in medical research and vaccine manufacturing, it began with cells taken from an aborted fetus, raising objections from abortion opponents that may come into sharper focus if the vaccine is used widely.

Russia’s announcement of a potential vaccine well ahead of the Western timeline of the end of the year could provide a welcome respite for Mr. Putin from a string of bad news.

Over the past year he has seen a steady decline in his approval ratings, which had soared to more than 80 percent after the annexation of Crimea in 2014. Now, with Russian troops bogged down in Syria and Libya, foreign adventures have lost their appeal for most Russians.

Mr. Putin has also stumbled in domestic affairs. He was uncharacteristically passive in the spring as Russia erupted into one of the world’s hot spots for the coronavirus pandemic. And he has had no answers for the economic malaise enveloping the country, as the pandemic has flattened prices for oil and other natural resources that are the main engine of the Russian economy.

Russia has already used the vaccine race as a propaganda tool, even in the absence of published scientific evidence to support its claims as the front-runner. The vaccine, for example, was branded Sputnik V, recalling the Soviet Union’s launch of a first satellite, beating the United States.

For the last several months, state television has promoted the idea that Russia is leading the competition. In May, it reported that the first person in the world to be vaccinated against the virus was a Russian researcher who had injected himself even before monkey trials had been completed.

Russia also tested the vaccine on soldiers, raising concerns about consent, though the Ministry of Defense said that all the soldiers had volunteered.

Kirill Dmitriev, the head of a government-controlled fund that invested in the vaccine, denied in a conference call with journalists on Tuesday that Russia had cut corners on testing, or that it had stolen intellectual property to get ahead.

[eagle-eyez]

https://ift.tt/eA8V8J

Johnson & Johnson Friday said it has submitted an application to the Indian drug regulator to conduct a study of its COVID-19 vaccine in adolescents aged 12-17 years.

The US-based pharmaceutical company noted that it is committed to facilitating global equitable access to its COVID-19 vaccine and recognise the unmet needs of children.

"On 17 August, 2021, we submitted an application to the Central Drugs Standard Control Organisation (CDSCO) to conduct a study of the Johnson & Johnson COVID-19 vaccine in India in adolescents aged 12-17 years," a J&J India spokesperson said in a statement.

Why is this relevant?

If granted the due approval, this will be the third vaccine candidate to be tested on adolescents in India. However, Indian manufacturers Bharat Biotech and Zydus Cadila have already beat J&J in that race.

Earlier today, Zydus Cadila's ZyCov-D was granted emergency use approval for vaccinating those aged 12 and above. Bharat Biotech's Covaxin, on the other hand is also in the final stages of its clinical trial for children as young as 2 years of age, and has shown 'promising results'. It expects to be ready for approval and roll out by next month.

To ultimately achieve herd immunity, it is imperative that COVID-19 vaccine clinical trials continue to move forward not only in adults but in the adolescent and infant population as well.

Furthermore, J&J vaccine's single-dose regimen and a higher tolerance for temperature could also boost the availability of the shots even in remote parts of the country. This gains in significance given that the country has recently been criticised for its slow pace of vaccination.

Is J&J vaccine also available for adults?

Earlier this month, the government had given Emergency Use approval to J&J's single-dose COVID-19 vaccine in India.

While announcing the approval, Union Health Minister Mansukh Mandaviya had said the approval would further boost the country's collective fight against the novel coronavirus infection.

The six vaccines granted Emergency Use Authorisation in India are Serum Institute's Covishield, Bharat Biotech's Covaxin, Russia's Sputnik V, Zydus Cadila's ZyCov-D, Moderna, and J&J.

How is it different?

Unlike its US counterparts, Moderna and Pfizer vaccines, the Johnson & Johnson vaccine does not use messenger RNA (mRNA) to help the body build its defenses against the virus. Instead, it is an adenovector vaccine like the Oxford-AstraZeneca vaccine.

In this case, the gene of the coronavirus' signature spike protein is added to an adenovirus, a common virus that causes colds or flu-like symptoms, which when introduced into the body, delivers the instructions that teach human cells to make the spike protein. That causes the immune system to react by making antibodies to attack the spike protein, so if the person is exposed to COVID-19, the immune system is ready to fight it. It must also be mentioned that the adenovirus is modified so it can enter cells but cannot replicate or cause illness.

How does it fare?

Johnson & Johnson vaccine is currently the only vaccine, which is effective after only one dose. Authorities can use this vaccine on people who may be hard to reach or who are otherwise unlikely to get a second dose.

Unlike all Indian vaccines, which have to be stored at 2-8 degrees Celsius, the Johnson & Johnson vaccine can be refrigerated for up to three months at normal temperatures. This would allow the government to send these stocks to rural parts of the country where the cold chain may not be well developed.

Johnson & Johnson said a study showed the vaccine was 85 percent effective against "severe/critical disease and demonstrated protection against hospitalisation and death".

The vaccine was effective across regions studied globally, including in South Africa and Brazil, "where there was a high prevalence of rapidly emerging Beta and Zeta (P.2) variants during the study period", according to the company.

The vaccine was 66.3 percent effective in clinical trials (efficacy) at preventing laboratory-confirmed COVID-19 infection in people who received the vaccine and had no evidence of being previously infected.

A single dose of the vaccine generated neutralising antibodies against a range of Sars-CoV-2 variants of concern, including against Delta (B.1.617.2), Beta (B.1.351), Gamma (P.1).

