Tag Archives: COVID-19. vaccines

The new coronavirus variant in Britain: How worrying is it?

By Kate Kelland

LONDON (Reuters) – A new variant of the pandemic SARS-CoV-2 coronavirus is spreading rapidly in Britain and prompting high levels of concern among its European neighbors, some of which have cut transport links.

The strain, referred to by some experts as the B.1.1.7 lineage, is not the first new variant of the pandemic virus to emerge, but is said to be up to 70% more transmissible than the previously dominant strain in the United Kingdom.

ARE THE CONCERNS JUSTIFIED?

Most scientists say yes. The new variant has rapidly become the dominant strain in cases of COVID-19 in parts of southern England, and has been linked to an increase in hospitalization rates, especially in London and in the adjacent county of Kent.

While it was first seen in Britain in September, by the week of Dec. 9 in London, 62% of COVID-19 cases were due to the new variant. That compared to 28% of cases three weeks earlier.

The governments of Australia, Italy and the Netherlands say they detected cases of the new strain. It was identified in the Netherlands in early December.

A few cases of COVID-19 with the new variant have also been reported to the ECDC, Europe’s disease monitoring agency, by Iceland and Denmark. Media reports in Belgium say cases have also been detected there.

“It is right to take it seriously,” said Peter Openshaw, a professor of experimental medicine at Imperial College London. Shaun Fitzgerald, a visiting professor at the University of Cambridge, said the situation was “extremely concerning.”

WHY?

The main worry is that the variant is significantly more transmissible than the original strain. It has 23 mutations in its genetic code – a relatively high number of changes – and some of these are affecting its ability to spread.

Scientists say it is about 40%-70% more transmissible. The UK government said on Saturday it could increase the reproduction “R” rate by 0.4.

This means it is spreading faster in Britain, making the pandemic there yet harder to control and increasing the risk it will also spread swiftly in other countries.

“The new B.1.1.7 … still appears to have all the human lethality that the original had, but with an increased ability to transmit,” said Martin Hibberd, professor of emerging infectious disease at the London School of Hygiene & Tropical Medicine.

WILL COVID-19 VACCINES PROTECT AGAINST THIS VARIANT?

Scientists say there’s no evidence that vaccines currently being deployed in the UK – made by Pfizer and BioNtech – or other COVID-19 shots in development will not protect against this variant.

“It’s unlikely that this will have anything more than a minor, if any, effect on the vaccine’s effectiveness,” said Adam Finn, a vaccine specialist and professor of pediatrics at Bristol University.

Britain’s chief scientific adviser Patrick Vallance also said COVID-19 vaccines appeared to be adequate in generating an immune response to the variant of the coronavirus.

“We are not seeing…any gross changes in the spike protein that will reduce vaccine effectiveness so far,” said Julian Tang, professor and clinical virologist at Leicester University.

DOES THE NEW VARIANT AFFECT TESTING?

To some extent, yes.

One of the mutations in the new variant affects one of three genomic targets used by some PCR tests. This means that in those tests, that target area, or “channel”, would come up negative.

“This has affected the ability of some tests to detect the virus,” said Robert Shorten, an expert in microbiology at the Association for Clinical Biochemistry & Laboratory Medicine.

Since PCR tests generally detect more than one gene target, however, a mutation in the spike protein only partly affects the test, reducing that risk of false negative results.

ARE THERE OTHER SIGNIFICANT SARS-CoV-2 VARIANTS ABOUT?

Yes. Strains of the COVID-19-causing virus have emerged in recent months in South Africa, Spain, Denmark and other countries that have also raised concern.

However none, so far, has been found to contain mutations that make it more deadly, or more likely to be able to evade vaccines or treatments.

DID THIS NEW VARIANT ORIGINATE IN BRITAIN?

Vallance said on Saturday he thought the new variant might have started in the UK. Some scientists in Europe have credited British expertise in genomic surveillance for identifying the mutation.

“The UK has one of the most comprehensive genetic surveillance programs in the world – 5% to 10% all virus samples are genetically tested. Few countries do better,” Steven Van Gucht, head of viral diseases at the Belgian Institute of Health, told a news conference on Monday.

(Additional reporting by Philip Blenkinsop in Brussels, editing by Josephine Mason and Mark Heinrich)

Mnuchin says COVID aid checks would spur more jobs than unemployment supplement

WASHINGTON (Reuters) – U.S. Treasury Secretary Steven Mnuchin said on Wednesday that President Donald Trump would rather send $600 checks to Americans as part of a new coronavirus aid package than supplemental unemployment benefits, arguing that it would put more people back to work more quickly.

Mnuchin, speaking to reporters on a videoconference, said the $916 billion plan he proposed on Tuesday evening would use $40 billion to extend base unemployment benefits and spend $140 billion on direct payments.

