AstraZeneca COVID-19 vaccine shows promise in elderly, trial results by Christmas

By Kate Kelland and Alistair Smout

LONDON (Reuters) – AstraZeneca and Oxford University’s potential COVID-19 vaccine produced a strong immune response in older adults, data published on Thursday showed, with researchers expecting to release late-stage trial results by Christmas.

The data, reported in part last month but published in full in The Lancet medical journal on Thursday, suggest that those aged over 70, who are at higher risk of serious illness and death from COVID-19, could build robust immunity.

“The robust antibody and T-cell responses seen in older people in our study are encouraging,” said Maheshi Ramasamy, a consultant and co-lead investigator at the Oxford Vaccine Group.

“We hope that this means our vaccine will help to protect some of the most vulnerable people in society, but further research will be needed before we can be sure.”

Late-stage, or Phase III, trials are ongoing to confirm the findings, researchers said, and to test whether the vaccine protects against infection with SARS-CoV-2 in a broad range of people, including people with underlying health conditions.

Results of those trials should definitely be known by Christmas, the Oxford Vaccine Group’s director, Andrew Pollard, said, adding it was too early to know whether and how well the vaccine works in preventing COVID-19 disease.

“We’re still waiting to get to the point where we can do the analysis to just work out how well the vaccine can protect people, and we’re getting ever closer to that,” he told journalists.

“We are optimistic that we’ll be able to do that before Christmas, and obviously we’ll share that with you as soon as we can at that point.”

The Oxford-AstraZeneca COVID-19 vaccine candidate, called AZD1222 or ChAdOx1 nCoV-19, had been among the front-runners in global efforts to develop shots to protect against infection with the novel coronavirus, or SARS-CoV-2.

But rival drugmakers Pfizer Inc, BioNTech and Moderna Inc have in the past 10 days edged ahead, releasing data from late-stage COVID-19 vaccine trials that shows more than 90% efficacy.

“We’re not in a rush. We and it’s not a competition with the other developers,” Oxford’s Pollard said, adding that AstraZeneca would release headline efficacy data before it was published in an academic journal.

Oxford University has set a target of 53 infections to start the interim analysis of its late-stage trial results, though “lots of cases” in its trial arms in Britain, South Africa and Brazil mean the exact number of infections reported could differ.

Unlike the Pfizer-BioNTech and Moderna shots, both of which use new technology known as messenger RNA (mRNA), AstraZeneca’s is a viral vector vaccine made from a weakened version of a common cold virus found in chimpanzees.

The Phase II trial reported in The Lancet involved a total of 560 healthy volunteers, with 160 aged 18-55, 160 aged 56-69, and 240 aged 70 or over.

Volunteers got two doses of the vaccine or a placebo, and no serious side effects related to the AZD1222 vaccine were reported, the researchers said.

AstraZeneca has signed several supply and manufacturing deals with companies and governments around the world.

(Reporting by Kate Kelland; Additional reporting by Alistair Smout; Editing by Matthew Lewis, Alexander Smith and Nick Macfie)

Post-Brexit UK announces largest military spending since Cold War

By Andrew MacAskill and William James

LONDON (Reuters) – Britain announced its biggest military spending increase since the Cold War on Thursday, pledging to end the “era of retreat” as it seeks a post-Brexit role in a world Prime Minister Boris Johnson warned was more perilous than for decades.

Johnson said the extra spending reflected the need to upgrade military capabilities even as the COVID-19 pandemic pummels the economy and strains public finances. He outlined plans for a new space command, an artificial intelligence agency and said the navy would be restored as Europe’s most powerful.

Outlining the first conclusions from a big review of foreign policy and defense, he announced an extra 16.5 billion pounds ($22 billion) for the military over the next four years. The defense budget is now just under 42 billion pounds a year.

“The era of cutting our defense budget must end, and it ends now,” Johnson told parliament by video link from his Downing Street office, where he is isolating after contact with someone who tested positive for COVID-19.

“I have done this in the teeth of the pandemic, amid every other demand on our resources, because the defense of the realm and the safety of the British people must come first.”

