Tag: vaccine

 

COVID-19 vaccine won’t be ready in weeks, nor mandatory

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Harris says she would absolutely take a vaccine if it was recommended by public health professionals, but not if only President Trump says to.

USA TODAY

The claim: COVID-19 vaccine will be ready in weeks, and the government will force everyone to get it

The global effort to develop a COVID-19 vaccine has been a priority since the coronavirus pandemic started. Seven months into the U.S. outbreak, vaccine candidates are facing skepticism by some in the general public and various elected officials.  

Leading health officials, such as Dr. Anthony Fauci, have maintained that a vaccine likely won’t be widely available until mid-2021. Meanwhile, President Donald Trump has promised a vaccine before Election Day, prompting the Democratic vice presidential candidate Kamala Harris to accuse Trump of politicizing the vaccine and to question its safety, noting that she would take it only if the health experts said it was safe.  

The effectiveness and safety of a COVID-19 vaccine is not the only thing people are worried about. Vaccine conspiracy theories that originated in anti-vaxxer communities have thrived anew in the COVID-19 era, including claims that the vaccine would implant microchips or that it will be mandatory for every American.

A post from from Before It’s News, a website that allows anyone to contribute, — which was shared 38,00 times as of Oct. 15 — furthers the conspiracy theory of a mandatory vaccine, with a headline reading, “The Government Has Released Their Initial Plans to Force a Vaccine on Everyone.”

The post also says, “Three potential vaccines are currently in Stage 3 trials in the United States and could be ready in weeks,” citing Trump.

USA TODAY reached out to the site’s Facebook page for comment.

We’ll look at the two claims here: Will a vaccine be mandatory? And, what does the development and distribution timeline really look like?

Will a vaccine be ready in weeks?

According to the Centers for Disease Control and Prevention, the general cycle for the development of a new vaccine has six stages: exploratory stage, pre-clinical stage, clinical development, regulatory review and approval, manufacturing and quality control. 

The global prioritization of finding a COVID-19 vaccine has shortened the timeline of its development, which for a regular vaccine would usually take years. However, vaccine developers and institutions like the CDC are following existing protocols to ensure the vaccine’s safety and effectiveness. 

As of Oct. 15, according to the World Health Organization, 42 vaccine candidates are in clinical evaluations and 156 are in preclinical evaluations.

16-year-old Katelyn Evans gets the first of two shots as part of a trial testing Pfizer’s COVID-19 vaccine in minors. (Photo: Cincinnati Children’s Hospital)

The post from Before It’s News cites a Sept. 15 comment from Trump where he said a vaccine could be ready in a “matter of weeks.” On Oct. 5, Trump said vaccines would be ready “momentarily.” However, scientists disagree.

On Sept. 16, Dr. Robert Redfield, director of the CDC, said that while an effective vaccine could be developed before the

South Korean authorities stick to flu vaccine plan after deaths rise to 48

By Heekyong Yang

SEOUL (Reuters) – The number of South Koreans who have died after getting flu shots has risen to 48, the Korea Disease Control and Prevention Agency (KDCA) said on Saturday, adding that the vaccines would continue to reduce the chance of having simultaneous epidemics.

The health authorities said they found no direct link between the deaths and the shots. They plan to carry on with the state-run vaccination programme to try to avoid having to fight both the flu and the coronavirus over the coming winter.

“After reviewing death cases so far, it is not the time to suspend a flu vaccination programme since vaccination is very crucial this year, considering … the COVID-19 outbreaks,” KDCA Director Jeong Eun-kyung told a briefing.

Jeong said the review had shown no direct link between the flu shots and the 26 deaths that have been investigated.

Some 20 initial autopsy results from the police and the National Forensic Service showed that 13 people died of cardiovascular, cerebrovascular and other disorders not caused by the vaccination.

The death toll among those who have been vaccinated rose by 12 cases from a day earlier to 48 on Saturday.

The rising deaths have caused some doctors and politicians to call for a halt to the government campaign to vaccinate about 30 million of the country’s 54 million people.