A $908 billion bipartisan plan under negotiations by congressional leaders had called for $180 billion for unemployment benefits, including a supplemental payment of $300 a week for idled workers for 16 weeks. The $600 checks would go to both unemployed workers and those with jobs, and families would also get $600 per child, Mnuchin said.

“We obviously want to get people back to work. By sending out checks, we’re putting money into the economy for people. This will have the impact of creating demand, which will have the impact of creating jobs,” Mnuchin said.

“There are a lot of people who like checks, including the President, and there’s a lot of support both among Republicans and Democrats,” he added.

He said he was “cautiously hopeful” that the two parties could reach agreement on aid to support the economy until COVID-19 vaccines are widely available.

Haggling over aid proposals continued on Wednesday as the House of Representatives passed a one-week government funding measure to buy more time on a broader spending package and coronavirus relief

Mnuchin said that aside from the debate over unemployment benefits, the two major sticking points were disagreements over new funds for state and local governments and demands to shield businesses, school districts and non-profit groups from coronavirus-related lawsuits.

The Treasury proposal roughly mirrors the bipartisan proposal in other areas, including $160 billion for state and local governments, $320 billion for small businesses, and $82 billion for schools, with other funds for transportation, the postal service, child care and Community Development Financial Institutions to help under-served communities.

(Reporting by David Lawder. Editing by Gerry Doyle)

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)

Most Americans to be vaccinated for COVID-19 by July, CDC chief expects

(Reuters) – A top U.S. health official told a U.S. Senate committee on Wednesday that he expects COVID-19 vaccinations to take place over many months and that most Americans could be vaccinated by July of 2021 at the latest.

U.S. Centers for Disease Control and Prevention head Robert Redfield said he expects there to be about 700 million doses of vaccines available by late March or April, enough for 350 million people.

“I think that’s going to take us April, May, June, you know, possibly July, to get the entire American public completely vaccinated,” Redfield told the U.S. Senate Health, Education, Labor and Pensions Committee.

Redfield, U.S. Food and Drug Administration head Stephen Hahn, U.S. National Institute of Allergy and Infectious Diseases head Anthony Fauci and Health and Human Services official Brett Giroir were testifying on the COVID-19 pandemic, which has caused more than 200,000 deaths in the United States.

There is no vaccine for COVID-19 yet, but there are several in late stage trials here, including from Pfizer Inc., Moderna Inc. and Johnson & Johnson. Companies have begun manufacturing the vaccine in anticipation of a fast regulatory authorization once they are shown to work.

Fauci said he expects 50 million doses to be available in November and 100 million by the end of December. He expects a total of 700 million doses by April.

Health officials and President Donald Trump have presented different views about when the vaccines will be ready for most Americans. The process for deciding how to distribute vaccines falls largely to the CDC.

Redfield said Operation Warp Speed, the government group with officials from the departments of Health and Human Services and Defense, will ultimately decide how to allocate the vaccines.

PLAYING DEFENSE

Senator Patty Murray, the highest ranking Democrat on the committee, pointed to some reported examples of Trump administration pressure on the health agencies, including FDA authorizations of hydroxychloroquine and convalescent plasma as treatments for COVID-19 and changes in the CDC’s guidance on testing for asymptomatic individuals.

“Any of these examples of political pressure would be alarming on their own. But together they paint a clear pattern of interference that is downright terrifying,” she said.

Redfield and Hahn defended their agencies against criticism of their handling of the pandemic, telling the committee they were using science as their guide, not politics.

“FDA will not authorize, or approve, a vaccine that we would not feel comfortable giving to our families,” Hahn said.

Redfield said the agency’s change to guidance for testing for asymptomatic individuals with close contact to a COVID-19 positive person was poorly written. It has since been updated to make it clear that such individuals should get a test, he said.

The CDC will release new guidance on the role of aerosolized coronavirus in its spread, Redfield said. The agency took down a Sept. 18 update to its transmission guidance that mentioned airborne virus for the first time, as it lacked the needed technical review.

Redfield also said that based on an antibody testing study, about 90 percent of Americans are still vulnerable to the virus.

(Reporting by Michael Erman and Manas Mishra in Bengalaru; Writing by Caroline Humer; Editing by Chizu Nomiyama, Bernadette Baum and Howard Goller)

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)

GSK profit misses as vaccine sales disappoint, stockpiling eases

By Pushkala Aripaka and Ludwig Burger

(Reuters) – Britain’s GSK <GSK.L> on Wednesday missed second-quarter profit estimates following reduced sales of its existing vaccines and as patients used up treatments stockpiled during coronavirus lockdowns that have eased.

The world’s largest vaccine maker also surprised the market with the announcement it did not receive any government funding to produce its efficacy booster technology, which is being used in many potential coronavirus vaccine collaborations, including one with France’s Sanofi <SASY.PA>.