NEW GLOBAL ROLE

Britain was the main battlefield ally of the United States in Iraq and Afghanistan and, alongside France, the principal military power in the European Union. But its 2016 vote to leave the EU has made its global role uncertain at a time when China is rising and President Donald Trump has cast doubt on U.S. support for traditional allies.

The military spending announcement comes just a week after Johnson promised U.S. President-elect Joe Biden that Britain was determined to remain a valuable military ally.

Christopher Miller, acting U.S. defense secretary in Trump’s outgoing administration, welcomed the extra spending.

“The UK is our most stalwart and capable ally, and this increase in spending is indicative of their commitment to NATO and our shared security,” he said. “With this increase, the UK military will continue to be one of the finest fighting forces in the world.”

The government said the increase will cement Britain’s position as the largest defense spender in Europe and second-largest in NATO.

A national cyber force will be established alongside the new space command, which will be capable of launching its first rocket by 2022. These and other new projects will create up to 10,000 jobs, the government said.

Britain’s main opposition Labor Party said the increase was long overdue after the ruling Conservative government cut the size of the armed forces by a quarter in the last decade.

The extra funding will raise further concerns about how the government manages its defense and security budget after repeated accusations it allowed costs to spiral for overly-ambitious projects.

A report by lawmakers said on Thursday that Britain’s GCHQ spying agency ignored evidence and broke its budget in choosing an expensive central London headquarters for a newly-created cyber-security center.

After media reports that billions of pounds could be cut from Britain’s foreign aid budget, Defense Secretary Ben Wallace told Sky News that higher defense spending would not come at the expense of aid.

“It doesn’t mean to say we are abandoning the battlefield of international aid, we’re still one of the most generous givers of international aid,” Wallace said.

(Additional reporting by Elizabeth Piper in London; Editing by Catherine Evans)

U.S. travel restrictions at Canada, Mexico borders set to be extended until Dec. 21 — official

By David Shepardson

WASHINGTON (Reuters) – The United States’ land borders with Canada and Mexico are expected to remain closed to non-essential travel until Dec. 21 at the earliest amid a rising number of U.S. coronavirus cases, a Homeland Security Department official told Reuters.

The current restrictions expire on Saturday and the three countries are expected to approve another 30-day extension, the official said on Wednesday. The United States leads the world in COVID-19 cases and deaths.

The restrictions were first put in place in March to control the spread of COVID-19.

Canada’s CTV News also reported that the travel restrictions in place at the Canada-U.S. land border were expected to remain in effect for at least another month.

The DHS official told Reuters the agency was “continuing to look at appropriate public health criteria for a future re-evaluation of existing restrictions.”

The restrictions are particularly painful for U.S. and Canadian towns along the border that are tightly intertwined.

Statistics Canada said earlier that U.S. visits to Canada by automobile had plummeted by more than 95% in August from August 2019.

(Reporting by David Shepardson; Editing by Chizu Nomiyama and Peter Cooney)

COVID-19 survivors may have long lasting immunity; Pfizer vaccine is 95% effective in trial

COVID-19 survivors may have long lasting immunity; Pfizer vaccine is 95% effective in trial
By Nancy Lapid

(Reuters) – The following is a roundup of some of the latest scientific studies on the novel coronavirus and efforts to find treatments and vaccines for COVID-19, the illness caused by the virus.

Immune protection against severe reinfection appears lasting

Regardless of their detectable antibody levels, most COVID-19 survivors are likely to have lasting protection against severe COVID-19 if they become re-infected, thanks to other components of the body’s immune response that remember the new coronavirus in different ways, researchers say. In a study of 185 patients, including 41 who had been infected more than six months earlier, scientists at La Jolla Institute for Immunology in California found that multiple branches of the immune system – not just antibodies – recognized the novel coronavirus for at least eight months. For example, so-called memory B cells that could recognize the virus and produce antibodies to fight it were more abundant six months after infection than at one month, they reported in a paper posted on Monday on bioRxiv ahead of peer review. The new findings “suggest that the immune system can remember the virus for years, and most people may be protected from severe COVID-19 for a substantial time,” said study leaders Shane Crotty and Alessandro Sette.