Controversies

The vaccine was one of the early candidates to have been cleared by the US Centers for Disease Control, and Prevention (US CDC) and was said to have high efficacy at preventing hospitalisation and death in people. But the vaccine has run into one hurdle after another, notwithstanding the promising trial results.

For instance, On 13 April, the US government paused the administration of the vaccine to investigate a few cases in which people experienced blood clots after receiving the vaccine. All of the cases emerged within two weeks of vaccination. But on 23 April, US health officials lifted the pause after scientific advisers decided the vaccine’s benefits outweigh the risks.

Again, earlier in the month social media users shared posts, which claimed that the vaccine contains aborted fetal DNA as an ingredient, to which the Roman Catholic Archdiocese of New Orleans released a statement calling it "morally compromised". It was later clarified that while the vaccine used lab-replicated fetal cells during its production process, the vaccine itself does not contain any fetal cells.

Besides, as per recent reports, the vaccine increases the risk of Guillain-Barré syndrome during the 42 days following the vaccination. While the vaccine has not been proven to be a causative effect of the disorder, influenza and shingles vaccines have been linked to an increased risk of contracting the syndrome.

Originally posted here: https://ift.tt/3mgpcnK

[orbemnews]

After India Jabs Millions, Its Covid-19 Vaccine Shows Potency NEW DELHI — India’s ambitious but troubled campaign to vaccinate its vast population against Covid-19 — and, in the process, to burnish its own reputation as a manufacturer and innovator — just got a big boost. An Indian drug company said late Wednesday that initial results from clinical trials involving nearly 26,000 subjects showed that a homegrown Indian vaccine was both safe and effective. The company, Bharat Biotech, said that its Covaxin vaccine had an initial efficacy rate of 81 percent. The results from the interim analysis have yet to be peer reviewed, the company said. It was unclear how effective Covaxin would prove to be in a final analysis. Still, the results were met with relief in India. Covaxin had been approved by government officials in January and administered to millions of people before it had been publicly proved to be safe or effective. Many people in India, including frontline health care workers, had feared Covaxin could be ineffective or worse, slowing down New Delhi’s campaign to inoculate 1.3 billion people. Officials in Brazil, where the government had bought doses of Covaxin, had recently questioned whether this vaccine actually worked. The results this week could alleviate some of those concerns, said Dr. Anant Bhan, a health researcher at Melaka Manipal Medical College in southern India. Still, he said, questions will linger over Covaxin until the research is completed. “This data will now need to be examined by the regulator in India and could then have an impact on the regulatory decisions with regards to the vaccine,” Dr. Bhan said. If the results hold, they could also benefit Narendra Modi, India’s prime minister, and his Hindu nationalist political party. Mr. Modi has stressed making India self-reliant, and an effective, Indian-developed vaccine could help that campaign. India’s approval of Covaxin for emergency use was announced in early January on the same day as approval of the Oxford-AstraZeneca vaccine, which is known in India as Covishield. When the vaccination drive started less than two weeks later, most people were not allowed to choose which jab they got. To support the vaccine, Mr. Modi publicly took the Covaxin jab on Monday. Images of other federal ministers and heads of regional governments taking the Indian-made vaccine were posted on social media. But Gargeya Telakapalli, a public health expert, said the emergency approval of Covaxin raised suspicions among frontline workers and prompted questions about India’s regulatory process. That added uncertainty to the vaccination process in general. Updated  March 4, 2021, 5:30 a.m. ET “I know many health care workers who were not very confident to take Covaxin and preferred Covishield,” said Mr. Telakapalli, who works in India with the People’s Health Movement, a global network of grass-roots health activists. “The rush for the approval has not helped Covaxin, although no one is saying there is any problem with the vaccine.” In part because of the risk of getting a vaccine that hadn’t been proved safe, many people in India have declined to get jabbed, contributing to the slow rollout of the campaign. The effort to vaccinate the country’s huge population was already logistically challenging, involving transporting doses to far-flung places while controlling the environment around them. The government aimed to vaccinate about 300 million people by August. As of Wednesday, it had inoculated about 16 million. At that rate, covering the population could take years. The authorities have expanded eligibility from essential workers to include people over 60 and those above 45 with significant health risks. Last week, an advisory board for Central Drugs Standard Control Organization, India’s pharmaceutical regulator, rejected Bharat Biotech’s request for a Covaxin trial on children between the ages of 5 and 18, saying the company should first submit a report on the efficacy of its vaccine. What You Need to Know About the Vaccine Rollout The uncertainty could hinder Bharat Biotech’s ambitions to sell Covaxin to countries like Brazil. Last week, prosecutors there sought the immediate suspension of Covaxin purchases after the government signed a contract to buy 20 million doses. The company has been undaunted. Bharat Biotech, which developed Covaxin with the National Institute of Virology and the Indian Council of Medical Research, has already supplied 5.5 million shots of its vaccine for the Indian government’s vaccination campaign. On Wednesday, the company said the final stage of the Covaxin trial had involved 25,800 volunteers across the country. Officials at the Indian Council of Medical Research said in a statement that the eight-month effort to produce a locally made vaccine was a testament to the country’s emergence as a global vaccine superpower. “The development and deployment of Covaxin ensures that India has a powerful weapon in its arsenal in a continually evolving pandemic situation and will go a long way in helping us win the war against Covid-19,” said Dr. Samiran Panda, an official at the council. Source link Orbem News #Covid19 #India #jabs #Millions #Potency #Shows #Vaccine

[atlanticcanada]

Health Canada in 'final stages' of AstraZeneca COVID-19 vaccine review

Health Canada is in its “final stages” of reviewing the AstraZeneca COVID-19 vaccine candidate, according to the agency’s senior medical adviser Dr. Supriya Sharma.