GSK shares traded down, falling 2% at 1,1575 pence as vaccine sales of 1.1 billion pounds ($1.43 billion) fell short of the 1.26 billion pounds consensus https://www.gsk.com/en-gb/investors/analyst-consensus/analyst-consensus.

It had rallied earlier on Wednesday following the announcement of a deal to supply Britain with the potential coronavirus vaccine it is working on with Sanofi.

Rather than developing its own vaccine in the global race to combat the pandemic, GSK has focused on contributing its adjuvant technology to at least seven other global firms.

Lockdowns slowed the take-up of other kinds of immunisation.

GSK said inoculation of children was back to pre-COVID-19 levels, but adolescent and adult vaccination was not.

“In the second quarter, with lockdown measures, we have seen an impact on people’s willingness, or being able to access vaccines,” Chief Executive Emma Walmsley said on a media call, adding there were early signs the attitude was changing.

Asked about the price agreed in the deal with Britain, Walmsley only said GSK does not expect to profit from the product during the pandemic.

She said any short-term earnings would be partly be reinvested into pandemic preparedness and donated to developing countries.

Revenue from GSK’s shingles vaccine, Shingrix, a blockbuster, also fell, but was above analyst expectations, while group turnover and adjusted earnings per share in the three months ended June 30 missed analyst consensus.

For the full year, the company expects annual earnings to decline in the range of 1% to 4%, unchanged from previous forecasts.

Sanofi raised its 2020 earnings forecast on Wednesday after strong second-quarter results.

(Reporting by Pushkala Aripaka, Ankur Banerjee in Bengaluru; and Ludwig Burger in Frankfurt; Editing by Bernard Orr and Barbara Lewis)

‘Vaccine nationalism’: Is it every country for itself?

By Kate Kelland and Julie Steenhuysen

LONDON/CHICAGO (Reuters) – It’s dog eat dog in the world of COVID-19 vaccines.

That’s the fear of global health agencies planning a scheme to bulk-buy and equitably distribute vaccines around the world. They are watching with dismay as some wealthier countries have decided to go it alone, striking deals with drugmakers to secure millions of doses of promising candidates for their citizens.

The deals – including those agreed by the United States, Britain and the European Union with the likes of Pfizer, BioNtech, AstraZeneca and Moderna – are undermining the global drive, experts say.

“Everybody doing bilateral deals is not a way to optimize the situation,” said Seth Berkley, chief executive of the GAVI alliance which co-leads the scheme called COVAX designed to secure rapid and fair global access to COVID-19 vaccines.

Pfizer said this week it was in concurrent talks with the EU and several of its member states on supplying them with its potential vaccine.

And in the latest swoop, Britain announced a deal on Wednesday to secure advanced supplies of potential COVID-19 vaccines from GlaxoSmithKline and Sanofi.

This, according to global health charity Medecins Sans Frontieres (MSF), will further fuel “the global scramble to hoard vaccines by rich countries” and feed “a dangerous trend of vaccine nationalism”.

The concern is that vaccine supply and allocation in this pandemic will echo the last – caused by the H1N1 flu virus in 2009/2010 – when rich nations bought up the available supply of vaccines, initially leaving poor countries with none.

In that instance, since H1N1 turned out to be a milder disease and the pandemic ultimately petered out, the impact on infections and deaths from vaccine imbalances was limited.

However COVID-19 is a far greater threat, and leaving swathes of the world’s people vulnerable will not only harm them, but also extend the pandemic and the damage it can cause, health experts say.

“There is a risk that some countries are doing exactly what we feared – which is every man for himself,” said Gayle Smith, former head of the U.S. Agency for International Development and CEO of the One Campaign, a non-profit aimed at ending poverty and preventable disease.

‘I AM WORRIED’

More than 75 wealthier countries including Britain have expressed interest in the COVAX financing scheme, which is also co-led by the World Health Organization and the Coalition for Epidemic Preparedness Innovations, or CEPI, joining 90 poorer ones who would be supported through donations.

But the United States, China and Russia are not among countries expressing interest in COVAX, according to GAVI.

And an EU source said last week that the European Commission, which is the bloc’s executive arm and leads EU talks with drugmakers, has advised EU countries not to buy COVID-19 vaccines via COVAX.

“I am worried,” said Thomas Bollyky, director of the global health program at the Council on Foreign Relations. “What is happening with the handful of nations that are locking up supply of vaccine competes with the multilateral supply deals.

“At the end of the day, vaccine manufacturing is a finite resource. You can expand it, but only so much.”

Experts estimate the world can reasonably hope to have around 2 billion doses of effective COVID-19 vaccines by the end of next year, if several of the leading candidates prove effective in expedited late-stage trials currently underway. COVAX’s aim is to distribute doses for at least 20% of its signed-up countries’ populations.

ANOTHER TWO YEARS?