Final data from Pfizer vaccine trial shows 95% efficacy

Final results from Pfizer Inc’s pivotal COVID-19 vaccine trial show it had a 95% success rate – even higher than an earlier analysis – and two months of follow-up data without serious side effects, the company said on Wednesday. In the study involving about 43,000 volunteers, 162 of the 170 who contracted COVID-19 had received a placebo, not the vaccine. Of the 10 participants who had severe COVID-19, only one had received the vaccine. The final analysis of the trial’s data comes a week after interim results showed the vaccine was more than 90% effective. Moderna Inc on Monday released preliminary data for its vaccine, showing 94.5% effectiveness. Pfizer said the efficacy its two-dose vaccine, developed with German partner BioNTech SE, was consistent across different age and ethnic groups. Efficacy in adults over age 65 was over 94%. Pfizer said it expects to make up to 50 million vaccine doses this year – enough to inoculate 25 million people – and up to 1.3 billion doses in 2021.

Respiratory muscle damage linked to severe COVID-19

Critically ill COVID-19 patients develop virus-induced damage of respiratory muscles, scientists at Amsterdam UMC in The Netherlands reported on Monday in JAMA Internal Medicine. They performed autopsy studies of the diaphragm, the main respiratory muscle, in 26 COVID-19 patients who died in the intensive care unit (ICU) and 8 ICU patients who died without COVID-19. In everyone, the diaphragm muscle cell membranes contained a protein called ACE2, which the new coronavirus uses as an entryway into cells. The researchers found genetic evidence of the virus in diaphragm muscle cells in some of those who died from COVID-19, and microscopy analyses showed much more connective tissue scarring (fibrosis) in COVID-19 patients’ diaphragms, indicating damage, study coauthor Coen Ottenheijm told Reuters. He said the diaphragm damage may help explain why it is often difficult for COVID-19 patients to breathe on their own again after they have been on mechanical ventilators in the ICU. It may also explain the persistent shortness of breath in patients recovering from COVID-19.

Cardiac arrest survival is down during the pandemic

U.S. data from early this year suggest the pandemic has led to decreased survival rates after “out-of-hospital” cardiac arrest. Based on nationwide data, the proportion of patients whose hearts could be restarted was 21% lower in March-April 2020 than in the same period in 2019, researchers reported on Saturday at the annual American Heart Association meeting, held virtually this year, and in JAMA Cardiology. The proportion of patients who survived to be discharged from hospitals was also lower in 2020, at 6.6%, versus 9.8% in 2019. Survival rates after out-of-hospital cardiac arrest had nearly doubled in the last 20 years, and “we want to make sure we don’t lose those gains,” said coauthor Dr. Paul Chan of St. Luke’s Mid-America Heart Institute in Missouri. Dr. Clifton Callaway of the University of Pittsburgh, who viewed the presentation but was not involved in the study, said other viewers noted it is more difficult for paramedics to work wearing full personal protective gear as it takes time to put on and can impede emergency care. Furthermore, some patients may have delayed calling for help over concerns of becoming infected with the coronavirus. And some may have also had COVID-19, making their medical condition more severe.

(Reporting by Nancy Lapid, Linda Carroll and Michael Erman; Editing by Bill Berkrot)

New York City public schools to close on Thursday as COVID-19 cases rise: mayor

(Reuters) – New York City Mayor Bill de Blasio said on Wednesday that the city’s public school district, the largest in the U.S., would be closed for in-person learning starting on Thursday to ward off the increasing spread of COVID-19.

“New York City has reached the 3% testing positivity 7-day average threshold. Unfortunately, this means public school buildings will be closed as of tomorrow, Thursday Nov. 19, out (of) an abundance of caution. We must fight back the second wave of COVID-19,” the mayor said on Twitter.