On Tuesday during a technical briefing, Sharma said that Health Canada is currently going back and forth with the pharmaceutical company about what information the label will include.

“That's what we're in the process of doing right now,” she said, adding that this process can take “some time” before finalizing the review, which has been conducted in collaboration with the European Medicines Agency.

Health Canada’s regulatory experts have been assessing the submission from AstraZeneca and Oxford University for safety and efficacy since Oct. 1, 2020. It’s a two-dose vaccine, which several other nations have approved for use, including Britain, Australia, and South Africa.

Newsletter sign-up: Get The COVID-19 Brief sent to your inbox

Sharma said that the review of the AstraZeneca vaccine has been more “complicated” due in part to the way the clinical trials were set up, noting that there is a trial ongoing in the United States.

As well, in recent days and weeks questions have been raised about the efficacy of the vaccine in certain circumstances.

For example South Africa has suspended plans to vaccinate its health care workers with the AstraZeneca vaccine after a clinical trial indicated it is less effective against the variant strain predominant in that country.

And, France has advised against administering the AstraZeneca vaccine to people over the age of 65, citing a lack of data.

Sharma said that while this information is taken into account, it isn’t delaying Canada’s process.

“As we're getting new information certainly we're incorporating it into that review, but that hasn't extended our timelines. We're just taking that information, and for example if there's time when we're waiting for the company to get back to us, we're using that time to look at any new additional information that's come through,” she said.

“The goal of course is to make sure that that review is independent, it’s science and evidence-based, and when we finally do have an authorization that whatever information that we have on that label as part of the product monograph, correctly reflects all of the science and the evidence.”

Should the AstraZeneca vaccine be granted regulatory approval, it would be the third vaccine deemed safe for use in this country, following the Pfizer-BioNTech and Moderna vaccines.

During his Rideau Cottage address on Tuesday, Prime Minister Justin Trudeau said that Health Canada officials are “working around the clock” on the AstraZeneca and other ongoing regulatory assessments. The agency is also currently evaluating the Johnson & Johnson and Novavax vaccine candidates.

Typically, the vaccine submission review process can take up to a year, but because of an emergency order, Health Canada has been able to expedite the authorization process. The order allows the agency to assess rolling information as it comes in from the pharmaceutical companies’ studies, rather than having to wait until the end of its work to begin reviewing the findings.

Canada has secured access to 20 million doses of the AstraZeneca vaccine, up to 38 million doses of the Johnson & Johnson vaccine, and up to 76 million doses of the Novavax vaccine.

The federal government has been aiming to have shipments of any newly-approved vaccines arrive in Canada as quickly as possible once Health Canada gives them the green light.

In the case of AstraZeneca, it’s possible that up to 500,000 doses of its vaccine could land in Canada before the end of March, according to Procurement Minister Anita Anand.

from CTV News - Atlantic https://ift.tt/3cWccyR

[billyagogo]

Covid-19: Novavax vaccine shows 89% efficacy in UK trials

New Post has been published on https://newsprofixpro.com/moxie/2021/01/29/covid-19-novavax-vaccine-shows-89-efficacy-in-uk-trials/

Covid-19: Novavax vaccine shows 89% efficacy in UK trials

image copyrightGetty Images

image captionBiotech firm Novavax has labs in the US (pictured) and has carried out trials in the UK and South Africa

A new coronavirus vaccine has been shown to be 89% effective in large-scale UK trials.

The Novavax jab is the first to show in trials that it is effective against the new virus variant found in the UK, the BBC’s medical editor Fergus Walsh said.

The UK has secured 60 million doses of the jab, which will be made in Stockton-on-Tees in north-east England.

Janssen, a company owned by Johnson & Johnson, is also investigating whether giving two doses will give either stronger or longer-lasting protection.

The company said its initial findings showed one dose prevented 85% of severe cases.

Both the Novavax and Janssen jabs will need to be reviewed by regulators before they can be used.

The PM welcomed the “good news”, with doses of the Novavax jab expected to be delivered in the second half of this year if approved for use by the Medicines and Healthcare Products Regulatory Agency (MHRA), the government said.

The UK has so far approved three coronavirus vaccines for emergency use – one from Oxford University and AstraZeneca, another by Pfizer and BioNTech, and a third from drug firm Moderna.

The Novavax jab, which is given in two doses, was shown to be 89.3% effective at preventing Covid-19 in participants in its Phase 3 clinical trial in the UK, and around 86% effective at protecting against the new UK variant. The jab’s efficacy against the original Covid-19 strain was calculated to be 95.6%.

The Phase 3 trials – the final stage before a vaccine is looked at by a regulator – enrolled more than 15,000 people aged between 18-84, of whom 27% were older than 65, US firm Novavax said.

In the South African part of the trial, where most of the cases were the South African variant of the virus, the vaccine was 60% effective among those without HIV.

Stan Erck, chief executive of Novavax, said the results from the UK trial were “spectacular” and “as good as we could have hoped”, while the efficacy in South Africa was “above people’s expectations”.