While encouraging people to get flu vaccines, Jeong issued precautions to take before getting the shot, such as drinking enough water and telling healthcare workers about any underlying medical conditions. She also advised people to wait 15-30 minutes before leaving the clinic where they receive their vaccine.

“If possible, try to get the flu shot when it’s warm, since there are concerns that low temperatures could affect cardiovascular disease or cerebrovascular disease,” she said.

The KDCA said 9.4 million people had been inoculated as of Friday in the programme that began in September, with 1,154 cases of adverse reactions.

South Korea reported 77 new coronavirus cases as of Friday midnight, bringing total infections to 25,775, with 457 deaths.

(Reporting by Heekyong Yang; Editing by Tom Hogue)

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South Korean officials find no direct link between flu vaccine and recent deaths

The country’s government has rolled out a flu vaccine campaign, concerned about the potential simultaneous spread of coronavirus and influenza.

At least 36 people have died after taking flu vaccinations since last Friday, including a 17-year-old. The average age of those who died was 74, according to the South Korean Disease Control and Prevention Agency (KDCA).

As of Friday, more than 14 million people had gotten the flu vaccine, of which 9.4 million were children, elderly, and pregnant women, according to the KDCA.

Ki Moran, a professor at South Korea’s National Cancer Centre, said the flu vaccine is known to cause serious side effects in one out of 10 million people.

In 2019, 227,000 people over the age of 65 died in South Korea, she added. That’s an average of 621 deaths a day, to put the recent figures into perspective.

The KDCA decided on Friday not to suspend the flu vaccinations. The vaccination expert committee will hold a meeting Saturday morning to review additional data, according to a KDCA statement.

Rare side effects

This might be your most important flu shot ever

The KDCA’s Friday meeting came after rising scrutiny from experts and politicians.

On Friday, South Korean Prime Minister Chung Sye-kyun called for a thorough investigation into the deaths, citing public anxiety, according to a press release by the Health Ministry. He did not call for a halt to the vaccination campaign.

The Korean Medical Association, a coalition of 130,000 doctors, has urged the government to suspend the vaccination program for a week until they determined the cause of the deaths.

In a statement, the Korean Vaccine Society emphasized the importance of the flu vaccine, especially “for children, the elderly, and patients with chronic diseases and low immune system.” The organization cited concerns about the possible spread of flu during the Covid-19 pandemic.

Experts globally are preparing for flu season in the middle of the pandemic. “This is a critical year for us to try to take flu as much off the table as we can,” said Dr. Robert Redfield, director of the US Centers for Disease Control and Prevention, in an interview with the AMA’s JAMA Network.

One reason is to decrease the strain on public health services and hospitals, which are bracing for a winter wave. Experts say it possible to get Covid-19 and the flu simultaneously — and, because flu symptoms look so similar to that of Covid-19, it will be impossible to rule out a coronavirus diagnosis without a test. That means a case of the flu can cause substantial disruption to work and school.

In South Korea, Covid-19 has infected 25,775 people and killed 457, according to Johns Hopkins University.

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To Find a Coronavirus Vaccine, GlaxoSmithKline Is Bonding With Its Biggest Competitors

The Covid-19 pandemic is turning some fierce drug-industry foes into the best of frenemies.

The pharmaceutical giant standing at the center of this team of rivals is

GlaxoSmithKline


GSK 0.57%

PLC, the world’s largest vaccine maker by sales. The British company is jointly developing a Covid-19 antibody drug with a San Francisco upstart, offering rivals a proprietary ingredient that is designed to boost a vaccine’s power and planning to share research study results.

“We felt this very unusual situation required something that GSK hadn’t done before, and something we hadn’t seen in the industry before either,” says Roger Connor, president of Glaxo’s vaccines business.

What makes Glaxo’s collaboration so unusual is that competition typically defines the relationship among drugmakers. Company researchers race to be first to bring a new kind of therapy to market or work on treatments that can outdo older medicines, while marketers roll out campaigns designed to boost sales at the expense of rivals.