(Reporting by Gabriella Borter; Editing by Chizu Nomiyama)

U.S. death toll from COVID-19 nears quarter million as infection rates soar

By Gabriella Borter and Anurag Maan

(Reuters) – The death toll from COVID-19 in the United States approached 250,000 on Wednesday, the day after the country recorded the highest number of victims in nearly four months, a chilling sign for a healthcare system already struggling to cope.

On Tuesday, the pandemic claimed 1,596 lives in the United States, more than on any single day since July 27, contributing to a total of 248,898 confirmed deaths since the pandemic began, according to a Reuters tally.

For weeks, health officials and healthcare workers have warned that hospitals in all regions could soon become overwhelmed, with widespread community transmission of the virus evident in many places.

“I’m the most concerned I’ve been since this pandemic started,” Dr. Tom Inglesby, director of Johns Hopkins Center for Health Security, told CNN on Wednesday.

Nationwide, the number of patients hospitalized with COVID-19 topped 75,000 on Tuesday, setting a new record. The Midwest has become the epicenter, reporting almost a half-million cases in the week ending on Monday. In Wisconsin, 90.6% of Intensive Care Unit beds were occupied as of Wednesday, state data showed.

Forty-one U.S. states have reported daily record increases in COVID-19 cases in November, 20 have registered new all-time highs in coronavirus-related deaths from day to day, and 26 have reported new peaks in hospitalizations, according to a Reuters tally of public health data.

Government officials in at least 18 states, representing both sides of the U.S. political divide, have issued sweeping new public health mandates this month. These range from stricter limits on social gatherings and non-essential businesses to new requirements for wearing masks in public places.

Even officials who initially bristled at the idea of the government imposing social restrictions have changed tune as the virus has spread.

In South Dakota, about 2% of residents currently have COVID-19, according to state data. The city of Sioux Falls voted to institute a mask mandate on Tuesday night, a week after Mayor Paul TenHaken voted the mandate down. TenHaken shifted to supporting the ordinance after the South Dakota State Medical Association urged the city council to mandate masks. State Governor Kristi Noem, a Republican, has continued to oppose government restrictions to curb COVID-19.

White House spokeswoman Kayleigh McEnany on Wednesday called the wave of new restrictions an overreach by state and local officials.

“The American people know how to protect their health,” she told Fox News in an interview. “We don’t lose our freedom in this country. We make responsible health decisions as individuals.”

(Reporting by Gabriella Borter in New York and Anurag Maan in Bengaluru; additional reporting by Susan Heavey and Maria Caspani; Editing by Rosalba O’Brien)

U.S. judge blocks expulsions of unaccompanied children under Trump’s pandemic-related border rules

By Ted Hesson and Mica Rosenberg

WASHINGTON (Reuters) – A U.S. district court judge on Wednesday blocked expulsions of unaccompanied children caught crossing into the United States, a setback for the outgoing Trump administration, which said the policy was aimed at limiting the spread of the coronavirus.

U.S. District Judge Emmet Sullivan in the District of Columbia ruled that the minors were likely to suffer irreparable harm because they could be subject to sexual abuse and other violence, as well as face the possibility of torture and death if summarily returned to their home countries.

President Donald Trump has made immigration curbs a central part of his four-year term in office and enacted a series of sweeping immigration restrictions during the pandemic.

President-elect Joe Biden, has vowed to reverse many of the Republican president’s hardline immigration policies.

Biden has not yet commented on how he would handle the emergency border rules that allow for rapid deportations. A Biden campaign official told Reuters that he would defer to health experts on such restrictions.

A U.S. Border Patrol official said in a September court filing that 8,800 unaccompanied minors were expelled under the border rules between their enactment on March 20 and Sept. 9.

Overall, the United States has expelled roughly 197,000 migrants caught crossing the U.S.-Mexico border from March through the end of September, though those figures include migrants who may have crossed multiple times.

Lee Gelernt, an attorney with the American Civil Liberties Union (ACLU), which represented plaintiffs in the lawsuit, said the policy was a “pretext” for Trump to close the border to children and asylum seekers from Central America.