He told the BBC the manufacturing plant in Stockton-on-Tees should be up and running by March or April, with the company hoping to get approval for the vaccine from the MHRA around the same time.

media captionNovavax chief executive: UK trial results are “spectacular”

Minister Lucy Frazer told BBC Breakfast the government could not put an exact timeframe on when the Novavax jab might be approved as the regulation process is “out of our control”.

Health Secretary Matt Hancock said the new vaccine would be “another weapon in our arsenal to beat this awful virus”, if approved.

Prof Paul Heath, chief investigator of the UK Novavax trial, said the trial findings were “enormously exciting”, particularly because of the jab’s efficacy against the UK variant.

These extremely encouraging trial results suggest another powerful vaccine against coronavirus could soon be within reach.

It works in a slightly different way to the ones that are already available – but does the same job of teaching the body’s immune system to recognise and fight the pandemic virus.

What is more, it appears to be effective against emerging and more infectious variants of coronavirus too – something scientists have feared might not be possible because the vaccines were all designed to match the original virus, not these new, mutated versions.

Protection against illness from the new UK variant was high – around 86%.

Even with the South Africa variant, which has undergone the most worrisome changes, it offered a level of protection similar to that given by flu shots against influenza.

England’s chief medical officer Prof Chris Whitty said, if the jab is approved, it “increases our future resilience” against the virus.

Nadhim Zahawi, the UK minister responsible for the vaccine rollout, said he was “particularly thrilled” to see the positive results as he had taken part in Novavax’s trials himself.

media captionHow does a vaccine get approved?

In total, the UK has ordered 100 million doses of the Oxford-AstraZeneca vaccine and 40 million of the Pfizer-BioNTech vaccine – both are currently being rolled out in the UK.

Another 17 million doses of the Moderna vaccine, which was approved by the MHRA in early January, are expected in the spring.

The aim is to give everyone in the top four priority groups – up to 15 million people – a first dose by mid-February.

Pfizer and Moderna vaccines rely on technology that has not been used in previous vaccines, but the Novavax jab uses a more traditional method of recreating part of the spike protein of the virus to stimulate the immune system.

Like the Oxford vaccine, the Novavax jab can be stored at regular fridge temperature – which means it can be distributed more easily.

More than 7.4 million people in the UK have so far received a first dose of a coronavirus vaccine, according to the latest government figures.

Meanwhile, the latest estimate for the UK’s R rate from the government’s scientific advisory group, Sage, is 0.7 to 1.1. It means that on average, every 10 people with the virus will infect between seven and 11 other people. Last week, the R rate was between 0.8 and 1.

The latest growth rate range is between -5% and 0%, indicating that the number of new infections is broadly flat or shrinking by up to 5% every day.

Separately, the EU’s vaccine contract with AstraZeneca has been published, in a growing row over reduced supplies of their jab.

Kate Bingham, who used to chair the UK’s Vaccine Taskforce, said the reason the UK had a good supply of vaccines compared with other countries was because of its ability to get clinical trials completed quickly and at a high standard through the NHS’s registry – with some 400,000 volunteers signing up “before the US even started their Phase 3 studies”.

The UK recorded a further 1,239 deaths within 28 days of a positive coronavirus test on Thursday. There have also been another 28,680 new infections.

How have you been affected by the issues relating to coronavirus? Email haveyoursay@bbc.co.uk.

Please include a contact number if you are willing to speak to a BBC journalist. You can also get in touch in the following ways:

If you are reading this page and can’t see the form you will need to visit the mobile version of the BBC website to submit your question or comment or you can email us at HaveYourSay@bbc.co.uk. Please include your name, age and location with any submission.

Read More

[healthpediaindia]

AstraZeneca Vaccine Final-Stage Trial Results - 70.4 percent Efficient

AstraZeneca-Oxford First To Publish Final-Stage Trial Results; Vaccine 70.4 percent Efficient #covid19vaccine #coronavirus #astrazeneca #oxforduniversity #astrazenecavaccine

Oxford University and AstraZeneca became the first Covid-19 vaccine makers to publish final-stage clinical trial results in a scientific journal. Researchers from the University of Oxford and pharmaceutical major AstraZeneca presented a pooled analysis of phase 3 trials of their vaccine against COVID-19 across two different dose regimens, which showed that the vaccine is safe and has an average…

[bbcbreakingnews]

