Tag Archives: AstraZeneca

India sees early vaccine launch as AstraZeneca deliveries run late

By Krishna N. Das

NEW DELHI (Reuters) – India raced ahead with work on its coronavirus vaccine while Britain’s AstraZeneca said its deliveries were running “a little bit late” as countries around the world sought to conquer the pandemic and rescue their economies.

A vaccine is seen as the world’s best bet for taming a virus that has infected more than 48 million people, led to more than 1.2 million deaths, roiled economies and disrupted billions of lives since it was first identified in China in December.

Australia is beefing up its prospective arsenal against the pandemic to 135 million doses of various vaccine candidates.

“We aren’t putting all our eggs in one basket,” Prime Minister Scott Morrison said on Thursday.

Some 45 vaccine candidates are in human trials worldwide, with Pfizer Inc saying it could file in late November for U.S. authorization, opening up the possibility of a vaccine being available in the United States by the end of the year.

Moderna and AstraZeneca are close behind the largest U.S. drugmaker and are likely to have early data on their vaccine candidates before the end of the year.

An Indian government-backed vaccine could be launched as early as February – months earlier than expected – as last-stage trials begin this month and studies have so far showed it is safe and effective, a senior government scientist told Reuters.

Bharat Biotech, a private company that is developing COVAXIN with the government-run Indian Council of Medical Research (ICMR), had earlier hoped to launch it only in the second quarter of next year.

“The vaccine has shown good efficacy,” senior ICMR scientist Rajni Kant, who is also a member of its COVID-19 task force, said at the research body’s New Delhi headquarters.

“It is expected that by the beginning of next year, February or March, something would be available.”

Bharat Biotech could not immediately be contacted.

A launch in February would make COVAXIN the first India-made vaccine to be rolled out.

VACCINE KEPT FROZEN

AstraZeneca has signed multiple deals to supply more than three billion doses of its candidate to countries around the world.

But a summer dip in British coronavirus infections had pushed back test results, leading the drugmaker to delay deliveries of shots to the government.

Britain’s vaccines chief said on Wednesday it would receive just 4 million doses of the potential vaccine this year, against initial estimates for 30 million by Sept. 30.

AstraZeneca said on Thursday it was holding back deliveries while it awaits the data from late-stage clinical trials in order to maximize the shelf-life of supplies.

“We are a little bit late in deliveries, which is why the vaccine has been kept in frozen form,” CEO Pascal Soriot said on a conference call.

AstraZeneca and its partner on the project, the University of Oxford, said that data from late-stage trials should land this year.

The United States leads the world in both the number of COVID deaths and infections and the pandemic was a polarizing issue in Tuesday’s presidential election in which votes were still being counted.

Australia’s Morrison said the government would buy 40 million vaccine doses from Novavax and 10 million from Pfizer and BioNTech.

That adds to the 85 million doses Australia has already committed to buy from AstraZeneca and CSL Ltd should trials prove successful.

Among other vaccine candidates around the world, a growing number of Russians are unwilling to be inoculated once a vaccine becomes widely available, the Levada Centre, Russia’s only major independent pollster, said this week.

Russia, raising eyebrows in the West, is rolling out its “Sputnik V” vaccine for domestic use despite the fact that late-stage trials have not yet finished.

(Reporting by Reuters bureaus; Writing by Nick Macfie; Editing by Angus MacSwan)

Britain prepares for COVID-19 vaccine as Oxford forecasts result this year

By Alistair Smout and Guy Faulconbridge

LONDON (Reuters) – Late-stage trial results of a potential COVID-19 vaccine being developed by the University of Oxford and AstraZeneca could be presented this year as the British government prepares for a possible vaccination rollout in late December or early 2021.

A vaccine is seen as a game-changer in the battle against the coronavirus, which has killed more than 1.2 million people worldwide, shuttered swathes of the global economy and turned normal life upside down for billions of people.

There are more than 200 candidates under development and the vaccine being developed by Oxford and licensed to British drugmaker AstraZeneca is seen as a front-runner.

“I’m optimistic that we could reach that point before the end of this year,” Oxford Vaccine Trial Chief Investigator Andrew Pollard said of the chances of presenting trial results.

Pollard told British lawmakers that establishing whether or not the vaccine worked would likely come this year, after which the data would have to be carefully reviewed by regulators and then a political decision made on who should receive it.