The U.S. Department of Justice, U.S. Department of Homeland Security and White House did not immediately respond to requests for comment.

(Reporting by Ted Hesson in Washington and Mica Rosenberg in New York; Editing by Chizu Nomiyama and Nick Macfie)

Pfizer ends vaccine trial with 95% success rate, paving way for a shot this year

By Michael Erman and Ludwig Burger

(Reuters) – Pfizer Inc and BioNTech could secure emergency U.S. and European authorization for their COVID-19 vaccine next month after final trial results showed it had a 95% success rate and no serious side effects, the drugmakers said on Wednesday.

The efficacy of the shot was found to be consistent across different ages and ethnicities – a promising sign given the disease has disproportionately affected the elderly and certain groups including Black people.

The U.S. Food and Drug Administration could grant emergency-use approval towards the end of the first half of December or early in the second half, BioNTech Chief Executive Ugur Sahin told Reuters TV. Conditional approval in the European Union could be secured in the second half of December, he added.

“If all goes well I could imagine that we gain approval in the second half of December and start deliveries before Christmas, but really only if all goes positively,” he said.

The success rate of the vaccine developed by U.S. firm Pfizer and Germany’s BioNTech is the highest of any candidate in late-stage clinical trials so far, and experts said it was a significant achievement in the race to end the pandemic.

Pfizer said 170 volunteers in its trial involving over 43,000 people contracted COVID-19 but 162 of them had only been given a placebo, meaning the vaccine was 95% effective. Of the 10 people who had severe COVID-19, one had received the vaccine.

“A first in the history of mankind: less than a year from the sequence of the virus to the large-scale clinical trial of a vaccine, moreover based on a whole new technique,” said Enrico Bucci, a biologist at Temple University in Philadelphia. “Today is a special day.”

BioNTech’s Sahin said the U.S. emergency authorization would be applied for on Friday.

The FDA committee tentatively plans to meet on Dec. 8-10, a source familiar with the situation said, though the dates could still change. The FDA did not respond to requests for comment.

COVID-19 RUNS RAMPANT

The final trial analysis comes a week after initial results showed the vaccine was more than 90% effective. Moderna Inc <MRNA.O> released preliminary data for its vaccine on Monday, showing 94.5% effectiveness.

The better-than-expected results from the two vaccines, both developed with new messenger RNA (mRNA) technology, have raised hopes for an end to a pandemic that has killed more than 1.3 million people and wreaked havoc upon economies and daily life.

The Pfizer-BioNTech shot was found to have 94% efficacy in people over 65 years, which experts said was crucial at a time when COVID-19 is running rampant around the world with record numbers of new cases and hospitalizations.

“This is the evidence we needed to ensure that the most vulnerable people are protected,” said Andrew Hill, senior visiting research fellow at the University of Liverpool’s department of pharmacology.

Global shares rose as the trial results countered concerns around the stubbornly high global infection rate. Pfizer shares were up 1.6% while BioNTech jumped 3.8% in the United States. By contrast, Moderna dropped 4.2%.

Investors have treated vaccine development as a race between companies, although there is likely to be global demand for as much vaccine as can be produced for the foreseeable future.

DISTRIBUTING SHOTS

Pfizer says it expects to make as many as 50 million vaccine doses this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021.

While some groups such as healthcare workers will be prioritized in the United States and Britain for vaccinations this year, it will be months before large-scale rollouts begin in either country.

Pfizer also has agreements with the European Union, Germany and Japan where distribution could begin next year.

Mike Ryan, the World Health Organization’s top emergency expert, said it would be at least 4-6 months before significant levels of vaccination were taking place around the world.

Distribution of a Pfizer-BioNTech shot is complicated by the need to store it at ultra-cold temperatures of -70 degrees Celsius. It can, however, be kept in a normal fridge for up to five days, or up to 15 days in a thermal shipping box.

Moderna’s vaccine can be stored for up to six months at -20C though it is expected to be stable for 30 days at normal fridge temperatures of 2 to 8 degrees Celsius (36°-46°F).