‘Adverse event’ won’t affect vaccine rollout plan: Government

NEW DELHI: The initial causality assessment of the adverse event in the “Covishield” vaccine trials being conducted by Pune-based Serum Institute of India (SII) did not necessitate stoppage of the trial and has not impacted timelines for the vaccine’s rollout, the government said on Tuesday. The Centre was responding to the claim of a Chennai-based man who has sought Rs 5 crore compensation from SII as his health worsened during clinical trials for the Covid-19 vaccine developed by the UK’s Oxford University and AstraZeneca. SII has said the event is not linked to the vaccine, which, it said, is safe and immunogenic. SII has warned of a retaliatory Rs 100-crore defamation suit. Asked why the event was not disclosed by the government or SII until media reports came out, health secretary Rajesh Bhushan said there is no reason to conclude that processes and due diligence in dealing with such an incident were not followed. He listed the stages of scrutiny up to the final conclusion by the DCGI (Drug Controller General of India) that the ill-health and hospitalisation (a serious adverse event) were not linked to the vaccine. Further asked what the position of the Indian Council for Medical Research was on the “intimidatory” move by SII to seek Rs 100-crore damages, Bhushan said ICMR has no view on a legal proceeding between two entities such as those in question. “Due processes were followed in reporting the adverse event… We have been given to understand that there is a court case so we cannot comment on the specifics of the case,” he said. He pointed out that vaccines against Covid are being developed under extraordinary circumstances in a timeline of 12-18 months. “If a vaccine is developed in four years, it is seen as extraordinary,” he said while assuring that safety will not be lost sight of. ICMR director general Dr Balram Bhargava said adverse events occur with drugs, vaccines or any other health interventions. “It is the role of the regulator after collating all the data to ascertain or refute whether there is a causal link between the event and the intervention. This is done purely on scientific basis and the assessment is done with very objectively based criteria,” he said. In statement on Tuesday, SII said the vaccine won’t be released for mass immunisation unless proven immunogenic and safe. In a more mellow tone, it said while the adverse event is not related to the vaccine, the company was “sympathetic’’ with the participant’s medical condition. The doctor in charge of the trial has said the event was found unconnected with the vaccine and the patient’s hospitalisation was paid for. The participant reported severe disorientation. Highlighting adverse events that have happened during previous trials for polio, measles or rotavirus, vaccine experts said some events are likely to happen when thousands of people are in trials though there is a need for thorough investigation. Some illnesses are likely to happen to vaccinated people even if the vaccine is safe, said vaccine expert Gagandeep Kang in a series of tweets. “No vaccine (or drug from aspirin to zinc) is absolutely risk-free. But no vaccine is licensed where benefits don’t hugely outweigh any risk. To know risk is rare is no consolation when AEFIs (adverse event following immunisation) occur, but it is important as a society to understand risks exist & are measured,” Kang said, explaining how adverse events vary and are reported. The health ministry plans to come out with detailed guidelines that will address issues around vaccine safety and create awareness and dispel misinformation. Bhushan admitted there can be a case of “vaccine hesitancy” and reiterated Prime Minister Narendra Modi’s appeal to experts and vaccine-makers to prevent doubts and fears from clouding the public mind. Bharat Biotech, which is developing the Covid-19 vaccine Covaxin, also had an adverse event in August during the Phase 1 trial when a volunteer had to be hospitalised after being given the vaccine. The Hyderabad-based firm had found the incident as not vaccine-related. “When you have this context (Covid), then there is a potentiality that commercial interests would dictate certain strategic actions of commercial entities. Governments of the day have nothing to do with it. However, the responsibility of the government is that we must educate the people about safety, effectiveness of the vaccine and that all disinformation is countered promptly,” Bhushan said. The government maintained that a subject is supposed to sign a prior infofrmed consent form about possible adverse events. Besides, the trials are multi-centric and there is an institutional ethics committee at each trial site that evaluates and reports such adverse events to the drug regulator. There are also data safety monitoring boards consisting of domain experts to monitor clinical trials on a day-to-day basis. Both ethics committee and DSMB are independent of the vaccine developer and the government and report any adverse events, along with their assessment and recommendation on whether there is a need to halt the trials.

source https://bbcbreakingnews.com/2020/12/02/adverse-event-wont-affect-vaccine-rollout-plan-government/

[phgq]

PH gov't to meet AstraZeneca for possible vaccine vs. Covid-19

#PHnews: PH gov't to meet AstraZeneca for possible vaccine vs. Covid-19

MANILA – Foreign Affairs Secretary Teodoro Locsin Jr. said officials from the Philippine government are scheduled to meet on Friday with representatives from AstraZeneca, one of the leading developers of a candidate vaccine against coronavirus disease (Covid-19).

"We're meeting AstraZeneca later with FDA (Food and Drug Administration). Will assure them fairness across the board, no favors, no funny stuff, we need all the vaccines we can get," he said in a tweet.

Locsin noted that once the supply is available, the European drug maker's candidate vaccine would be "sold at cost".

Meanwhile, he clarified that AstraZeneca has no plans to extend its trials to Southeast Asia after FDA Director-General Eric Domingo said the pharmaceutical firm has expressed interest to conduct a clinical study in the Philippines.

"I just talked to AstraZeneca. It is not conducting trials anywhere in Southeast Asia and yet Indonesia has preordered 100 million doses; so since we are all equal members of one human race it doesn't matter. The primary consideration should be cost per dosage," he said.

The clinical trials of AstraZeneca and University of Oxford's experimental Covid-19 vaccine have recently resumed in the US after it was put on hold due to an illness of a volunteer.

Manila is also in talks with Chinese firms currently in the final stages of clinical trials.

Last week, China’s Sinovac Biotech submitted to the FDA Philippines its application to conduct Phase 3 of clinical trials of its vaccine in the country.

The government is also evaluating vaccines of Russia’s Gamaleya Research Institute and other pharmaceutical companies, including Pfizer.

The Department of Health earlier said the third phase of the World Health Organization (WHO) Solidarity Trial on a possible Covid-19 vaccine is also set to start in the Philippines by end of 2020.

Manila, meanwhile, has secured membership to the Gavi COVAX alliance to ensure access to the global Covid-19 vaccine supply.

The COVAX or Covid-19 Vaccines Global Access Facility, co-led by the WHO, represents the largest portfolio of potential Covid-19 vaccines. It is a global initiative among vaccine manufacturers and foreign governments to provide countries an efficient vaccine against coronavirus.