In the age of Covid-19, old adversaries are uniting around a common enemy: the new coronavirus. Their nascent partnership is now visible in everything from trials to research to manufacturing. Glaxo and eight other pharmaceutical firms even took the rare step of issuing a joint pledge last month to seek regulatory approvals for their vaccines only after proving their safety and effectiveness in large, final-stage clinical trials.

How far along each of the vaccines are

Testing stages typically move from ‘preclinical,’ before the vaccine is deemed appropriate to test in people, to the three phases of human clinical trials.

So far, 44 candidates have made it to clinical trials.

Type of vaccine

Viral vector

Ten of these have advanced into phase 3, which tests whether the dose that would be given to the public works safely.

The most common area of cooperation thus far is manufacturing. Some longtime rivals are striking deals to stretch their capacity to meet anticipated demand. Roche Holding AG is helping manufacture an antiviral drug in development by rival Regeneron.

Amgen Inc.

will help make

Eli Lilly

& Co.’s antiviral drugs if the treatments are authorized by regulators.

Pfizer

has dedicated manufacturing capacity to turning out doses of remdesivir, an antiviral made by rival

Gilead Sciences Inc.

The camaraderie also extends to the traditionally cutthroat realm of research.

Regeneron Pharmaceuticals Inc.

scientists contributed to research on a vaccine in development by

BioNTech SE

and Pfizer Inc., and were co-authors on a paper this summer detailing the results. In another rare move,

Merck

& Co.’s research and development chief called his Glaxo counterpartment in April to pass along a tip that one of Glaxo’s molecules showed promise in Merck’s Covid-19 lab tests.

Glaxo’s most prominent contribution to this new era of collaboration is its decision to share a proprietary vaccine component known as an adjuvant—an ingredient that helps boost a vaccine’s protective power by rousing the body’s immune response. Glaxo now has agreements to supply that ingredient to four vaccine developers, including French drugmaker

Sanofi SA,

and stands ready to

AstraZeneca and Johnson & Johnson to resume COVID-19 vaccine trials as U.S. daily cases top 71,000

On Friday, both AstraZeneca and Johnson & Johnson announced that their coronavirus vaccine trials are set to resume in the U.S. after hitting pause when volunteers became sick. The Food and Drug Administration gave the green light after investigations found no link between those cases and the vaccine.

The announcement comes as the U.S. recorded more than 71,000 coronavirus cases on Thursday, which is the highest single-day increase since July, according to figures from Johns Hopkins University. A total of 41 states are reporting an increase in average new cases, and 15 states have reported record hospitalizations in the last week.

“This really does become a moment where all Americans have to recognize that each of us individually has a responsibility if we want to turn this around,” said Dr. Francis Collins, director of the National Institutes of Health.

In hot spot Wisconsin, new cases are up nearly 40% compared to two weeks ago. Wisconsin resident Ava Pennicuik, 15, is still suffering from hot flashes and extreme fatigue three months after recovering from COVID-19.

“I still feel sick sometimes. Some days are good and then some days aren’t,” said Pennicuik. “Like one day I’ll have a really bad day and also super dizzy and tired, and I’ll have to take a nap, and the other day, like, I can just do stuff, like, normally.”

The latest data from researchers at the University of Washington says wearing face masks in public could save nearly 130,000 lives in the U.S. this fall and winter.

Katelyn Evans, 16, became the first teen to get an injection as part Pfizer’s COVID-19 vaccine study at Cincinnati Children’s Hospital, the Associated Press reported. It’s part of a push to safely inoculate school-age children.  

“I figured, you know, the more people they test, the more information they get and the sooner they can put out a vaccine to keep everyone safe,” said Evans.

Since the pandemic began, more than half a million American children have been infected with COVID-19. While vaccine trials continue to move forward, the first shots are unlikely to be recommended for kids. Vaccines can’t be given to children unless they’ve been tested in their age group, the AP reported.

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Johnson & Johnson, AstraZeneca coronavirus vaccine trials set to resume

The AstraZeneca vaccine trial, on hold in the United States since early September, also got the greenlight Friday to restart from the Food and Drug Administration, according to a company statement.

