Tag Archives: COVID-19

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)

India reports record daily jump of 95,735 coronavirus cases

BENGALURU (Reuters) – India reported record jumps in new coronavirus infections and deaths on Thursday, taking its tally of cases past 4.4 million, health ministry figures showed.

In the last 24 hours, 95,735 new infections were detected, with 1,172 deaths accounting for the highest single-day mortality figures in more than a month, to push the toll beyond 75,000.

Infections are growing faster in India than anywhere else in the world and the United States is the only nation worse affected.

(Editing by Clarence Fernandez)

Severe COVID-19 riskier than heart attack for young adults; antibiotic shows no benefit

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.

More young adults survive heart attacks than severe COVID-19

Among COVID-19 patients treated at 419 U.S. hospitals from April through June, only about 5% were ages 18 to 34. But that group had “substantial rates of adverse outcomes,” according to a report on Wednesday in JAMA Internal Medicine. Roughly one in five needed intensive care, one in 10 needed mechanical ventilation, and nearly 3% died. While the mortality rate is lower than in older adults, it is roughly double the death rate of young adults from heart attacks, the authors say. Obesity, high blood pressure, and diabetes were tied to higher risk for adverse events. For young adults with more than one of these conditions, the risk of a bad outcome was similar to middle-aged adults without the risk factors. More than half of hospitalized young adults were Black or Hispanic, “consistent with prior findings of disproportionate illness severity in these demographic groups,” the authors said. “Given the sharply rising rates of COVID-19 infection in young adults, these findings underscore the importance of infection prevention measures in this age group,” the concluded.

Antibiotic fails to help hospitalized COVID-19 patients

The antibiotic azithromycin did not appear to provide any benefit to hospitalized COVID-19 patients who were having trouble breathing, according to a study in Brazil. At 57 hospitals, 243 COVID-19 patients who needed oxygen or mechanical ventilation were randomly assigned to receive azithromycin, while 183 similar patients did not get the antibiotic. All received other standard treatment, which in Brazil included hydroxychloroquine, a malaria drug that other studies have shown provides little or no benefit. While azithromycin did not appear to do any harm, after 15 days it was not associated with any patient improvement nor did it reduce their risk of death. In an April survey of more than 6,000 physicians in 30 countries, azithromycin was the second most commonly prescribed treatment for COVID-19, the study investigators wrote in The Lancet medical journal. The absence of any benefit in this new study “suggests that the routine use of this strategy should be avoided,” they said.

Risk of catching COVID-19 while hospitalized can be low

Among nearly 8,500 patients admitted to a large Boston hospital between early March and the end of May, only two became sick with coronavirus infections that may have been acquired while they were hospitalized, doctors report. One likely was infected by a spouse who initially appeared well during daily visits but who developed symptoms while the patient was still hospitalized. That was before visitor restrictions and universal masking rules had been implemented. The other patient developed symptoms four days after leaving the hospital. The source of the infection is not known. According to a paper published on Wednesday in JAMA Network Open, infection control efforts at the hospital included dedicated COVID-19 units with airborne infection isolation rooms, personal protective equipment for staff and monitoring to make sure those were used correctly, universal masking, visitor restriction, and liberal COVID-19 testing of symptomatic and asymptomatic patients. These “robust and rigorous infection control practices may be associated with minimized risk” of COVID-19 spreading through hospitals, the authors conclude. Their findings, if replicated at other U.S. hospitals, “should provide reassurance to patients,” they said.

Longer-term COVID-19 lung damage can improve over time

COVID-19 lung damage persists long term but tends to improve, researchers reported on Monday at the European Respiratory Society International Virtual Congress. Researchers studied 86 hospitalized COVID-19 patients, 48% of whom had a smoking history and 21% of whom required intensive care. At 6 weeks after discharge, 47% of patients still reported feeling short of breath. By 12 weeks, that dropped to 39%. CT scans still showed lung damage in 88% of patients at six weeks, dropping to 56% at 12 weeks. “Overall, this study shows that COVID-19 survivors have persisting pulmonary impairment weeks after recovery. Yet, overtime, a moderate improvement is detectable,” lead researcher Dr. Sabina Sahanic, from University Clinic of Internal Medicine in Innsbruck, Austria, said during a press briefing. A related study featured at the meeting stressed the importance of early pulmonary rehabilitation after COVID-19 patients come off a ventilator. This should include balance and walking, muscle strengthening, respiratory exercises and endurance training. “The sooner rehabilitation started and the longer it lasted, the faster and better was the improvement in patients’ walking and breathing capacities and muscle gain,” coauthor Yara Al Chikhanie, from Grenoble Alps University in France, said in a statement.