“Our bit – we are getting closer to but we are not there yet,” Pollard, director of the Oxford Vaccine Group, said.

Asked if he expected the vaccine would start to be deployed before Christmas, he said: “There is a small chance of that being possible but I just don’t know.”

The National Health Service (NHS) in England is preparing to start distributing possible COVID-19 vaccines before Christmas in case one is ready by the end of the year.

The Oxford/AstraZeneca vaccine is expected to be one of the first from big pharma to be submitted for regulatory approval, along with Pfizer and BioNTech’s candidate.

“If I put on my rose-tinted specs, I would hope that we will see positive interim data from both Oxford and from Pfizer/BioNTech in early December and if we get that then I think we have got the possibility of deploying by the year end,” Kate Bingham, the chair of the UK Vaccine Taskforce, told lawmakers.

Prime Minister Boris Johnson said there was the prospect of a vaccine in the first quarter of 2021. AstraZeneca is presenting its third quarter financial results on Thursday.

‘GAME CHANGER’

Work on the Oxford viral vector vaccine, called AZD1222 or ChAdOx1 nCoV-19, began in January. It is made from a weakened version of a common cold virus that causes infections in chimpanzees.

The chimpanzee cold virus has been genetically changed to include the genetic sequence of the so-called spike protein which the coronavirus uses to gain entry to human cells. The hope is that the human body will then attack the novel coronavirus if it sees it again.

If Oxford’s vaccine works, it could eventually allow the world to return to some measure of normality.

Asked what success looked like, Pollard said: “Good is having vaccines that have significant efficacy – so whether, I mean, that is 50, 60, 70, 80 percent, whatever the figure is – is an enormous achievement.

“It’s a complete game changer and a success if we meet those efficacy end points,” he said, adding it would relieve pressure on the health system.

But Pollard and Bingham agreed that the world would not return to normal immediately. Asked about the chances of a vaccine that would wipe out the coronavirus next year, Bingham said the prospects were “very slim.”

“(But the chances) to get a vaccine that has an effect of both reducing illness, and reducing mortality (are) very high,” Bingham said, adding she was more than 50% confident there would be such a vaccine by early summer.

(Reporting by Alistair Smout and Guy Faulconbridge; Editing by Nick Macfie and Alexander Smith)

Exclusive: New global lab network will compare COVID-19 vaccines head-to-head

By Kate Kelland

LONDON (Reuters) – A major non-profit health emergencies group has set up a global laboratory network to assess data from potential COVID-19 vaccines, allowing scientists and drugmakers to compare them and speed up selection of the most effective shots.

Speaking to Reuters ahead of announcing the labs involved, Melanie Saville, director of vaccine R&D at the Coalition for Epidemic Preparedness Innovations (CEPI), said the idea was to “compare apples with apples” as drugmakers race to develop an effective shot to help control the COVID-19 pandemic.

The centralized network is the first of its kind to be set up in response to a pandemic.

In a network spanning Europe, Asia and North America, the labs will centralize analysis of samples from trials of COVID-19 candidates “as though vaccines are all being tested under one roof”, Saville said, aiming to minimize the risk of variation in results.

“When you start off (with developing potential new vaccines) especially with a new disease, everyone develops their own assays, they all use different protocols and different reagents – so while you get a readout, the ability to compare between different candidates is very difficult,” she told Reuters.

“By taking the centralized lab approach … it will give us a chance to really make sure we are comparing apples with apples.”

The CEPI network will initially involve six labs, one each in Canada, Britain, Italy, the Netherlands, Bangladesh and India, Saville said.

Hundreds of potential COVID-19 vaccines are in various stages of development around the world, with shots developed in Russia and China already being deployed before full efficacy trials have been done, and front-runners from Pfizer, Moderna and AstraZeneca likely to have final-stage trial results before year-end.

Typically, the immunogenicity of potential vaccines is assessed in individual lab analyses, which aim to see whether biomarkers of immune response – such as antibodies and T-cell responses – are produced after clinical trial volunteers receive a dose, or doses, of the vaccine candidate.

But with more than 320 COVID-19 vaccine candidates in the works, Saville said, the many differences in data collection and evaluation methods are an issue.