The full list of candidate vaccines under COVAX is as follows:

Inovio, United States of America (Phase I/II)

Moderna, United States of America (Phase III) 

CureVac, Germany (Phase I)

Institut Pasteur/Merck/Themis, France/ United States of America /Austria (Preclinical)

AstraZeneca/University of Oxford, United Kingdom of Great Britain and Northern Ireland (Phase III)

University of Hong Kong, China (Preclinical)

Novavax, United States of America (Phase I/II)

Clover Biopharmaceuticals, China (Phase I)

University of Queensland/CSL, Australia (Phase I)

As of October 29, there are 376,935 confirmed Covid-19 cases in the country, including 7,147 deaths and 329,848 recoveries. (PNA) 

***

References:

* Philippine News Agency. "PH gov't to meet AstraZeneca for possible vaccine vs. Covid-19." Philippine News Agency. https://www.pna.gov.ph/articles/1120227 (accessed October 30, 2020 at 10:57PM UTC+14).

* Philippine News Agency. "PH gov't to meet AstraZeneca for possible vaccine vs. Covid-19." Archive Today. https://archive.ph/?run=1&url=https://www.pna.gov.ph/articles/1120227 (archived).

[brajeshupadhyay]

Moderna, Pfizer publish COVID-19 vaccine trial blueprints amid criticism of Donald Trump's response to pandemic

Washington: US biotech firm Moderna, one of nine companies in the late stages of clinical trials for a COVID-19 vaccine, became the first to publish the complete blueprints of its study following calls for greater transparency.

Pfizer, the other American company currently carrying out Phase 3 trials in the US, followed suit a short time later and there is now added pressure for the remainder to do the same.

Phase 3 is the final stage before approval, in which a vaccine and a placebo are tested on thousands of participants to verify the medicine is safe and effective.

The vaccine race has become deeply politicized in the US in the run-up to the presidential election in November, as President Donald Trump touts a quick vaccine in response to criticism of his handling of the pandemic.

Trump repeated on Wednesday that the first vaccine would be approved by October, increasing concerns that the White House will place pressure on the approval body, the Food and Drug Administration (FDA).

"I don't trust Donald Trump," his rival from the Democratic party Joe Biden said Wednesday.

Experts and officials in the Republican president's administration agree that it's not possible to predict the results of the trials that are underway, and it's highly unlikely to have strong data before the end of 2020.

Vaccine doses will be initially very limited, according to health authorities.

Moderna's CEO Stephane Bancel said on Thursday his company would know whether their vaccine works by November. "October is possible but unlikely," he told CNBC.

The trial protocol published Thursday, which runs to 135 pages and is marked "confidential," fixes the parameters of the experiment.

The most important of these is how it will judge whether results are conclusive.

Wait for it

The reality of an immunization trial is that it's necessary to wait until a certain number of volunteers become naturally infected, in order to compare outcomes in the placebo group against the group given the vaccine.

So the decline in the rate of infection in the US could theoretically delay the results - possibly until December, said Bancel.

As of Thursday, Moderna had recruited 25,296 volunteers. Among them, 10,025 had received their second dose, 28 days after the first.

It'll take a few more weeks to recruit the full quotient of 30,000 participants and for them to receive their second doses.

Only COVID-19 infections recorded two weeks or more after the second dose are counted, to give the vaccine sufficient time to take effect.

Interim analyses by a committee of independent experts are planned over the course of the trial to verify whether a high statistical threshold of effectiveness has been reached, and to monitor for serious side effects.

The FDA has stated its bar for approval is a vaccine that reduces the risk of falling sick with COVID-19 by 50 percent.

The Moderna trial protocol "has the key information (for) stopping rules, interim analyses and efficacy assumptions. Applaud their transparency," Eric Topol, director of the Scripps Research Institute and one of the critics leading the charge against possible political interference, told AFP.

Pressure on

Moderna also said that 28 percent of its participants were from racial minority groups.

Having sufficient participants among black and Hispanic people in particular is crucial in obtaining statistically representative results for these communities that have been disproportionately hit by the pandemic.

The decision by Moderna, which has received $2.5 billion in US government money, left a spotlight on Pfizer, whose CEO has repeatedly said the company will have its results by the end of October, which is in line with Trump's wishes.

A spokeswoman told AFP, Pfizer has traditionally not shared the full in-depth study protocol, but "the COVID-19 pandemic is a unique circumstance and the need for transparency is clear."

"As a result, the company is making the full protocol for its self-funded Covid-19 vaccine pivotal study available to reinforce Pfizer's longstanding commitment to scientific and regulatory rigor that benefits patients."

The other frontrunner is AstraZeneca, which has co-developed a vaccine with the University of Oxford.

The medicine's global trials were suspended last week after a participant had an unexplained illness, but were later restarted in the UK, Brazil, and South Africa. The US remains the exception for reasons that aren't yet known.

via Blogger https://ift.tt/32GurTp

[pharmaphorumuk]

Coronavirus pharma news roundup – 24/07/20

With coronavirus vaccine trials finally showing positive results, analysts are starting to wonder what access challenges might lie ahead. We highlight the top R&D, digital and market access news for COVID-19 from the past week.

Data from more than 1,000 healthy volunteers dosed with a coronavirus vaccine developed at Oxford University and AstraZeneca suggest the shot is safe and stimulates an immune response against the virus.