(Reporting by Nancy Lapid; Editing by Bill Berkrot)

New York City restaurants can resume indoor dining on Sept 30: governor

(Reuters) – New York City restaurants will be able to resume indoor dining at 25-percent capacity with some restrictions on Sept. 30, New York Governor Andrew Cuomo told a news conference on Wednesday.

Cuomo said the restrictions will include mandatory temperature checks at the door and requiring one member of each party to provide contact information to enable contact tracing should there be a COVID-19 outbreak.

Cuomo also said the state would establish a whistleblowing system whereby patrons can report restaurants not in compliance.

(Reporting by Nathan Layne in Wilton, Connecticut, Editing by Franklin Paul and David Gregorio)

U.S. COVID-19 deaths surpass 190,000; Iowa and South Dakota emerge as new hotspots

By Anurag Maan

(Reuters) – Coronavirus deaths in the United States topped 190,000 on Wednesday along with a spike in new cases in the U.S. Midwest with states like Iowa and South Dakota emerging as the new hotspots in the past few weeks.

Iowa currently has one of the highest rates of infection in the nation, with 15% of tests last week coming back positive. Nearby South Dakota has a positive test rate of 19% and North Dakota is at 18%, according to a Reuters analysis.

The surge in Iowa and South Dakota is being linked to colleges reopening in Iowa and an annual motorcycle rally last month in Sturgis, South Dakota.

Kansas, Idaho and Missouri are also among the top 10 states for positive test rates.

New coronavirus infections have fallen for seven weeks in a row for the United States with a death rate of about 6,100 per week from COVID-19 in the last month.

On a per capita basis, the United States ranks 12th in the world for the number of deaths, with 58 deaths per 100,000 people, and 11th in the world for cases, with 1,933 cases per 100,000 residents, according to a Reuters analysis.

U.S. confirmed cases are highest in the world with now over 6.3 million followed by India with 4.4 million cases and Brazil with 4.2 million. The U.S. death toll is also the highest in the world.

The U.S. Centers for Disease Control and Prevention had forecast last month that the U.S. death toll will reach 200,000 to 211,000 by Sept. 26.

The University of Washington’s health institute last week forecasted that the U.S. deaths from the coronavirus will reach 410,000 by the end of the year.

(Reporting by Anurag Maan in Bengaluru; Editing by Lisa Shumaker)

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)

COVID-19 cases rise in U.S. Midwest and Northeast, deaths fall for third week

(Reuters) – Several states in the U.S. Midwest and Northeast have seen new COVID-19 cases increase for two weeks in a row, though nationally both new infections and deaths last week remained on a downward trend, a Reuters analysis showed.

The United States reported more than 287,000 new cases in the week ended Sept. 6, down 1.4% from the previous week and marking the seventh straight week of declines. More than 5,800 people died from COVID-19 last week, the third week in a row that the death rate has fallen.

Nevertheless, 17 states have seen cases rise for at least two weeks, according to the Reuters tally of state and county reports. They include Missouri, North Dakota and Wisconsin, where between 10% and 18% of people tested had the new coronavirus.

In the Northeast, Delaware, New Hampshire, New Jersey and New York also reported increases in new cases for at least two weeks, though the positive test rate ranged from a low of 0.9% in New York to a high of 4.3% in Delaware — below the 5% level the World Health Organization considers concerning.

In some states, testing has increased as schools reopened. New York City, for instance, is testing 10% to 20% of students and staff every month. The University of Illinois is testing students twice a week.

Nationally, the share of all tests that came back positive for COVID-19 fell for a fifth week to 5.5%, well below a peak of nearly 9% in mid-July, according to data from The COVID Tracking Project, a volunteer-run effort to track the outbreak.

The United States tested on average 741,000 people a day last week, up 5% from the prior week, but down from a peak in late July of over 800,000 people a day.