As well as potential variations in markers of immunity, there are differences in how and where samples are collected, transported and stored – all of which can impact the quality and usefulness of the data produced, and make comparisons tricky.

And with a range of different vaccine technologies being explored – from viral vector vaccines to ones based on messenger RNA – standard evaluation of their true potential “becomes very complex”, she said.

“With hundreds of COVID-19 vaccines in development … it’s essential that we have a system that can reliably evaluate and compare the immune response of candidates currently undergoing testing,” she said.

By centralizing the analysis in a lab network, much of what Saville called the “inter-laboratory variability” can be removed, allowing for head-to-head comparisons.

CEPI says all developers of potential COVID-19 vaccines can use the centralized lab network for free to assess their candidates against a common protocol. For now, the network will assess samples from early-stage vaccine candidate testing and first and second stage human trials, but CEPI said it hoped to expand its capacity to late stage (Phase III) trial data in the coming months.

Results produced by the network will be sent back to the developer, with neither CEPI nor the network owning the data.

CEPI itself is co-funding nine of the potential COVID-19 vaccines in development, including candidates from Moderna, AstraZeneca, Novavax and CureVac.

(Reporting by Kate Kelland, editing by Mark Potter)

Factbox: Latest on the worldwide spread of coronavirus

(Reuters) – Coronavirus infections slowed in Australia and New Zealand, while Britain said it was at a “tipping point” on COVID-19 as European countries mulled tightening restrictions to curb a sharp resurgence in cases.

EUROPE

* Britain is at a tipping point on COVID-19, health minister Matt Hancock said, warning that a second national lockdown could be imposed if people don’t follow government rules designed to stop the spread of the virus.

* The Czech government could declare a state of emergency if a recent spike in cases continues in the coming days, Health Minister Adam Vojtech said.

* Protesters in some poorer areas of Madrid that are facing a lockdown to stem a soaring infection rate took to the streets on Sunday to call for better health provisions, complaining of discrimination by the authorities.

* Russia reported 6,148 new cases on Sunday, the second straight day when the daily number of cases exceeded 6,000.

* French health authorities reported 10,569 new confirmed COVID-19 cases on Sunday, down from the previous day’s record increase of 13,498.

ASIA-PACIFIC

* Schools in Seoul and nearby areas resumed in-person classes for the first time in almost a month after daily cases dropped to the lowest levels since mid-August.

* Australia’s coronavirus hotspot of Victoria reported on Monday its lowest daily rise in infections in three months, although state Premier Daniel Andrews said there were no plans yet to ease restrictions sooner than expected.

* New Zealand Prime Minister Jacinda Ardern lifted all coronavirus restrictions across the country, except in second-wave hotspot Auckland, as the number of new infections slowed to a trickle.

AMERICAS

* The United States set a one-day record with over 1 million coronavirus diagnostic tests being performed, but the country needs 6 million to 10 million a day to bring outbreaks under control, according to various experts.

* Brazil and Argentina, Latin American nations seeking more time to commit to the global COVID-19 vaccine facility known as COVAX, said they intend to do so as soon as possible after missing Friday’s deadline.

MIDDLE EAST AND AFRICA

* Morocco signed a deal with Russia’s R-Pharm to buy a COVID-19 vaccine produced under a license from Britain’s AstraZeneca, the health ministry said, as its total number of cases approached 100,000.

* Israel entered a second nationwide lockdown at the onset of the Jewish high-holiday season, forcing residents to stay mostly at home amid a resurgence in new cases.

MEDICAL DEVELOPMENTS

* Moderna Inc said it was on track to produce 20 million doses of its experimental coronavirus vaccine by the end of the year, while maintaining its goal of readying 500 million to 1 billion doses in 2021.

ECONOMIC IMPACT

* British manufacturers see no evidence of a ‘V’-shaped recovery from the pandemic underway and many are planning to slash investment, a business survey showed.

(Compiled by Devika Syamnath and Alex Richardson; Edited by Shounak Dasgupta)

Explainer: When will COVID-19 vaccines be generally available in the U.S.?

By Carl O’Donnell and Michael Erman

(Reuters) – U.S. President Donald Trump and the head of the Centers for Disease Control and Prevention (CDC) this week disagreed about when a COVID-19 vaccine would become widely available. Trump has said one could initially be available by the Nov. 3 election, while the CDC director said vaccines were likely to reach the general public around mid-2021, an assessment more in line with most experts.