The focus is now moving on how to get the in-depth safety and efficacy results needed to get Oxford’s jab formally approved – including the possibility of a controversial “challenge trial” where healthy subjects are given the vaccine and then exposed to the virus to test the levels of protection it confers.

The US government has agreed to pay Pfizer and BioNTech $1.95 billion to secure access to 100 million doses of their coronavirus vaccine on approval, just days after promising results in a clinical trial. Meanwhile, the UK has secured 90 million doses of the companies’ vaccine, with an option of 40 million doses if they check out in trials.

Concerns have emerged about access to some potential COVID-19 vaccines after pharma executives from three companies said they expect to make profits from their products in evidence to a US Congressional panel.

JP Morgan has downgraded its valuation of Moderna, saying its $37 billion market cap is way too high even if its COVID-19 vaccine mRNA-1273 succeeds in clinical trials.

An inhaled drug developed by the UK firm Synairgen greatly reduces the chances of patients hospitalised with COVID-19 from progressing to more serious stages of the disease, trial results have shown

A smartphone app developed by medical software specialist Allm is being trialled in Japan to see if it can help patients with milder coronavirus symptoms recuperate at home, without tying up healthcare resources.

Roche has announced half-year results showing the COVID-19 pandemic affected sales of its key products, with currency headwinds also weighing on revenues.

Healthware has launched a new online resource that aggregates information and analysis on how to respond to the huge changes COVID-19 has wrought across life sciences and healthcare.

The post Coronavirus pharma news roundup – 24/07/20 appeared first on .

from https://pharmaphorum.com/views-analysis-market-access/coronavirus-pharma-news-roundup-24-07-20/

[manuelsblogposts]

Two Potential COVID-19 Vaccines Enter Final Stage Clinical Trials

Late-stage Phase II/III trials are currently underway in the UK, Brazil and South Africa and are due to start in the US,with the goal of delivery a COVID-19 vaccine in early 2021. Image: Ulrike Leone / Pixabay As the world races to develop an antidote for the coronavirus, two potential COVID-19 vaccines have passed early-stage clinical trials and are on schedule to be made available in early 2021. ChAdOx1 nCoV-19 The vaccine, called ChAdOx1 nCoV-19, was conceived at Oxford University in the United Kingdom and will be manufactured by AstraZeneca. In Phase I/II COV001 trial, the compound drug stimulated both neutralizing antibodies and active immune cells, or T-cells. Generating a robust immune response against the SARS-CoV-2 virus in all evaluated participants, while showing no significant side effects. Late-stage Phase II/III trials are currently underway in the UK, Brazil and South Africa and are due to start in the US. Trials will define how well the vaccine will protect from the COVID-19 disease and measure safety and immune responses in different age ranges and at various doses. If successful, the coronavirus vaccine will be made available early next year. More Info: AstraZeneca mRNA-1273 The other vaccine that past pass early-stage clinical trials is being developed by Moderna. Identified as mRNA-1273, the medication induced anti–SARS-CoV-2 immune responses in all participants with no serious safety concerns identified. Read the full article

[bbcbreakingnews]

India has initiated an integrated response against Covid-19 pandemic: Vardhan

NEW DELHI: From development of indigenous vaccines to novel point-of-care diagnostics, India has initiated an integrated response to overcome the unprecedented Covid-19 pandemic, Union minister Harsh Vardhan said on Saturday. Speaking at the 8th BRICS STI Ministerial Meeting held on Friday, Vardhan said India is also hosting clinical trials for all the major vaccines, and about 20 vaccines are in different stages of development. Two of them are in the most advanced stage of development. COVAXIN developed through ICMR-Bharat Biotech collaboration and COVISHIELD from the Serum Institute of India. Both are in Phase-III clinical trial stage, he added. “India has initiated an integrated response to overcome this unprecedented Covid-19 pandemic. “From the development of indigenous vaccines, novel point-of-care diagnostics and therapeutic formulations based on traditional knowledge, to establishing research resources and offering services, Indian R&D entities, both public and private, are working relentlessly to develop effective interventions for combating the pandemic,” Vardhan, who holds the charge of Health Ministry as well as the Science and Technology Ministry, said. Valery Falkov, Russian minister of science and higher education, Marcos Pontes, Brazilian minister of science, technology and innovation, Huang Wei, first vice minister of science and technology, China, Bonginkosi Emmanuel Nzimande, South African minister of higher education, science and technology and several other dignitaries from member countries participated in the meeting. Vardhan said more than 100 start-ups have developed innovative products for Covid-19. He said the government has announced a $120 million grant for Covid-19 vaccine research. This is being provided for CovidSuraksha (Mission for protection from Covid) and is to be used purely for research and development in this field, he said. “The grant does not cover the actual cost of the vaccine and its distribution expenses, which will be made separately as and when the vaccine is available,” he said. Vardhan said India is also hosting clinical trials for all the major vaccine contenders. Serum Institute of India, the world’s largest vaccine manufacturer, is conducting trials for the vaccine developed by Oxford University, he said. “One of our pharma giants, Dr Reddy’s Laboratories, will distribute the Russian vaccine in India after conducting final-stage human trials and receiving regulatory approval,” the minister said. Vardhan said India will actively contribute in implementation of BRICS STI Calendar of Activities 2020-21 and support continuation of scientific activities under BRICS MOU on Science, Technology and Innovation. The BRICS member leaders applauded India for the ‘SERBPOWER’ (Promoting Opportunities For Women in Exploratory Research) scheme launched last month, the Department of Science and Technology said. “We have recently launched a scheme ‘SERBPOWER’ to encourage and support emerging as well as eminent women researchers to undertake R&D activities in areas of science and engineering. We may think of networking BRICS women scientists through a dedicated platform and mechanism,” he added.