Berkley of GAVI said, however, that if self-interested countries or regions snapped those up to cover their entire populations – instead of sharing them across nations and protecting the most at-risk people first – the pandemic could not be controlled.

“If you were to try to vaccinate the entire U.S., (and) the entire EU, for example, with two doses of vaccine – then you’d get to about 1.7 billion doses. And if that is the number of doses that’s available, there’s not a lot left for others.”

If a handful, or even 30 or 40 countries have vaccines, but more than 150 others don’t, “then the epidemic will rage there” Berkley said.

“This virus … moves around like lightning. So you’ll end up in a situation where you will not be able to go back to normal. You won’t be able to have commerce, tourism, travel, trade, unless you can get the whole pandemic to be slowed down.”

He and Smith and other health experts said ending the pandemic meant ending it globally.

“It’s the difference from a pandemic (for) another two years as opposed to one year,” Smith added. “The economics and health consequences of that are enormous.”

(Reporting by Kate Kelland in London and Julie Steenhuysen in Chicago; Editing by Pravin Char)

Moderna says COVID-19 vaccine pricing to ensure broad access

(Reuters) – Moderna Inc plans to price its experimental coronavirus vaccine in a way that ensures broad access, it said on Wednesday, adding that it did not intend to conduct late-stage trials of the vaccine outside the United States.

Moderna began the U.S. government-backed trial on Monday, among a handful of companies that have started final testing of their experimental vaccines on tens of thousands of healthy volunteers.

Chief Executive Officer Stéphane Bancel declined to comment on the specific price of the vaccine on a conference call with analysts.

“We are highly aware of our obligation during the pandemic phase to be responsible in how we price the vaccine,” Bancel said.

The Financial Times reported on Tuesday, citing unnamed sources, that the company was planning to price the vaccine at $50 to $60 per course, at least $11 more than another vaccine from Pfizer Inc and BioNTech.

Moderna executives also said the enrollment for the late-stage trial was on track and the company had seen tremendous interest from clinical sites.

(Reporting by Manas Mishra in Bengaluru; Editing by Saumyadeb Chakrabarty)

J&J, U.S. government plan 1 billion doses of coronavirus vaccine

By Julie Steenhuysen

(Reuters) – Johnson & Johnson said on Monday that it and the U.S. government will invest $1 billion to create enough manufacturing capacity to make more than 1 billion doses of a vaccine it is testing to stop the new coronavirus that has killed more than 35,000 people around the world.

As part of the arrangement, the U.S. government will pay $421 million to support the company’s efforts to build new manufacturing capacity in the United States.

J&J said it had selected its own lead vaccine candidate and would start human testing by September, with an eye on having it ready under an emergency use authorization in early 2021, far quicker than the typical 18 month period that it takes for vaccines to be tested, approved and then manufactured.

J&J Chief Scientific Officer Dr. Paul Stoffels told Reuters the company had to start ramping up manufacturing capacity now, even before it has a signal that its experimental vaccine candidate works. The company will start making the vaccine at risk, without knowing for sure that it works.

“That is the only option for us to get it on time,” Stoffels said in a phone interview.

The company has a manufacturing plant in the Netherlands that can make up to 300 million doses of vaccine, Stoffels said, adding that “absolutely will not be sufficient for the world.”

He said J&J is starting to build a plant in the United States now so it can be ready to manufacture vaccines by the end of the year, when data from its clinical trials will show whether the vaccine works.

Nearly half of the $1 billion will come from the U.S. Biomedical Advanced Research and Development Authority (BARDA), which is looking to expand on J&J’s previous collaboration with the agency.

Stoffels said the company is also scouting for manufacturing plants in other parts of Europe and Asia that are capable of making the type of vaccine the company is working on.

So far, J&J has not given any doses of its vaccine to humans. But Stoffels said the coronavirus vaccine will be based on the same technology used to make its Ebola vaccine, which has been widely used in people, and the company believes it will prove safe.

Safety testing of vaccines is even more important than for treatments as they are given to healthy people to prevent infection. That could be 1 billion people or more around the world.

In lab studies, the vaccine candidate has produced strong neutralizing antibodies to the virus – the type needed to make a successful vaccine.

J&J will continue testing the vaccine in animal studies this summer and plans to start human trials in September.

The new coronavirus, which began in Wuhan, China, has infected people in most countries around the world. The United States, with over 143,00 confirmed case of COVID-19 – the illness caused by the virus – has the most cases globally.

Moderna Inc <MRNA.O> this month began initial testing of it’s experimental coronavirus vaccine in healthy volunteers, making it the early front-runner in the race to develop a viable vaccine.

(This story corrects to say “$421 million” in second paragraph)

(Reporting by Manas Mishra in Bengaluru and Caroline Humer in New York; Editing by Nick Zieminski and Bill Berkrot)