When a potential adverse event occurs during a clinical trial, the testing is typically stopped so that an independent data and safety monitoring board can thoroughly investigate and determine whether the problem was likely related to the vaccine. Rules around clinical trials and patient privacy usually restrict details from being released, but the tremendous scrutiny of the coronavirus vaccine trials has led many experts to call for greater transparency in disclosing and explaining the reasons for such halts.

In the Johnson & Johnson trial, which was paused on Oct. 12, a man who received a vaccination suffered a stroke that may have been triggered by an infection. To conclude it was not likely to be related to the shot, investigators probed not only the medical details of the event, but also examined a safety database of 100,000 people who have received vaccines that use the same underlying technology.

The investigation found “no clear cause” of the incident, according to a company statement. It also found no evidence the vaccine triggered the event, the details of which were not disclosed by the company. The independent board that monitors the trial recommended lifting the pause.

“With the information which we gathered to date and the information from external experts, the company found no evidence the vaccine candidate caused it,” Paul Stoffels, chief scientific officer of Johnson & Johnson said in an interview. He did not offer any details of the illness, citing patient privacy.

The company is testing the only vaccine that aims to protect people with a single shot; other prospective vaccines require a return visit and second shot three to four weeks after the first to trigger a protective immune response.

It was the second late-stage vaccine trial put on hold in recent weeks; the vaccine being developed by AstraZeneca and the University of Oxford was halted on Sept. 6 after a British participant developed a neurological problem. While the AstraZeneca study had resumed in the rest of the world, it did not get clearance to restart in the U.S. until Friday.

AstraZeneca spokeswoman Michele Meixell did not provide further information on the illness, but said the FDA reviewed data from the trials running around the world before concluding it was safe to restart. She said the company was adding a new expert panel “to provide advice on diagnosis and causality assessment of neurological events,”in addition to continuing standard company oversight and the independent data and safety committee.

Pausing and unpausing clinical trials happens routinely, and experts have said that the public should be confident the process worked as intended to protect the health and safety of participants.

“We see this all the time during clinical research,” said Carlos del Rio, an infectious diseases physician at Emory University School of Medicine. “As long as the data and safety monitoring

AstraZeneca, J&J vaccine trials back on track in US

Two major clinical trials for experimental Covid-19 vaccines got back on track in the United States Friday — providing a glimmer of hope as the number of cases skyrocket across the country.

Covid-19 has now killed more than 223,000 Americans, and the health crisis is a top issue in the presidential election pitting incumbent Donald Trump against Joe Biden.

AstraZeneca announced that the trial of its vaccine candidate, developed with Britain’s University of Oxford, has resumed in the US, the only country where it remained suspended following a participant’s illness six weeks ago.

“The Food and Drug Administration (FDA) today authorized the restart in the US, following the resumption of trials in other countries in recent weeks,” the drugmaker said.

The trial was suspended worldwide on September 6, but resumed shortly thereafter in Britain, and in the following weeks in South Africa, Brazil and Japan, with authorities determining the illness was not apparently linked to the vaccine.

“The FDA reviewed all safety data from trials globally and concluded it was safe to resume the trial,” AstraZeneca said.

The company added it was hoping to have results later this year, “depending on the rate of infection within the communities where the clinical trials are being conducted.”

The AstraZeneca/Oxford vaccine project is one of the most promising and advanced in the world to combat the global pandemic, which has now claimed the lives of 1.1 million people.

It is one of 10 vaccine candidates being tested on tens of thousands of people in so-called phase 3 trials.

In the United States, the two top candidates vying to get a green light from the FDA are those made by Pfizer and Moderna. Both expect to request approval next month.

Many countries are counting on using the AstraZeneca/Oxford vaccine to inoculate their populations. 

The drugmaker pre-sold hundreds of millions of doses on several continents, and signed partnership deals with other producers to ensure the doses could be made locally.

– ‘No evidence’ vaccine to blame –

Shortly after AstraZeneca’s announcement, Johnson & Johnson said it was preparing to resume recruitment for its parallel trial, which was suspended last week after a volunteer fell ill.