WHAT DOES IT MEAN FOR A VACCINE TO BE GENERALLY AVAILABLE?

General availability is when every American who wants the vaccine can get it. There are currently no COVID-19 vaccines approved by U.S. regulators, although a handful are in late-stage trials to prove they are safe and effective.

Experts estimate that at least 70% of roughly 330 million Americans would need to be immune through a vaccine or prior infection to achieve what is known as herd immunity, which occurs when enough people are immune to prevent the spread of the virus to those unable to get a vaccine.

HOW LONG BEFORE VACCINE PRODUCTION IS FULLY RAMPED UP?

Most vaccines in development will require two doses per person.

The CDC anticipates that 35 million to 45 million doses of vaccines from the first two companies to receive authorization will be available in the United States by the end of this year. The current front runners are Pfizer Inc and Moderna Inc.

Drugmakers have been more ambitious with their calculations. AstraZeneca Plc has said it could deliver as many as 300 million doses of its experimental vaccine in the United States by as early as October. Pfizer and German partner BioNTech SE have said they expect to have 100 million doses available worldwide by the end of 2020, but did not specify how much of that was earmarked for the United States. Moderna on Friday said it is on track to make around 20 million doses by the end of the year and between 500 million and 1 billion doses a year beginning in 2021.

Obtaining enough doses to inoculate everyone in the United States will likely take until later in 2021. CDC Director Robert Redfield told a congressional hearing on Wednesday that vaccines may not be widely available to everyone in the United States until the second or third quarter of next year.

WHO WOULD GET AN APPROVED VACCINE FIRST?

The CDC decision will likely broadly follow recommendations from the National Academies of Sciences, Engineering and Medicine. The CDC has said the earliest inoculations may go to healthcare workers, people at increased risk for severe COVID-19, and essential workers.

It is unclear when a vaccine will be available for children as major drugmakers have yet to include them in late-stage trials. Pfizer and BioNTech have filed with regulators seeking to start recruiting volunteers as young as 16 for vaccine studies.

WHICH COMPANIES WILL LIKELY ROLL OUT A VACCINE QUICKLY?

Pfizer has said it could have compelling evidence that its vaccine works by the end of October. Moderna says it could have similar evidence in November. The vaccines would first need to be approved or authorized for emergency use by U.S. regulators.

Drugmakers have already started manufacturing supplies of their vaccine candidates to be ready as soon as they get the go ahead. The U.S. Department of Defense and the CDC plan to start distribution of vaccines within 24 hours of regulatory authorization.

Several drugmakers including Pfizer, AstraZeneca, Johnson & Johnson and Novavax Inc have all said they expect to produce at least 1 billion doses of their vaccines next year if they get regulatory authorization.

Sanofi SA and GlaxoSmithKline Plc are also working on developing a vaccine they say could be authorized next year.

(Reporting by Carl O’Donnell and Michael Erman in New York; additional reporting by Caroline Humer; editing by Peter Henderson and Bill Berkrot)

Exclusive: AstraZeneca COVID-19 vaccine trial in U.S. on hold until at least midweek – sources

By Julie Steenhuysen and Marisa Taylor

CHICAGO (Reuters) – AstraZeneca’s COVID-19 vaccine trial remains on hold in the United States pending a U.S. investigation into a serious side effect in Britain even as other trials of the vaccine resume, sources familiar with the details told Reuters.

AstraZeneca on Saturday said it had restarted its trial in Britain after regulators completed their review of a serious side effect in one trial participant there.

This was the first indication that the U.S. trial will remain on hold until the U.S. Food and Drug Administration and a safety panel investigate the case.

Enrollment in the company’s global trials of the vaccine, which it is developing with researchers at Oxford University, was put on pause on Sept. 6.

Sources told Reuters that enrollment of new patients and other trial procedures for the pivotal U.S. trial were being rescheduled until at least midweek and that it was not clear how long it would take for the FDA to complete its probe.

Governments around the world are desperate for a vaccine to help end the pandemic, which has caused more than 900,000 deaths and global economic turmoil. The World Health Organization (WHO) had flagged AstraZeneca’s as the most promising. A prolonged delay in the U.S. trial could slow access to the vaccine in the United States.