The post India has initiated an integrated response against Covid-19 pandemic: Vardhan appeared first on BreakingNews.

source https://bbcbreakingnews.com/2020/11/14/india-has-initiated-an-integrated-response-against-covid-19-pandemic-vardhan/

[ericfruits]

Oxford University is leading in the vaccine race

BY OXFORD’S EASTERN bypass road, some way from the famous spires, sits an unremarkable collection of glass office buildings that includes the Jenner Institute. Described by an industry observer as “a slightly dusty corner” of the university, until six months ago it mostly busied itself with useful but ill-funded research into diseases suffered by people in poor countries. Now it is the likeliest candidate to produce the world’s first vaccine against covid-19.

With governments all over the world pouring money into it, the effort to get a vaccine has come to resemble a more urgent version of the space race. According to a tally maintained by the Milken Institute, an American think-tank, 180 vaccines are in development. In late June China waved through an emergency authorisation to allow its armed forces to use a vaccine that remains incompletely tested. A number of American vaccines are doing well, but have yet to progress to late-stage testing. Soumya Swaminathan, chief scientist for the World Health Organisation, says the Oxford vaccine is the leading candidate.

Oxford’s vaccine is already in three late-stage trials. Only one other vaccine, developed by Sinopharm, a Chinese firm, has started a late-stage trial, and it does not have the global support and finance that Oxford’s does. AstraZeneca, a British pharmaceutical company, is building an international supply chain to make sure that the vaccine is available “widely and rapidly”.

It might be clear by the end of August whether or not the vaccine is effective. A single successful trial showing efficacy would allow a regulator to approve the vaccine for emergency use—something that would probably pave the way for use in high- risk groups. That could happen in October. The firm thinks that full approval, which would require results from multiple trials, could come early in 2021. Vaccine development routinely takes 10-15 years, so this would be a remarkable result.

Oxford, which rivals Cambridge as Britain’s best life-sciences university, is rich not just in talent but also in research money. None of the 60 or so groups at the university working on the disease waited for government funding. “I think it’s one of the reasons Oxford has done so well in this,” says an insider. “We just got on and did it.” Other Oxford researchers have since identified the first drug proven to reduce mortality from covid-19. But the Jenner Institute may turn out to have made the biggest breakthrough of all.

The institute started work on January 11th, the day after covid-19’s genetic material was sequenced. It had previously developed a vaccine for a closely related virus that causes MERS, another coronavirus disease. Sarah Gilbert, head of the laboratory at the institute that had done the work, and her team have now engineered a chimpanzee virus to deliver a portion of the covid-19 genetic material into the body, thus generating an immune response.

Once the vaccine had been made, the medicines regulator, the MHRA, rushed through approval for clinical trials. In normal times it has 60 days to respond to a request; in this case, it gave its approval in a week. Later-stage trials were expedited by using interim data from earlier trials, rather than waiting for final data.

At the same time, factories had to be found to produce the vaccine. In March the UK Bioindustry Association carried out a survey, which found that “there was limited capability to scale to significant volumes,” says Steve Bates, the association’s chief executive. That changed quickly as Oxford worked with domestic manufacturers. In April it signed a deal with AstraZeneca which soon had hundreds of staff working on scaling up the vaccine.

The vaccine is grown inside cells that are cultured in vats called bioreactors. Production starts small, at 200 litres. When AstraZeneca is happy with what it produces in the smallest bioreactor it will scale up production. Four bioreactors of 2,000 litres can produce a billion doses in two months. Although AstraZeneca is not a vaccine company, the processes for producing a vaccine are similar to those it uses for its biotechnology products.

According to AstraZeneca, making each dose of the vaccine costs about as much as a cup of coffee. Two billion doses have already been ordered. The company has agreed to supply over a billion doses to Europe, Britain, America, and GAVI, a vaccine finance group. The Serum Institute of India is also producing an additional one billion doses of the Oxford vaccine, mainly for low- and middle-income countries, of which 400m will be made before the end of 2020. In Britain, 30m doses will be available by September.

But the big question—whether the immune response that the vaccine generates is enough to protect against the disease—is as yet unanswered. In an ongoing British trial designed to find this out, 7,000 patients have been injected with it; further trials have just started in Brazil and South Africa. These should also determine whether the vaccine is safe, whether it produces a rare reaction in which it exacerbates rather than ameliorates the disease and whether one or two doses are required to provide protection.

If the vaccine works, governments will have to decide who should get it first. In Britain, the Joint Committee on Vaccination and Immunisation, which advises the government, has recommended that front-line health- and social-care workers, then those most vulnerable, should be first in the queue. But it has warned that its advice may change should more data become available on the transmission dynamics of the disease or the effects of a vaccine.

Boris Johnson has called the race for the vaccine “the most urgent shared endeavour of our lifetimes”. It is not, he insists, “a competition between countries”. But he would no doubt be delighted if the world’s first vaccine came from Oxford. Aside from extricating the world from a crisis, such a triumph would go some way to mitigating the blow to Britain’s international reputation dealt by the government’s poor management of the epidemic.■

This article appeared in the Britain section of the print edition under the headline "Moonshot"

https://ift.tt/2CWjG4Y