“After a thorough evaluation of a serious medical event experienced by one study participant, no clear cause has been identified,” the group said in a statement.

“The company has found no evidence that the vaccine candidate caused the event.”

Just before Friday’s announcements, a top US official involved with Operation Warp Speed, the government’s vaccine initiative, said he expected the J&J trial to resume quickly.

Paul Mango, from the US Department of Health and Human Services, also said he expected the country to have enough doses on hand to vaccinate the “most vulnerable” Americans before year’s end.

“By the end of January, we believe we’ll be able to vaccinate all seniors,” Mango said, adding that by March or April, “we believe we’ll be able to vaccinate any American who desires a vaccination.”

ico/acb-sst/mjs

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Chicago curfew; Louisiana football; Pfizer, kids vaccine

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COVID ravaged McKinley County, where roughly 74% of the population is non-Hispanic Native American — mostly Navajo and Zuni — and access to resources is scarce.

USA TODAY

As new cases of COVID-19 continue to rise across the U.S. and Europe, a patient from the Netherlands was airlifted to a German intensive care unit Friday, the first such international airlift since the global pandemic began.

In the U.S., new coronavirus restrictions in Chicago go into effect Friday for two weeks as the nation’s third largest city fights a surge of COVID-19 infections. Mayor Lori Lightfoot on Thursday announced a 10 p.m. curfew for all nonessential businesses and ordered bars and breweries without food licenses to shut down indoor service.

Meanwhile, in Louisiana, more high school football fans will be allowed to attend games in open-air stadiums in some parishes starting Friday. Stadiums will be allowed to have crowds at 50% capacity in parishes where less than 5% of coronavirus tests have been positive in the last two weeks, Gov. John Bel Edwards said Thursday.

Here’s what to know today:

  • France surpassed 1 million confirmed cases of COVID-19 Friday, according to Johns Hopkins University data. India, Brazil, Russia, Argentina and Spain previously passed that grim milestone.
  • The U.S. reported more than 71,000 new cases of COVID-19 on Thursday, according to Johns Hopkins data. The last time daily cases exceeded 71,000 was during the summer surge in July.
  • Wyoming on Thursday became one of the last states to reach 10,000 cases, with half of its infections reported in the last month, according to USA TODAY analysis. Only New Hampshire (9,994), Maine (6,063) and Vermont (1,987) had less than 10,000 cases as of Thursday night.
  • President Donald Trump and former Vice President Joe Biden sparred bitterly over the pandemic Thursday during the second and final debate. Trump claimed the virus would “go away” while Biden warned of a “dark winter.”
  • Pfizer is the only leading drug company that’s producing a coronavirus vaccine to allow minors into trails. The company recently lowered the age of participation to 16, aiming to include at least 3,000 older teens.  
  • The Food and Drug Administration on Thursday approved the antiviral drug remdesivir as a treatment for patients with COVID-19 who require hospitalization.

📈 Today’s numbers: The U.S. has reported more than 8.4 million cases and 223,000 deaths, according to Johns Hopkins University data. The global totals: 41.7 million cases and 1.1 million deaths.

🗺️ Mapping coronavirus: Track the U.S. outbreak in your state.

When will there be a COVID-19 vaccine? In general, scientists and public health experts say a COVID-19 vaccine could be approved at the earliest by December, but that doesn’t mean it will be widely available to most Americans. The federal government is developing a distribution plan that would get vaccines to various populations first, such as essential workers, those most vulnerable to COVID-19 and the elderly. See what USA TODAY’s expert panel has to say.

Why people of color are dying from COVID-19: Communities 

The Trump Administration Shut a Vaccine Safety Office Last Year. What’s the Plan Now?

As the first coronavirus vaccines arrive in the coming year, government researchers will face a monumental challenge: monitoring the health of hundreds of millions of Americans to ensure the vaccines don’t cause harm.

Purely by chance, thousands of vaccinated people will have heart attacks, strokes and other illnesses shortly after the injections. Sorting out whether the vaccines had anything to do with their ailments will be a thorny problem, requiring a vast, coordinated effort by state and federal agencies, hospitals, drug makers and insurers to discern patterns in a flood of data. Findings will need to be clearly communicated to a distrustful public swamped with disinformation.