FATIGUE AND HEADACHES

Pfizer said its two-dose vaccine, called BNT162b2, was well-tolerated and that side effects were mostly mild to moderate, and cleared up quickly.

It said the only severe adverse events experienced by volunteers were fatigue and headaches. Out of 8,000 participants, 2% had headaches after the second dose while 3.8% experienced fatigue. Older adults tended to report fewer and milder adverse events.

“These are extraordinary results, and the safety data look good,” said David Spiegelhalter, a professor and expert in risk and evidence communication at the University of Cambridge.

“It would be interesting to see what adverse reactions were reported by the group getting the placebo, since that gives an idea of how much of the adverse effects are due to the vaccination process, and how much is due to the vaccine itself.”

Of the dozens of drugmakers and research groups racing to develop vaccines against COVID-19, the next data release will likely be from AstraZeneca Plc with the University of Oxford in November or December. Johnson & Johnson says it is on track to deliver data this year.

Authorization of vaccines for children will take longer. Only Pfizer has started vaccinating volunteers under the age of 18 in trials, giving shots to children as young as 12. Moderna and Johnson & Johnson have said they hope to start testing the vaccine in younger patients soon.

(Reporting by Michael Erman in Maplewood, N.J.; Additional reporting by Ankur Banerjee in Bengaluru, Caroline Humer in New York, Dan Levine in San Francisco, Elizabeth Howcroft, Kate Kelland and Josephine Mason in London, Emilio Parodi in Milan and Stephanie Nebehay in Geneva; Writing by David Clarke; Editing by Pravin Char)

FDA approves first COVID-19 test kit for home use

(Reuters) – The U.S. Food and Drug Administration said on Tuesday it had approved the first COVID-19 self-testing kit for home use that provides results within 30 minutes.

The single-use test, made by Lucira Health, has been given emergency use authorization for home use with self-collected nasal swab samples in individuals aged 14 and older who are suspected of COVID-19 by their health care provider, the FDA said.

“While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home,” FDA Commissioner Stephen Hahn said.

The kit can also be used at hospitals and point-of-care settings but samples should be collected by a healthcare provider if the individuals who are tested are younger than 14 years, the health regulator said.

Although a recent string of positive news from Moderna Inc and Pfizer Inc on their potential vaccines has raised hopes in combating the disease, testing still is a key factor in controlling the spread of the virus.

“We look forward to proactively working with test developers to support the availability of more at-home test options,” said Jeff Shuren, the director of the FDA’s Center for Devices and Radiological Health.

The United States crossed 11 million total infections on Sunday, just eight days after reaching the 10 million mark.

(Reporting by Shubham Kalia in Bengaluru; Editing by Anil D’Silva)

Senate blocks confirmation of Trump Fed nominee Shelton

(Reuters) – The U.S. Senate on Tuesday blocked President Donald Trump’s nomination of Judy Shelton to the board of the Federal Reserve, making her the latest in a string of failed nominees to the central bank.

Trump’s Republican Party has a 53-47 majority in the current Senate, but several were absent, including two who were quarantining due to exposure to COVID-19, and others joined Democrats in voting ‘no’ in the so-called cloture vote.

The vote was 47 to 50 with Senate Majority Leader Mitch McConnell voting ‘no’ to preserve the option to reconsider later.

Shelton, an adviser to Trump’s 2016 presidential campaign who has argued the nation would be better off returning to the gold standard, as recently as 2017 criticized the Fed’s power over money and financial markets as “quite unhealthy.” During her Senate confirmation process, she called the Fed’s bond-buying and zero rates in the last crisis “extreme.”

Her views on interest rates have moved in lockstep with Trump’s. She lambasted easy money before Trump’s presidency, but supported it after he took office, and has expressed skepticism over the Fed’s need to set policy independently from the president and Congress.

Other Trump Fed nominees that failed to be confirmed included former Republican presidential candidate Herman Cain, who later died of COVID-19.

(Reporting by Patricia Zengerle and Doina Chiacu; writing by Ann Saphir; editing by Jonathan Oatis and Edward Tobin)