The British adverse event involved a study patient thought to be suffering a rare spinal inflammatory disorder called transverse myelitis.

An AstraZeneca spokeswoman declined to comment on when the U.S. trial would resume. She said in an email the company “will continue to work with health authorities across the world, including the FDA, and be guided as to when other clinical trials can resume.”

The status of the South African and Indian trials remains unknown, but the trial in Brazil has also restarted. The company has not commented on timing of resumption in other parts of the world besides Britain.

FDA did not immediately respond to a request for comment.

(Reporting by Julie Steenhuysen and Marisa Taylor; Editing by Peter Henderson and Cynthia Osterman)

AstraZeneca expects COVID vaccine result by year-end if trials resume

By John Miller and Ludwig Burger

ZURICH/FRANKFURT (Reuters) – AstraZeneca should still know by year-end whether its experimental vaccine protects people against coronavirus, as long as it is cleared to resume trials soon, its chief executive said on Thursday amid doubts over its rollout.

Governments desperate to put an end to the COVID-19 pandemic which has caused more than 900,000 deaths and huge economic and social disruption during 2020 are pinning their hopes on a vaccine.

However British drugmaker AstraZeneca suspended late-stage trials on its potential vaccine this week after an illness in a participant in Britain who was reported to be suffering from symptoms associated with transverse myelitis, a rare spinal inflammatory disorder.

The World Health Organization (WHO) has flagged the AstraZeneca vaccine, which is being developed with the University of Oxford, as the most promising for coronavirus.

CEO Pascal Soriot said during an online event on Thursday that AstraZeneca did not yet know the diagnosis of the participant who was ill, adding that it was not clear if the volunteer had transverse myelitis and more tests were needed.

The diagnosis would be submitted to an independent safety committee and this would usually then say whether trials can be resumed, Soriot said, adding it was usual for such pauses.

“It’s very common, actually, and many experts will tell you this,” Soriot said, adding: “The difference with other vaccine trials is, the whole world is not watching them, of course. They stop, they study, and they restart.”

Shares in AstraZeneca fell on Wednesday after the trial halt raised doubts about the timeline for the vaccine’s rollout.

AstraZeneca would supply vaccines to countries at the same time to ensure a fair and equitable distribution, Soriot said, reiterating that the company was close to having capacity to produce 3 billion doses at sites set up around the world to prevent governments from restricting distribution.

With up to 60,000 people set to participate in the study program, AstraZeneca’s CEO said the volume was typical of vaccine trials and large enough to spot rare side effects.

“With this you are going to pick up very rare events.” he said, adding that a planned staggered launch, prioritizing at-risk groups, would provide further assurance for the masses that are set to be covered by government plans at a later stage.

Serum Institute of India, one of AstraZeneca’s development and production partners, said on Thursday it was joining the suspension, backtracking on remarks that it did not face any issues.

‘DIFFICULT TO BE SURE’

Transverse myelitis cases after a vaccination have been documented before, but concrete links between the condition and vaccinations have not been established, experts said.

The U.S.-based Mayo Clinic concludes that the association so far is not strong enough to warrant limiting any vaccine.

A 2009 review in the journal Lupus of nearly 40 years of English-language publications found 37 cases of transverse myelitis associated with hepatitis B vaccines, measles-mumps-rubella, diphtheria-tetanus-pertussis and others.

The vaccines remained on the market, Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, said.

Linking such an autoimmune response to a single factor like a vaccine is problematic, he said, given the number of immunological, hormonal or environmental factors at play.

“It’s terribly difficult to be sure,” Evans said.

RBC Capital Markets analyst Bryan Abrahams cautioned the trial participant’s condition must be thoroughly investigated.

“Even a single case could possibly imply a rate or association higher in the study than what is normally observed sporadically” he wrote to investors, adding a one in 10,000 risk, if confirmed, would likely be unacceptable.

BioNTech, among the frontrunners in the vaccine race with partner Pfizer, echoed remarks by Soriot that clinical halts are a common feature of immunization trials.

“Safety is a top priority,” its CEO Ugur Sahin told Reuters.