For now, Operation Warp Speed, created by the Trump administration to spearhead development of coronavirus vaccines and treatments, is focused on getting vaccines through clinical trials in record time and manufacturing them quickly.

The next job will be to monitor the safety of vaccines once they’re in widespread use. But the administration last year quietly disbanded the office with the expertise for exactly this job. Its elimination has left that long-term safety effort for coronavirus vaccines fragmented among federal agencies, with no central leadership, experts say.

“We’re behind the eight ball,” said Daniel Salmon, who served as the director of vaccine safety in that office from 2007 to 2012, overseeing coordination during the H1N1 flu pandemic in 2009. ”We don’t even know who’s in charge.”

An H.H.S. spokeswoman declined to answer detailed questions about why the vaccine office, set up in 1987, was closed or how the health agencies were planning to track the safety of vaccines once they are injected into millions of people. In a brief statement, she said that Operation Warp Speed was working closely with the Centers for Disease Control and Prevention “to synchronize the IT systems” involved in monitoring vaccine safety data.

Scientists at the C.D.C. and the Food and Drug Administration have decades of experience tracking the long-term safety of vaccines. They’ve created powerful computer programs that can analyze large databases.

“It’s like satellites looking at the weather,” said Dr. Bruce Gellin, the president of the Sabin Vaccine Institute, who headed the National Vaccine Program Office from 2002 to 2017.

But monitoring hundreds of millions of Americans who may get different coronavirus vaccines from a variety of drug makers by summer is like tracking a major storm beyond anything researchers have dealt with before.

The closest parallel was in the spring of 2009, when a new strain of H1N1 influenza emerged, and researchers raced to make a vaccine. From October 2009 to January 2010, it was administered to over 82 million people in the United States.

As the vaccine was developed, Dr. Gellin and other federal officials and scientists organized a system to monitor the population for severe side effects and to promptly share results with the public. Eleven years later, it looks like the lessons of 2009 are being forgotten, experts say.

“We got all these different agencies together, we created governance around it, we created a

Johnson & Johnson coronavirus vaccine trial will resume soon

The Johnson & Johnson coronavirus vaccine trial, paused due to an unexplained illness in a participant, will resume very soon. An independent committee investigated the case of a man in the trial who suffered a stroke and concluded it was not related to the vaccine, according to two individuals familiar with the trial who spoke on the condition of anonymity.



a sign on the side of a road: Signs direct volunteers for a coronavirus vaccine trial at a trailer compound in National City, California in early October. (REUTERS/Mike Blake)


© Mike Blake/Reuters
Signs direct volunteers for a coronavirus vaccine trial at a trailer compound in National City, California in early October. (REUTERS/Mike Blake)

The study, the only late-stage human test of a coronavirus vaccine that requires just a single shot, was paused by Johnson & Johnson on Oct. 12. It was the second late-stage trial to pause; testing of the vaccine being developed by AstraZeneca and the University of Oxford has been on hold in the United States since early September after a a British participant developed a neurological problem.

Moncef Slaoui, the head of Operation Warp Speed, told Bloomberg that both trials could resume as early as this week, pending clearance from the Food and Drug Administration.

When an adverse event occurs during a clinical trial, the testing is typically stopped so that an independent data safety and monitoring board can thoroughly investigate and determine whether the problem was likely related to the vaccine. Rules around clinical trials and patient privacy restrict specific details of adverse events from being released, but the tremendous scrutiny of the coronavirus vaccine trials has led many experts to call for greater transparency in disclosing and explaining the reasons behind trial pauses.

In the Johnson & Johnson trial, a man who received a vaccination suffered a stroke that may have been triggered by an infection.

To come to the conclusion that the event was not related to the vaccination, the investigation probed not only the medical details of the event, but also examined a safety database of 100,000 people who have received vaccines that use the same underlying technology.

Johnson & Johnson spokesman Jake Sargent declined to comment.

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