(Writing by Lisa Shumaker; Graphic by Chris Canipe; Editing by Tiffany Wu)

U.S. CDC reports 188,688 deaths from coronavirus

(Reuters) – The U.S. Centers for Disease Control and Prevention (CDC) said on Tuesday the number of deaths due to the new coronavirus had risen by 175 to 188,688 and reported 6,287,362 cases, an increase of 26,146 cases from its previous count.

The CDC reported its tally of cases of the respiratory illness known as COVID-19, caused by a new coronavirus, as of 4 pm ET on Sept. 7 versus its previous report a day earlier.

The CDC figures do not necessarily reflect cases reported by individual states.

(Reporting by Trisha Roy in Bengaluru; Editing by Aditya Soni)

Senate to vote on COVID-19 aid as soon as this week: McConnell

WASHINGTON (Reuters) – The Republican-led U.S. Senate will introduce a new proposal on coronavirus relief legislation on Tuesday and could schedule a vote as soon as this week, Senate Majority Leader Mitch McConnell said.

He said the new proposal would target “some of the very most urgent healthcare, education, and economic issues.”

“It does not contain every idea our party likes. I am confident Democrats will feel the same. Yet Republicans believe the many serious differences between our two parties should not stand in the way of agreeing where we can agree and making law that helps our nation,” McConnell’s statement said.

Earlier, White House chief of staff Mark Meadows said he was hopeful there would be another round of federal COVID-19 stimulus funding before the Nov. 3 presidential election, but signaled no breakthrough in talks with congressional Democrats.

Interviewed on Fox Business Network, Meadows said he hoped legislation put forward by Senate Republicans would provide a basis for a future agreement with Democratic lawmakers and that negotiations were ongoing.

(Reporting by Susan Heavey and Doina Chiacu; Editing by Howard Goller)

WHO’s Tedros says ‘vaccine nationalism’ would prolong pandemic

By Stephanie Nebehay and Emma Farge

GENEVA (Reuters) – WHO Director-General Tedros Adhanom Ghebreyesus said on Friday that “vaccine nationalism” would only slow the effort to quash the pandemic and called for vaccines to be used fairly and effectively.

Tedros said 78 high-income countries had now joined the “COVAX” global vaccine allocation plan, bringing the total to 170 countries, and the “number is growing”. He urged others to join by the Sept. 18 deadline for binding commitments.

Joining the plan guaranteed those countries access to the world’s largest portfolio of vaccines, with nine candidates currently in the pipeline, he said, adding that a further four were “promising”.

The WHO and the GAVI vaccine alliance are leading the COVAX facility, aimed at helping buy and distribute vaccination shots fairly around the world.

But some countries that have secured their own supplies through bilateral deals, including the United States, have said they will not join COVAX.

“Vaccine nationalism will prolong the pandemic, not shorten it,” Tedros told a WHO briefing in Geneva, without mentioning any specific countries.

“If and when we have an effective vaccine, we must also use it effectively … In other words, the first priority must be to vaccinate some people in all countries, rather than all people in some countries,” he said, adding that priority should be given to healthcare workers, the elderly and those with underlying conditions.

Tedros thanked Germany, Japan, Norway and the European Commission for joining COVAX during the last week.

“Certainly by the middle of 2021 we should start to see some vaccines actually moving into countries and populations,” said WHO chief scientist Soumya Swaminathan, reiterating earlier comments.

Noting that there were 13 experimental vaccines currently in clinical trails, Swaminathan called it an “optimistic scenario” since the typical success rate of 10% could mean several vaccines are approved.

But Swaminathan said that no vaccine should be approved for a worldwide rollout until it had undergone sufficient scrutiny.

“No vaccine is going to be mass-deployed until regulators are confident, governments are confident, and the WHO is confident it has met the minimum standard of safety and efficacy,” she said.

Results were expected from some of the candidates already in phase 3 trials, each involving thousands of participants, by the end of the year or early 2021, Swaminathan said.

“We are not going to have enough for the whole world right at the beginning,” she said adding that scaling up of manufacturing would take time.

“Eventually there will be enough for everyone but it will mean prioritization,” she said.

(Reporting by Stephanie Nebehay and Emma Farge; Editing by Alison Williams and Giles Elgood)