(Additional reporting by Patricia Weiss and Josephine Mason; Editing by Alexander Smith)

AstraZeneca pauses coronavirus vaccine trial

LONDON (Reuters) – AstraZeneca has suspended global trials of its experimental coronavirus vaccine after an unexplained illness in a participant, knocking the British drugmaker’s shares on Wednesday as prospects for an early rollout dimmed.

The vaccine to combat COVID-19, which AstraZeneca is developing with the University of Oxford, has been described by the World Health Organization as probably the world’s leading candidate and the furthest developed.

However, AstraZeneca said on Tuesday it had paused trials, including late-stage ones, to allow an independent committee to review safety data, and it was working to minimize any potential impact on the timeline.

“It is obviously a challenge to this particular vaccine trial,” Britain’s Health Secretary Matt Hancock told Sky News.

The stakes are high because AstraZeneca, Britain’s largest drugmaker by market value, has already agreed to supply close to three billion doses to governments across the globe.

This is more than any other vaccine project, but asked whether the pause would set back the development process, Britain’s Hancock said: “Not necessarily, it depends on what they find when they do the investigation”.

Most states will contribute financially to developing the vaccine, even if the trial fails.

‘ROUTINE ACTION’

Britain’s medical regulator said it is urgently reviewing information available to determine whether trials can restart as quickly as possible.

A New York Times report citing a person familiar with the situation said a participant based in Britain was found to have transverse myelitis, an inflammatory syndrome that affects the spinal cord and is often sparked by viral infections.

Whether this was directly linked to AstraZeneca’s vaccine remains unclear, it said. AstraZeneca declined to comment.

A person familiar with the situation told Reuters the illness occurred in the British trial which began in May with more than 12,000 participants, from 5 years old to beyond 70.

The U.S. trial, with a targeted 30,000 participants, was launched last week for the vaccine AZD1222, which is also in late-stage clinical trials in Brazil and South Africa.

Additional trials are planned in Japan and Russia, with a targeted 50,000 participants globally.

South Korea said it would look into the suspension and review its plan to participate in manufacturing the vaccine and health ministry official Yoon Tae-ho added such suspensions of clinical trials were not rare “as various factors interact”.

This was echoed by Germany’s Leukocare, which is working on a vaccine similar to AstraZeneca’s but is at an earlier stage.

“When you are inoculating 20,000 people, it is a foregone conclusion that at some point you will have severe adverse events. As soon as a link to the vaccine can clearly be ruled out, the trial continues,” CEO Michael Scholl said.

Immune related conditions such as inflammations, however, would be subject to particular scrutiny, he added.

The Oxford vaccine is designed to instruct human cells to make distinguishing parts of the coronavirus. That allows the immune system to build an arsenal against future infections.

A harmless virus known as adenovirus is used to bring the genetic instruction into the body, an approach which is also being pursued by China’s CanSino, Russia’s Gamaleya institute or Johnson & Johnson.

Backers of the Gamaleya candidate, the first Russian COVID-19 vaccine, underscored the difference between their jab, based on a adenovirus in humans, and the British contender with an adenovirus found in monkeys.

“We have consistently drawn attention to human adenoviral platform being much safer and much more studied than any other new platform,” the head of Russia’s sovereign wealth fund Kirill Dmitriev told Reuters.

In choosing a monkey virus, AstraZeneca, as well as Leukocare, are trying to avoid the risk of the immune system attacking the vector, due to a previous bout with an adenovirus.

The decision to put the trial on hold has impacted clinical trials being conducted by other vaccine makers, which are looking for signs of similar reactions, Stat said.

Serum Institute of India said its trials of AstraZeneca’s vaccine were ongoing and had not faced any issues.

The U.S. National Institutes of Health, which is providing funding for AstraZeneca’s trial, declined to comment.

Moderna said in an emailed statement it was “not aware of any impact” to its ongoing COVID-19 vaccine study.

Leading U.S. and European vaccine developers pledged on Tuesday to uphold scientific safety and efficacy standards for their experimental vaccines.

Nine companies, including AstraZeneca, Moderna and Pfizer, issued an “historic pledge” after concerns that safety standards might slip under political pressure to rush out a vaccine.

The other signatories were Johnson & Johnson, Merck & Co, GlaxoSmithKline, Novavax Inc, Sanofi and BioNTech.

(Reporting by Guy Fauconbridge, Estelle Shirbon, Kate Kelland in London, Deena Beasley; Additional reporting by Peter Henderson in San Francisco, Rocky Swift in Tokyo, Sangmi Cha in Seoul and Miyoung Kim in Singapore; Editing by Alexander Smith)

U.S., European COVID vaccine developers pledge to uphold testing rigor

By Ludwig Burger, Patricia Weiss and Caroline Copley

FRANKFURT (Reuters) – Nine leading U.S. and European vaccine developers pledged on Tuesday to uphold the scientific standards their experimental immunizations will be held against in the global race to contain the coronavirus pandemic.

The companies, including Pfizer, GlaxoSmithKline and AstraZeneca, issued what they called a “historic pledge” after a rise in concern that safety and efficacy standards might slip in the rush to find a vaccine.

The companies said in a statement they would “uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines”.

The other signatories were Johnson & Johnson, Merck & Co., Moderna, Novavax, Sanofi and BioNTech.

The promise to play by established rules underlines a highly politicized debate over what action is needed to rein in COVID-19 quickly and to jump start global business and trade.

The head of the U.S. Food and Drug Administration (FDA) said last month COVID-19 vaccines may not necessarily need to complete Phase Three clinical trials – large-scale testing intended to demonstrate safety and efficacy – as long as officials are convinced the benefits outweigh the risks.

This prompted a call for caution from the World Health Organization (WHO).

Developers globally have yet to produce large-scale trial data showing actual infections in participants, yet Russia granted approval to a COVID-19 vaccine last month, prompting some Western experts to criticize a lack of testing.

The head of China’s Sinovac Biotech has said most of its employees and their families have already taken an experimental vaccine developed by the Chinese firm under the country’s emergency-use program.

Chinese companies or institutions, which are involved in several leading vaccine projects, did not sign the statement.

PROMISE ON SAFETY AND EFFICACY

“We want it to be known that also in the current situation we are not willing to compromise safety and efficacy,” said co-signatory Ugur Sahin, chief executive of Pfizer’s German partner BioNTech.

“Apart from the pressure and the hope for a vaccine to be available as fast as possible, there is also a lot of uncertainty among people that some development steps may be omitted here.”

BioNTech and Pfizer could unveil pivotal trial data as early as October, potentially placing them at the center of bitter U.S. politics before the Nov. 3 presidential election.

President Donald Trump has said it is possible the United States will have a vaccine before the election. His Democratic rival, Kamala Harris, has said she would not take his word alone on any potential coronavirus vaccine.

The nine companies said they would follow established guidance from expert regulatory authorities such as the FDA.

Among other hurdles, approval must be based on large, diverse clinical trials with comparative groups that do not receive the vaccine in question. Participants and those working on the trial must not know which group they belong to, according to the pledge.

BioNTech’s Sahin said there must be statistical certainty of 95%, in some cases higher, and that a positive reading on efficacy does not come just from random variations but reflects the underlying workings of the compound.

The development race has intensified safety concerns about an inoculation, polls have shown.

Western regulators have said they would not cut corners but rather prioritize the review workload and allow for development steps in parallel that would normally be handled consecutively.

Sahin declined to comment on regulators specifically or on what events prompted the joint statement.

The chief executive of German vaccine developer Leukocare, which did not sign the pledge, was more forthright.

“What Russia did – and maybe also there are tendencies in the U.S. to push the approval of a vaccine which has not been sufficiently developed in clinic – bears a huge risk,” said CEO Michael Scholl.

“My biggest fear is that we will approve vaccines that are not safe and that will have a negative impact on the concept of vaccinations in general.”

Leukocare is working with Italy’s ReiThera and Belgium’s Univercells to produce a COVID-19 vaccine currently in phase I testing.

(Reporting by Ludwig Burger, Patricia Weiss in Frankfurt and Caroline Copley in Berlin; Editing by Susan Fenton and Timothy Heritage)

U.S. secures 300 million doses of potential AstraZeneca COVID-19 vaccine

By Aakash B, Guy Faulconbridge and Kate Holton

BENGALURU/LONDON (Reuters) – The United States has secured almost a third of the first 1 billion doses planned for AstraZeneca’s experimental COVID-19 vaccine by pledging up to $1.2 billion, as world powers scramble for medicines to get their economies back to work.

While not yet proven to be effective against the coronavirus, vaccines are seen by world leaders as the only real way to restart their stalled economies, and even to get an edge over global competitors.

After President Donald Trump demanded a vaccine, the U.S. Department of Health and Human Services (HHS) agreed to provide up to $1.2 billion to accelerate British drugmaker AstraZeneca’s vaccine development and secure 300 million doses for the United States.

“This contract with AstraZeneca is a major milestone in Operation Warp Speed’s work toward a safe, effective, widely available vaccine by 2021,” U.S. Health Secretary Alex Azar said. The first doses could be available in the United States as early as October, according to a statement from HHS.

The vaccine, previously known as ChAdOx1 nCoV-19 and now as AZD1222, was developed by the University of Oxford and licensed to AstraZeneca. Immunity to the new coronavirus is uncertain and so the use of vaccines is unclear.

The U.S. deal allows a late-stage, or Phase III, clinical trial of the vaccine with 30,000 people in the United States.

Cambridge, England-based AstraZeneca said it had concluded agreements for at least 400 million doses of the vaccine and secured manufacturing capacity for 1 billion doses, with first deliveries due to begin in September.

Now the most valuable company on Britain’s blue-chip FTSE 100 Index, AstraZeneca has already agreed to deliver 100 million doses to people in Britain, with 30 million as soon as September. Ministers have promised Britain will get first access to the vaccine.

VACCINE SCRAMBLE

With leaders across the world surveying some of the worst economic destruction since at least World War Two and the deaths of more than 327,000 people, many are scrambling for a vaccine.

The U.S. government has struck deals to support vaccine development with Johnson & Johnson (J&J), Moderna and Sanofi, sparking fears the richest countries will be able to protect their citizens first.

Sanofi’s chief angered the French government earlier this month when he said vaccine doses produced in the United States could go to U.S. patients first, given the country had supported the research financially.

“We have a lot of things happening on the vaccine front or the therapeutic front,” Trump told reporters at the White House when asked about the AstraZeneca announcement. “You’re going to have a lot of big announcements over the next week or two” on therapeutics.

Trump, during a Thursday visit to a Ford Motor Co plant in Michigan, said the U.S. military is “in gear so we can give out 150 to 250 million shots quickly.”

AstraZeneca said it was in talks with governments and partners around the world – such as the Serum Institute of India – to increase access and production and is speaking to various organizations on fair allocation and distribution.

“We would like to thank the U.S. and UK governments for their substantial support to accelerate the development and production of the vaccine,” AstraZeneca Chief Executive Pascal Soriot said.

The Serum Institute of India, the world’s largest maker of vaccines by volume, has dedicated one of its facilities with a capacity to produce up to 400 million doses annually to producing the Oxford vaccine.

“We are scaling up on a conservative basis of about 4 to 5 million doses a month to begin with,” Chief Executive Adar Poonawalla told Reuters, adding the company was in discussions with AstraZeneca.

COVID-19 PROTECTION?

A Phase I/II clinical trial of AZD1222 began last month to assess safety, immunogenicity and efficacy in over 1,000 healthy volunteers aged 18 to 55 across several trial centers in southern England. Data from the trial is expected shortly.

There are currently no approved treatments or vaccines for COVID-19.

Governments, drugmakers and researchers are working on around 100 programs. Experts are predicting a safe, effective means of preventing the disease could take 12 to 18 months to develop.

Only a handful of the vaccines in development have advanced to human trials, an indicator of safety and efficacy, and the stage at which most fail.

“AstraZeneca recognizes that the vaccine may not work but is committed to progressing the clinical program with speed and scaling up manufacturing at risk,” it said.

Other drugmakers including Pfizer Inc, J&J and Sanofi are in various stages of vaccine development.

U.S.-based Inovio Pharmaceuticals said Wednesday its experimental vaccine produced protective antibodies and immune system responses in mice and guinea pigs.

And Moderna this week released positive data for its potential vaccine, which it said produced protective antibodies in a small group of healthy volunteers.

(Reporting by Aakash Jagadeesh Babu in Bengaluru, Ludwig Burger in Frankfurt and Zeba Siddiqui in New Delhi; writing by Guy Faulconbridge; editing by Alexander Smith, Jan Harvey, Mark Potter, Jonathan Oatis and Leslie Adler)